ground_truth_classifications.json

{"This Decision shall apply until 13 April 2014.": "constitutive", "Financial institutions within the territories of the Member States or under their jurisdiction shall be prohibited from opening representative offices, subsidiaries or banking accounts in Syria.": "regulatory", "It shall be prohibited to provide, directly or indirectly, financing or financial assistance, including financial derivatives, as well as insurance and reinsurance, related to the prohibitions referred to in paragraph 1.": "constitutive", "Paragraph 1 shall not affect commitments established prior to 1 December 2011.": "constitutive", "Paragraph 1 shall not apply to the provision of:                          (a)                        health or travel insurance to natural persons;                                  (b)                        compulsory or third party insurance to Syrian persons, entities or bodies based in the Union;                                  (c)                        insurance or re-insurance to the owner of a vessel, aircraft or vehicle chartered by a Syrian person, entity or body and which person, entity or body is not listed in Annex I or II.": "constitutive", "The prohibition in paragraphs 1 and 2 shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 1 December 2011.": "constitutive", "The prohibitions set out in points (a) and (c) of Article 14:                          (i)                        shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 23 September 2011;                                  (ii)                        shall not prevent the extension of a participation, if such extension is an obligation under an agreement concluded before 23 September 2011.": "constitutive", "The purchase, import or transport from Syria of crude oil and petroleum products shall be prohibited.": "constitutive", "The purchase, import or transport of arms and related material of all types, including weapons and ammunition, military vehicles and equipment, paramilitary equipment and spare parts for the aforementioned, from Syria or originating in Syria, shall be prohibited.": "constitutive", "The sale, supply, transfer or export of certain equipment, goods and technology which might be used for internal repression or for the manufacture and maintenance of products which could be used for internal repression, to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be prohibited, whether originating or not in their territories.": "regulatory", "This Decision shall enter into force on the date of its publication in the             Official Journal of the European Union            .": "constitutive", "Where, pursuant to paragraphs 3 to 7, a Member State authorises the entry into, or transit through, its territory of persons listed in Annex I, the authorisation shall be limited to the purpose for which it is given and to the person concerned therewith.": "constitutive", "All target benchmarks shall be assessed annually on the basis of the evaluation reports referred to in Article 13(1) and, where appropriate, be revised accordingly in the framework of the evaluation referred to in Article 13(4).": "regulatory", "Information referred to in paragraph 1 shall be communicated for each control and/or inspection and shall continue to be listed and updated in each report until the action is concluded under the laws of the Member State concerned.": "constitutive", "The risk assessment by each Member State shall consider, on the basis of past experience and using all available and relevant information, how likely a non-compliance is to happen and, if it were to happen, the potential consequence(s).": "regulatory", "The risk management strategy referred to in paragraph 1 shall be coordinated at regional level through a joint deployment plan as defined in Article 2(c) of Regulation (EC) No 768/2005.": "constitutive", "The specific control and inspection programme shall apply until 31 December 2018.": "constitutive", "The specific control and inspection programme shall ensure the uniform and effective implementation of conservation and control measures applicable to stocks referred to in Article 1.": "constitutive", "Where appropriate, the risk levels and targets lists referred to in paragraph 1 shall be updated by using information collected during joint inspection and surveillance activities.": "constitutive", "It shall apply from 1 July 2013.": "constitutive", "The financial reference amount intended to cover the expenditure related to the mandate of the EUSR in the period from 1 July 2013 to 30 June 2014 shall be EUR 1\u00a0050\u00a0000.": "constitutive", "Technical formats shall be put in place to facilitate the transmission of information from the Member States to the Commission (Eurostat), in particular for the purpose of supporting quality management and process documentation related to the statistics covered by this Regulation.": "regulatory", "In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.": "constitutive", "Privileges and immunities of the EUSR and his staff        The privileges, immunities and further guarantees necessary for the completion and smooth functioning of the mission of the EUSR and the members of his staff shall be agreed with the host countries, as appropriate.": "regulatory", "The expenditure shall be managed in accordance with the procedures and rules applicable to the general budget of the Union.": "constitutive", "The financial reference amount intended to cover the expenditure related to the mandate of the EUSR in the period from 1 July 2013 to 31 December 2013 shall be EUR 506\u00a0500.": "constitutive", "The management of the expenditure shall be subject to a contract between the EUSR and the Commission.": "constitutive", "Accreditation shall aim at obtaining assurance that all appropriate security measures have been implemented and that a sufficient level of protection of the EUCI and of the CIS has been achieved in accordance with this Decision.": "constitutive", "Effective IA shall ensure appropriate levels of confidentiality, integrity, availability, non-repudiation and authenticity.": "constitutive", "Only approved equipment or devices shall be used for protecting EUCI at the level CONFIDENTIEL UE/EU CONFIDENTIAL or above.": "constitutive", "The accreditation statement shall determine the maximum classification level of the information that may be handled in a CIS as well as the corresponding terms and conditions.": "constitutive", "This Decision shall enter into force on the date of its adoption.": "constitutive", "Implementing Decision 2011/861/EU is amended as follows:                    (1)                  Article 2 is replaced by the following:                \u2018The derogation provided for in Article 1 shall apply to the goods and the quantities set out in the Annex which are declared for release for free circulation in the Union from Kenya during the period from 1 January 2011 until 30 September 2014 or until the date of provisional application of the Economic Partnership Agreement between the East African Community on the one part and the European Union and its Member States on the other part, if this date is the earlier.\u2019;                            (2)                  Article 6 is replaced by the following:                \u2018This Decision shall apply from 1 January 2011 until 30 September 2014.\u2019;                            (3)                  The Annex is replaced by the text set out in the Annex to this Decision.": "constitutive", "This Decision shall enter into force on the day of its adoption.": "constitutive", "Termination of the recognition, as referred to in the first paragraph, shall not affect the validity of marketing authorisations granted on the basis of Regulation (EC) No 507/2006 to medicinal products referred to in point 2 of Article 2 thereof or granted in accordance with the procedure referred to in Article 21 of Regulation (EC) No 1234/2008.": "constitutive", "The EWRS shall enable the Commission and the competent authorities responsible at national level to be in permanent communication for the purposes of alerting, assessing public health risks and determining the measures that may be required to protect public health.": "constitutive", "The EWRS shall include a selective messaging functionality allowing personal data to be communicated only to national competent authorities involved in contact tracing measures.": "constitutive", "The epidemiological surveillance network shall bring into permanent communication the Commission, the ECDC, and the competent authorities responsible at national level for epidemiological surveillance.": "constitutive", "The obligation to provide the information referred to in points (b) and (c) shall only apply if such measures or arrangements are in place or are provided for as part of national preparedness and response planning.": "constitutive", "Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.": "regulatory", "Where the risk assessment is to be made public, the national competent authorities shall receive it prior to its publication.": "regulatory", "They shall apply those provisions from 1 February 2015.": "constitutive", "This Directive shall enter into force on the twentieth day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "This Regulation shall enter into force on the date of its publication in the         Official Journal of the European Union        .": "constitutive", "Any transfer of ownership of the content of the clinical trial master file shall be documented.": "regulatory", "Any alteration to the content of the clinical trial master file shall be traceable.": "regulatory", "This Regulation shall enter into force on the day of its publication in the             Official Journal of the European Union            .": "constitutive", "That additional information shall be provided by means of the secure system for the exchange of information referred to in the second paragraph of Article 15 of this Regulation.": "constitutive", "This Regulation shall enter into force on the seventh day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "This Regulation shall enter into force subject to and as from the date of the entry into force of the Treaty of Accession of Croatia.": "constitutive", "A decision not to suspend the implementation of the transfer decision shall state the reasons on which it is based.": "constitutive", "A reply refusing the request shall state the reasons on which the refusal is based.": "constitutive", "Any delays in the reply shall be duly justified.": "constitutive", "Failure to reply within the two-week period shall be tantamount to accepting the request and shall entail the obligation to take charge or take back the person, including the obligation to provide for proper arrangements for arrival.": "constitutive", "For the purposes of this Regulation, the situation of a minor who is accompanying the applicant and meets the definition of family member shall be indissociable from that of his or her family member and shall be a matter for the Member State responsible for examining the application for international protection of that family member, even if the minor is not individually an applicant, provided that it is in the minor\u2019s best interests.": "regulatory", "In view of the application of the criteria referred to in Articles 8, 10 and 16, Member States shall take into consideration any available evidence regarding the presence, on the territory of a Member State, of family members, relatives or any other family relations of the applicant, on condition that such evidence is produced before another Member State accepts the request to take charge or take back the person concerned, pursuant to Articles 22 and 25 respectively, and that the previous applications for international protection of the applicant have not yet been the subject of a first decision regarding the substance.": "regulatory", "It shall apply to applications for international protection lodged as from the first day of the sixth month following its entry into force and, from that date, it will apply to any request to take charge of or take back applicants, irrespective of the date on which the application was made.": "constitutive", "Procedures for access to legal assistance shall be laid down in national law.": "regulatory", "Such reply shall be given within two weeks of receipt of the request.": "constitutive", "That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.": "regulatory", "That period shall be extended by two months at the initiative of the European Parliament or of the Council.": "constitutive", "The authorities referred to in paragraph 1 shall receive the necessary training with respect to the application of this Regulation.": "regulatory", "The criteria for determining the Member State responsible shall be applied in the order in which they are set out in this Chapter.": "constitutive", "The information exchanged shall only be used for the purposes set out in paragraph 1 of this Article and shall not be further processed.": "constitutive", "The lack of consent, including a refusal to consent, shall not constitute an obstacle to the transfer.": "constitutive", "The personal interview shall take place in a timely manner and, in any event, before any decision is taken to transfer the applicant to the Member State responsible pursuant to Article 26(1).": "regulatory", "The power to adopt delegated acts referred to in Articles 8(5) and 16(3) shall be conferred on the Commission for a period of 5 years from the date of entry into force of this Regulation.": "constitutive", "The request for the person referred to in Article 18(1)(b), (c) or (d) to be taken back shall be made using a standard form and shall include proof or circumstantial evidence as described in the two lists mentioned in Article 22(3) and/or relevant elements from the person\u2019s statements, enabling the authorities of the requested Member State to check whether it is responsible on the basis of the criteria laid down in this Regulation.": "constitutive", "The same treatment shall be applied to children born after the applicant arrives on the territory of the Member States, without the need to initiate a new procedure for taking charge of them.": "constitutive", "This common leaflet shall also include information regarding the application of Regulation (EU) No 603/2013 and, in particular, the purpose for which the data of an applicant may be processed within Eurodac.": "constitutive", "Where a Member State issues a residence document to the applicant, the obligations specified in Article 18(1) shall be transferred to that Member State.": "regulatory", "Where a person is detained pursuant to this Article, the period for submitting a take charge or take back request shall not exceed one month from the lodging of the application.": "constitutive", "Where an organisation is appointed as a representative, it shall designate a person responsible for carrying out its duties in respect of the minor, in accordance with this Regulation;                            (l)                  \u2018residence document\u2019 means any authorisation issued by the authorities of a Member State authorising a third-country national or a stateless person to stay on its territory, including the documents substantiating the authorisation to remain on the territory under temporary protection arrangements or until the circumstances preventing a removal order from being carried out no longer apply, with the exception of visas and residence authorisations issued during the period required to determine the Member State responsible as established in this Regulation or during the examination of an application for international protection or an application for a residence permit;                            (m)                  \u2018visa\u2019 means the authorisation or decision of a Member State required for transit or entry for an intended stay in that Member State or in several Member States.": "constitutive", "Where applicable, it shall inform, using the \u2018DubliNet\u2019 electronic communication network set up under Article 18 of Regulation (EC) No 1560/2003, the Member State previously responsible, the Member State conducting a procedure for determining the Member State responsible or the Member State which has been requested to take charge of, or to take back, the applicant.": "regulatory", "Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.": "constitutive", "Where the applicant is in possession only of one or more residence documents which have expired less than two years previously or one or more visas which have expired less than six months previously and which enabled him or her actually to enter the territory of a Member State, paragraphs 1, 2 and 3 shall apply for such time as the applicant has not left the territories of the Member States.": "regulatory", "Furthermore, the review shall specifically consider different life-cycle phases, the feasibility of establishing and applying the Ecodesign requirements on other significant environmental aspects such as noise, material use efficiency, including requirements on durability, dismantlability, recyclability, standardised interfaces for rechargers, as well as information requirements on the content of certain Critical Raw Materials and minimum number of loading cycles and battery replacement issues.": "constitutive", "Points 1.2 and 1.4 of Annex II shall apply as from 1 January 2016.": "constitutive", "Points 3 and 6.1 of Annex II shall apply as from the entry into force of the Regulation.": "constitutive", "The main unit of a desktop thin client must be intended for use in a permanent location (e.g. on a desk) and not for portability.": "constitutive", "This Regulation shall enter into force on the twentieth day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "Identification        The Faeroe Islands shall be identified as a country allowing non-sustainable fishing of the Atlanto-Scandian herring stock.": "regulatory", "It shall apply from 1 October 2013.": "constitutive", "However, it shall not be less than the minimum subsistence figure, i.e. the basic salary of a member of temporary staff of the Union at the first step of Grade\u00a01.": "regulatory", "The Final Act attached to this Decision shall be approved on behalf of the Union.": "constitutive", "Article\u00a03        This Decision shall be published in the         Official Journal of the European Union        .": "constitutive", "The work of the Performance Review Body to carry out the tasks referred to in Article 3(3), (4), (5) and (6)(a) of Implementing Regulation (EU) No 390/2013, including the costs of the chair and members of the Performance Review Body as well as the relevant staff costs of Eurocontrol's performance review unit, shall be financed from the budget of the Union.": "constitutive", "This Decision shall enter into force on 1 December 2014.": "constitutive", "The references of the following standards shall be published in the part C of the         Official Journal of the European Union        :                    (a)                  EN 15649-2:2009+A2:2013 \u2018Floating leisure articles for use on and in the water \u2014 Part 2: Consumer information\u2019;                            (b)                  EN 957-6:2010+A1:2014 for \u2018Stationary training equipment \u2014 Part 6: Treadmills, additional specific safety requirements and test methods\u2019.": "constitutive", "The obligations to transpose and implement this Directive shall not apply to the Republic of Cyprus and the Republic of Malta for as long as no railway system is established on their territories.": "constitutive", "A candidate pre-basic mother plant shall be free from the pests listed in Annex II, as regards the genus or species concerned.": "constitutive", "A pre-basic mother plant produced by renewal shall be free from the viruses and viroids listed in Annex II, as regards the genus or species concerned.": "constitutive", "Basic mother plants and basic material shall be maintained in fields isolated from potential sources of infection by aerial vectors, root contact, cross infection by machinery, grafting tools and any other possible sources.": "constitutive", "By way of derogation from paragraph 2, where a candidate pre-basic mother plant is a seedling, visual inspection, sampling and testing shall only be required in respect of viruses, viroids or virus-like diseases transmitted by pollen and listed in Annex II, as regards the genus or species concerned, provided that an official inspection has confirmed that the seedling concerned was grown from a seed produced by a plant free from symptoms caused by those viruses, viroids and virus-like diseasesand that that seedling has been maintained in accordance with Article 8(1) and (3).": "constitutive", "However, pending the registration of the variety, the mother plant concerned and the material produced from it may only be used for the production of basic or certified material and shall not be marketed as pre-basic, basic or certified material.": "constitutive", "Pre-basic mother plants and pre-basic material shall be maintained in a manner that ensures that they are individually identified throughout the production process.": "constitutive", "That acceptance shall take place on the basis of an official inspection and the testing results, records and procedures used by the supplier pursuant to Article 30.": "constitutive", "That observation shall be based on one of the following elements:                    (a)                  the official description for registered varieties, as referred to in Implementing Directive 2014/97/EU and for varieties legally protected by a plant variety right; or                            (b)                  the description accompanying the application for varieties which are the subject of an application for registration in any Member State, as referred to in Implementing Directive 2014/97/EU;                            (c)                  the description accompanying the application for a plant variety right;                            (d)                  the officially recognised description of a variety as referred to in Article 7(2)(c)(iii) of Directive 2008/90/EC.": "constitutive", "That period of time shall be considered appropriate when it allows phenotype validation of the plants as regards the trueness to the description of the variety based on the observation of the fruit production or of the vegetative development of rootstocks.": "constitutive", "The percentage of certified mother plants or certified material, which is infested by the pests listed in Part B of Annex I, shall not exceed the tolerance levels as set out therein.": "constitutive", "The propagating material and fruit plants shall be propagated from a certified mother plant which fulfils the soil requirements of Article 22.": "constitutive", "The propagating material, and fruit plants, shall fulfil the requirements set out in Article 7, Article 8(6) and Articles\u00a012, 21 and 22.": "constitutive", "The testing method for viruses, viroids, virus-like diseases and phytoplasmas applied to candidate pre-basic mother plants shall be biological indexing on indicator plants.": "constitutive", "The trueness of CAC material to the description of its variety shall be established by the observation of the expression of the characteristics of the variety.": "regulatory", "Where point (b) or point (c) of paragraph 2 applies, the pre-basic mother plant shall only be accepted if a report, produced by any responsible official body in the Union or in a third country, is available proving that the respective variety is distinct, uniform and stable.": "constitutive", "MIPs shall set out the Union's strategic and/or mutual interests and priorities, the specific objectives and expected results.": "constitutive", "That committee shall be a committee within the meaning of Regulation (EU) No\u00a0182/2011.": "regulatory", "The Partnership Instrument shall support measures that respond in an effective and flexible manner to objectives arising from the Union's bilateral, regional or multilateral relationships with third countries and shall address challenges of global concern and ensure an adequate follow-up to decisions taken at a multilateral level.": "constitutive", "The attainment of that objective shall be measured, inter alia, by the progress made by key partner countries in the fight against climate change or in promoting the environmental standards of the Union;                            (b)                  implementing the international dimension of \u2018Europe\u00a02020\u2019.": "constitutive", "Should the conditions for reduction of import ceilings provided for in Articles 13 and 14 be both met simultaneously, only the higher reduction (R           i          or r           i          ) shall be applied.": "constitutive", "The persons and entities listed in the Annex to this Regulation shall be added to the list set out in Annex I to Regulation (EU) No 269/2014.": "constitutive", "This Regulation shall enter into force on the date of its publication in the         Official Journal of the European\u00a0Union        .": "constitutive", "Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the clinical trial.": "constitutive", "Any item of the agenda of the meeting shall be placed at the request of the Commission or a Member State.": "constitutive", "CHAPTER IX          MANUFACTURING AND IMPORT OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS          Scope of this Chapter        This Chapter shall apply to the manufacture and import of investigational medicinal products and auxiliary medicinal products.": "constitutive", "For clinical trials involving more than one Member State the assessment process of substantial modification shall include three phases:                    (a)                  an initial assessment phase performed by the reporting Member State within 19 days from the validation date;                            (b)                  a coordinated review phase performed within 12 days from the end of the initial assessment phase involving all Member States concerned; and                            (c)                  a consolidation phase performed by the reporting Member State within seven days from the end of coordinated review phase.": "constitutive", "For clinical trials that fulfil the conditions set out in paragraph 3, informed consent shall be deemed to have been obtained if:                    (a)                  the information required under points (a), (b), (d) and (e) of Article 29(2) is given, in accordance with what is laid down in the protocol, prior to the inclusion of the subject in the clinical trial, and this information makes clear, in particular, that the subject can refuse to participate in, or withdraw at any time from, the clinical trial without any resulting detriment; and                            (b)                  the potential subject, after being informed, does not object to participating in the clinical trial.": "constitutive", "For the purposes of this Article and Articles 19 and 23, the reporting date shall be the date on which the final assessment report is submitted to the sponsor and to the other Member States concerned.": "constitutive", "For the purposes of this Regulation, the temporary halt or early termination of a clinical trial for reasons of a change of the benefit-risk balance shall be notified to the Member States concerned through the EU portal.": "constitutive", "For this purpose, provision of the investigational medicinal product or information to a future potential marketing authorisation holder on safety matters shall not be considered a joint development; and                                    (c)                  all suspected unexpected serious adverse reactions to investigational medicinal products occurring in any of the subjects of the clinical trial, which are identified by or come to the attention of the sponsor after the end of the clinical trial.": "constitutive", "It shall apply as from six months after the publication of the notice referred to in Article 82(3), but in any event no earlier than 28 May 2016.": "constitutive", "Member States may choose not to apply paragraph 1 as regards clinical trials to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical trial who shall be the addressee for all communications with the sponsor provided for in this Regulation.": "regulatory", "Notification shall be done by way of a single decision within 38 days from the validation date.": "constitutive", "Notification shall be done by way of one single decision within five days from the reporting date or from the last day of the assessment referred to in Article 7, whichever is later.": "constitutive", "Paragraph 1 shall not apply where no authorised auxiliary medicinal product is available in the Union or where the sponsor cannot reasonably be expected to use an authorised auxiliary medicinal product.": "regulatory", "References to Directive 2001/20/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex VII.": "constitutive", "Reporting with regard to auxiliary medicinal products        Safety reporting with regard to auxiliary medicinal products shall be made in accordance with Chapter 3 of Title IX of Directive 2001/83/EC.": "constitutive", "That notification shall be made within 15 days from the end of the clinical trial in the last Member State concerned.": "constitutive", "That notification shall be made within 15 days from the start of the clinical trial in relation to that Member State.": "constitutive", "That notification shall be made within 15 days from the temporary halt of the clinical trial in all Member States concerned and shall include the reasons for such action.": "constitutive", "That period shall be extended by two months at the initiative of the European Parliament or the Council.": "constitutive", "The EU portal shall be technically advanced and user-friendly so as to avoid unnecessary work.": "constitutive", "The application dossier for the authorisation of a clinical trial shall contain all required documentation and information necessary for the validation and assessment referred to in Chapter II and relating to:                    (a)                  the conduct of the clinical trial, including the scientific context and arrangements taken,                            (b)                  the sponsor, investigators, potential subjects, subjects, and clinical trial sites;                            (c)                  the investigational medicinal products and, where necessary, the auxiliary medicinal products, in particular their properties, labelling, manufacturing and control;                            (d)                  measures to protect subjects;                            (e)                  justification as to why the clinical trial is a low-intervention clinical trial, in cases where this is claimed by the sponsor.": "constitutive", "The assessment of the aspects referred to in paragraph 1 shall constitute Part I of the assessment report.": "constitutive", "The clinical trial master file shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated, taking into account all characteristics of the clinical trial, including in particular whether the clinical trial is a low-intervention clinical trial.": "constitutive", "The coordinated review shall be performed within a maximum of 12 days from receipt of the additional information and the further consolidation shall be performed within a maximum of seven days from the end of the coordinated review.": "constitutive", "The data submitted, in accordance with the first subparagraph, describing medicinal products and substances shall comply with Union and international standards for the identification of medicinal products and active substances.": "constitutive", "The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.": "constitutive", "The informed consent shall be documented.": "constitutive", "The period for the reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency shall take account of the seriousness of the reaction and shall be as follows:                    (a)                  in the case of fatal or life-threatening suspected unexpected serious adverse reactions, as soon as possible and in any event not later than seven days after the sponsor became aware of the reaction;                            (b)                  in the case of non-fatal or non-life-threatening suspected unexpected serious adverse reactions, not later than 15\u00a0days after the sponsor became aware of the reaction;                            (c)                  in the case of a suspected unexpected serious adverse reaction which was initially considered to be non-fatal or non-life threatening but which turns out to be fatal or life-threatening, as soon as possible and in any event not later than seven days after the sponsor became aware of the reaction being fatal or life-threatening.": "regulatory", "The products referred to in the first paragraph shall be labelled appropriately in order to ensure the safety of the subject and the reliability and robustness of data generated in the clinical trial.": "constitutive", "The relevant information regarding the traceability, storage, return and destruction of medicinal products referred to in paragraph 1 shall be contained in the application dossier.": "regulatory", "The subject shall be informed that the summary of the results of the clinical trial and a summary presented in terms understandable to a layperson will be made available in the EU database, referred to in Article 81 (the \u2018EU database\u2019), pursuant to Article 37(4), irrespective of the outcome of the clinical trial, and, to the extent possible, when the summaries become available.": "regulatory", "This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a clinical trial.": "constitutive", "Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).": "constitutive", "Where the Member State concerned has not notified the sponsor of its decision within the period referred to in paragraph 1, the conclusion of the assessment report shall be deemed to be the decision of the Member State concerned on the application for authorisation of the substantial modification.": "constitutive", "Where the Member State concerned has not notified the sponsor of its decision within the periods set out in paragraphs 5 and 6, the substantial modification shall be deemed to be authorised in that Member State.": "constitutive", "Where the Member State concerned has not notified the sponsor within the period referred to in paragraph 1, the substantial modification applied for shall be deemed to concern an aspect covered by Part II of the assessment report and the application dossier shall be deemed to be complete.": "constitutive", "Where the conclusion of the reporting Member State as regards Part I of the assessment report is that the conduct of the clinical trial is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of the additional Member State concerned.": "constitutive", "Where the reporting Member State has not notified the sponsor within the period referred to in the second subparagraph, the substantial modification applied for shall be deemed to concern an aspect covered by Part I of the assessment report and the application dossier shall be deemed to be complete.": "constitutive", "Where the sponsor does not provide additional information within the period determined by the reporting Member State in accordance with the third subparagraph, the application shall be deemed to have lapsed in all Member States concerned.": "constitutive", "Where the sponsor does not provide additional information within the period set by the reporting Member State in accordance with the third subparagraph, the application shall be deemed to have lapsed in all Member States concerned.": "constitutive", "Where the sponsor does not provide the requested additional information within the period set by the Member State concerned in accordance with the second subparagraph, the application shall be deemed to have lapsed in that Member State.": "regulatory", "Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 3 and 5.": "constitutive", "Where the subjects are incapacitated subjects, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant disease and the patient population concerned or after taking advice on clinical, ethical and psychosocial questions in the field of the relevant disease and the patient population concerned.": "regulatory", "Where the subjects are pregnant or breastfeeding women, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant condition and the population represented by the subject concerned.": "regulatory", "Entry into force        This Regulation shall enter into force on the twentieth day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "For the purpose of valuing the contributions referred to in point (b) of paragraph 2 of this Article and Article 13(3)(b) of the Statutes, the costs shall be determined in accordance with the usual cost accounting practices of the entities concerned, to the applicable accounting standards of the country where the entity is established, and to the applicable International Accounting Standards and International Financial Reporting Standards.": "constitutive", "Rules for participation and dissemination        Regulation (EU) No\u00a01290/2013 shall apply to the actions funded by the FCH 2 Joint Undertaking.": "regulatory", "The FCH 2 Joint Undertaking shall replace and succeed the FCH Joint Undertaking as established by Regulation (EC) No\u00a0521/2008.": "regulatory", "The number of seconded national experts expressed in full-time equivalents shall be added to the information on staff as referred to in Article 6(4) in line with the annual budget.": "constitutive", "The other conditions of the contract shall remain unchanged.": "constitutive", "Applications for approval of a minor amendment concerning protected designations of origin or protected geographical indications shall be accompanied by the updated single document, if amended, which shall be drawn up in accordance with the form set out in Annex I.": "constitutive", "For the purposes of Article 51(2) of Regulation (EU) No 1151/2012 a reasoned statement of opposition shall be drawn up in accordance with the form set out in Annex III to this Regulation.": "constitutive", "It shall be drawn up in accordance with the form provided for in that Annex.": "constitutive", "It shall not repeat general obligations and, in particular, technical characteristics inherent to all products of that type and related mandatory legal requirements.": "constitutive", "Only the method necessary for obtaining the specific product shall be described and in a way that enables reproduction of the product anywhere.": "constitutive", "The amended product specification shall be drawn up in accordance with the form set out in Annex II to this Regulation.": "constitutive", "The amended single document shall be drawn up in accordance with the form set out in Annex I to this Regulation.": "constitutive", "The date of submission of an amendment application shall be the date on which the application is delivered to the Commission by electronic means.": "constitutive", "The name of a protected designation of origin, a protected geographical indication or a traditional speciality guaranteed shall be registered in its original script.": "constitutive", "This Regulation shall enter into force on the day of its publication in the         Official Journal of the European Union        .": "constitutive", "Amendment to Regulation (EC) No 1415/2004        In Annex I to Regulation (EC) No 1415/2004, the column regarding maximum annual fishing effort for demersal species for the United Kingdom in Table A \u2018Demersal species excluding those covered by Regulation (EC) No\u00a02347/2002\u2019, is replaced by the following:                      Total                    \u201850\u00a0021\u00a0901                    ICES V, VI                  24\u00a0017\u00a0229                    ICES VII                  25\u00a0756\u00a0266                    ICES VIII                  248\u00a0406                    ICES IX                  0                    ICES X                  0                    CECAF 34.1.1                  0                    CECAF 34.1.2                  0                    CECAF 34.2.0                  0\u2019                Entry into force        This Regulation shall enter into force on the day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "Expenditure shall only be eligible for Union part-financing if it has been paid by Italy to the beneficiary by 30 September 2015.": "constitutive", "The maximum level of Union part-financing shall be as follows:                    (a)                  for the destruction of hatching eggs falling within CN code 0407\u00a011\u00a000, it shall be a flat rate of EUR 0,13824 per hatching egg of laying hens for a maximum of 38\u00a0016 pieces;                            (b)                  for the processing of hatching eggs falling within CN code 0407\u00a011\u00a000, it shall be a flat rate of EUR 0,1106 per hatching egg for a maximum of 4\u00a0687\u00a0600 pieces of hatching eggs of layers and for a maximum of 28\u00a0450 pieces of hatching eggs of broilers;                            (c)                  for the processing of eggs in shell for human consumption falling within CN code 0407\u00a011\u00a000, it shall be a flat rate of EUR 0,0136 per egg for a maximum of 1\u00a0703\u00a0520 pieces;                            (d)                  for the reduction of incubation of hatching eggs of layers, it shall be a flat rate of EUR 0,01672 per hatching egg of CN code 0407\u00a011\u00a000 for a maximum of 549\u00a0720 pieces;                            (e)                  for the culling and disposal of chicks falling within CN code 0105, it shall be a flat rate of:                            (i)                          EUR 0,140959 per chick of broilers for a maximum of 171\u00a0920 heads;                                    (ii)                          EUR 0,162354 per chick of roosters for a maximum of 436\u00a0247 heads;                                    (iii)                          EUR 0,248 per chick of layers for a maximum of 62\u00a0800 heads;                                    (iv)                          EUR 0,780307 per chick of turkeys for a maximum of 40\u00a0500 heads;                                    (f)                  for the early slaughter of flocks of broiler, broiler breeding flocks, turkey parent flocks and broiler grandparent flocks, it shall be a flat rate of:                            (i)                          EUR 0,86 per broiler for a maximum of 19\u00a0200 heads;                                    (ii)                          EUR 2,94912 per breeding broiler for a maximum of 14\u00a0500 heads;                                    (iii)                          EUR 2,94912 per broiler grandparent for a maximum of 4\u00a0485 heads;                                    (iv)                          EUR 13,824 per turkey parent for a maximum of 19\u00a0004 heads;                                    (g)                  for the temporary biosecurity fall in production, it shall be a flat rate of:                            (i)                          EUR 0,423936 per m                         2                        per week for broilers for a maximum of 286\u00a0597 m                         2                        for a maximum amount of EUR 521\u00a0040,69                                    (ii)                          EUR 0,3779 per m                         2                        per week for turkeys for a maximum of 271\u00a0759 m                         2                        for a maximum amount of EUR 603\u00a0604,35;                                    (iii)                          EUR 0,12 per m                         2                        per week for barn pullets for a maximum of 438\u00a0930 m                         2                        for a maximum amount of EUR 310\u00a0937,64;                                    (iv)                          EUR 0,096 per m                         2                        per week for cage pullets for a maximum of 370\u00a0000 m                         2                        for a maximum amount of EUR 355\u00a0200;                                    (v)                          EUR 0,3779 per m                         2                        per week for guinea fowls for a maximum of 2\u00a0440 m                         2                        for a maximum amount of EUR 5\u00a0161,20;                                    (vi)                          EUR 0,5714 per m                         2                        per week for ducks for a maximum of 570 m                         2                        for a maximum amount of EUR 2\u00a0605,55;                                    (vii)                          EUR 0,3041 per m                         2                        per week for rural layers for a maximum of 7\u00a0000 m                         2                        for a maximum amount of EUR 17\u00a0031,17;                                    (viii)                          EUR 0,04 per barn layer chick per week for a maximum of 326\u00a0450 chicks for a maximum amount of EUR 81\u00a0743,18;                                    (ix)                          EUR 0,032 per cage layer chick per week for a maximum of 100\u00a0000 chicks for a maximum amount of EUR 14\u00a0176;                                    (x)                          EUR 0,092 per cage layer per week for a maximum of 649\u00a0440 heads for a maximum amount of EUR 2\u00a0415\u00a0631,05;                                    (xi)                          EUR 0,116 per barn layer per week for a maximum of 1\u00a0067\u00a0300 heads for a maximum amount of EUR 3\u00a0219\u00a0212,86                                    (xii)                          EUR 0,124 per free range layer per week for a maximum of 59\u00a0160 heads for a maximum amount of EUR 13\u00a0644,66;                                    (xiii)                          EUR 0,144 per organic layer per week for a maximum of 124\u00a0500 heads for a maximum amount of EUR 167\u00a0924,16.": "constitutive", "It shall apply from 1 December 2014.": "constitutive", "Fees for arranging and carrying out the technical examination of a variety being the subject of an application for a Community plant variety right (examination fee) shall be paid in accordance with Annex I for each growing period started.": "constitutive", "It shall apply from 1 January 2015 and expire on 31 December 2015.": "constitutive", "This Regulation shall enter into force on the day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "Conditions for entitlement to the tariff treatment        Entitlement to benefit from the tariff treatment set out in Article 2 shall be subject to:                    (a)                  Ecuador complying with the rules of origin referred to in Article 1(c) and the procedures related thereto, including, as appropriate, the effective administrative cooperation provisions applicable on 12 December 2014;                            (b)                  Ecuador abstaining from introducing new duties or charges having equivalent effect and new quantitative restrictions or measures having equivalent effect for imports from the Union, or from increasing existing levels of duties or charges or from introducing any other restrictions from 12 December 2014;                            (c)                  maintaining the ratification and ensuring effective implementation on the part of Ecuador of the covenants, conventions and protocols listed in the Annex, and accepting without reservation the reporting requirements, regular monitoring and review of Ecuador\u2019s implementation record in accordance with the provisions of the covenants, conventions and protocols it has ratified;                            (d)                  Ecuador cooperating with the Commission and providing all information necessary to assess Ecuador\u2019s compliance with the requirements in point (c);                            (e)                  Ecuador conducting continuous efforts to sign and ratify the Protocol of Accession.": "constitutive", "Policy objectives        The mandate of the EUSR shall be based on the policy objectives of the Union regarding human rights as set out in the Treaty on European Union, the Charter of Fundamental Rights of the European Union as well as the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy:                    (a)                  enhancing the Union's effectiveness, presence and visibility in protecting and promoting human rights in the world, notably by deepening Union cooperation and political dialogue with third countries, relevant partners, business, civil society and international and regional organisations; and through action in relevant international forums;                            (b)                  enhancing the Union's contribution to strengthening democracy and institution building, the rule of law, good governance, respect for human rights and fundamental freedoms worldwide;                            (c)                  improving the coherence of Union action on human rights and the integration of human rights in all areas of the Union's external action.": "constitutive", "Article\u00a014        Review        The implementation of this Decision and its consistency with other contributions from the Union to the region shall be kept under regular review.": "constitutive", "If, following an internal investigation, no case can be made against a staff member about whom allegations have been made, the investigation in question shall be closed, with no further action taken, by decision of the AACC, who shall inform the staff member in writing.": "regulatory", "The position to be adopted on the Union's behalf on the Rules of Procedure of the Conference of States Parties to the ATT at the Conference's first session to be held on\u00a024-27\u00a0August\u00a02015 shall be in accordance with this Decision, including its Annex, and be expressed by the Member\u00a0States acting jointly in the interests of the Union.": "regulatory", "Article 4a of Implementing Decision 2013/426/EU is replaced by the following:          \u2018This decision shall apply until 31 December 2019.\u2019          This Decision is addressed to the Member States.": "constitutive", "All elements in black shall be C0, M0, Y0 and\u00a0K100 and those in warm yellow shall be C0, M10, Y100 and K0.": "constitutive", "By way of derogation from the first subparagraph of Article 2(2), the following rules shall apply to combined health warnings to be placed on the front of unit packets having a flip-top lid:                    (a)                  where the lid is smaller than the surface area foreseen for the photograph in Article 2(2) and compliance with that provision would result in the photograph being split upon opening:                            (i)                          the text warning shall be placed at the top of the combined health warning, with the cessation information and photograph underneath as illustrated in section 4 of the Annex; and                                    (ii)                          the photograph shall occupy at least 50 % of the surface area of the combined health warning, the text warning at least 30 % and the cessation information at least 10 % but no more than 12 % of the surface area of the combined health warning inside the outer black border;                                    (b)                  where the lid is larger than the surface area foreseen for the photograph in Article 2(2) and compliance with that provision would result in the text warning or cessation information being split upon opening:                            (i)                          the photograph shall be placed at the top of the combined health warning, with the text warning and cessation information underneath as illustrated in section 1 of the Annex; and                                    (ii)                          the photograph shall occupy at least 50 % of the surface area of the combined health warning, the text warning at least 30 % and the cessation information at least 10 % but no more than 12 % of the surface area of the combined health warning inside the outer black border.": "regulatory", "The photograph shall occupy 35 %, the text warning 50 % and the cessation information 15 % of the surface area of the combined health warning inside the outer black border.": "constitutive", "The text warning shall be printed in white on a black background.": "constitutive", "Where the height of the combined health warning is greater than 20 % but less than 65 % of its width, manufacturers shall lay out the combined health warnings in a side-by-side format as illustrated in section 2 of the Annex.": "constitutive", "Where the height of the combined health warning is greater than 70 % of its width, manufacturers shall lay out the combined health warnings in a stacked format as illustrated in section 1 of the Annex.": "constitutive", "Where the side-by-side format is used, the photograph shall be placed on the left half of the combined health warning, with the text warning at the top right and the cessation information at the bottom right of the warning as illustrated in section 2 of the Annex.": "regulatory", "If no confirmation is given or the procedure is not closed by the liaison body, the AAC system shall close the procedure automatically.": "constitutive", "In relation to each instance, the information exchanged through the AAC system shall at least include:                    (a)                  contact details of the competent authorities and officials dealing with the instance;                            (b)                  a description of the possible non-compliance;                            (c)                  the identification, where possible, of the business operators associated with it;                            (d)                  details of animals or goods associated with a possible instance of non-compliance with food or feed law;                            (e)                  an indication of whether the information is exchanged for the purpose of:                            (i)                          formulating a request for assistance or replying to one; or                                    (ii)                          introducing a notification of non-compliance or responding to one;                                    (f)                  an indication of the liaison body to which the request for assistance or notification of non-compliance is addressed;                            (g)                  an indication of whether the request for assistance or the notification of non-compliance relates to a possible instance of a non-compliance perpetrated through deceptive fraudulent practices and whether access to it is to be limited to the liaison bodies referred to in Article 4.": "constitutive", "In relation to the responsibility to manage the AAC system, for the processing of any personal data that might result from Article 5 of this Decision, the Commission shall be regarded as controller as defined in Article 2(d) of Regulation (EC) No 45/2001.": "regulatory", "Those applications shall be evaluated in accordance with the criteria on which they are based.": "constitutive", "Where those studies are linked to specific brands, the explicit and implicit references to the brand shall be removed and the redacted version shall be accessible.": "constitutive", "This Decision shall enter into force on 18\u00a0December\u00a02015.": "constitutive", "For tissues and cells which remain in storage and which are only released for circulation after the expiry of this five-year period and for which the application of the Single European Code is not possible, in particular because the tissues and cells are stored under deep-freeze conditions, the tissue establishments shall use the procedures applicable to products with small labels as laid down in Article 10b paragraph 1(f).": "constitutive", "The Single European Code referred to in Article 10(1) shall comply with the specifications set out in this Article and in Annex VII.": "constitutive", "The Single European Code shall be printed with the Donation Identification Sequence and Product Identification Sequence separated by a single space or as two successive lines.": "constitutive", "Tissues and cells used for advanced therapy medicinal products shall be traceable under this Directive at least until transferred to the ATMP manufacturer.": "constitutive", "Without prejudice to paragraphs 2 or 3 of this Article, a Single European Code shall be applied to all tissues and cells distributed for human application.": "constitutive", "That review shall involve scientific expertise and shall be based on operational data gathered, with the assistance of Member States, on a long-term basis after the date of application of this Regulation.": "constitutive", "It shall apply from 1 April 2015.": "constitutive", "For each environmental action referred to in points (b) and (c) of the third subparagraph, the national framework shall indicate:                    (a)                  the justification of the action, on the basis of its environmental impact; and                            (b)                  the specific commitment(s) entailed.": "regulatory", "The aid shall be paid and the security lodged in accordance with Article 11(2) shall be released only on condition that proof of implementation of the programmed expenditure referred to in point (b) of the first subparagraph of this paragraph is provided by 30 April of the year following that for which the expenditure in question was programmed, and on the basis that the entitlement to the aid is established.": "regulatory", "Completion of box 2 and 10 of the certificate of origin Form A shall be optional.": "constitutive", "Compliance with paragraphs 1 to 4 shall be considered as satisfied unless the customs authorities have reason to believe the contrary; in such cases, the customs authorities may request the declarant to provide evidence of compliance, which may be given by any means, including contractual transport documents such as bills of lading or factual or concrete evidence based on marking or numbering of packages or any evidence related to the goods themselves.\u2019                            (8)                  In Article 84, the following is added as a second subparagraph:                \u2018Subsections 2 and 7 shall apply                 mutatis mutandis                to exports from the Union to a beneficiary country for the purposes of bilateral cumulation.\u2019                            (9)                  Article 86 is amended as follows:                            (a)                          paragraph 2(a) is replaced by the following:                                    \u2018(a)                                  the countries involved in the cumulation are, at the time of exportation of the product to the Union, beneficiary countries for which the preferential arrangements have not been temporarily withdrawn in accordance with Regulation (EU) No 978/2012;\u2019                                            (b)                          in paragraph 4 the third subparagraph is replaced by the following:                        \u2018The following country shall be stated as country of origin on the proof of origin made out by the exporter of the product to the Union, or, until the application of the registered exporter system, issued by the authorities of the beneficiary country of exportation:                                    \u2014                                  in the case of products exported without further working or processing, the beneficiary country appearing on the proofs of origin referred to in Article 95a(1) or in the third indent of Article 97m(5),                                            \u2014                                  in the case of products exported after further working or processing, the country of origin as determined pursuant to the second subparagraph.\u2019                                            (c)                          the following paragraph 10 is added:                        \u201810.": "constitutive", "Each competent authority in a beneficiary country referred to in Article 69(1)(a) and each customs authority in a Member State referred to in Article 69(2)(a) that has introduced data into the REX system shall be considered the controller with respect to the processing of those data.": "regulatory", "However, re-consignors who are not registered shall be permitted to make out replacement statements on origin where the total value of originating products of the initial consignment to be split exceeds EUR 6\u00a0000 if they attach a copy of the initial statement on origin made out in the beneficiary country.": "regulatory", "Revocation of registrations shall only take effect for the future, i.e. in respect of statements on origin made out after the date of revocation.": "constitutive", "Such a retrospective statement shall be admissible if presented to the customs authorities in the Member State of lodging of the customs declaration for release for free circulation at the latest two years after the importation.": "constitutive", "The Commission shall have the right to rectify, erase or block the data.": "regulatory", "The date of issue of the certificate of origin Form A shall be indicated in box 11.": "constitutive", "The initial statement on origin shall be marked with the word \u201cReplaced\u201d, \u201cRemplac\u00e9e\u201d or \u201cSustituida\u201d.": "constitutive", "The obligations provided for in paragraph 1 shall also apply to suppliers who provide exporters with suppliers' declarations certifying the originating status of the goods they supply.": "constitutive", "The registration shall be valid as of the date on which the competent authorities of a beneficiary country or the customs authorities of a Member State receive a complete application for registration, in accordance with paragraph 4.": "constitutive", "The replacement statement on origin shall be marked \u201cReplacement statement\u201d, \u201cAttestation de remplacement\u201d or \u201cComunicaci\u00f3n de sustituci\u00f3n\u201d.": "constitutive", "The scheme shall apply in the following cases:                            (a)                          in cases of goods satisfying the requirements of this section exported by a registered exporter;                                    (b)                          in cases of any consignment of one or more packages containing originating products exported by any exporter, where the total value of the originating products consigned does not exceed EUR 6\u00a0000.": "constitutive", "The signature to be entered in that box, which is reserved for the competent governmental authorities issuing the certificate, as well as the signature of the exporter's authorised signatory to be entered in box 12, shall be handwritten.\u2019                                    (24)                  In Article 97p, paragraph 6 is replaced by the following:                \u20186.": "constitutive", "Without prejudice to Article 97k(5), certificates of origin Form A issued in accordance with the first subparagraph of this paragraph shall be admissible in the Union as proof of origin if they are issued before the date of registration of the exporter concerned.": "constitutive", "This Regulation shall enter into force on 8 April 2015.": "constitutive", "The number of voting rights referred to in Article 13(1a)(b) of Directive 2004/109/EC relating to financial instruments which provide exclusively for a cash settlement, with a linear, symmetric pay-off profile with the underlying share shall be calculated on a delta-adjusted basis with cash position being equal to 1.": "constitutive", "Article 3        (1)\u00a0\u00a0\u00a0Questionnaires must be requested from the Commission within 15 days from publication of this Regulation in the         Official Journal of the European Union.": "constitutive", "In such exceptional circumstances, a statement of the reasons why such summary is not possible must be provided.": "constitutive", "The advance shall be paid on condition that the beneficiary has lodged a bank guarantee or an equivalent security at least equal to 110 % of the amount of that advance in favour of the Member State concerned in accordance with Chapter IV of Delegated Regulation (EU) No 907/2014.": "regulatory", "The procedure for the certification, approval and verification of wine without a PDO or PGI pursuant to Article\u00a0120(2)(a) of Regulation (EU) No 1308/2013 shall require administrative evidence to support the veracity of the wine grape variety(-ies) or the vintage year shown on the label or conveyed in the presentation of the wines concerned.": "regulatory", "By way of derogation from the Common Customs Tariff, the import duty for common wheat falling under CN code 1001\u00a099\u00a000, of a quality other than high quality as defined in Annex II to Commission Regulation (EU) No 642/2010                 (                   *1                  )                , shall be fixed in the framework of the quotas opened by this Regulation.": "regulatory", "The personal data related to the disputes referred to in points (a) to (c) of the first paragraph shall be deleted from the platform at the latest six months after their conclusion.": "constitutive", "This list shall be based on the following criteria:                    (a)                  the geographical address of the parties to the dispute as provided for in the electronic complaint form pursuant to the Annex to Regulation (EU) No\u00a0524/2013; and                            (b)                  the sector that the dispute relates to.": "constitutive", "This Regulation shall enter into force on the third day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "Article\u00a02        This Regulation shall enter into force on the day following that of its publication in the         Official Journal of the European\u00a0Union        .": "constitutive", "For the purpose of point (f) of paragraph\u00a01 of this Article, the limitation period to exclude and/or impose financial penalties on an economic operator provided for in Article\u00a03 of Regulation (EC, Euratom) No\u00a02988/95 shall apply.": "constitutive", "In such cases, the decision to publish the information shall duly take into consideration the right to privacy and other rights provided for in Regulation (EC) No\u00a045/2001.": "constitutive", "In those cases, information about any appeals, their status and their outcome, as well as any revised decision of the contracting authority, shall be published without delay.": "regulatory", "It shall only be published in accordance with Article\u00a0106(16) and (17) of this Regulation.": "constitutive", "Paragraphs\u00a05 and\u00a06 shall not apply to the contribution of the Union to entities which are subject to a separate discharge procedure under Articles\u00a0208 and\u00a0209.": "constitutive", "Participation in procurement procedures shall be open on equal terms to all persons within the scope of the Treaties and to any other natural or legal person in accordance with the specific provisions in the basic instruments governing the cooperation sector concerned.": "constitutive", "Performance of the contract shall not start before the contract is signed.": "constitutive", "Procurement procedures for awarding concession contracts or public contracts, including framework contracts shall take one of the following forms:                            (a)                          open procedure;                                    (b)                          restricted procedure, including through a dynamic purchasing system;                                    (c)                          design contest;                                    (d)                          negotiated procedure, including without prior publication;                                    (e)                          competitive dialogue;                                    (f)                          competitive procedure with negotiation;                                    (g)                          innovation partnership;                                    (h)                          procedures involving a call for expression of interest.": "regulatory", "That decision shall take effect three months after its notification to the economic operator.": "constitutive", "The Commission shall also be empowered to adopt delegated acts in accordance with Article\u00a0210 concerning criteria for assimilating non-profit organisations to international organisations.\u2019.": "regulatory", "The Commission shall be empowered to adopt delegated acts in accordance with Article\u00a0210 concerning detailed rules on inter-institutional procurement.\u2019.": "regulatory", "The Commission shall be empowered to adopt delegated acts in accordance with Article\u00a0210 concerning detailed rules on the further definition and scope of public and concession contracts, on applicable nomenclature by reference to the \u201cCommon Procurement Vocabulary\u201d, on mixed contracts, on economic operators, as well as on framework contracts and specific contracts based thereon, covering the maximum duration of framework contracts and the award of and methods for implementing specific contracts based on framework contracts concluded with a single economic operator or with several economic operators, respectively.\u2019.": "regulatory", "The Commission shall be empowered to adopt delegated acts in accordance with Article\u00a0210 concerning detailed rules on the requirements for the advertising of procedures by reference to their value in comparison to the thresholds referred to in Article\u00a0118(1), on advertising which the contracting authority may undertake with full respect for the principle of non-discrimination, and on the content and publication of notices.\u2019.": "regulatory", "The arrangements for submitting tenders shall be such as to ensure that there is genuine competition and that the contents of tenders remain confidential until they are all opened simultaneously.": "constitutive", "The economic operator and the notified contracting authorities shall have at least\u00a015 days to submit their observations;                                    (d)                          in the cases referred to in points (d) and (f) of Article\u00a0106(1), the notification referred to in point (b) of this paragraph and the opportunity referred to in point (c) of this paragraph may be exceptionally deferred where there are compelling legitimate grounds to preserve the confidentiality of an investigation or of national judicial proceedings, until such compelling legitimate grounds to preserve the confidentiality cease to exist;                                    (e)                          where the request of the contracting authority is based, inter alia, on the information provided by OLAF, that Office shall cooperate with the panel in accordance with Regulation (EU, Euratom) No\u00a0883/2013, with due regard to the respect for procedural and fundamental rights, and to the protection of whistle-blowers;                                    (f)                          the panel shall adopt its recommendation within\u00a045 days from the receipt of the request of the contracting authority.": "regulatory", "The institutions within the meaning of Article\u00a02, executive agencies and bodies within the meaning of Articles\u00a0208 and\u00a0209 shall be deemed to be contracting authorities in the case of contracts awarded on their own account, except where they purchase from a central purchasing body.": "regulatory", "The number of candidates invited shall be sufficient to ensure genuine competition.": "constitutive", "The provisions of Chapter\u00a01 of Title V of Part One relating to the general provisions on procurement shall be applicable to contracts covered by this Title subject to the special provisions relating to thresholds and the arrangements for awarding external contracts to be laid down in the delegated acts adopted pursuant to this Regulation.": "constitutive", "The recommendation of the panel to exclude and/or impose a financial penalty shall contain, where applicable, the following elements:                            (a)                          the facts or findings referred to in Article\u00a0106(2) and their preliminary classification in law;                                    (b)                          an assessment of the need to impose a financial penalty and its amount;                                    (c)                          an assessment of the need to exclude the economic operator concerned and, in that case, the suggested duration of such an exclusion;                                    (d)                          an assessment of the need to publish the information related to the economic operator who is excluded and/or subject to a financial penalty;                                    (e)                          an assessment of remedial measures taken by the economic operator, if any.": "constitutive", "The required guarantee shall be proportionate to the estimated value of the contract and shall be set at an appropriate level in order to prevent discrimination against diverse economic operators.": "constitutive", "The retention period for the information transmitted in accordance with paragraph\u00a03 of this Article shall not exceed one year.": "constitutive", "This Chapter shall apply to:                                    (a)                                  procurement where the Commission does not award contracts for its own account;                                            (b)                                  procurement by entities or persons entrusted pursuant to point (c) of Article\u00a058(1) where provided for in the financing agreement referred to in Article\u00a0189.\u2019;                                            (b)                          paragraph\u00a04 is replaced by the following:                        \u20184.": "constitutive", "Any joint recommendation by Member States as referred to in the first subparagraph shall be submitted by 29\u00a0November 2018.": "constitutive", "From 1 January 2015, the monofilament or twines diameter of bottom-set gillnets shall not exceed 0,5\u00a0mm.\u2019;                            (2)                  in Title II, the following chapters are added:                  \u2018CHAPTER IV                      Conservation and sustainable exploitation of red coral                    Scope                This Chapter shall apply without prejudice to Article 4(2) and points (e) and (g) of Article 8(1) of Regulation (EC) No 1967/2006 or any stricter measures stemming from Council Directive 92/43/EEC                 (                   9                  )                .": "constitutive", "Red coral from colonies of red coral whose basal diameter is smaller than 7 mm at the trunk, measured within one centimetre from the base of the colony, shall not be harvested, retained on board, transhipped, landed, transferred, stored, sold or displayed or offered for sale as raw product.": "regulatory", "The harvesting of red coral shall be prohibited at depths of less than 50 metres until the GFCM indicates otherwise.": "constitutive", "Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).": "constitutive", "Import authorisations shall be valid for nine months from the date of issue until 31 December 2016 at the latest.": "constitutive", "Recovery of the aid referred to in Article 1(4) shall be immediate and effective.": "constitutive", "Entry into force        This Decision shall enter into force on the date of its adoption.": "constitutive", "This Decision shall enter into force on the day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "A member of the contract staff whose work or conduct has not proved adequate for establishment in his post shall be dismissed.": "regulatory", "An appeal to the Court of Justice of the European\u00a0Union shall lie only if:                    \u2014                  the AACC has previously had a complaint submitted to it pursuant to Article\u00a0168(2) within the period prescribed therein, and                            \u2014                  the complaint has been rejected by express decision or by implied decision.": "constitutive", "Any period of leave granted in accordance with the third paragraph shall not count for the purposes of the first\u00a0paragraph of Article\u00a040(2).": "constitutive", "Article\u00a0148        The severity of the disciplinary penalties imposed shall be commensurate with the seriousness of the misconduct.": "constitutive", "Article\u00a04        With the exception of the Chief Executive and the Deputy Chief Executive of the Agency who are subject to the provisions of Article\u00a010(1) of Decision (CFSP)\u00a02015/1835, temporary staff shall not be engaged for more than four years, but their engagement may be limited to any shorter duration.": "regulatory", "Article\u00a043        In the case of medically certified serious illness or disability of a member of temporary staff's spouse, relative in the ascending line, relative in the descending line, brother or sister, the member of temporary staff shall be entitled to a period of family leave without basic salary.": "regulatory", "Article\u00a054 and, except for the third sentence of the second paragraph, Article\u00a03 of Annex I shall apply.": "constitutive", "Article\u00a065        The daily subsistence allowance shall be as set out in Article\u00a010 of Annex IV.": "constitutive", "Article\u00a067        Payment of sums due shall be as set out in Articles\u00a017 and\u00a018 of Annex IV.": "constitutive", "Article\u00a081        The surviving spouse of a member of the temporary staff shall be entitled to a survivor's pension in accordance with Chapter\u00a03 of Annex V.": "regulatory", "As provided for in Annex III, overtime worked by members of temporary staff in grade AST\u00a01 to AST\u00a04 shall entitle them either to compensatory leave or to remuneration where the requirements of the service do not allow compensatory leave during the month following that in which the overtime was worked.": "regulatory", "Benefits paid under the social security scheme provided for in Sections B and C shall be charged to the budget of the Agency.": "constitutive", "CHAPTER\u00a04              Working conditions              Section A              Parental or family leave            Article\u00a042        A member of temporary staff shall be entitled to up to six months of parental leave without basic salary for every child, to be taken during the first twelve years after the birth or adoption of the child.": "regulatory", "CHAPTER\u00a04              Working conditions            Article\u00a0111        Articles\u00a042 to\u00a058 shall apply by analogy.": "constitutive", "CHAPTER\u00a08              Termination of employment            Article\u00a096        Apart from cessation on death, the employment of temporary staff shall cease:                    (a)                  at the end of the month in which the member of temporary staff reaches the age of\u00a066;                            (b)                  where the contract is for a fixed period:                            (i)                          on the date stated in the contract;                                    (ii)                          at the end of the period of notice specified in the contract giving the member of the temporary staff or the Agency the option to terminate earlier.": "regulatory", "During parental leave, the member of temporary staff's membership of the social security scheme shall continue; the acquisition of pension rights, dependent child allowance and education allowance shall be maintained.": "regulatory", "For the part of the basic salary actually received, the member of temporary staff's contribution shall be calculated by using the same percentages as if he were in full-time employment.": "constitutive", "Function group AST/SC shall comprise six grades, corresponding to clerical and secretarial duties.": "constitutive", "He shall also retain his right to severance grant if, after completing his military service or alternative service, he pays up his pension contributions retroactively.": "regulatory", "However, Article\u00a068(4) and (5) shall not apply to a member of the contract staff who has remained in the service of the Agency until the age of\u00a063, unless he has been employed for more than 3\u00a0years as a member of such staff.": "constitutive", "If a member of temporary staff is appointed head of unit, director or director-general, and provided that he has performed his new duties satisfactorily during the first nine months, he shall retroactively benefit from advancement by one step in his grade at the time the appointment comes into effect.": "regulatory", "If the Invalidity Committee finds that these conditions are no longer fulfilled, the contract staff member shall resume service with the Agency, providing his contract has not expired.": "constitutive", "In such cases the staff member shall not receive full remuneration until the competent court has ordered his release.": "constitutive", "Information referred to in the first subparagraph shall be given in writing.": "constitutive", "It shall be deducted monthly from the salaries of member of temporary staff.": "constitutive", "It shall be effected by classifying such contract staff in the first step of the next higher grade.": "constitutive", "It shall be renewable.": "constitutive", "Members of the contract staff shall contribute one third of the financing of the unemployment insurance scheme.": "constitutive", "One month at the latest before the expiry of the probationary period, a report shall be made on the ability of the member of the contract staff to perform the duties pertaining to his post and also on his efficiency and conduct in the service.": "regulatory", "Paragraphs\u00a01 and\u00a02 shall not apply to documents, deeds, reports, notes or information in any form whatsoever held for the purposes of, or created or disclosed to the member of temporary staff in the course of, proceedings in legal cases, whether pending or closed.": "constitutive", "Paragraphs\u00a04 and\u00a05 shall apply where family allowances are paid to such a person.": "constitutive", "Payment shall resume if, before the expiry of that period, the former member of the temporary staff again fulfils the said conditions and is not entitled to national unemployment benefit.": "regulatory", "Reasons must be given for the decision.": "constitutive", "Recruitment as a member of the contract staff shall require at least:                    (a)                  in function group I, successful completion of compulsory education;                            (b)                  in function groups II and III:                            (i)                          a level of post-secondary education attested by a diploma; or                                    (ii)                          a level of secondary education attested by a diploma giving access to post-secondary education, and appropriate professional experience of at least three years; or                                    (iii)                          where justified in the interests of the service, professional training or professional experience of an equivalent level;                                    (c)                  in function group IV:                            (i)                          a level of education which corresponds to completed university studies of at least three years attested by a diploma; or                                    (ii)                          where justified in the interests of the service, professional training of an equivalent level.": "constitutive", "Sexual harassment shall be treated as discrimination based on gender.": "constitutive", "Specific decisions regarding appointment, establishment, promotion, transfer, determination of administrative status and termination of service of a member of temporary staff shall be published in the Agency.": "constitutive", "That report shall state whether the performance level of the staff member has been satisfactory.": "constitutive", "The Agency shall also be entitled to reject one of the Disciplinary Board members.": "regulatory", "The allowance shall be set at:                    (a)                  60 % of the basic salary for an initial period of\u00a012 months;                            (b)                  45 % of the basic salary for the\u00a013th to the\u00a024th month;                            (c)                  30 % of the basic salary for the\u00a025th to the\u00a036th month.": "constitutive", "The amount of the severance grant shall be based on the salary for the grade and step occupied by the member of the contract staff when he became an invalid.": "constitutive", "The contribution shall be\u00a010,3 % of the member of temporary staff's basic salary, the weightings provided for in Article\u00a060 not being taken into account.": "constitutive", "The deliberations and proceedings of the Disciplinary Board shall be secret.": "constitutive", "The initial contract and the first renewal must be of a total duration of not less than six months for function group I and not less than nine\u00a0months for the other function groups.": "constitutive", "The normal working hours of a member of temporary staff on shiftwork must not exceed the annual total of normal working hours.": "regulatory", "The orphan's pension of a person treated as a dependent child as defined in Article\u00a02(4) of Annex IV, may not exceed twice the dependent child allowance.": "constitutive", "The paid sick leave provided for in Article\u00a053 shall not, however, exceed three months or the length of time worked by the member of the temporary staff, where the latter is longer.": "constitutive", "The payments shall be charged to the budget of the Agency.": "constitutive", "The period during which the unemployment allowance is payable to a former member of the temporary staff may not be more than\u00a024 months from the date of termination of service and shall in no case exceed the equivalent of one third of the actual length of service completed.": "regulatory", "The period of notice shall not, however, commence to run during pregnancy, if confirmed by a medical certificate, maternity leave or sick leave, provided such sick leave does not exceed three months.": "constitutive", "The period shall begin:                    \u2014                  on the date of notification of the decision taken in response to the complaint,                            \u2014                  on the date of expiry of the period prescribed for the reply where the appeal is against an implied decision rejecting a complaint submitted pursuant to Article\u00a0168(2); nevertheless, where a complaint is rejected by express decision after being rejected by implied decision but before the period for lodging an appeal has expired, the period for lodging the appeal shall start to run afresh.": "constitutive", "The rate of contribution shall be reviewed and adapted as necessary by the Council after a period of\u00a0six years in the light of the unemployment risk of the contract staff of the Agency.": "constitutive", "The request for recovery must be made no later than five years from the date on which the sum was paid.": "constitutive", "The second paragraph of Article\u00a042 shall apply.": "constitutive", "The situation of a suspended staff member must be definitively settled within six months of the date on which the suspension takes effect.": "constitutive", "The staff member concerned shall be heard before such action is taken by the AACC.": "regulatory", "The weightings, the deductions, the annual review and the adjustments shall be determined according to the rules set out in Articles\u00a063, 64, 65, 65a and\u00a066a of the Staff Regulations of Officials of the European\u00a0Union, laid down in Council Regulation (EEC, Euratom, ECSC) No\u00a0259/68         (           3          )        (hereinafter referred to as \u2018the EU Staff Regulations\u2019).": "constitutive", "There shall be only one personal file for each member of temporary staff.": "constitutive", "Under those arrangements, entire working days shall not be granted for members of temporary staff in grade AD/AST\u00a09 or higher.": "constitutive", "Unemployment allowances paid to former members of the contract staff who are unemployed shall be subject to the same rules as those laid down in Regulation (EEC, Euratom, ECSC) No\u00a0260/68.": "constitutive", "When considering comparative merits, the AACC shall in particular take account of the reports on the members of contract staff, the use of languages in the execution of their duties other than the language for which they have produced evidence of thorough knowledge in accordance with Article\u00a0105(3)(e) and, where appropriate, the level of responsibilities exercised by them.": "regulatory", "Where inventions are the subject of patents, the name of the inventor or inventors shall be stated.": "constitutive", "Where the invalidity of the contract staff member arises from an accident in the course of or in connection with the performance of his duties, from an occupational disease, from a public spirited act or from risking life and limb to save another human being, the invalidity allowance shall not be less than\u00a0120 % of the basic monthly salary of a function group I, grade\u00a01, step\u00a01 contract staff member.": "constitutive", "Where, in accordance with Article\u00a060, the remunerations are adapted, the same update shall be applied to pensions.": "constitutive", "This Decision shall enter into force on the day of its publication in the         Official Journal of the European Union        .": "constitutive", "Requests for exemption from the duty extended by Article\u00a01 shall be made in writing in one of the official languages of the European Union and must be signed by a person authorised to represent the entity requesting the exemption.": "constitutive", "Conditions for landing catches and by-catches not subject to the landing obligation        Catches and by-catches of turbot in fisheries not subject to the landing obligation shall be retained on board or landed only if they have been taken by Union fishing vessels flying the flag of a Member State having a quota and that quota is not exhausted.": "constitutive", "Definitions        For the purposes of this Regulation, definitions set out in Article\u00a04 of Regulation (EU) No\u00a01380/2013 shall apply.": "constitutive", "Entry into force        This Regulation shall enter into force on the day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "In addition, the following definitions shall apply:                    (a)                  \u2018Black Sea\u2019 means the geographical sub-area\u00a029 as defined in Annex\u00a0I to Regulation (EU) No\u00a01343/2011 of the European Parliament and of the Council                 (                   4                  )                ;                            (b)                  \u2018fishing vessel\u2019 means any vessel equipped for commercial exploitation of marine biological resources;                            (c)                  \u2018Union fishing vessel\u2019 means a fishing vessel flying the flag of a Member\u00a0State and registered in the Union;                            (d)                  \u2018total allowable catch\u2019 (TAC) means:                            (i)                          in fisheries subject to the landing obligation referred to in Article\u00a015 of Regulation (EU) No\u00a01380/2013, the quantity that can be caught from each stock each year;                                    (ii)                          in all other fisheries, the quantity that can be landed from each stock each year;                                    (e)                  \u2018quota\u2019 means a proportion of the TAC allocated to the Union, a Member\u00a0State or a third country.": "constitutive", "Definitions        For the purposes of this Regulation, the following definitions shall apply:                    (a)                  \u2018transnational producer organisation\u2019 means any producer organisation of which the member producers' holdings are located in more than one Member State;                            (b)                  \u2018transnational association of producer organisations\u2019 means any association of producer organisations of which the member organisations are located in more than one Member State;                            (c)                  \u2018transnational interbranch organisation\u2019 means any interbranch organisation of which the members are engaged in production, processing or trade in the products covered by the organisation's activities in more than one Member State.": "constitutive", "CHAPTER III          CONFORMITY OF THE PPE          Presumption of conformity of PPE        PPE which is in conformity with harmonised standards or parts thereof the references of which have been published in the         Official Journal of the European\u00a0Union        shall be presumed to be in conformity with the essential health and safety requirements set out in Annex\u00a0II covered by those standards or parts thereof.": "constitutive", "Cases in which obligations of manufacturers apply to importers and distributors        An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and he shall be subject to the obligations of the manufacturer set out in Article\u00a08 where he places PPE on the market under his name or trademark or modifies PPE already placed on the market in such a way that compliance with this Regulation may be affected.": "regulatory", "Changes in the design or characteristics of the PPE and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account.": "regulatory", "Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.": "constitutive", "During demonstrations, adequate measures shall be taken to ensure the protection of persons.": "constitutive", "EC type-examination certificates and approval decisions issued under Directive\u00a089/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.": "constitutive", "General principles of the CE marking        The CE marking shall be subject to the general principles set out in Article\u00a030 of Regulation\u00a0(EC) No\u00a0765/2008.": "constitutive", "It shall take effect the day following the publication of the decision in the         Official Journal of the European Union        or at a later date specified therein.": "constitutive", "Proprietary rights shall be protected.": "constitutive", "Provisions concerning the use of PPE        This Regulation shall not affect Member States' entitlement, in particular when implementing Directive\u00a089/656/EEC, to lay down requirements concerning the use of PPE, provided that those requirements do not affect the design of PPE which is placed on the market in accordance with this\u00a0Regulation.": "constitutive", "The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the kinds of PPE for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article\u00a024.": "constitutive", "The contact details shall be in a language easily understood by end-users and market surveillance authorities.": "constitutive", "The mandate shall allow the authorised representative to do at least the following:                    (a)                  keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the PPE has been placed on the market;                            (b)                  further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the PPE;                            (c)                  cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative's mandate.": "constitutive", "The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the kinds of PPE concerned and the relevant attestation of competence.": "constitutive", "The penalties provided for shall be effective, proportionate and dissuasive.": "constitutive", "The personnel responsible for carrying out conformity assessment tasks shall have the following:                    (a)                  sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;                            (b)                  satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;                            (c)                  appropriate knowledge and understanding of the essential health and safety requirements set out in Annex II, of the applicable harmonised standards, and of the relevant provisions of Union harmonisation legislation and of national legislation;                            (d)                  the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.": "constitutive", "Where PPE is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts.": "constitutive", "Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.": "constitutive", "The entry criteria set out in Article 4 shall apply, except for point (b) of the first subparagraph of this paragraph where institutions start reporting information from the next reporting reference date where they have exceeded the relevant applicable threshold on one reporting reference date.": "constitutive", "As an exception to paragraphs 4 and 5 supervisory financial reporting concerning less significant credit institutions the assets of which have a total value, on a consolidated basis, of EUR 3\u00a0billion or less shall include the information specified in Annex III, as a common minimum, instead of the information specified in paragraph 4 of this Article.": "regulatory", "The Urban Development Fund shall take the form of a loan fund and shall be set up and managed by a financial intermediary with contributions from the ESIF programme and a mobilisation of co-financing of at least 30 % from the financial intermediary and co-investors.": "constitutive", "The rates of the provisional anti-dumping duty applicable to the net, free-at-Union-frontier price, before duty, of the product described in paragraph 1 and produced by the company listed below shall be as follows:                     Company                  Provisional anti-dumping duty rate (%)                  TARIC additional code                    BMZ- Open Joint-Stock Company \u2018Byelorussian Steel Works \u2014 Management Company of \u201cByelorussian Metallurgical Company\u201d Holding\u2019                  12,5                  C197                    All other companies                  12,5                  C999                3.": "constitutive", "The release for free circulation in the Union of the product referred to in paragraph 1 shall be subject to the provision of a security deposit equivalent to the amount of the provisional duty.": "constitutive", "However, for addressing purposes, and also as the removable storage medium bears an explicit security classification marking, the medium shall be carried in at least an ordinary envelope but may require additional physical protection measures, such as bubble wrap envelopes.": "regulatory", "All CIS shall be identified, assigned to a system owner and recorded in an inventory.": "constitutive", "Effective IT security shall ensure appropriate levels of:                    (a)                  authenticity: the guarantee that information is genuine and from bona fide sources;                            (b)                  availability: the property of being accessible and usable upon request by an authorised entity;                            (c)                  confidentiality: the property that information is not disclosed to unauthorised individuals, entities or processes.": "constitutive", "IT security issues shall be taken into account from the start of the development and implementation of Commission CISs.": "regulatory", "The recovery of encrypted data shall be carried out only when authorised in accordance with the framework defined by the Directorate-General for Human Resources and Security;                            (n)                  respect any instructions from the relevant Data Controller(s) concerning the protection of personal data and the application of data protection rules on security of the processing;                            (o)                  notify the Directorate-General for Informatics of any exceptions to the Commission's IT security policy including relevant justifications;                            (p)                  report any unresolvable disagreements between the data owner and the system owner to the head of the Commission department, communicate IT security incidents to the relevant stakeholders in a timely manner as appropriate according to their severity as laid down in Article 15;                            (q)                  for outsourced systems, ensure that appropriate IT security provisions are included in the outsourcing contracts and that IT security incidents occurring in the outsourced CIS are reported in accordance with Article 15;                            (r)                  for CIS providing shared IT services, ensure that a defined security level is provided, clearly documented and security measures are implemented for that CIS in order to reach the defined security level.": "constitutive", "This process shall aim at determining the levels of IT security risks and defining security measures to reduce such risks to an appropriate level and at a proportionate cost.": "constitutive", "For administrative purposes the code number assigned to the product group \u2018tourist accommodation\u2019 shall be \u2018051\u2019.": "constitutive", "The minimum amount of points required in accordance with paragraph 1 shall be increased by the following:                    (a)                  3 points where food services are provided by the management or owner of the tourist accommodation service;                            (b)                  3 points where green areas are made available to guests by the management or owner of the tourist accommodation service;                            (c)                  3 points where leisure or fitness facilities are offered by the management or owner of the tourist accommodation service or 5 points if those leisure or fitness facilities consist in a wellness centre accessible to non-residents.": "constitutive", "The RCC shall be based at EUCAP Sahel Mali's Headquarters in Bamako.": "constitutive", "It shall apply from 1 July 2017.": "constitutive", "The manual method ZP, referred to in point (h) of the first subparagraph, shall only be authorised for abattoirs having a slaughter line with a capacity to process no more than 40 pigs per hour.": "regulatory", "In particular, where proposals are made on the spot on matters which are not yet the subject of a Union position, and which fall within the exclusive competence of the Union, the position of the Union shall be established on the proposal concerned through coordination as described in the first subparagraph, including on the spot, before a decision on that proposal is taken by the Conference of States Parties.": "regulatory", "Certification of CO         2        savings        The reduction in CO         2        emissions from the use of the BMW engine idle coasting function referred to in Article 1 shall be determined using the methodology set out in the Annex.": "constitutive", "The expenditure financed by the amount set out in paragraph 1 shall be managed in accordance with the procedures and rules applicable to the general budget of the Union.": "constitutive", "The rules on grants provided for in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council         (           5          )        shall apply to this grant agreement.": "constitutive", "They shall apply those provisions from 1 January 2018.": "constitutive", "In case of crystalline silicon photovoltaic cells this declaration shall be drafted as follows: \u2018I, the undersigned, certify that the (volume) of crystalline silicon photovoltaic cells sold for export to the European Union covered by this invoice was manufactured by (company name and address) (TARIC additional code) in (country concerned).": "constitutive", "Unless otherwise specified, the provisions in force concerning customs duties shall apply.": "constitutive", "This Regulation shall enter into force on the date following that of its publication in the         Official Journal of the European Union        .": "constitutive", "Entry into force and application        This Regulation shall enter into force on the twentieth day following that of its publication in         the Official Journal of the European Union        .": "constitutive", "In the case of ARMs, the notifications referred to in paragraph 5 shall also be made to any competent authority to whom the ARM submits transaction reports.": "constitutive", "It shall apply from the date that appears first in the second subparagraph of Article 93(1) of Directive 2014/65/EU.": "constitutive", "The information set out in paragraph 1 shall include:                    (a)                  a description of the processes for selection, appointment, performance evaluation and removal of senior management and members of the management body;                            (b)                  a description of the reporting lines and the frequency of reporting to the senior management and the management body;                            (c)                  a description of the policies and procedures on access to documents by members of the management body.": "constitutive", "The inventory of conflicts of interest as referred to in paragraph 1(a) shall include conflicts of interest arising from situations where the data reporting services provider:                    (a)                  may realise a financial gain or avoid a financial loss, to the detriment of a client;                            (b)                  may have an interest in the outcome of a service provided to a client, which is distinct from the client's interest in that outcome;                            (c)                  may have an incentive to prioritise its own interests or the interest of another client or group of clients rather than the interests of a client to whom the service is provided;                            (d)                  receive or may receive from any person other than a client, in relation to the service provided to a client, an incentive in the form of money, goods or services, other than commission or fees received for the service.": "constitutive", "The requirement to correct or cancel erroneous transaction reports or report omitted transactions shall not extend to errors or omissions which occurred more than five years before the date that the ARM became aware of such errors or omissions.": "constitutive", "The period referred to in paragraph\u00a01 shall not apply where the member of temporary staff can demonstrate that it is unreasonable having regard to all the circumstances of the case.": "regulatory", "A detailed report shall be made for each on-the-spot check indicating at least the following information:                    (a)                  the aid scheme and the application checked;                            (b)                  the names and functions of the persons present;                            (c)                  the actions, measures and documents checked, including the audit trail and supporting evidence verified; and                            (d)                  the results of the check.": "constitutive", "Actions under promotion and communication measures shall be additional to any ongoing promotion and communication actions not related to crisis prevention and management being applied by the producer organisation concerned in their operational programme.": "constitutive", "CHAPTER VIII          FINAL PROVISIONS          Entry into force and application        This Regulation shall enter into force on the seventh day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "During the periods of application set out in Part A of Annex VII to Delegated Regulation (EU) 2017/891, the standard import values shall remain applicable until they are changed.": "constitutive", "For the purpose of the calculation of the degree of organisation of producers in the fruit and vegetables sector, the value of fruit and vegetables production from producer groups formed pursuant to Article 125e of Regulation (EC) No 1234/2007 shall also be taken into account.": "constitutive", "However, in respect of environmental and phytosanitary questions and crisis prevention and management measures, the rules of the Member State where the respective actions take place shall apply.": "constitutive", "Investments referred to in points (c) and (d) of paragraph 3 shall be eligible for support where they contribute to soil protection, water or energy saving, improvement or maintenance of water quality, habitats or biodiversity protection, climate change mitigation, and reduction or improved management of waste, although their contribution is not quantifiable.": "constitutive", "Invoices used shall be established in the name of the producer organisation, association of producer organisations or the subsidiary complying with the 90\u00a0% requirement referred to in Article 22(8) of Delegated Regulation (EU) 2017/891 or, subject to Member State approval, in the name of one or more of its producer members.": "constitutive", "It shall also ensure the coordination of checks and payments in respect of actions of the operational programmes implemented on the territory of the other Member States.": "regulatory", "Operational programmes shall indicate:                    (a)                  the extent to which the different measures complement and are consistent with other measures, including measures financed or eligible for support by other Union funds, and in particular under Regulation (EU) No 1305/2013 and promotion programmes approved under Regulation (EU) No 1144/2014 of the European Parliament and of the Council                 (                   7                  )                .": "constitutive", "Packages of products for free distribution shall display the European emblem together with one or more of the statements set out in Annex VI.": "constitutive", "Producer organisations which are members of transnational associations of producer organisations shall apply for aid in the Member State where they are recognised regarding actions implemented on the territory of that Member State.": "regulatory", "Such information shall include the basis on which the contribution is calculated, the unit amount thereof, the activities covered and their associated costs.": "constitutive", "The amount reimbursed shall not exceed 48\u00a0% of the Union financial assistance referred to in Article 32(1)(b) of Regulation (EU) No 1308/2013.": "constitutive", "The check shall take place following receipt of the notification referred to in Article 44(1) of Delegated Regulation (EU) 2017/891, within the time limits set in accordance with paragraph 2 of that Article.": "constitutive", "The checks on the destination of products withdrawn from the market shall include:                    (a)                  a sample check on the stock records to be kept by recipients and on the financial accounts of the charitable organisations and institutions concerned where the second subparagraph of Article 46(2) of Delegated Regulation (EU) 2017/891 applies; and                            (b)                  checks on compliance with the relevant environmental requirements.": "constitutive", "The checks referred to in paragraph 1 shall verify whether:                    (a)                  targets are measurable and can be monitored and achieved through the proposed actions; and                            (b)                  the operations for which aid is requested are in compliance with the applicable national and Union laws in particular, State aid, rural development and promotion programmes, and obligatory standards established by national legislation or the national strategy.": "constitutive", "The description of the objectives shall indicate measurable targets, so as to facilitate the monitoring of progress gradually made in implementing the programme;                            (c)                  the proposed measures, including the actions for crisis prevention and management;                            (d)                  the duration of the programme; and                            (e)                  the financial aspects, in particular:                            (i)                          the method of calculation and the level of financial contributions;                                    (ii)                          the procedure for financing the operational fund;                                    (iii)                          information necessary to justify different levels of contribution; and                                    (iv)                          the budget and timetable for operations for each implementation year of the programme.": "constitutive", "The on-the-spot checks shall cover all the commitments and obligations of the producer organisation or association of producer organisations, its members or subsidiaries, where applicable, which can be checked at the time of the visit and which could not have been checked during the administrative checks.": "constitutive", "The producer organisations shall be the final beneficiaries of the aid.": "regulatory", "The request for Union reimbursement of the national financial assistance shall also contain:                    (a)                  details of the producer organisations concerned;                            (b)                  the amount of assistance paid, limited for each producer organisation to the amount initially authorised; and                            (c)                  a description of the operational fund showing the total amount, the Union financial assistance, the national financial assistance and the contributions of the producer organisations and of the members.": "constitutive", "This risk analysis shall serve as the basis to establish the minimum frequency of second-level checks for each producer organisation.": "constitutive", "Where applications are submitted after the date provided for in paragraph\u00a01, the aid shall be reduced by 1\u00a0% for each day the application is late.": "constitutive", "It shall apply from the date of entry into force of the Agreement.": "constitutive", "The products originating in Albania, Bosnia and Herzegovina, the former Yugoslav Republic of Macedonia, the\u00a0customs territory of Kosovo, Montenegro, and in Serbia covered by Chapters 7 and 8 of the Combined Nomenclature shall be admitted for import into the Union without quantitative restrictions or measures having equivalent effect and with exemption from custom duties and charges having equivalent effect.": "constitutive", "As an exception to Articles 7 and 14, credit institutions that have been given a waiver regarding the application of prudential requirements on an individual basis, in accordance with Article 7 or 10 of Regulation (EU) No 575/2013, shall not be required to report supervisory financial information on an individual basis in accordance with this Regulation.": "constitutive", "As supervised entities apply different accounting standards, only information related to valuation rules, including methods for estimation of credit risk losses, which exist under the relevant accounting standards and are applied by the corresponding supervised entities on an individual or consolidated basis shall be submitted.": "constitutive", "For this purpose, the total value of the assets of credit institutions, on a consolidated basis, shall be determined on the basis of the prudential consolidated reporting in accordance with applicable law.": "regulatory", "Paragraphs 2, 3, 5 and 6 shall be subject to the following exceptions:                            (a)                          supervisory financial reporting concerning less significant credit institutions the assets of which have a total value equal to or less than EUR 3\u00a0billion shall include the information specified in Annex III, as a common minimum, instead of the information specified in paragraphs 2, 3, 5 or 6;                                    (b)                          a less significant branch shall not report supervisory financial information if the total value of its assets is below or equal to EUR 3\u00a0billion.": "constitutive", "The information concerning significant credit institutions and significant branches specified in Articles 6 and 7 shall have the following reporting reference dates:                            (a)                          for quarterly reporting, 31 March, 30 June, 30 September and 31 December;                                    (b)                          for semi-annual reporting, 30 June and 31 December;                                    (c)                          for annual reporting, 31 December.": "constitutive", "The supervisory financial reporting referred to in paragraph 4 shall take place with the frequency specified in Article 11 of Implementing Regulation (EU) No 680/2014 and shall include the common minimum information specified in paragraph 2 of Annex I.": "constitutive", "The supervisory financial reporting shall take place with the frequency specified in Article 9 of Implementing Regulation (EU) No 680/2014.": "constitutive", "This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.": "constitutive", "Where more than one credit institution within a supervised group applies prudential requirements on a consolidated basis, paragraph 1 shall apply only to the credit institution established in a participating Member State and at the highest level of consolidation.": "constitutive", "The import licence application and the import licence shall mention a single country of origin.\u2019                            (5)                  In Article 8, the following paragraph is added:                \u2018By way of derogation from the first paragraph, the release into free circulation in the Union of common wheat of a quality other than high quality originating in Canada shall be conditional upon production of an origin declaration.": "constitutive", "This Regulation shall enter into force the day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "Quota exhaustion        The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2017 shall be deemed to be exhausted from the date set out in that Annex.": "constitutive", "Entry into force and application        This Regulation shall enter into force on the twentieth day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "The information to be provided to the competent authority of the home Member State, as set out in Articles 1 and\u00a06, shall refer to both the head office of the firm and its branches and tied agents.": "constitutive", "Each innovative action shall be implemented within a maximum period of four years\u2019.": "constitutive", "The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation        This Regulation shall enter into force on the twentieth day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "All project components shall be flanked by proactive and innovative public outreach activities, and resources be allocated accordingly.": "constitutive", "The projects to be financed by the Union shall support:                    (a)                  certified auxiliary seismic (AS) stations that are part of the CTBTO International Monitoring System (IMS);                            (b)                  the development of noble gas sampling systems through study of materials for improved adsorption of xenon;                            (c)                  continuing the radio-xenon background measurement campaigns in different regions of the world;                            (d)                  the Ensemble Prediction System to quantify uncertainties and confidence level in Atmospheric Transport Modelling (ATM) simulations;                            (e)                  the scientific evaluation of the increase in resolution for ATM tools;                            (f)                  the development of new software;                            (g)                  enhancing the on-site inspection noble gas processing and detection;                            (h)                  enhancing the automatic processing and integration capabilities in seismic, hydro-acoustic and infrasound National Data Centre-in-a-Box;                            (i)                  integrated outreach and capacity-building targeting State Signatories and Non-Signatories.": "constitutive", "Subject to the conditions referred to in paragraph 3, the Union's macro-financial assistance shall be made available by the Commission in two instalments, each of which shall consist of a loan and a grant element.": "regulatory", "The Union's macro-financial assistance shall be implemented in accordance with Regulation (EU, Euratom) No\u00a0966/2012 of the European Parliament and of the Council         (           6          )        and Commission Delegated Regulation (EU) No\u00a01268/2012         (           7          )        .": "constitutive", "The loan agreement and the grant agreement referred to in Article\u00a03(3) shall contain provisions:                    (a)                  ensuring that Georgia regularly checks that financing provided from the budget of the Union has been properly used, takes appropriate measures to prevent irregularities and fraud, and, if necessary, takes legal action to recover any funds provided under this Decision that have been misappropriated;                            (b)                  ensuring the protection of the Union's financial interests, in particular providing for specific measures in relation to the prevention of, and fight against, fraud, corruption and any other irregularities affecting the Union's macro-financial assistance, in accordance with Council Regulation (EC, Euratom) No\u00a02988/95                 (                   8                  )                , Council Regulation (Euratom, EC) No\u00a02185/96                 (                   9                  )                and Regulation (EU, Euratom) No\u00a0883/2013 of the European Parliament and of the Council                 (                   10                  )                ;                            (c)                  expressly authorising the Commission, including the European Anti-Fraud Office, or its representatives to carry out checks, including on-the-spot checks and inspections;                            (d)                  expressly authorising the Commission and the Court of Auditors to perform audits during and after the availability period of the Union's macro-financial assistance, including document audits and on-the-spot audits, such as operational assessments; and                            (e)                  ensuring that the Union is entitled to early repayment of the loan and/or to full repayment of the grant where it has been established that, in relation to the management of the Union's macro-financial assistance, Georgia has engaged in any act of fraud or corruption or any other illegal activity detrimental to the financial interests of the Union.": "constitutive", "Where the conditions referred to in the first subparagraph of paragraph\u00a03 are not met, the Commission shall temporarily suspend or cancel the disbursement of the Union's macro-financial assistance.": "regulatory", "Article\u00a02        This Decision shall enter into force on the day of its publication in the         Official Journal of the European\u00a0Union        .": "constitutive", "If the content or circumstances of the report, as submitted for recognition to the Commission on 1\u00a0April 2016, change in a way that might affect the conditions required for the recognition made in Article 1, such changes shall be notified to the Commission without delay.": "regulatory", "This Decision shall enter into force on the twentieth day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "This Decision shall enter into force on the day of its publication in the             Official Journal of the European Union            .": "constitutive", "The measures referred to in Article 9(2) shall apply with regard to entries 19, 20 and 21 in Annex IV until 2\u00a0April 2019.\u2019.": "constitutive", "For the purposes of this Decision, the following definitions shall apply:                        1.": "constitutive", "The position to be taken on behalf of the Union at the meeting of the plenary session of the Central Commission for the Navigation of the Rhine (CCNR) where the European standards for professional qualifications in inland navigation (references cesni (18)_29 to cesni (18)_42) are decided upon shall be to support all proposals aligning the requirements of the Regulations for Rhine navigation personnel with those of the European standards for professional qualifications in inland navigation.": "constitutive", "The position to be taken on behalf of the Union within the European Committee for drawing up standards in the field of inland navigation (CESNI) on 8\u00a0November 2018 shall be to agree to the adoption of the European standards for professional qualifications in inland navigation (references cesni (18)_29 to cesni (18)_42).": "constitutive", "This Regulation shall enter into force on the day following its publication in the         Official Journal of the European Union        .": "constitutive", "The financial contributions by the members other than the Union or their constituent entities to the operational costs referred to in paragraph 3(b) shall be at least EUR 182\u00a0500\u00a0000 over the period provided for in Article 1 of this Regulation.": "constitutive", "These financial contributions shall be made as payments to the BBI Joint Undertaking or as financial contributions to indirect actions funded by the BBI Joint Undertaking.\u2019.": "constitutive", "In the Annex to Delegated Regulation (EU) 2016/1675, in the table in point I the following lines are inserted:                      \u201811                    Sri Lanka                      12                    Trinidad and Tobago                      13                    Tunisia\u2019                  This Regulation shall enter into force on the twentieth day following that of its publication in the         Official Journal of the European Union        .": "constitutive", "The national territories listed in Annex III shall be excluded.": "constitutive", "The precision requirements shall be as set out in Annex II.": "constitutive", "A manufacturer for which the certified CO                         2                        savings are no longer taken into account may apply for a new certification of the vehicles concerned in accordance with the procedure laid down in Article 11, or may, where appropriate, make a request for an amendment of the approval decision in accordance with Article\u00a012a, which shall be supported by such evidence that is required to confirm the appropriateness of the testing methodology and the level of CO                         2                        savings achieved by the innovative technology.\u2019.": "constitutive", "In the case referred to in the second subparagraph of point 1.2.3.1 of sub-Annex 6 or point 3.2.3.1 of sub-Annex 7 to Annex XXI to Regulation (EU) 2017/1151, the baseline vehicle shall be the test vehicle\u00a0H.": "constitutive", "Where the application for the approval of an innovative technology as an eco-innovation is made by reference to the WLTP as referred to in Article 2(4)(b), the baseline vehicle shall be the vehicle within the interpolation family or the road loads matrix family which represents the worst case for the purpose of demonstrating the eco-innovation savings.": "constitutive", "Applications shall also include the commitment to grub up the area planted with vines at the latest by the end of the fourth year from the date on which new vines have been planted.": "constitutive", "Existing stocks shall be carried forward to the next annual period.": "constitutive", "For the production of liqueur wine, the registers shall show for each batch being prepared:                    (a)                  the date of addition of any of the products listed in point (3)(e) and (f) of Part II of Annex VII to Regulation (EU) No 1308/2013;                            (b)                  the type and volume of the product added.": "constitutive", "In the cases of previous consignments of a product, a reference to the document under cover of which the product was previously transported shall be recorded in the register.": "constitutive", "Such communication shall refer to the previous wine year.": "constitutive", "The certification shall be carried out through random and risk based checks, in accordance with Articles 36 and\u00a037 of Delegated Regulation (EU) 2018/273 and Chapter VI of this Regulation.": "regulatory", "The communication shall be made in the form set out in Part\u00a0III of Annex IV to this Regulation;                            (f)                  where Member States decide to apply the priority criterion referred to in Article 64(2)(h) of Regulation (EU) No 1308/2013, the thresholds decided in relation to the minimum and maximum size of holdings as referred to in point H of Annex II to Delegated Regulation (EU) 2018/273.": "regulatory", "The containers shall also bear the relevant particulars required by the Member States to allow the competent authorities to identify their contents using the register.": "constitutive", "The data of the vineyard register as provided for in Article 7 of Delegated Regulation (EU) 2018/273 shall be kept for as long as it is necessary for the purposes of monitoring and verifying the measures or the scheme to which they relate and in any event for, respectively, at least five wine years in case of data relating to the measures or at least ten wine years in case of data relating to the scheme of authorisation for vine plantings, following the wine year to which they relate.": "regulatory", "The inward and outward register and the documents concerning the operations recorded therein shall be kept for at least five years after the accounts to which they refer have been closed.": "constitutive", "The particulars referred to in Article 14(1)(a) and Articles 15 and 19 shall be recorded in the register:                    (a)                  in the case of entries, not later than the working day following receipt; and                            (b)                  in the case of losses, personal and family consumption or withdrawals, not later than the third working day following the recognition, consumption or dispatch.": "constitutive", "The period between the submission of the request to convert and the granting of the authorisations shall not exceed three months.": "constitutive", "The procedure shall be carried out in the Member State in which the wine is produced.": "constitutive", "The production declaration referred to in paragraph 1 shall contain at least the following information:                    (a)                  identity of the producer;                            (b)                  place where products are held;                            (c)                  category of products used for wine production: grapes, grape must (concentrated, rectified concentrated or partially fermented), or new wines still in fermentation;                            (d)                  name and address of suppliers;                            (e)                  areas planted with vines under production, including those for experimental purposes, in which the grapes originate, indicated in hectares and with reference to the location of the vineyard parcel;                            (f)                  volume, indicated in hectolitres or 100 kg, of the wine products obtained since the beginning of the wine year and held at the date of the declaration, broken down by colour (red/ros\u00e9 or white), category of products used (grapes, new wines still in fermentation, must, including partially fermented but excluding concentrated and rectified concentrated), and one of the following types:                            (i)                          wine with a PDO;                                    (ii)                          wine with a PGI;                                    (iii)                          varietal wine without PDO/PGI;                                    (iv)                          wine without PDO/PGI;                                    (v)                          all other products of the wine year, including concentrated must, rectified concentrated must.": "constitutive", "The selection of samples shall take account of the geographical situation of vineyards in the Member States listed in Part II of Annex III.": "constitutive", "The specific size and the location of the area(s) to be grubbed up and of the area(s) to be replanted in the same applicant's holding for which the authorisation is to be granted shall be identified in the applications.": "regulatory", "These notifications shall be made in the form set out in Part II of Annex IV to this Regulation;                            (c)                  a notification on the restrictions decided by Member States in relation to replantings in the same holding as referred to in Article 8 of this Regulation.": "constitutive", "Where a product changes category without undergoing one of the operations referred to in Article 29 of Delegated Regulation (EU) 2018/273, in particular in the case of fermentation of grape must, the quantities and the type of product obtained after the change shall be noted in the register.": "constitutive", "Where the wine growers selected for the sample are subject in the same year to on-the-spot checks in the framework of the measures referred to in point (a)(i) and (ii), such on-the-spot checks shall be counted for reaching the 5\u00a0% yearly threshold without the need to repeat them.": "constitutive", "This Regulation shall enter into force on 1\u00a0July 2018.": "constitutive", "Sufficient length of the life of the ELTIF        For the purpose of Article 18(3) of Regulation (EU) 2015/760, the life of an ELTIF shall be considered sufficient in length to cover the life-cycle of each of the individual assets of the ELTIF where the following conditions are met:                    (a)                  the ELTIF aligns the date for the end of its life to the date of the end of the investment horizon of the individual asset within the ELTIF portfolio which has the longest investment horizon at the time of the submission of the application for authorisation as an ELTIF to the competent authority of the ELTIF;                            (b)                  any investment made by the ELTIF after the date of its authorisation as an ELTIF does not have a residual investment horizon exceeding the remaining life of the ELTIF at the time that investment is made.": "constitutive", "The purpose of hedging the risks arising from exposures to assets referred to in the first subparagraph shall only be considered to be fulfilled where the use of that financial derivative instrument results in a verifiable and objectively measurable reduction of those risks at the ELTIF level.": "constitutive", "The use of the financial derivative instruments aimed to provide a return for the ELTIF shall not be deemed to serve the purpose of hedging the risks.": "constitutive", "Regulation (EC) No 673/2005 is amended as follows:                    (1)                  Article 2 of Regulation (EC) No 673/2005 is replaced by the following:                \u2018An                 ad valorem                duty of 0,3\u00a0% additional to the customs duty applicable under Regulation (EU) No 952/2013                 (                   *1                  )                shall be imposed on the products originating in the United States of America listed in Annex I to this Regulation.": "regulatory", "For the purposes of Article 32(6) of Regulation (EU) No 1307/2013, the eligibility of areas used for the production of hemp shall be subject to the use of seed of the varieties listed in the \u2018Common Catalogue of Varieties of Agricultural Plant Species\u2019 on 15 March of the year in respect of which the payment is granted and published in accordance with Article 17 of Council Directive 2002/53/EC                 (                   *1                  )                .": "constitutive", "Point 5 of Article 1 shall apply with respect to aid applications relating to calendar year 2019 and subsequent calendar years.": "constitutive", "Entry into force            This Regulation shall enter into force on the day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "Definitions            For the purposes of this Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 and in Article 2 of Regulation (EC) No 882/2004 shall apply.": "constitutive", "For the purposes of Article 11(3), the definitions set out in Regulation (EC) No 396/2005 shall apply.": "constitutive", "The reporting obligations set out in paragraph 1 shall be deemed to be satisfied where Member States register in TRACES the CEDs issued by their respective competent authorities in accordance with this Regulation.": "constitutive", "This Regulation shall enter into force on the third day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "Quota exhaustion            The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2018 shall be deemed to be exhausted from the date set out in that Annex.": "constitutive", "Recommitments of those amounts to the same action under the national programme or transfers of those amounts to other actions under the national programme shall be possible where duly justified in the revision of the relevant national programme.": "constitutive", "Such measures shall not include any measures related to detention.": "constitutive", "To effectively pursue the objectives of solidarity and fair sharing of responsibility between the Member States referred to in TFEU, and within the limits of available resources, the Commission shall be empowered to adopt delegated acts in accordance with Article\u00a026 of this Regulation to adjust the lump sum referred to in paragraph 1 of this Article, taking into account in particular the current rates of inflation, relevant developments in the field of transfer of applicants for international protection and of beneficiaries of international protection from one Member State to another and in the field of resettlement and other ad hoc humanitarian admission, as well as factors which can optimise the use of the financial incentive brought by the lump sums.\u2019;                                          (2)                      in the heading and the introductory wording of Article 25, the words \u2018beneficiaries of international protection\u2019 are replaced by the words \u2018applicants for international protection or of beneficiaries of international protection\u2019.": "regulatory", "This Decision shall enter into force on the day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "However, it shall not apply if Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.": "constitutive", "It shall apply from 26\u00a0January 2020.": "constitutive", "Following the provision of consent the applicant shall receive an email containing:                          (a)                        confirmation that the applicant's application file is retained for an additional period of three years from the end of the validity of the travel authorisation;                                  (b)                        a link to the consent tool;                                  (c)                        notification that the data is retained for the purpose of facilitating a new application and that those data may be used for the purposes referred to in Article 71(o) of Regulation (EU) 2018/1240;                                  (d)                        notification that consent may be withdrawn at any time until the end of the additional retention period;                                  (e)                        notification that the applicant is advised to retain their current application number to reuse the retained application file for the purpose of submitting a new application.": "constitutive", "Prior to giving the consent, the applicant shall be informed:                          (a)                        about the fact if consent is provided, the application file is retained for an additional period of three years from the end of the validity period of the travel authorisation;                                  (b)                        about the fact that consent may be withdrawn at any time until the end of the additional retention period;                                  (c)                        about the fact that the data shall be retained for the purpose of facilitating a new application;                                  (d)                        about the fact that the data may be used in accordance with Article 71(o) of Regulation (EU) 2018/1240;                                  (e)                        about the procedures for exercising the rights under Articles 17 to 24 of Regulation (EU) 2018/1725; the contact details of the data protection officer of the European Border and Coast Guard Agency, of the European Data Protection Supervisor and of the national supervisory authority of the Member State of first intended stay where the travel authorisation has been issued by the ETIAS Central System, or of the Member State responsible where the travel authorisation has been issued by an ETIAS National Unit.": "regulatory", "The application number shall be the same as the one provided to applicants via the ETIAS email service on submission of their application.": "constitutive", "The consent tool shall be designed and implemented to ensure the confidentiality, integrity and availability of processed data and to ensure non-repudiation of transactions.": "constitutive", "The tool shall also include measures to protect against non-human behaviour.": "constitutive", "They shall be stored for no longer than one year after the end of the extended retention period of the application file, unless they are required for monitoring procedures which have already begun.": "constitutive", "Upon expiry of its retention period, the application file shall automatically be erased from the ETIAS Central System as referred to in Article 54(3) of Regulation (EU) 2018/1240.": "constitutive", "Access shall be withheld or permitted for other categories of staff in accordance with the table set out in the Annex.": "constitutive", "Any security incidents involving CONFIDENTIEL UE/EU CONFIDENTIAL or SECRET UE/EU SECRET information that is carried by staff or couriers shall be reported for subsequent investigation to the Security Directorate of the Directorate-General for Human Resources and Security, via the LSO of the relevant Commission department.": "regulatory", "Both layers shall state the intended recipient's name, job title and address, as well as a return address in case delivery cannot be made.": "constitutive", "CONFIDENTIEL UE/EU CONFIDENTIAL and SECRET UE/EU SECRET documents shall not be left unattended during any breaks in the meeting.": "constitutive", "CONFIDENTIEL UE/EU CONFIDENTIAL and SECRET UE/EU SECRET information shall only be released to a third country or international organisation if the recipient has a need-to-know and the country or international organisation has an appropriate legal or administrative framework in place, such as a security of information agreement or an administrative arrangement with the Commission.": "constitutive", "Documents on removable storage media that are either no longer required, or have been transferred onto an appropriate CIS, shall be securely removed or deleted using approved products or methods.": "constitutive", "However, no more copies shall be made than are strictly necessary.": "constitutive", "In accordance with Article 19(3)(a) of Decision (EU, Euratom) 2015/444, CONFIDENTIEL UE/EU CONFIDENTIAL and SECRET UE/EU SECRET information shall be handled in a Secured Area               (                 8                )              .": "constitutive", "Only the documents to be provided shall be stored on the media.": "constitutive", "Only the necessary number of documents shall be signed for and issued to participants and interpreters, as appropriate, at the start of the discussion.": "constitutive", "Participants shall be reminded that portable electronic devices are to be left outside the meeting room during discussion of CONFIDENTIEL UE/EU CONFIDENTIAL or SECRET UE/EU SECRET items.": "regulatory", "Removable storage media that are used to transport CONFIDENTIEL UE/EU CONFIDENTIAL and SECRET UE/EU SECRET information shall be accompanied by a dispatch note, detailing the removable storage media containing the classified information, as well as all files contained on them, to allow the recipient to make the necessary verifications and to confirm receipt.": "regulatory", "The delivery receipt, which itself shall not be classified, shall quote the reference number, date and copy number of the document, but not the subject.": "constitutive", "The doors shall be closed.": "constitutive", "The inner layer of packaging shall be marked as CONFIDENTIEL UE/EU CONFIDENTIAL or SECRET UE/EU SECRET.": "constitutive", "The operational details of emergency evacuation and destruction plans shall themselves be classified as RESTREINT UE/EU RESTRICTED.": "constitutive", "The parts that remain classified shall be replaced by:                           PART NOT TO BE DECLASSIFIED                        either in the body of the text itself, if the part that remains classified is a part of a paragraph, or as a paragraph, if the part that remains classified is a specific paragraph or more than one paragraph.": "constitutive", "The use of removable storage media shall be strictly controlled and accounted for.": "constitutive", "This Decision shall apply to all Commission departments and in all premises of the Commission.": "constitutive", "Where a classified document is handled or stored electronically on removable storage media, such as USB sticks, CDs or memory cards, the classification marking shall be clearly visible on the displayed information itself, as well as in the filename and on the removable storage medium.": "constitutive", "Where applicable, removable storage media shall be handled in accordance with any security operating procedures relating to the encryption system used.": "constitutive", "Where the originating department no longer exists and its responsibilities have not been taken on by another service, the decision to downgrade or declassify shall be taken jointly by the Heads of Unit or Directors of the recipient Directorates-General.": "constitutive", "Within the Commission, the EUCI Registry managed by the Secretariat-General shall as a general rule be the main point of entry and exit for classified information exchanges with other Union institutions, agencies, bodies and offices.": "constitutive", "\u2014                        The details of the document shall not be discussed over the phone on a non-secured line or in an email.": "constitutive", "\u2014                        The inner layer of packaging shall bear an official seal to indicate that it is an official consignment and is not to undergo security scrutiny.": "constitutive", "This Directive shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "An authorisation concerning goods listed in Annex II shall be an individual authorisation.": "constitutive", "Annex IV shall only comprise goods that could be used for the purpose of capital punishment and have been approved or actually used for capital punishment by one or more third countries that have not abolished capital punishment.": "constitutive", "Article\u00a027            Processing of personal data            Personal data shall be processed and exchanged in accordance with the rules laid down in Regulation (EU)\u00a02016/679 and Regulation (EU)\u00a02018/1725.": "constitutive", "Article\u00a028            Use of information            Without prejudice to Regulation (EC) No\u00a01049/2001 of the European\u00a0Parliament and of the Council             (               14              )            and national legislation on public access to documents, information received pursuant to this Regulation shall be used only for the purpose for which it was requested.": "constitutive", "Article\u00a08            Trade fairs            It shall be prohibited for any natural or legal person, entity or body, including a partnership, whether resident or established in a Member\u00a0State or not, to display or offer for sale any of the goods listed in Annex II in an exhibition or fair taking place in the Union, unless it is demonstrated that, given the nature of the exhibition or fair, such display or offering for sale is neither instrumental in nor promotes the sale or supply of the relevant goods to any person, entity or body in a third country.": "regulatory", "Article\u00a09            Advertising            It shall be prohibited for any natural or legal person, entity or body, including a partnership, that is resident or established in a Member\u00a0State and sells or purchases advertising space or advertising time from within the Union, for any natural person who has the nationality of a Member\u00a0State and sells or purchases advertising space or advertising time from within the Union, and for any legal person, entity or body incorporated or constituted under the law of a Member\u00a0State, that sells or purchases advertising space or advertising time from within the Union, to sell to or purchase from any person, entity or body in a third country advertising space in print media or on the Internet or advertising time on television or radio in relation to goods listed in Annex II.": "regulatory", "Except for the supply of information mentioned in paragraph\u00a02 to the authorities of the other Member\u00a0State and to the Commission, this Article shall be without prejudice to applicable national rules concerning confidentiality and professional secrecy.": "constitutive", "For the purpose of this Regulation Ceuta, Helgoland and Melilla shall be treated as part of the customs territory of the Union.": "constitutive", "If no end-use statement is provided, it shall be up to the exporter to demonstrate who will be the end-user and what use will be made of the goods.": "regulatory", "Pending such verification, the export shall not take place.": "constitutive", "The delegation of power shall be tacitly extended for periods of an identical duration, unless the European\u00a0Parliament or the Council opposes such extension not later than three months before the end of each period.": "constitutive", "The discussions in the group shall be kept confidential;                                  (b)                        information on the measures taken by the Member\u00a0States pursuant to Article\u00a033(1) and notified to the Commission pursuant to Article\u00a033(2).": "constitutive", "The power to adopt delegated acts referred to in Article\u00a024 shall be conferred on the Commission for a period of five years from\u00a016\u00a0December\u00a02016.": "constitutive", "The refusal to grant an authorisation, if it is based on a national prohibition adopted in accordance with Article\u00a014(1), shall not constitute an authorisation refused within the meaning of paragraphs\u00a01, 2 and\u00a03 of this Article.": "regulatory", "The rules laid down in the second and third subparagraphs shall apply to the verification of the intended end-use and the risk of diversion.": "constitutive", "This Regulation shall have the same territorial scope of application as the Treaties, except for the first subparagraph of Article\u00a03(1), the first subparagraph of Article\u00a04(1), Articles\u00a05, 11, 13, 14, 16 and\u00a018, Article\u00a020(1) to\u00a0(4) and Article\u00a022, which shall apply to:                          \u2014                        the customs territory of the Union;                                  \u2014                        the Spanish territories of Ceuta and Melilla;                                  \u2014                        the German territory of Helgoland.": "constitutive", "This report shall not include information the disclosure of which a Member\u00a0State considers to be contrary to the essential interests of its security.": "constitutive", "When deciding on applications for an authorisation for the supply of technical assistance related to goods listed in Annex III, the criteria set out in Article\u00a012 shall be taken into account to assess:                          (a)                        whether the technical assistance would be supplied to a person, entity or body that might use the goods to which the technical assistance relates for torture or other cruel, inhuman or degrading treatment or punishment; and                                  (b)                        whether the technical assistance would be used to repair, develop, manufacture, test, maintain or assemble goods listed in Annex III for, or to supply technical assistance to, a person, entity or body that might use the goods to which the technical assistance relates for torture or other cruel, inhuman or degrading treatment or punishment.": "constitutive", "An application shall be made to the Commission and shall include:                          (a)                        the name of, and contact person for, the manufacturer;                                  (b)                        evidence that the manufacturer is eligible for a derogation under paragraph 1;                                  (c)                        details of the passenger cars or light commercial vehicles which it manufactures including the test mass and specific emissions of CO                       2                      of those passenger cars or light commercial vehicles; and                                  (d)                        a specific emissions target consistent with its reduction potential, including the economic and technological potential to reduce its specific emissions of CO                       2                      and taking into account the characteristics of the market for the type of passenger car or light commercial vehicle manufactured.": "regulatory", "Applications for a derogation, including the information supporting it, notifications under paragraph 5, revocations under paragraph 6, any imposition of an excess emissions premium under paragraph 7 and measures adopted pursuant to paragraph 8, shall be made publicly available, subject to Regulation (EC) No 1049/2001 of the European Parliament and of the Council               (                 19                )              .": "constitutive", "As part of the review referred to in paragraph 1 of this Article, the Commission shall evaluate the possibility to assign the revenue from the excess emissions premiums to a specific fund or a relevant programme, with the objective to ensure a just transition towards a climate-neutral economy as referred to in Article 4.1 of the Paris Agreement, in particular to support re-skilling, up-skilling and other skills training and reallocation of workers in the automotive sector in all affected Member States, in particular in the regions and the communities most affected by the transition.": "regulatory", "Entry into force            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "For the purposes of determining each manufacturer's average specific emissions of CO               2              , the following percentages of each manufacturer's new passenger cars registered in the relevant year shall be taken into account:                          \u2014                        95\u00a0% in 2020,                                  \u2014                        100\u00a0% from 2021 onwards.": "regulatory", "From 1\u00a0January 2025, a zero- and low-emission vehicles' benchmark equal to a 15\u00a0% share of the respective fleets of new passenger cars and new light commercial vehicles shall apply in accordance with points 6.3 of Parts A and B of Annex I, respectively.": "constitutive", "It shall apply from 1\u00a0January 2020.": "constitutive", "It shall take effect the day following the publication of the decision in the               Official Journal of the European Union              or at a later date specified therein.": "constitutive", "Paragraph 5 shall not apply where all the manufacturers included in the pool are part of the same group of connected manufacturers.": "constitutive", "Such technologies shall be taken into consideration only if the methodology used to assess them is capable of producing verifiable, repeatable and comparable results.": "constitutive", "The M               0              and TM               0              values referred to in Parts A and B of Annex I shall be adjusted as follows:                          (a)                        by 31\u00a0October 2020, the M                       0                      value in point 4 of Part A of Annex I shall be adjusted to the average mass in running order of all new passenger cars registered in 2017, 2018, and 2019.": "constitutive", "The excess emissions premium under paragraph 1 shall be calculated using the following formula:                              (Excess emissions \u00d7 EUR 95) \u00d7 number of newly registered vehicles.": "constitutive", "The list published under paragraph 1 of this Article shall also indicate whether the manufacturer has complied with the requirements of Article 4 with respect to the preceding calendar year.": "constitutive", "Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2).": "constitutive", "Upon application by a supplier or a manufacturer, CO               2              savings achieved through the use of innovative technologies or a combination of innovative technologies (\u2018innovative technology packages\u2019) shall be considered.": "constitutive", "Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No\u00a0182/2011 shall apply.": "regulatory", "For the purposes of triggering inadmissibility and calculating the duration of the inadmissibility period, only offences committed as from 1\u00a0January 2013 and for which a decision was adopted within the meaning of paragraph 1 shall be taken into account.": "regulatory", "It shall apply from 1\u00a0September 2019.": "constitutive", "Amendments to Regulation (EC) No\u00a0595/2009            Regulation (EC) No\u00a0595/2009 is amended as follows:                        (1)                      in Article 2, first paragraph, the following sentence is added:                    \u2018It shall also apply, for the purpose of Articles 5a, 5b, and 5c, to vehicles of categories O                     3                    and O                     4                    .\u2019;                                (2)                      the following Articles are inserted:                      \u2018Specific requirements for manufacturers with regard to the environmental performance of vehicles of categories M                       2                      , M                       3                      , N                       2                      , N                       3                      , O                       3                      and O                       4                          1.": "constitutive", "For the purpose of determining a manufacturer\u2019s compliance with its specific CO               2              emissions targets in the reporting periods of the years 2025 to 2029, account shall be taken of its emission credits or emission debts determined in accordance with point 5 of Annex I, which correspond to the number of new heavy-duty vehicles, excluding vocational vehicles, of the manufacturer in a reporting period, multiplied by:                          (a)                        the difference between the CO                       2                      emissions reduction trajectory as referred to in paragraph 2 and the average specific CO                       2                      emissions of that manufacturer, if that difference is positive (\u2018emission credits\u2019); or                                  (b)                        the difference between the average specific CO                       2                      emissions and the specific CO                       2                      emissions target of that manufacturer, if that difference is positive (\u2018emission debts\u2019).": "regulatory", "That additional weight shall be indicated in the official proof required in accordance with Article 6.": "constitutive", "That specific CO             2            emissions target shall be the sum, over all vehicle sub-groups, of the products of the following values:                        (a)                      the CO                     2                    emissions reduction target referred to in point (a) or (b) of the first paragraph of Article 1, as applicable;                                (b)                      the reference CO                     2                    emissions;                                (c)                      the manufacturer\u2019s share of vehicles in each vehicle sub-group;                                (d)                      the annual mileage and payload weighting factors applied to each vehicle sub-group.": "constitutive", "The 2030 target shall be assessed in accordance with the European Union commitments under the Paris Agreement.": "constitutive", "The date of simulation shall be the date reported in accordance with data entry 71 in point 2 of Part B of Annex I.\u2019;                                  (4)                      in Article 10, paragraph 1 is replaced by the following:                      \u20181.": "constitutive", "The report referred to in paragraph 1 of this Article shall also, in particular, include the following:                          (a)                        an assessment of the effectiveness of the system of emission credits and emission debts referred to in Article 7 and the appropriateness of extending its application to 2030 and beyond;                                  (b)                        an assessment of the deployment of zero- and low-emission heavy-duty vehicles, taking into account the targets set out in Directive 2009/33/EC, as well as relevant parameters and conditions affecting the placing on the market of such heavy-duty vehicles;                                  (c)                        an assessment of the effectiveness of the incentive mechanism for zero- and low-emission heavy-duty vehicles set out in Article 5 and the appropriateness of its different elements, with a view to adjusting it for the period after 2025 towards a possible differentiation by zero-emission driving range and vehicle sub-group, combined with mileage payload weighting factors, with a date of application that provides at least three years of lead time;                                  (d)                        an assessment of the roll-out of the necessary recharging and refuelling infrastructure, of the possibility of introducing engine CO                       2                      emission performance standards, in particular for vocational vehicles, and of the real-world representativeness of the CO                       2                      emission and fuel consumption values determined in accordance with Regulation (EU) 2017/2400;                                  (e)                        strictly for the purpose of this Regulation, considerations of heavy-duty vehicles and vehicle combinations taking into account weights and dimensions applicable to national transport, for example modular and intermodal concepts, while also assessing possible transport safety and efficiency aspects, intermodal, environmental, infrastructural and rebound effects as well as the geographical situation of Member States;                                  (f)                        an assessment of the VECTO simulation tool to ensure that this tool is updated continually and in a timely manner;                                  (g)                        an assessment of the possibility of developing a specific methodology to include the potential contribution to CO                       2                      emissions reductions of the use of synthetic and advanced alternative liquid and gaseous renewable fuels, including e-fuels, produced with renewable energy and meeting the sustainability and greenhouse gas emissions saving criteria referred to in Directive (EU) 2018/2001 of the European Parliament and of the Council                       (                         17                        )                      ;                                  (h)                        an assessment of the feasibility of introducing an open, transparent and non-discriminatory pooling mechanism between manufacturers;                                  (i)                        an assessment of the level of the excess CO                       2                      emissions premium to ensure that it exceeds the average marginal costs of the technologies needed to meet the CO                       2                      emissions targets.": "constitutive", "Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 16(2) of this Regulation.": "constitutive", "Paragraph 1 shall apply also in respect of commercial air transport operators operating fewer than 243 flights per period of three consecutive four-month periods that depart from or arrive in an aerodrome situated in the territory of a Member State.": "constitutive", "This Regulation shall enter into force on the twentieth day following its publication in the             Official Journal of the European Union            .": "constitutive", "A delegated act adopted pursuant to Article 3(7), Article 4(1) and Article 6(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.": "constitutive", "Data collected under this Regulation shall be based on representative samples drawn from sampling frames set up at national level that allow persons or households to be selected at random, with a known probability of selection.": "constitutive", "For points (b) and (c) of the first subparagraph, the number of detailed topics that may be changed shall be rounded up to the nearest integer.": "constitutive", "For the purpose of a derogation or authorisation as referred to in paragraphs 1 to 4, a Member State shall submit a duly justified request to the Commission by 4 February 2020, within three months of the date of entry into force of the delegated or implementing act concerned, or six months before the end of the period for which a current derogation or authorisation has been granted.": "regulatory", "It shall apply from 1 January 2021.": "constitutive", "Pre\u2010checked aggregated data shall be transmitted for the compilation of monthly unemployment statistics.": "regulatory", "Such derogations shall not be granted on the same grounds as the authorisations referred to in paragraphs 3 and 4.": "constitutive", "That additional information shall be provided in the form of quality reports that demonstrate, in particular, how the data and microdata transmitted, and the metadata and information, meet the quality requirements.": "constitutive", "The Union financial contribution referred to in paragraph 1 of this Article under the Multiannual Financial Framework 2014 to 2020 shall be provided in accordance with Article 7 of Regulation (EU) No 99/2013 of the European Parliament and of the Council               (                 21                )              , point (a) of Article 16(1) of Regulation (EU) No 1296/2013 of the European Parliament and of the Council               (                 22                )              , Article 6 of Regulation (EU) No 1291/2013 of the European Parliament and the Council               (                 23                )              , Article 58 of Regulation (EU) No 1303/2013 of the European Parliament and of the Council               (                 24                )              , Article 5 of Regulation (EU) No 282/2014 of the European Parliament and of the Council               (                 25                )              , or Article 6 of Regulation (EU) 2017/825 of the European Parliament and of the Council               (                 26                )              .": "constitutive", "The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.": "constitutive", "The financial resources shall be re\u2010evaluated in light of developments with regard to the implementation of this Regulation.": "constitutive", "The sampling frames shall contain all the information necessary for the sample design, such as information needed for stratification purposes and for contacting the persons or households.": "constitutive", "The statistics shall be grouped in accordance with the Annex.\u2019;                                  (2)                      Article 4 is replaced by the following:                        \u2018                      Domain                        This Regulation shall cover the enterprises and the information society domain, as defined in the Annex.\u2019;                                  (3)                      in Article 8, paragraph 1 is replaced by the following:                      \u20181.": "constitutive", "Transitional arrangements for implementing measures            The implementing measures adopted before 1 January 2021 pursuant to Regulations (EC) No 808/2004, (EC) No 452/2008 and (EC) No 1338/2008 shall continue to apply until they have expired or have been replaced or repealed.": "constitutive", "For each relevant currency, the technical information used to calculate the best estimate in accordance with Article 77 of Directive 2009/138/EC, the matching adjustment in accordance with Article 77c of that Directive and the volatility adjustment in accordance with Article 77d of that Directive shall be the following:                          (a)                        the relevant risk-free rate term structures set out in Annex I;                                  (b)                        the fundamental spreads for the calculation of the matching adjustment set out in Annex II;                                  (c)                        for each relevant national insurance market, the volatility adjustments set out in Annex III.": "constitutive", "Principal payments from maturing marketable debt securities issued by international organisations and multilateral development banks shall be reinvested by purchasing eligible marketable debt securities issued by international organisations and multilateral development banks.": "regulatory", "Subject to the requirements laid down in this Article, euro-denominated marketable debt securities issued by central, regional or local governments of a Member State whose currency is the euro, recognised agencies located in the euro area, international organisations located in the euro area and multilateral development banks located in the euro area shall be eligible for purchases by the Eurosystem central banks under the PSPP.": "constitutive", "The reinvestment of principal payments shall be distributed over the year to allow for a regular and balanced market presence.": "constitutive", "It shall apply from 1 March 2020.": "constitutive", "The position to be taken on behalf of the Union within the International Maritime Organization\u2019s Marine Environment Protection Committee during its 75             th            session shall be to support the adoption of the amendments to regulations 2, 14 and 18 and appendices I and VI of Annex VI to the International Convention for the Prevention of Pollution from Ships, as laid down in the Annex to IMO document MEPC 75/3.": "regulatory", "Definitions            For the purposes of this Decision, the definitions contained in Regulation (EU) No 468/2014 of the European Central Bank (ECB/2014/17)             (               3              )            shall apply.": "constitutive", "Identification of pending procedures shall include procedures pertaining to the exercise of the tasks in the areas referred to in Article 4(1)(a) and 4(1)(c) of Regulation (EU) No 1024/2013.": "constitutive", "The loan shall have a maximum average maturity of 15 years.": "constitutive", "This Decision shall apply until 27 October 2021.": "constitutive", "This Decision shall apply from 1 January 2021 until 31 December 2026.": "constitutive", "The standards for the medical fitness referred to in Article 23(6) of Directive (EU) 2017/2397 shall be those laid down in Annex IV to this Directive.": "constitutive", "Quota exhaustion            The fishing quota allocated to Spain for the stock of white marlin in the Atlantic Ocean for 2020 referred to in the Annex shall be deemed to be exhausted from the date set out in that Annex.": "constitutive", "For operations for which the beneficiary is reimbursed on the basis of simplified cost options and where the implementation of the actions constituting the basis for reimbursement is suspended as a result of the outbreak of COVID-19, the Member State concerned may reimburse the beneficiary on the basis of the outputs planned for the period of the suspension, even if no actions are delivered, provided that all of the following conditions are met:                                    (a)                                  the implementation of the actions is suspended after 31 January 2020;                                            (b)                                  the suspension of the actions is due to the outbreak of COVID-19;                                            (c)                                  the simplified cost options correspond to a genuine cost borne by the beneficiary, which shall be demonstrated by the beneficiary, and cannot be recovered or compensated for; for recoveries and compensation which are not provided by the Member State, the Member State may consider this condition to be met on the basis of a declaration by the beneficiary; recoveries and compensation shall be deducted from the amount corresponding to the simplified cost option;                                            (d)                                  the reimbursement to the beneficiary is limited to the period of the suspension of the actions.": "constitutive", "This Regulation shall enter into force on the day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "Where the implementation of operations is suspended as a result of the outbreak of COVID-19, a Member State may consider the expenditure during the suspension to be eligible expenditure even if no services are delivered, provided that all of the following conditions are met:                                    (a)                                  the implementation of the operation is suspended after 31 January 2020;                                            (b)                                  the suspension of the operation is due to the outbreak of COVID-19;                                            (c)                                  the expenditure has been incurred and paid;                                            (d)                                  the expenditure constitutes a genuine cost to the beneficiary and cannot be recovered or compensated for; for recoveries and compensation which are not provided by the Member State, the Member State may consider this condition to be met on the basis of a declaration by the beneficiary; recoveries and compensation shall be deducted from the expenditure;                                            (e)                                  the expenditure is limited to the period of the suspension of the operation.": "constitutive", "Delegated Regulation (EU) 2016/1238 and Implementing Regulation (EU) 2016/1240 shall apply save as otherwise provided for in this Regulation.": "constitutive", "Each application shall refer to the products listed in the Annex, indicating the relevant CN code.": "constitutive", "Security            When submitting an application for aid for the products eligible for aid, the amount of the security required in accordance with Article 4(b) of Delegated Regulation (EU) 2016/1238 shall be EUR 100/tonne.": "constitutive", "By way of derogation from the second sentence of Article 62(3) of Regulation (EU) No 1308/2013, those wine growers who hold replanting authorisations that have expired or will expire in 2020 shall not be subject to administrative penalty referred to in Article 89(4) of Regulation (EU) No 1306/2013, under the conditions that they inform the competent authorities by 31 December 2020 that they do not intend to make use of their authorisation and do not wish to benefit from the extension of their validity referred to in paragraph 3 of this Article.": "regulatory", "Wine growers benefitting from the extension referred to in paragraph 1 shall not be eligible for support for green harvesting referred to in Article 47 of Regulation (EU) No 1308/2013 on either the newly planted area or the area which is due to be grubbed up.": "constitutive", "If the total value of the assets of a less significant branch cannot be determined on the basis of the prudential reporting, it shall be determined on the basis of statistical data reported pursuant to Regulation (EU) No 1071/2013 of the European Central Bank                 (                   *1                  )                .": "regulatory", "If the total value of the assets cannot be determined on the basis of the prudential consolidated reporting, it shall be determined on the basis of the most recent audited consolidated annual accounts, and if those annual accounts are not available, on the basis of the consolidated annual accounts prepared in accordance with applicable national accounting laws.": "regulatory", "For the purposes of paragraphs 1 and 2, a Member State shall submit a duly justified request to the Commission by 13 October 2020 or within three months of the date of entry into force of the implementing act concerned, or six months before the end of the period for which the current derogation was granted, as appropriate.": "regulatory", "That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council                             (                               *8                              )                            .": "regulatory", "They shall relate to reference periods of one calendar month and shall be supplied to the Commission (Eurostat) within two months of the end of the reference month.": "constitutive", "Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2) no later than 18 months before the end of the reference period, where the data refer to a calendar year, and no later than six months before the end of the reference period, where the data refer to a period of less than a year.\u2019;                            (11)\u00a0\u00a0\u00a0Article 11 is replaced by the following:                          \u2018Committee procedure                            1.": "constitutive", "The Union contribution through payment of the final balance in the final accounting year shall not exceed the total Union contribution to each programme as laid down in the Commission implementing decision approving the programme.\u2019;                                    (9)                      Article 77 is amended as follows:                                (a)                              in paragraph 5, \u201830 September 2024\u2019 is replaced by \u201815 February 2025\u2019;                                        (b)                              the following paragraph 6 is added:                              \u20186.": "constitutive", "Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis        Articles 66 and 67 shall not apply to radiopharmaceuticals used as diagnostic investigational medicinal products or as diagnostic auxiliary medicinal products.": "regulatory", "The application of Article 3 of Implementing Regulation (EU) 2020/595 shall be suspended for the period from 10 July 2020 to 16 July 2020.": "constitutive", "This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union.": "constitutive", "Articles 1 and 2, Article 43 and Articles 48 to 54 and Article 56 of Delegated Regulation (EU) 2016/1149 and Articles 1, 2 and 3, Articles 19 to 23, Article 25, Articles 27 to 31, the second subparagraph of Article 32(1) and Articles 33 to 40 of Commission Implementing Regulation (EU) 2016/1150                               (                                 *3                                )                              shall apply                               mutatis mutandis                              to the support for distillation of wine in case of crisis.": "constitutive", "Entry into force and application            This Regulation shall enter into force on the day of its publication in the             Official Journal of the European Union            .": "constitutive", "In less developed regions, the Union contribution to the costs of restructuring and conversion shall not exceed 90 %.\u2019;                                  (7)                      in Article 7, paragraph 2 is replaced by the following:                      \u20182.": "constitutive", "The selection of the EGE\u2019s members shall be carried out following a public call for applications to be published on the Register of Commission expert groups and other similar entities (\u2018the Register of expert groups\u2019).": "regulatory", "Annex I shall contain, where available, the information necessary to identify the natural or legal persons, entities or bodies concerned.": "regulatory", "It shall be prohibited to participate, knowingly and intentionally, in activities the object or effect of which is to circumvent the measures referred to in Article 3.": "regulatory", "This Regulation shall apply:                        (a)                      within the territory of the Union, including its airspace;                                (b)                      on board any aircraft or vessel under the jurisdiction of a Member State;                                (c)                      to any natural person inside or outside the territory of the Union who is a national of a Member State;                                (d)                      to any legal person, entity or body, inside or outside the territory of the Union, which is incorporated or constituted under the law of a Member State;                                (e)                      to any legal person, entity or body in respect of any business done in whole or in part within the Union.": "constitutive", "This Decision shall take effect on the date of its notification.": "constitutive", "All relevant documents, including the agendas, the minutes and the participants\u2019 submissions, shall be made available either on the Register of expert groups or via a link from the Register to a dedicated website, where this information can be found.": "regulatory", "Each opinion shall be transmitted to the President of the Commission or to a representative designated by the President.": "constitutive", "Exceptions to publication shall only be foreseen where it is deemed that disclosure of a document would undermine the protection of a public or private interest as defined in Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council               (                 6                )              .": "constitutive", "In principle, the group shall adopt its opinions and statements by consensus.": "constitutive", "Participants in the activities of the EGE and its sub-groups shall not be remunerated for the services they offer.": "regulatory", "Submission of a duly completed DOI form shall be necessary in order to be eligible to be appointed as a member in a personal capacity.": "constitutive", "The Identification Committee shall consist of three members, appointed by the member of the Commission responsible for the Commission department providing the secretariat of the EGE and supported by a secretariat provided by the responsible Commission department.": "regulatory", "The working procedures, based on the rules of procedure, shall seek to ensure that all members may take an active role in the activities of the group.": "constitutive", "Amendments to Implementing Decision (EU) 2015/686            Implementing Decision (EU) 2015/686 is amended as follows:                        (1)                      Article 7 is replaced by the following:                      \u2018Authorisation holder                      The authorisation holder shall be Bayer Agriculture BV, Belgium, representing Bayer CropScience LP, United States.\u2019;                                  (2)                      Article 9 is replaced by the following:                      \u2018Addressee                      This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.\u2019;                                  (3)                      point (a) of the Annex is replaced by the following:                                \u2018(a)                              Applicant and authorisation holder:                            Name: Bayer Agriculture BV                            Address: Scheldelaan 460, 2040 Antwerp, Belgium                            On behalf of Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States.\u2019                              Amendments to Implementing Decision (EU) 2015/687            Implementing Decision (EU) 2015/687 is amended as follows:                        (1)                      Article 6 is replaced by the following:                      \u2018Authorisation holder                      The authorisation holder shall be Bayer Agriculture BV, Belgium, representing Bayer CropScience LP, United States.\u2019;                                  (2)                      Article 8 is replaced by the following:                      \u2018Addressee                      This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.\u2019;                                  (3)                      point (a) of the Annex is replaced by the following:                                \u2018(a)                              Applicant and authorisation holder:                            Name: Bayer Agriculture BV                            Address: Scheldelaan 460, 2040 Antwerp, Belgium                            On behalf of Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States\u2019.": "regulatory", "Amendments to Implementing Decision (EU) 2016/1216            Implementing Decision (EU) 2016/1216 is amended as follows:                        (1)                      Article 6 is replaced by the following:                      \u2018Authorisation holder                      The authorisation holder shall be Bayer Agriculture BV, Belgium, representing Bayer CropScience LP, United States.\u2019;                                  (2)                      Article 8 is replaced by the following:                      \u2018Addressee                      This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.\u2019;                                  (3)                      point (a) of the Annex is replaced by the following:                                \u2018(a)                              Applicant and authorisation holder:                            Name: Bayer Agriculture BV                            Address: Scheldelaan 460, 2040 Antwerp, Belgium                            On behalf of Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States\u2019.": "regulatory", "Amendments to Implementing Decision (EU) 2018/1111            Implementing Decision (EU) 2018/1111 is amended as follows:                        (1)                      Article 7 is replaced by the following:                      \u2018Authorisation holder                      The authorisation holder shall be Bayer Agriculture BV, Belgium, representing Bayer CropScience LP, United States.\u2019;                                  (2)                      Article 10 is replaced by the following:                      \u2018Addressee                      This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.\u2019;                                  (3)                      point (a) of the Annex is replaced by the following:                                \u2018(a)                              Applicant and authorisation holder:                            Name: Bayer Agriculture BV                            Address: Scheldelaan 460, 2040 Antwerp, Belgium                            On behalf of Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States\u2019.": "regulatory", "Amendments to Implementing Decision (EU) 2019/1308            Implementing Decision (EU) 2019/1308 is amended as follows:                        (1)                      Article 7 is replaced by the following:                      \u2018Authorisation holder                      The authorisation holder shall be Bayer CropScience LP, United States, represented in the Union by Bayer Agriculture BV, Belgium.\u2019;                                  (2)                      Article 9 is replaced by the following:                      \u2018Addressee                      This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.\u2019;                                  (3)                      point (a) of the Annex is replaced by the following:                                \u2018(a)                              Applicant and authorisation holder:                            Name: Bayer CropScience LP                            Address: 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States                            Represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium\u2019.": "regulatory", "Amendments to Implementing Decision 2012/347/EU            Implementing Decision 2012/347/EU is amended as follows:                        (1)                      Article 6 is replaced by the following:                      \u2018Authorisation holder                      The authorisation holder shall be Bayer CropScience LP, United States of America, represented in the Union by Bayer Agriculture BV, Belgium.\u2019;                                  (2)                      Article 8 is replaced by the following:                      \u2018Addressee                      This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.\u2019;                                  (3)                      point (a) of the Annex is replaced by the following:                                \u2018(a)                              Applicant and authorisation holder:                            Name: Bayer CropScience LP                            Address: 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States                            Represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.\u2019                              Amendments to Implementing Decision 2013/649/EU            Implementing Decision 2013/649/EU is amended as follows:                        (1)                      Article 5 is replaced by the following:                      \u2018Authorisation holder                      The authorisation holder shall be Bayer Agriculture BV, Belgium, representing Bayer CropScience LP, United States.\u2019;                                  (2)                      Article 7 is replaced by the following:                      \u2018Addressee                      This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.\u2019;                                  (3)                      point (a) of the Annex is replaced by the following:                                \u2018(a)                              Applicant and authorisation holder:                            Name: Bayer Agriculture BV                            Address: Scheldelaan 460, 2040 Antwerp, Belgium                            On behalf of Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States\u2019.": "regulatory", "Article\u00a05            The Agreement shall not be construed as conferring rights or imposing obligations that can be directly invoked before Union or Member State courts and tribunals.": "constitutive", "Article\u00a02            This Decision shall enter into force on the date of its adoption.": "constitutive", "The Council may decide that the EUSR\u2019s mandate be terminated earlier, based on an assessment of the Political and Security Committee (PSC) and a proposal from the High Representative of the Union for Foreign Affairs and Security Policy (HR).\u2019;                                  (2)                      in Article\u00a014, the second paragraph is replaced by the following:                    \u2018The final comprehensive mandate implementation report of the EUSR shall be presented by 30\u00a0April 2021.\u2019.": "constitutive", "Article\u00a02            This Decision shall enter into force on the date of its publication in the             Official Journal of the European\u00a0Union            .": "constitutive", "Specified fruits originating in Argentina shall be introduced into the Union only if all of the following conditions are fulfilled:                                    (a)                                  the specified fruits have been produced in fields of production, consisting of one or more production units, which have been identified as unique and physically distinct parts of a field of production, and both the field of production and its production units have been officially approved by the National Plant Protection Organisation of Argentina for the purpose of export to the Union;                                            (b)                                  the approved fields of production and the production units thereof have been registered by the National Plant Protection Organisation of Argentina under respective unique identification codes (\u2018traceability codes\u2019);                                            (c)                                  the specified fruits have been produced in an approved production unit, which has undergone treatments and cultural measures, effective against                                 Phyllosticta citricarpa                                , at the appropriate time since the beginning of the last cycle of vegetation and their application has been verified under the official supervision of the National Plant Protection Organisation of Argentina;                                            (d)                                  official inspections, consisting in visual observations and, if symptoms are detected, sampling to test for the presence of                                 Phyllosticta citricarpa                                , have been carried out in the approved production units during the growing season, and no symptoms of                                 Phyllosticta citricarpa                                have been detected on the specified fruits since the beginning of the last cycle of vegetation;                                            (e)                                  a sample has been taken:                                            (i)                                          upon arrival to the packing facilities, prior to processing, of 200-400 fruits per lot of specified fruits, defined upon arrival in the packing facility;                                                    (ii)                                          along the line between arrival and packing in the packing facilities, of at least 1\u00a0% per lot of specified fruits defined in the packing line;                                                    (iii)                                          before departure from the packaging facility, of at least 1% per lot of specified fruits, defined after packing;                                                    (iv)                                          prior to export, as part of the final official inspection to issue the phytosanitary certificate, of at least 1\u00a0% per lot of specified fruits prepared for export;                                                    (f)                                  all of the specified fruits referred to in point (e) have been sampled, as far as possible, on the basis of any apparent symptom of                                 Phyllosticta citricarpa                                , and all of the sampled fruits referred to in point (e)(i) have been found free from                                 Phyllosticta citricarpa                                on the basis of visual inspections, whereas all of the sampled fruits referred to in point (e)(ii), (iii) and (iv) which showed symptoms of                                 Phyllosticta citricarpa                                , have been tested and found free from                                 Phyllosticta citricarpa                                ;                                            (g)                                  the specified fruits have been transported in packages with each package bearing a label with the traceability code of the production unit from which they originate;                                            (h)                                  before the start of the export season of the specified fruits, the National Plant Protection Organisation of Argentina has communicated to the Commission the list of approved production units per field of production, as well as the names of professional operators responsible for each approved field of production, and any updates related to the changes to that list, including the reason for those changes, have been immediately communicated to the Commission;                                            (i)                                  the specified fruits are accompanied by a phytosanitary certificate, which includes the number of packages from each production unit and, under the heading \u201cAdditional Declaration\u201d, the relevant traceability codes and the following statement: \u201cThe consignment complies with Article\u00a05b of Commission Implementing Decision (EU) 2016/715\u201d.": "constitutive", "Article\u00a01            Article\u00a010 of Decision (CFSP) 2019/797 is replaced by the following:                \u2018Article\u00a010                This Decision shall apply until 18\u00a0May 2022 and shall be kept under constant review.": "constitutive", "It shall apply from 17\u00a0April 2021.": "constitutive", "Article\u00a03            This Decision shall enter into force on the date of its adoption.": "constitutive", "For that purpose, it shall conclude the necessary agreement with UNODA.": "constitutive", "Article\u00a02            This Decision shall expire on 31\u00a0December 2024.": "constitutive", "Article\u00a01            The position to be taken on the Union\u2019s behalf in the 185th session of the UNECE World Forum for Harmonisation of Vehicle Regulations to be held between 23 and 25\u00a0November 2021 shall be to vote in favour of the proposals for modifications to UN Regulations Nos 0, 14, 16, 22, 24, 37, 45, 48, 49, 55, 58, 67, 79, 83, 86, 90, 94, 95, 100, 101, 110, 116, 118, 125, 128, 129, 133, 134, 135, 137, 145, 149, 150, 151, 152, 153, 157, 158 and\u00a0159, of the proposals for amendments to Consolidated Resolutions R.E.3 and R.E.5, of the proposals for amendments to Mutual Resolutions M.R.1 and M.R.2, and of the proposals for authorisations to amend UN GTR on pedestrian safety, and to develop UN GTRs on Global Real Driving Emissions and on brake particulate emissions.": "regulatory", "Article\u00a04            This Decision shall enter into force on the date of its adoption.": "constitutive", "This shall enable each part to be handled appropriately when detached from the other components.": "regulatory", "Article\u00a02            This Decision shall enter into force on the day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "The \u2018Union database on supply chain security \u2014 security equipment\u2019 shall be updated accordingly.": "constitutive", "Where it is possible to do so without compromising IT security, the Commission shall ensure that the data subjects are informed individually in an appropriate format.": "regulatory", "They shall apply those provisions from 1\u00a0July 2022.": "constitutive", "Derogation            The first subparagraph of Article 4(1), the first subparagraph of Article 13(1) and Article 13(2) of Regulation (EC) No 1967/2006 shall not apply in the territorial waters of France adjacent to the coast of the Provence-Alpes-C\u00f4te d\u2019Azur region to \u2018gangui\u2019 trawlers fulfilling the following requirements:                        (a)                      bearing a registration number mentioned in the French management plan adopted by France in accordance with Article 19 of Regulation (EC) No 1967/2006;                                (b)                      having a track record in the fishery of more than five years and not involving any future increase in fishing effort provided;                                (c)                      holding a fishing authorisation and operating under the management plan adopted by France in accordance with Article 19 of Regulation (EC) No 1967/2006.": "constitutive", "Article\u00a02            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "The rate of the definitive anti-dumping duty applicable to the net, free-at-Union-frontier price, before duty, of the products described in paragraph 1 and produced by the companies listed below, shall be as follows:                           Company                        Duty rate (%)                        TARIC additional code                          Guangdong Haomei New Materials Co., Ltd.                        21,2                        C562                          Guangdong King Metal Light Alloy Technology Co., Ltd.                        21,2                        C563                          Press Metal International Ltd.                        25,0                        C564                          Press Metal International Technology Ltd.                        25,0                        C565                          Other cooperating companies listed in Annex                        22,1                              All other companies                        32,1                        C999                        3.": "constitutive", "\u2019 If no such invoice is presented, the duty applicable to all other companies shall apply.": "constitutive", "Article\u00a03            Entry into force and application            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "The persons and entities listed in the Annex to this Regulation shall be added to the list set out in Annex II to Regulation (EU) No 36/2012.": "regulatory", "Those reports shall be made available on the website of the European Union Agency for Railways.": "regulatory", "This shall apply regardless of brand, subtype and the number of markets on which they are placed.": "regulatory", "This shall apply regardless of whether the goods are accompanied by a certificate of origin Form A issued in the beneficiary country or an invoice declaration or a statement on origin made out by the exporter.": "regulatory", "CHAPTER II            TRANSPORT CONTRACT, INFORMATION AND TICKETS              Transport contract            Subject to the provisions of this Chapter, the conclusion and performance of a transport contract and the provision of information and tickets shall be governed by the provisions of Title II and Title\u00a0III of Annex I.": "constitutive", "Details of the complaint-handling procedure shall be accessible to the public, including to persons with disabilities and to persons with reduced mobility.": "constitutive", "Entry into force            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union.": "constitutive", "If those passengers encounter recurrent delays or cancellations during the period of validity of the travel pass or season ticket, they shall be entitled to adequate compensation in accordance with the railway undertaking\u2019s compensation arrangements.": "regulatory", "Information shall be distributed and access shall be provided by appropriate technical means, such as application programming interfaces.": "constitutive", "It shall apply from 7 June 2023.": "constitutive", "Paragraph 1 shall also apply to passengers who hold a travel pass or season ticket.": "constitutive", "References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IV.": "constitutive", "Such a complaint shall be submitted within three months of the incident that it concerns.": "constitutive", "Such reports shall also be made available on the website of the European Union Agency for Railways.": "regulatory", "That common form shall be established in a format which is accessible to persons with disabilities and persons with reduced mobility.": "regulatory", "The adequate number of places for bicycles shall be defined in plans referred to in paragraph 5.": "constitutive", "The calculation of the period of delay shall not take into account any delay that the railway undertaking can demonstrate as having occurred outside the Union.": "constitutive", "The complaint-handling procedure shall be made accessible to persons with disabilities and to persons with reduced mobility.": "constitutive", "The minimum compensation for delays shall be as follows:                          (a)                        25\u00a0% of the ticket price for a delay of 60 to 119 minutes;                                  (b)                        50\u00a0% of the ticket price for a delay of 120 minutes or more.": "constitutive", "The reimbursement and the compensation referred to in paragraph 4 shall be paid within 30 days after the receipt of the request.": "constitutive", "The service quality standards shall at least cover the items listed in Annex III.": "constitutive", "The terms for the operation of the Single Points of Contact shall be established in the access rules referred to in Article 21(1).": "regulatory", "This threshold shall not exceed EUR\u00a04 per ticket.": "constitutive", "Where the available re-routing options are not communicated to the passenger within 100\u00a0minutes from the scheduled departure time of the delayed or cancelled service or the missed connection, the passenger shall be entitled to conclude such a contract with other providers of public transport services by rail, coach or bus.": "regulatory", "Where there are no such plans or the plans do not determine such a number, each train composition shall have at least four places for bicycles.": "regulatory", "Where there is no ticket office or ticketing machine in the station of departure, passengers shall be informed at the station of:                          (a)                        the possibility of purchasing tickets via telephone or the Internet or on board the train, and of the procedure for such purchase;                                  (b)                        the nearest railway station or place at which ticket offices or ticketing machines are available.": "regulatory", "It shall be prohibited to sell, supply, transfer, or export the goods listed in Annex VI, whether such goods originate or not in the Union, to any natural or legal person, entity or body in Belarus or for use in Belarus.": "regulatory", "It shall be prohibited to:                                    (a)                                  provide technical assistance, brokering services or other services related to the goods and technology referred to in paragraph 1 and to the provision, manufacture, maintenance and use of these goods and technology, directly or indirectly to any natural or legal person, entity or body in Belarus, as listed in Annex V;                                            (b)                                  provide financing or financial assistance related to the goods and technology referred to in paragraph 1, including in particular grants, loans and export credit insurance, for any sale, supply, transfer or export of these goods and technology, or for the provision of related technical assistance, brokering services or other services, directly or indirectly to any natural or legal person, entity or body in in Belarus, as listed in Annex V.": "regulatory", "The prohibitions in paragraphs 1 and\u00a02 shall not apply to exports, sale, supplies or transfers of dual-use goods and technology or the related provision of technical or financial assistance, for the maintenance and safety of existing civil nuclear capabilities, for non-military use or for a non-military end user.": "constitutive", "Article\u00a02            The amounts secured by way of the provisional anti-dumping duty under Implementing Regulation (EU) 2021/9 shall be definitively collected.": "constitutive", "The rates of the definitive anti-dumping duty applicable to the net, free-at-Union-frontier price, before duty, of the product described in paragraph 1 and produced by the companies listed below, shall be as follows:                            Country                        Company                        Definitive anti-dumping duty rate                        TARIC additional code                          Turkey                        \u00c7olako\u011flu Metalurji A.\u015e.": "constitutive", "Article\u00a021            Blending operations            Blending operations under the Fund shall be carried out in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation.": "constitutive", "Funding from the thematic facility shall be used for supporting actions in or in relation to third countries, within the objectives of the Fund, in particular in order to contribute to combating and preventing crime, including drug trafficking, trafficking in human beings and combating cross-border criminal smuggling networks.": "constitutive", "ICT systems used in the complementary area referred to in the first subparagraph shall provide data and services for the prevention, detection and investigation of criminal offences.": "constitutive", "Member States may continue after 1\u00a0January 2021 to support a project selected and started pursuant to Regulation (EU) No\u00a0513/2014, in accordance with Regulation (EU) No\u00a0514/2014, provided that all of the following conditions are met:                          (a)                        the project has two phases identifiable from a financial point of view, with separate audit trails;                                  (b)                        the total cost of the project exceeds EUR 500\u00a0000;                                  (c)                        payments made by the responsible authority to beneficiaries for the first phase of the project shall be included in payment requests to the Commission under Regulation (EU) No\u00a0514/2014 and expenditure for the second phase of the project shall be included in payment applications under Regulation (EU) 2021/1060;                                  (d)                        the second phase of the project complies with the applicable law and is eligible for support from the Fund under this Regulation and Regulation (EU) 2021/1060;                                  (e)                        the Member State commits to complete the project, render it operational and report on it in the annual performance report submitted by 15\u00a0February 2024.": "regulatory", "Moreover, the impact of the Fund shall be evaluated.": "constitutive", "Programming as referred to in Article\u00a022(5) of Regulation (EU) 2021/1060 shall be based on the types of intervention set out in Table 2 of Annex VI to this Regulation and shall include an indicative breakdown of the programmed resources by type of intervention within each specific objective set out in Article\u00a03(2) of this Regulation.": "constitutive", "Such equipment and ICT systems shall remain available and deployable for the objectives of the Fund.": "constitutive", "That opinion shall also state whether the audit work puts in doubt the assertions made in the management declarations submitted by the international organisation, including information on suspicions of fraud.": "regulatory", "The Commission decision approving a Member State\u2019s programme shall set the co-financing rate and the maximum amount of support from the Fund for the types of action covered by the contribution referred to in paragraphs 1 to 6.": "constitutive", "The amount referred to in point (b) of Article\u00a07(2) shall be allocated flexibly through a thematic facility, using shared, direct or indirect management as set out in work programmes.": "constitutive", "The contribution from the Union budget shall not exceed 75\u00a0% of the total eligible expenditure for a project.": "constitutive", "The document setting out the conditions for support referred to in Article\u00a073(3) of Regulation (EU) 2021/1060 shall include the requirements set out in this Article.": "constitutive", "The financial envelope for the implementation of the Fund for the period from 1\u00a0January 2021 to 31\u00a0December 2027 shall be EUR 1\u00a0931\u00a0000\u00a0000 in current prices.": "constitutive", "The mid-term evaluation and the retrospective evaluation shall be carried out in a timely manner in order to contribute to the decision-making process, including, where appropriate, to the revision of this Regulation.": "constitutive", "The provisions of this Regulation and of Regulation (EU) 2021/1060 shall apply to the second phase of a project as referred to in the first subparagraph of this paragraph.": "constitutive", "The use of equipment in the complementary area referred to in the first subparagraph shall not exceed 30\u00a0% of the total period of use of that equipment.": "constitutive", "Those resources shall be used for the benefit of the Member State concerned.": "constitutive", "Where reference is made to this paragraph, Article\u00a04 of Regulation (EU) No\u00a0182/2011 shall apply.": "constitutive", "Where the Commission does not provide observations by that deadline, the report shall be deemed to have been accepted.": "constitutive", "Within the specific objectives set out in paragraph 2, the Fund shall be implemented through the implementation measures listed in Annex II.": "constitutive", "It shall apply from 1\u00a0January 2021.": "constitutive", "However, in the case of an entry in the Internal Market Information System subject to the obligation under Article\u00a04(4), if the competent authority fails to comply with that obligation, the entry shall cease to be accessible in the Internal Market Information System on expiry of the deadline set by that Article for compliance with that obligation.": "constitutive", "Information exchanged via the Internal Market Information System in accordance with this Regulation shall remain accessible in the Internal Market Information System for 10 years from whichever of the following dates is the latest one, insofar as they are applicable to the refusal decision in question and taking account of any updates made pursuant to Article\u00a04:                          (a)                        the date recorded in the Internal Market Information System as the date on which the refusal decision was made;                                  (b)                        the date recorded in the Internal Market Information System as the date on which the entry was last updated to confirm that the refusal decision remains in force;                                  (c)                        the date recorded in the Internal Market Information System as the fixed end date of the refusal decision.": "constitutive", "Notwithstanding paragraph 1, for any refusal decision for which a date is recorded in the Internal Market Information System as the date from which revocation of the decision takes effect, the entry shall cease to be accessible in the Internal Market Information System on expiry of the period of 10 years from the date so recorded in the Internal Market Information System as the revocation date.": "constitutive", "Article\u00a01            Delegated Regulation (EU) 2019/2201 is amended as follows:                        (1)                      Article\u00a03 is replaced by the following:                      \u2018Article\u00a03                      Catch trigger level                      The catch trigger level which initiates real-time closures of fisheries under this Regulation shall be 20\u00a0% by number of juveniles of Northern prawn compared to the overall number of Northern prawn, in a sample.\u2019;                                  (2)                      in Article\u00a04, paragraph 1 is replaced by the following:                      \u20181.": "constitutive", "The results from those programmes shall be transmitted to the Commission no later than 6 months following the starting date of the programme and\u00a012 months thereafter.\u2019;                                          (5)                      in Article\u00a011, paragraph 2 is replaced by the following:                      \u20182.": "regulatory", "Article\u00a02            Reduction of the extension            For plant varieties for which one or more national plant variety rights have been granted prior to the grant of a Community plant variety right, but to which Article\u00a0116(4), fourth indent, of Regulation (EC) No\u00a02100/94 does not apply, the extension of the term provided for in Article\u00a01 of this Regulation shall be reduced by the longest period in full calendar years during which any national plant variety right or rights granted have been effective in a Member State in respect of the same variety prior to the grant of the Community plant variety rights.": "constitutive", "Article\u00a02            This Regulation shall enter into force on the day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "Article\u00a02            This Regulation shall enter into force on the date of its publication in the             Official Journal of the European Union            .": "constitutive", "Article\u00a01            Delegated Regulation (EU) 2020/2015 is amended as follows:                        (1)                      Article\u00a01 is replaced by the following:                    \u2018In the Union Waters of North-Western Waters (ICES subareas 5, 6 and\u00a07), of South-Western Waters (ICES subareas 8, 9 and\u00a010 (waters around Azores), and of CECAF zones 34.1.1, 34.1.2 and\u00a034.2.0 (waters around Madeira and the Canary Islands), the landing obligation provided for in Article\u00a015(1) of Regulation (EU) No\u00a01380/2013 shall apply in demersal and pelagic fisheries in accordance with this Regulation for the period 2021-2023.\u2019;                                (2)                      in Article\u00a06(1), the following point (f) is added:                                \u2018(f)                              plaice (                             Pleuronectes platessa                            ) caught in ICES divisions 7b to 7k with seines (SSC);\u2019;                                        (3)                      in Article\u00a010(4), point (b) is replaced by the following:                                \u2018(b)                              caught by bottom trawls in ICES subarea 8 until 31\u00a0December 2022.": "constitutive", "Article\u00a04            This Regulation shall enter into force on the day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "Point (2) of the Annex shall apply from 1\u00a0March 2022.": "constitutive", "Point (3) of the Annex shall apply as follows:                        \u2014                      rows concerning tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane, dichlorodioctylstannane, dioctyltin dilaurate; [1] stannane, dioctyl-, bis(coco acyloxy) derivs.": "constitutive", "Where a substantial modification relates to aspects covered by Parts I and II of the assessment report, the application for authorisation of that substantial modification shall be validated in accordance with Article 17.": "regulatory", "Article\u00a02            The Socialist Republic of Viet Nam shall be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.": "regulatory", "Article\u00a02            This Decision shall apply until 23\u00a0October 2022.": "constitutive", "The prohibitions set out in paragraph\u00a01 shall not apply to:                                  (a)                                public bodies or legal persons, entities or bodies which receive public funding from the Union or Member States, provided that the assistance and services referred to in paragraph\u00a01 are necessary for exclusively humanitarian purposes in the non-government controlled areas of Ukraine referred to in Article\u00a01;                                          (b)                                organisations and agencies which are pillar-assessed by the Union and with which the Union has signed a financial framework partnership agreement on the basis of which the organisations and agencies act as humanitarian partners of the Union, provided that the assistance and services referred to in paragraph 1 are necessary for exclusively humanitarian purposes in the non-government controlled areas of Ukraine referred to in Article\u00a01;                                          (c)                                organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures, provided that the assistance and services referred to in paragraph\u00a01 are necessary for exclusively humanitarian purposes in the non-government controlled areas of Ukraine referred to in Article\u00a01; or                                          (d)                                Member\u00a0States\u2019 specialised agencies, provided that the assistance and services referred to in paragraph\u00a01 are necessary for exclusively humanitarian purposes in the non-government controlled areas of Ukraine referred to in Article\u00a01.": "constitutive", "The GICHD and the AMAT shall perform their tasks under the responsibility of the HR.": "constitutive", "Those reports shall form the basis of the evaluation to be carried out by the Council.": "constitutive", "Article\u00a02            This Decision shall take effect on the day of its notification.": "constitutive", "No\u00a028/REV 3 (Determination of the content of waxes and fatty acid ethyl esters by capillary gas chromatography), shall be to support the decision to include an alternative method of analysis and make some slight changes to the existing method.": "constitutive", "They shall apply those provisions from 1\u00a0October 2022.": "constitutive", "Article\u00a02            Prohibitions            Directed fishing activities for the stock referred to in Article\u00a01 by vessels flying the flag of or registered in a Member State of the European Union shall be prohibited from the date set out in the Annex to this Regulation until 30\u00a0June 2022 included.": "regulatory", "Notwithstanding the first subparagraph, in the case of a Eurodac hit with data recorded pursuant to Article 14 of Regulation (EU) No 603/2013, the request shall be sent within two months of receiving that hit pursuant to Article 15(2) of that Regulation.": "regulatory", "Article\u00a01              (does not concern the English language)                Article\u00a02              (does not concern the English language)                Article\u00a03            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "Article\u00a03            Entry into force            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "CHAPTER IV            GENERAL PROVISIONS              Article\u00a09            Entry into force and application            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "This plan shall cover the official controls on food of animal origin entering the Union and intended to be placed on the Union market and on fishery products which are to be carried out on vessels when these call at a port in a Member State.": "constitutive", "It shall apply from\u00a01\u00a0July 2021 for as long as Regulation (EU) 2021/953 is applicable.\u2019.": "constitutive", "However, Article\u00a02 shall apply from 25\u00a0June 2022.": "constitutive", "Article\u00a02            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union.": "constitutive", "The EU type-approval certificate for a type of the automated driving system of a fully automated vehicle, as referred to in Article\u00a028(1) of Regulation (EU) 2018/858, shall be drawn up in accordance with Annex IV.": "constitutive", "Article\u00a04            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union            .": "constitutive", "A decision of revocation shall put an end to the delegation of power specified in that decision.": "constitutive", "Any measure ordered shall be proportionate to the nature, gravity, recurrence and duration of the infringement, without unduly restricting access to lawful information by recipients of the service concerned.": "constitutive", "Each Member\u00a0State shall have one vote.": "constitutive", "In addition to the information referred to in\u00a0Articles\u00a024(2), the providers of very large online platforms or of very large online search engines shall include in the reports referred to in paragraph\u00a01 of this Article the information on the average monthly recipients of the service for each Member\u00a0State.": "regulatory", "In carrying out the evaluations referred to in paragraph\u00a02, the Commission shall take into account the positions and findings of the European\u00a0Parliament, the Council, and other relevant bodies or sources, and shall pay specific attention to small and medium-sized enterprises and the position of new competitors.": "regulatory", "Recipients of the service, including individuals or entities that have submitted notices, addressed by the decisions referred to in\u00a0Article\u00a020(1) shall be entitled to select any out-of-court dispute settlement body that has been certified in accordance with paragraph\u00a03 of this Article in order to resolve disputes relating to those decisions, including complaints that have not been resolved by means of the internal complaint-handling system referred to in that\u00a0Article.": "regulatory", "Such information provided to the recipient of the service shall include a statement of reasons, the possibilities for redress that exist, and a description of the territorial scope of the order, in accordance with paragraph\u00a02.": "constitutive", "That functionality shall be directly and easily accessible from the specific section of the online platform\u2019s online interface where the information is being prioritised.": "constitutive", "That information shall be easily accessible, and shall be kept up to date.": "constitutive", "That information shall include at least the request or recommendation sent to the Digital Services Coordinator of establishment, the assessment by that Digital Services Coordinator, the reasons for the disagreement and any additional information supporting the referral.": "constitutive", "That information shall include information on any policies, procedures, measures and tools used for the purpose of content moderation, including algorithmic decision-making and human review, as well as the rules of procedure of their internal complaint handling system.": "constitutive", "The Board shall be composed of Digital Services Coordinators who shall be represented by high-level officials.": "regulatory", "The delegation of power referred to in Articles\u00a024, 33, 37, 40 and\u00a043 shall be conferred on the Commission for five years starting from\u00a016\u00a0November 2022.": "constitutive", "The failure of the provider of the online platform or of the online search engine concerned to submit its views pursuant to the third subparagraph shall not prevent the Commission from designating that online platform or that online search engine as a very large online platform or as a very large online search engine, respectively, based on other information available to it.": "constitutive", "The implementing act referred to in paragraph\u00a03 and the delegated act referred to in paragraph\u00a04 shall respect the following principles:                          (a)                        the estimation of the overall amount of the annual supervisory fee takes into account the costs incurred in the previous year;                                  (b)                        the annual supervisory fee is proportionate to the number of average monthly active recipients in the Union of each very large online platform or each very large online search engine designated pursuant to\u00a0Article\u00a033;                                  (c)                        the overall amount of the annual supervisory fee charged on a given provider of very large online platform or very large search engine does not, in any case, exceed\u00a00,05\u00a0% of its worldwide annual net income in the preceding financial year.": "constitutive", "The mechanisms referred to in paragraph\u00a01 shall be such as to facilitate the submission of sufficiently precise and adequately substantiated notices.": "constitutive", "The obligation laid down in the first subparagraph shall be limited to purchases of illegal products or services made within the six months preceding the moment that the provider became aware of the illegality.": "constitutive", "The officials and other accompanying persons authorised by the Commission to conduct an inspection shall be empowered to:                          (a)                        enter any premises, land and means of transport of the provider of the very large online platform or of the very large online search engine concerned or of the other person concerned;                                  (b)                        examine the books and other records related to the provision of the service concerned, irrespective of the medium on which they are stored;                                  (c)                        take or obtain in any form copies of or extracts from such books or other records;                                  (d)                        require the provider of the very large online platform or of the very large online search engine or the other person concerned to provide access to and explanations on its organisation, functioning, IT system, algorithms, data-handling and business practices and to record or document the explanations given;                                  (e)                        seal any premises used for purposes related to the trade, business, craft or profession of the provider of the very large online platform or of the very large online search engine or of the other person concerned, as well as books or other records, for the period and to the extent necessary for the inspection;                                  (f)                        ask any representative or member of staff of the provider of the very large online platform or of the very large online search engine or the other person concerned for explanations on facts or documents relating to the subject-matter and purpose of the inspection and to record the answers;                                  (g)                        address questions to any such representative or member of staff relating to the subject-matter and purpose of the inspection and to record the answers.": "regulatory", "The prohibition in paragraph\u00a01 shall not apply to practices covered by\u00a0Directive\u00a02005/29/EC or Regulation (EU)\u00a02016/679.": "constitutive", "The provider of intermediary services, the intended addressee or addressees and any other third party demonstrating a legitimate interest shall be entitled to participate in the proceedings before the competent judicial authority.": "regulatory", "The publication shall have regard to the rights and legitimate interests of the provider of the very large online platform or of the very large online search engine concerned, any other person referred to in\u00a0Article\u00a067(1) and any third parties in the protection of their confidential information.": "constitutive", "The reports shall be published in at least one of the official languages of the\u00a0Member\u00a0States.": "constitutive", "They shall include, at least:                          (a)                        the criteria which are most significant in determining the information suggested to the recipient of the service;                                  (b)                        the reasons for the relative importance of those parameters.": "regulatory", "This Article shall not affect the possibility for a judicial or administrative authority, in accordance with a Member\u00a0State\u2019s legal system, to require the service provider to terminate or prevent an infringement.": "constitutive", "This Article shall not apply to any orders referred to in\u00a0Article\u00a09.": "constitutive", "This Regulation shall not apply to any service that is not an intermediary service or to any requirements imposed in respect of such a service, irrespective of whether the service is provided through the use of an intermediary service.": "constitutive", "This Section shall not apply to providers of online platforms allowing consumers to conclude distance contracts with traders that previously qualified for the status of a micro or small enterprise as defined in Recommendation\u00a02003/361/EC during the\u00a012\u00a0months following their loss of that status pursuant to\u00a0Article\u00a04(2) thereof, except when they are very large online platforms in accordance with\u00a0Article\u00a033.": "constitutive", "This Section shall not apply to providers of online platforms allowing consumers to conclude distance contracts with traders that qualify as micro or small enterprises as defined in\u00a0Recommendation\u00a02003/361/EC.": "constitutive", "This Section, with the exception of\u00a0Article\u00a024(3) thereof, shall not apply to providers of online platforms that qualify as micro or small enterprises as defined in\u00a0Recommendation\u00a02003/361/EC.": "constitutive", "Those implementing acts shall be adopted in accordance with the advisory procedure referred to in\u00a0Article\u00a088.": "constitutive", "Those reports shall present systemic risks broken down by the Member States in which they occurred and in the Union as a whole, as applicable.": "constitutive", "Time shall begin to run on the day on which the decision becomes final.": "constitutive", "Where a provider of intermediary services fails to appoint a legal representative in accordance with\u00a0Article\u00a013, all Member\u00a0States and, in case of a provider of a very large online platform or very large online search engine, the Commission shall have powers to supervise and enforce in accordance with this\u00a0Article.": "regulatory", "Where reference is made to this paragraph, Article\u00a04 of Regulation (EU)\u00a0No\u00a0182/2011 shall apply.": "constitutive", "For the oils referred to in Part VIII, points 3 and\u00a06, of Annex VII to Regulation (EU) No\u00a01308/2013, no place of origin shall be displayed on the label.": "constitutive", "In the case of import from a third country, the place of origin shall be determined in accordance with Articles 59 to 63 of Regulation (EU) No\u00a0952/2013.": "constitutive", "Member States may decide that the harvesting year referred to in paragraph 1 shall be indicated on the label of olive oils referred to in that paragraph, of their domestic production, obtained from olives harvested on their territory and intended for their national markets only.": "constitutive", "References to the repealed Regulations shall be construed as references to this Regulation and to Commission Implementing Regulation (EU) 2022/2105 and shall be read in accordance with the correlation table in Annex III to this Regulation.": "constitutive", "The information referred to in paragraph 1 shall include the following details:                          (a)                        for the crowdfunding service provider, the ISO 17442 legal entity identifier (LEI) code;                                  (b)                        for the project owner:                                  (i)                                the LEI code, if the project owner is a legal person;                                          (ii)                                the identifier set out in Article\u00a06 of Delegated Regulation (EU) 2017/590, if the project owner is a natural person;                                          (c)                        for each individual project, the identifier of the crowdfunding offer determined in accordance with Article\u00a03 of Delegated Regulation (EU) 2022/2119.": "constitutive", "An application for support submitted by an operator shall be inadmissible for a period of time established pursuant to Annex II if the competent authority has determined in a decision that:                          (a)                        that operator has been involved in the operation, management or ownership of a fishing vessel included in the Union IUU vessel list as set out in Article\u00a027 of Regulation (EC) No\u00a01005/2008; or                                  (b)                        that operator has been involved in the operation, management or ownership of a vessel flagged to a country included in the list of non-cooperating third countries provided for in Article\u00a033 of Regulation (EC) No\u00a01005/2008.": "constitutive", "Article\u00a010            Permanent withdrawal of the fishing licence            Applications for support submitted by an operator whose fishing licence has been permanently withdrawn for any of the fishing vessels owned or controlled by that operator shall be inadmissible from the date of withdrawal of the fishing licence until the end of the period of eligibility of expenditure for an EMFAF contribution referred to in Article\u00a063(2) of Regulation (EU) 2021/1060, if that fishing licence was withdrawn:                        (a)                      in accordance with Article\u00a092(3) of Regulation (EC) No\u00a01224/2009 and Article\u00a0129(2) of Commission Implementing Regulation (EU) No\u00a0404/2011                     (                       8                      )                    ; or, if applicable,                                (b)                      as a result of sanctions for serious infringements imposed by the Member States in accordance with Article\u00a045 of Regulation (EC) No\u00a01005/2008.": "constitutive", "If a competent authority has determined in a decision that an operator has committed or is held liable for one of the offences set out in Article\u00a03 and Article\u00a04 of Directive 2008/99/EC               (                 6                )              of the European Parliament and of the Council, applications for support from the EMFAF made by that operator pursuant to Article\u00a027 of Regulation (EU) 2021/1139 shall be inadmissible pursuant to Annex III.": "constitutive", "CHAPTER VI            FINAL PROVISIONS              Article\u00a020            Entry into force            This Regulation shall enter into force on the twentieth day following that of its publication in the             Official Journal of the European Union.": "constitutive", "In the event that, after the entry into force of a Council Decision amending Annex XI to Decision 2014/512/CFSP, a vessel has transported the Russian crude oil or petroleum products referred to in paragraph 4, and the operator responsible for the transport knew or had reasonable cause to suspect that such crude oil or petroleum products were purchased above the price laid down in Annex XXVIII to this Regulation on the date of conclusion of the contract for such purchase, it shall be prohibited to provide the services referred to in paragraph 1 of this Article relating to the transport of crude oil or petroleum products that originate in Russia or are exported from Russia as referred to in paragraph 4 of this Article by that vessel for\u00a090 days following the date of unloading of the cargo purchased above the price\u00a0cap.\u2019                    ;                              (6)                      the following paragraphs are added:                      \u20189.": "regulatory", "It shall be prohibited to trade, broker or transport, including through ship-to-ship transfers, to third countries, crude oil falling under CN code 2709\u00a000, as of\u00a05\u00a0December 2022, or petroleum products falling under CN code 2710, as of\u00a05\u00a0February 2023, as listed in Annex XXV, which originate in Russia or which have been exported from Russia.\u2019                    ;                              (3)                      paragraph 5 is replaced by the following:                      \u20185.": "regulatory", "The prohibitions in paragraphs 1 and\u00a04 shall not apply:                                  (a)                                as of 5\u00a0December 2022, to crude oil falling under CN code 2709\u00a000, and as of\u00a05\u00a0February 2023, to petroleum products falling under CN code 2710, which originate in Russia or which have been exported from Russia provided that the purchase price per barrel of such products does not exceed the price laid down in Annex XXVIII;                                          (b)                                to crude oil or petroleum products as listed in Annex XXV where those goods originate in a third country and are only being loaded in, departing from or transiting through Russia, provided that both the origin and the owner of those goods are non-Russian;                                          (c)                                to the transport, or to technical assistance, brokering services, financing or financial assistance related to such transport, of the products mentioned in Annex XXIX to the third countries mentioned therein, for the duration specified in that Annex;                                          (d)                                as of 5\u00a0December 2022, to crude oil falling under CN code 2709\u00a000, which originates in Russia or which has been exported from Russia purchased above the price laid down in Annex XXVIII which is loaded onto a vessel at the port of loading prior to 5\u00a0December 2022 and unloaded at the final port of destination prior to 19\u00a0January 2023.\u2019                            ;                              (5)                      paragraph 7 is replaced by the following:                      \u20187.": "constitutive", "Each Member State concerned shall attribute the level of priority on the basis of the results of the risk assessment carried out in accordance with the procedures laid down in Article 5.": "regulatory", "Member States shall assess risks with regard to the stocks and area(s) covered, on the basis of the table set out in Annex I.": "regulatory", "Security of EU classified information        The EUSR and the members of the EUSR's team shall respect the security principles and minimum standards established by Council Decision 2011/292/EU of 31 March 2011 on the security rules for protecting EU classified information         (           2          )        .": "regulatory", "The EUSR shall present the Council, the Commission and the HR with a progress report by the end of December 2013, and, at the end of the EUSR's mandate, with a comprehensive report on the implementation of the mandate.": "regulatory", "The EUSR shall provide regular briefings to Member States' missions and the Union's delegations.": "regulatory", "The EUSR staff shall be co-located with the relevant EEAS departments or Union delegations/representations in third countries in order to contribute to the coherence and consistency of their respective activities.": "regulatory", "The PSC shall provide the EUSR with strategic guidance and political direction within the framework of the mandate, without prejudice to the powers of the HR.": "regulatory", "Prohibitions        Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex.": "regulatory", "The presence of material which contains, consists of or is produced from ACS-BN\u00d8\u00d87-1 oilseed rape in food or feed products notified under Article\u00a08(1)(a) and Article\u00a020(1), point (a), of Regulation (EC) No\u00a01829/2003 shall be tolerated until 31\u00a0December 2025, provided that this presence is:                            (a)                          adventitious or technically unavoidable; and                                    (b)                          in a proportion no higher than 0,1\u00a0% mass fraction.\u2019.": "regulatory", "The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.": "regulatory", "A specific EEA Statistical Programme for 2013 shall be developed jointly by the EFTA Statistical Office and Eurostat.": "regulatory", "The EEA Statistical Programme for 2013 shall be approved by the Contracting Parties according to their own internal procedures.": "regulatory", "Assistance in relation to claims        The EUSR and his staff shall assist in providing elements to respond any claims and obligations arising from the mandates of the previous EUSRs for the Middle East peace process, and shall provide administrative assistance and access to relevant files for such purpose.": "regulatory", "He shall help ensure that all Union instruments in the field are engaged coherently to attain the Union's policy objectives.": "regulatory", "In order to fulfil his mandate and specific responsibilities in the field the EUSR shall be fully dedicated to the Mission.": "regulatory", "Security        In accordance with the Union's policy on the security of staff deployed outside the Union in an operational capacity under Title V of the Treaty, the EUSR shall take all reasonably practicable measures, in conformity with his mandate and the security situation in his geographical area of responsibility, for the security of all staff under his direct authority, in particular by:                    (a)                  establishing a mission-specific security plan based on guidance from the EEAS, including mission-specific physical, organisational and procedural security measures, governing management of the secure movement of staff to, and within, the mission area, as well as management of security incidents and including a mission contingency and evacuation plan;                            (b)                  ensuring that all staff deployed outside the Union are covered by high risk insurance as required by the conditions in the mission area;                            (c)                  ensuring that all members of his team to be deployed outside the Union, including locally contracted staff, have received appropriate security training before or upon arriving in the mission area, based on the risk ratings assigned to the mission area by the EEAS;                            (d)                  ensuring that all agreed recommendations made following regular security assessments are implemented and providing the Council, the Commission and the HR, with written reports on their implementation and on other security issues within the framework of the mid-term and mandate implementation reports.": "regulatory", "The EUSR and the Civilian Operation Commander shall consult each other as required.": "regulatory", "If the originator of the classified information for which release is desired is not the Council, the GSC shall first seek the originator\u2019s written consent to release.": "regulatory", "In order to establish such a framework and define reciprocal rules on the protection of classified information exchanged:                    (a)                  the Union shall conclude agreements with third States or international organisations on security procedures for exchanging and protecting classified information (\u2018security of information agreements\u2019); or                            (b)                  the Secretary-General may enter into administrative arrangements on behalf of the GSC in accordance with paragraph 17 of Annex VI where the classification level of EUCI to be released is as a general rule no higher than RESTREINT UE/EU RESTRICTED.": "regulatory", "Member States shall take all appropriate measures, in accordance with their respective national laws and regulations, to ensure that when EUCI is handled or stored, this Decision is respected by:                    (a)                  personnel of Member States\u2019 Permanent Representations to the European Union, and national delegates attending meetings of the Council or of its preparatory bodies, or participating in other Council activities;                            (b)                  other personnel in Member States\u2019 national administrations, including personnel seconded to those administrations, whether they serve on the territory of the Member States or abroad;                            (c)                  other persons in the Member States duly authorised by virtue of their functions to have access to EUCI; and                            (d)                  Member States\u2019 contractors, whether on the territory of the Member States or abroad.": "regulatory", "The Security Committee shall be composed of representatives of the Member States\u2019 NSAs and be attended by a representative of the Commission and of the EEAS.": "regulatory", "The Security Committee shall organise its activities in such a way that it can make recommendations on specific areas of security.": "regulatory", "The competent authorities shall ensure that EUCI is appropriately classified, clearly identified as classified information and retains its classification level for only as long as necessary.": "regulatory", "Assessment and reporting        Member States shall assess the results of the AMR monitoring provided for in Articles 2 and 3 and include that assessment in the report on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance provided for in Article 9(1) of Directive 2003/99/EC.": "regulatory", "Following an alert pursuant to Article 9, on a request from the Commission or a Member State and on the basis of the available information, including the information referred to in Article 9 and the risk assessments referred to in Article 10, Member States shall consult each other within the HSC and in liaison with the Commission with a view to coordinating:                    (a)                  national responses to the serious cross-border threat to health, including where a public health emergency of international concern is declared in accordance with the IHR and falls within Article 2 of this Decision;                            (b)                  risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public and to healthcare professionals.": "regulatory", "For the purpose of paragraph 1, when substantially revising national preparedness planning, Member States shall inform the Commission in a timely manner of the main aspects of the revision of their preparedness planning at national level that are relevant to the objectives referred to in paragraph 1 and to the specific issues referred to in paragraph 2.": "regulatory", "Member States shall notify the Commission and other Member States of the designations referred to in paragraph 1 and of any change thereof.": "regulatory", "National competent authorities or the Commission shall notify an alert in the EWRS where the emergence or development of a serious cross-border threat to health fulfils the following criteria:                    (a)                  it is unusual or unexpected for the given place and time, or it causes or may cause significant morbidity or mortality in humans, or it grows rapidly or may grow rapidly in scale, or it exceeds or may exceed national response capacity; and                            (b)                  it affects or may affect more than one Member State; and                            (c)                  it requires or may require a coordinated response at Union level.": "regulatory", "The HSC shall have the following tasks:                    (a)                  supporting the exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Decision;                            (b)                  coordination in liaison with the Commission of the preparedness and response planning of the Member States in accordance with Article 4;                            (c)                  coordination in liaison with the Commission of the risk and crisis communication and responses of the Member States to serious cross-border threats to health, in accordance with Article 11.": "regulatory", "Where a competent authority establishes that notification of personal data made by it pursuant to Article 9(3) has subsequently proved to be in breach of Directive 95/46/EC because that notification was unnecessary for the implementation of the contact tracing measures at issue, it shall inform immediately the Member States to which that notification was transmitted.": "regulatory", "Where competent authorities implementing contact tracing measures communicate personal data necessary for contact tracing purposes through the EWRS pursuant to Article 9(3), they shall use the selective messaging functionality referred to in paragraph 2 of this Article and communicate the data only to the other Member States involved in the contact tracing measures.": "regulatory", "Member States shall determine how such reference is to be made.": "regulatory", "They shall forthwith communicate to the Commission the text of those provisions.": "regulatory", "As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.": "regulatory", "Each Member State shall notify the Commission without delay of the specific authorities responsible for fulfilling the obligations arising under this Regulation, and any amendments thereto.": "regulatory", "Family members who are beneficiaries of international protection        Where the applicant has a family member, regardless of whether the family was previously formed in the country of origin, who has been allowed to reside as a beneficiary of international protection in a Member State, that Member State shall be responsible for examining the application for international protection, provided that the persons concerned expressed their desire in writing.": "regulatory", "In assessing the best interests of the child, Member States shall closely cooperate with each other and shall, in particular, take due account of the following factors:                    (a)                  family reunification possibilities;                            (b)                  the minor\u2019s well-being and social development;                            (c)                  safety and security considerations, in particular where there is a risk of the minor being a victim of human trafficking;                            (d)                  the views of the minor, in accordance with his or her age and maturity.": "regulatory", "In those reports, the Member State concerned shall report on data to monitor compliance with the crisis management action plan, such as the length of the procedure, the detention conditions and the reception capacity in relation to the inflow of applicants.": "regulatory", "Member States shall ensure that the person concerned has access to legal assistance and, where necessary, to linguistic assistance.": "regulatory", "Member States shall examine any application for international protection by a third-country national or a stateless person who applies on the territory of any one of them, including at the border or in the transit zones.": "regulatory", "Monitoring and evaluation        By 21 July 2016, the Commission shall report to the European Parliament and to the Council on the application of this Regulation and, where appropriate, shall propose the necessary amendments.": "regulatory", "The Member State carrying out the transfer of an applicant or of another person as referred to in Article 18(1)(c) or (d) shall communicate to the Member State responsible such personal data concerning the person to be transferred as is appropriate, relevant and non-excessive for the sole purposes of ensuring that the competent authorities, in accordance with national law in the Member State responsible, are in a position to provide that person with adequate assistance, including the provision of immediate health care required in order to protect his or her vital interests, and to ensure continuity in the protection and rights afforded by this Regulation and by other relevant asylum legal instruments.": "regulatory", "The Member State concerned shall inform the Council and the Commission whether it intends to present a preventive action plan in order to overcome the pressure and/or problems in the functioning of its asylum system whilst ensuring the protection of the fundamental rights of applicants for international protection.": "regulatory", "The Member State concerned shall take all appropriate measures to deal with the situation of particular pressure on its asylum system or to ensure that the deficiencies identified are addressed before the situation deteriorates.": "regulatory", "The Member State conducting the personal interview shall make a written summary thereof which shall contain at least the main information supplied by the applicant at the interview.": "regulatory", "The obligations specified in Article 18(1) shall cease where the Member State responsible can establish, when requested to take charge or take back an applicant or another person as referred to in Article 18(1)(c) or (d), that the person concerned has left the territory of the Member States for at least three months, unless the person concerned is in possession of a valid residence document issued by the Member State responsible.": "regulatory", "The request to take charge shall contain all the material in the possession of the requesting Member State to allow the requested Member State to assess the situation.": "regulatory", "Throughout the entire process for early warning, preparedness and crisis management established in this Article, the Council shall closely monitor the situation and may request further information and provide political guidance, in particular as regards the urgency and severity of the situation and thus the need for a Member State to draw up either a preventive action plan or, if necessary, a crisis management action plan.": "regulatory", "When a Member State cannot or can no longer be held responsible in accordance with paragraph 1 of this Article and where it is established, on the basis of proof or circumstantial evidence as described in the two lists mentioned in Article 22(3), that the applicant \u2014 who has entered the territories of the Member States irregularly or whose circumstances of entry cannot be established \u2014 has been living for a continuous period of at least five months in a Member State before lodging the application for international protection, that Member State shall be responsible for examining the application for international protection.": "regulatory", "Where it is established, on the basis of proof or circumstantial evidence as described in the two lists mentioned in Article 22(3) of this Regulation, including the data referred to in Regulation (EU) No 603/2013, that an applicant has irregularly crossed the border into a Member State by land, sea or air having come from a third country, the Member State thus entered shall be responsible for examining the application for international protection.": "regulatory", "Where it is impossible to transfer an applicant to the Member State primarily designated as responsible because there are substantial grounds for believing that there are systemic flaws in the asylum procedure and in the reception conditions for applicants in that Member State, resulting in a risk of inhuman or degrading treatment within the meaning of Article 4 of the Charter of Fundamental Rights of the European Union, the determining Member State shall continue to examine the criteria set out in Chapter III in order to establish whether another Member State can be designated as responsible.": "regulatory", "Where the data are not processed automatically or are not contained, or intended to be entered, in a file, each Member State shall take appropriate measures to ensure compliance with this Article through effective checks.": "regulatory", "Where the preventive action plan includes measures aimed at addressing particular pressure on a Member State\u2019s asylum system which may jeopardise the application of this Regulation, the Commission shall seek the advice of EASO before reporting to the European Parliament and to the Council.": "regulatory", "Where the requested Member State accepts to take charge of or to take back an applicant or other person as referred to in Article 18(1)(c) or (d), the requesting Member State shall notify the person concerned of the decision to transfer him or her to the Member State responsible and, where applicable, of not examining his or her application for international protection.": "regulatory", "Where the requesting Member State has pleaded urgency in accordance with the provisions of Article 21(2), the requested Member State shall make every effort to comply with the time limit requested.": "regulatory", "Where there are amendments thereto, the Commission shall publish once a year an updated consolidated list.": "regulatory", "Where, on account of pregnancy, a new-born child, serious illness, severe disability or old age, an applicant is dependent on the assistance of his or her child, sibling or parent legally resident in one of the Member States, or his or her child, sibling or parent legally resident in one of the Member States is dependent on the assistance of the applicant, Member States shall normally keep or bring together the applicant with that child, sibling or parent, provided that family ties existed in the country of origin, that the child, sibling or parent or the applicant is able to take care of the dependent person and that the persons concerned expressed their desire in writing.": "regulatory", "Revision        The Commission shall review this Regulation and present the results of this review to the Ecodesign Consultation Forum no later than three and a half years after its entry into force in the light of technological progress.": "regulatory", "The competent authorities of the Member States shall make use of the catch certification scheme laid down in Chapter III of Regulation (EC) No 1005/2008 to identify any product covered by the prohibition set out in Article 5(1) of this Regulation.": "regulatory", "It shall provide this information using the questionnaire attached in the Annex to this Decision.": "regulatory", "The Performance Review Body shall act in full transparency and report directly to the Commission.": "regulatory", "The Performance Review Body shall adopt its rules of procedure, subject to prior approval by the Commission, by simple majority voting.": "regulatory", "As regards sampling and testing, as provided for in paragraph 1, Member States shall apply protocols of EPPO, or other protocols which are internationally recognised.": "regulatory", "During the official inspections, the responsible official body shall pay particular attention to:                    (a)                  the suitability and actual use of methods by the supplier for checking each of the critical points in the production process;                            (b)                  the overall competence of the supplier's staff to carry out the activities set out in Article 6(1) of Directive 2008/90/EC.": "regulatory", "In case of doubts concerning the presence of those pests, the responsible official body and, where appropriate, the supplier shall carry out sampling and testing of the basic mother plant or basic material concerned.": "regulatory", "In case of doubts concerning the presence of those pests, the supplier shall carry out sampling and testing of the CAC material concerned.": "regulatory", "Member States shall ensure that propagating material and fruit plants belonging to the genera and species listed in Annex I to Directive 2008/90/EC comply, during production and marketing, with Articles 3 to 27 of this Directive, as appropriate.": "regulatory", "Member States shall ensure that the responsible official bodies produce and keep records of the results and dates of all field inspections, sampling and testing carried out by them.": "regulatory", "Member States shall ensure that, during production of propagating material and fruit plants belonging to the genera and species listed in Annex I to Directive 2008/90/EC, suppliers comply with the requirements set out in Articles\u00a028 and 29.": "regulatory", "Requirements for the acceptance of a rootstock not belonging to a variety        The responsible official body shall accept a rootstock not belonging to a variety as a pre-basic mother plant if it is true to the description of its species and if it complies with Articles 8 to 12.": "regulatory", "The suppliers shall maintain pre-basic mother plants and pre-basic material in facilities, which are designated for the genera or species concerned, and which are insect proof and ensure freedom from infection through aerial vectors and any other possible sources throughout the production process.": "regulatory", "Verification of trueness to the description of the variety        The responsible official body and, where appropriate, the supplier shall regularly verify the trueness of pre-basic mother plant         s        and of pre-basic material to the description of their variety, in accordance with Article 5(2) and (3), as appropriate for the variety concerned and the propagation method used.": "regulatory", "Article\u00a07        Committee        The Commission shall be assisted by the Partnership Instrument Committee.": "regulatory", "During the consolidation phase, the reporting Member State shall take due account of the considerations of the other Member States concerned when finalising Part I of the assessment report and shall record how all such considerations have been dealt with.": "regulatory", "During the initial assessment phase, the reporting Member State shall develop a draft Part I of the assessment report and circulate it to all other Member States concerned.": "regulatory", "During the initial assessment phase, the reporting Member State shall develop a draft assessment report and circulate it to all Member States concerned.": "regulatory", "Each Member State concerned shall assess, for its own territory, the application with respect to the following aspects:                    (a)                  compliance with the requirements for informed consent as set out in Chapter V;                            (b)                  compliance of the arrangements for rewarding or compensating subjects with the requirements set out in Chapter V and investigators;                            (c)                  compliance of the arrangements for recruitment of subjects with the requirements set out in Chapter V;                            (d)                  compliance with Directive 95/46/EC;                            (e)                  compliance with Article 49;                            (f)                  compliance with Article 50;                            (g)                  compliance with Article 76;                            (h)                  compliance with the applicable rules for the collection, storage and future use of biological samples of the subject.": "regulatory", "Each Member State concerned shall notify the sponsor through the EU portal as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.": "regulatory", "In the case of early termination of the clinical trial for reasons not affecting the benefit-risk balance, the sponsor shall notify each Member State concerned through the EU portal of the reasons for such action and, when appropriate, follow-up measures for the subjects.": "regulatory", "In this case, that application shall be assessed in accordance with Article 7 and the Member State concerned shall notify its decision on the clinical trial in accordance with Article 8.": "regulatory", "Inspections shall be conducted under the responsibility of the Member State where the inspection takes place.": "regulatory", "Member States shall cooperate in assessing the information reported in accordance with Articles 42and 43.": "regulatory", "Monitoring        In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical trial is in compliance with the requirements of this Regulation, the sponsor shall adequately monitor the conduct of a clinical trial.": "regulatory", "Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation.": "regulatory", "That Member State shall report the suspected unexpected serious adverse reaction in accordance with paragraph 1 of this Article.": "regulatory", "The Commission shall draw up a report in respect of the delegated powers not later than six months before the end of the five year period.": "regulatory", "The Commission shall make publicly available the detailed ICH guidelines on good clinical practice referred to in the second paragraph.": "regulatory", "The Commission shall prepare in cooperation with the Member States a programme for the Union controls referred to in points (b) and (c) of paragraph 1.": "regulatory", "The Commission shall report on the findings of each Union control carried out.": "regulatory", "The Commission shall specify, by means of implementing acts, the detailed arrangements for the inspection procedures including the qualification and training requirements for inspectors.": "regulatory", "The European Medicines Agency established by Regulation (EC) No 726/2004 (the \u2018Agency\u2019) shall set up and maintain an electronic database for the reporting provided for in Articles 42 and 43.": "regulatory", "The Member States shall ensure compliance with the requirements of this Article by means of inspections.": "regulatory", "The additional Member State concerned shall refuse to authorise the clinical trial if it disagrees with the conclusion of the reporting Member State as regards Part I of the assessment report on any of the grounds referred to in second subparagraph of paragraph 4, or if it finds, on duly justified grounds, that the aspects addressed in Part II of the assessment report are not complied with, or where an ethics committee has issued a negative opinion which, in accordance with the law of the additional Member State concerned, is valid for that entire additional Member State.": "regulatory", "The applicant shall specify, in the application for authorisation, the types and pharmaceutical forms of the investigational medicinal product manufactured or imported, the manufacturing or import operations, the manufacturing process where relevant, the site where the investigational medicinal products are to be manufactured or the site in the Union to which they are to be imported, and detailed information concerning the qualified person.": "regulatory", "The ethical review shall be performed by an ethics committee in accordance with the law of the Member State concerned.": "regulatory", "The reporting Member State shall draw up an assessment report.": "regulatory", "The reporting Member State shall submit, through the EU portal, the final assessment report including its conclusion, to the sponsor and to the other Member States concerned within 38 days from the validation date.": "regulatory", "The reporting Member State shall take due account of the considerations of the Member States concerned and shall record how all such considerations have been dealt with.": "regulatory", "The sponsor shall appoint individuals within its organisation to be responsible for archives.": "regulatory", "The sponsor shall notify each Member State concerned of a temporary halt of a clinical trial in all Member States concerned for reasons not affecting the benefit-risk balance through the EU portal.": "regulatory", "The sponsor shall notify the Member States concerned, through the EU portal, of the event and the measures taken.": "regulatory", "Upon receipt of the additional information, the Member State concerned shall complete its assessment within a maximum of 19 days.": "regulatory", "When finalising Part I of the assessment report, the reporting Member State shall take due account of the considerations of the Member States concerned and shall record how all such considerations have been dealt with.": "regulatory", "When requested by a Member State concerned, the sponsor shall submit a translation of the report or of its summary in an official language of the Union indicated in the request.": "regulatory", "Where a Member State concerned intends to carry out an inspection on its territory or in a third country with regard to one or several clinical trials which are conducted in more than one Member State concerned, it shall notify its intention to the other Member States concerned, the Commission and the Agency, through the EU portal, and shall inform them of its findings after the inspection.": "regulatory", "Where relevant, the investigator shall send a follow-up report to the sponsor to allow the sponsor to assess whether the serious adverse event has an impact on the benefit-risk balance of the clinical trial.": "regulatory", "Where the sponsor of a clinical trial is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative.": "regulatory", "Where, regarding the aspects covered by Part I of the assessment report, the clinical trial is acceptable or acceptable subject to compliance with specific conditions, the Member State concerned shall include in its decision its conclusion on Part II of the assessment report.": "regulatory", "Without prejudice to any other provision of Union law or Commission guidelines, the sponsor and the investigator, when drawing up the protocol and when applying this Regulation and the protocol, shall also take appropriate account of the quality standards and the ICH guidelines on good clinical practice.": "regulatory", "Discharge        By way of derogation from Article 60(7) and Article 209 of Regulation (EU, Euratom) No\u00a0966/2012, the discharge for the implementation of the budget of the FCH 2 Joint Undertaking shall be given by the European Parliament, upon recommendation of the Council in accordance with the procedure provided for in the financial rules of the FCH 2 Joint Undertaking.": "regulatory", "The FCH 2 Joint Undertaking shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council and the Commission concerning internal investigations by the European Anti-Fraud Office (OLAF)         (           14          )        .": "regulatory", "The FCH 2 Joint Undertaking shall grant Commission staff and other persons authorised by the Commission or the FCH 2 Joint Undertaking, as well as the Court of Auditors, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits.": "regulatory", "The Governing Board shall adopt a decision laying down rules on the secondment of national experts to the FCH 2 Joint Undertaking and on the use of trainees.": "regulatory", "Where the Commission approves an amendment to the product specification that includes a change to the information recorded in the Registers, it shall delete the original data and record the new data with effect from the entry into force of the decision approving the amendment.": "regulatory", "The application of the individual duty rates specified for the companies mentioned in paragraph 2 shall be conditional upon presentation to the Member States' customs authorities of a valid commercial invoice, on which shall appear a declaration dated and signed by an official of the entity issuing such invoice, identified by his/her name and function, drafted as follows: \u2018I, the undersigned, certify that the (volume) of (product concerned) sold for export to the European Union covered by this invoice was manufactured by (company name and address) (TARIC additional code) in [country concerned].": "regulatory", "The amounts secured by way of the provisional anti-dumping duties pursuant to the Regulation (EU) 2016/1977 shall be definitively collected.": "regulatory", "The EUSR shall also report to Council working parties, in particular the Working Party on Human Rights, as necessary.": "regulatory", "The EUSR shall keep the Council and the Commission promptly informed of the composition of the team.": "regulatory", "The EUSR shall provide regular briefings to Member States' missions and Union delegations.": "regulatory", "The EUSR shall also report to Council working parties as necessary.": "regulatory", "The EUSR shall be accountable to the Commission for all expenditure.": "regulatory", "The EUSR shall contribute to the unity, consistency and effectiveness of the Union's action and shall help ensure that all Union instruments and Member\u00a0States' actions are engaged consistently, to attain the Union's policy objectives.": "regulatory", "Within the limits of the EUSR's mandate and the corresponding financial means made available, the\u00a0EUSR shall be responsible for constituting a team.": "regulatory", "Requests to participate and tenders which do not comply with all the minimum requirements set out in the procurement documents shall be rejected.": "regulatory", "Manufacturers shall ensure that none of the three elements of the combined health warning is split upon opening of the unit packet.": "regulatory", "The Commission shall establish, manage and update, as necessary, the AAC system.": "regulatory", "Upon request of one of the liaison bodies referred to in paragraph 2, the Commission shall give access to the AAC system to designated staff belonging to competent authorities at central or regional level within the same Member State.": "regulatory", "In their submission, manufacturers and importers shall mark all information which they consider to be a trade secret or otherwise confidential and shall, upon request, duly justify their claims.": "regulatory", "Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 October 2016 at the latest.": "regulatory", "Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.": "regulatory", "When a tissue establishment is authorised by two or more competent authorities for different types of tissues and cells or different activities, each competent authority shall update the information relating to those activities for which it is responsible;                                    (e)                          Alert the competent authorities of another Member State when they observe incorrect information in the EU Tissue Establishment Compendium relating to the other Member State or when they observe a situation of significant non-compliance with the provisions relating to the Single European Code relating to the other Member State;                                    (f)                          Alert the Commission and the other Competent Authorities when in their assessment the EU Tissue and Cell Product Compendium requires an update.": "regulatory", "The general assembly and the executive committee shall ensure a balanced and wide representation of all stakeholders, with emphasis on small-scale fleets, where appropriate.": "regulatory", "The general assembly shall appoint an executive committee of up to 25 members.": "regulatory", "The general assembly shall ensure equitable membership fees, which enable balanced and wide representation of all stakeholders taking into account their financial capacity.": "regulatory", "Operational programmes approved by 15 December shall be implemented from 1 January of the following year.": "regulatory", "A registered exporter number shall be assigned to the exporter by the competent authorities of the beneficiary country with a view to exporting under GSP schemes of the Union, Norway and Switzerland as well as Turkey, once that country fulfils certain conditions, to the extent that those countries have recognised the country where the registration has taken place as a beneficiary country.": "regulatory", "All beneficiary countries shall apply the registered exporter system as of 30 June 2020 at the latest.": "regulatory", "Before declaring goods for release for free circulation, the declarant shall take due care to ensure that the goods comply with the rules in this section, in particular, by checking:                            (i)                          on the public website that the exporter is registered in the REX system, where the total value of the originating products consigned exceeds EUR 6\u00a0000, and                                    (ii)                          that the statement on origin is made out in accordance with Annex 13d.\u2019                                    (19)                  Article 97d is replaced by the following:                \u2018Article 97d                1.": "regulatory", "Exporters, once registered, shall make out statements on origin for originating products consigned, where the total value thereof exceeds EUR 6\u00a0000, as of the date from which their registration is valid in accordance with Article 92(5).": "regulatory", "Exporters, once registered, shall make out statements on origin for originating products consigned, where the total value thereof exceeds EUR 6\u00a0000, as of the date on which their registration is valid in accordance with Article 92(5).": "regulatory", "For the purpose of establishing the origin of materials used within the framework of cumulation under Article 85, the exporter of a product manufactured using materials originating in a party with which cumulation is permitted shall rely on the proof of origin provided by the supplier of those materials on condition that that proof has been issued in accordance with the provisions of the GSP rules of origin of Norway, Switzerland or where applicable Turkey, as the case may be.": "regulatory", "On 1 January 2017, the customs authorities of Member States shall start the registration of exporters and re-consignors of goods established in their territories.": "regulatory", "The competent authorities of beneficiary countries and the customs authorities of Member States shall keep the data registered by them up-to-date.": "regulatory", "The competent authorities of beneficiary countries and the customs authorities of Member States shall upon receipt of the complete application form referred to in Annex 13c assign without delay the number of registered exporter to the exporter or, where appropriate, the re-consignor of goods and enter into the REX system the number of registered exporter, the registration data and the date from which the registration is valid in accordance with Article 92(5).": "regulatory", "The customs authorities of the Member States shall have access to consult the data registered by them, by the customs authorities of other Member States and by the competent authorities of beneficiary countries as well as by Norway, Switzerland and Turkey.": "regulatory", "The re-consignors of goods, whether registered or not, who make out replacement statements on origin as referred to in Article 97d shall keep the initial statements on origin they replaced for at least three years from the end of the calendar year in which the replacement statement on origin was made out, or longer if required by national law.": "regulatory", "Imports into the Union of hay (CN code ex\u00a01214\u00a090, as referred to in Chapter 12 of Annex I to Implementing Regulation (EU) 2019/2007) and straw (CN code ex\u00a01213\u00a000\u00a000, as referred to in Chapter 12 of Annex I to Implementing Regulation (EU) 2019/2007) coming from and originating in Great Britain and the Crown Dependencies shall be authorised.": "regulatory", "The authorisations for new plantings referred to in Article 64 of Regulation (EU) No 1308/2013 shall be granted annually.": "regulatory", "The position to be adopted on behalf of the Union within the Association Committee in Trade configuration established by Article 465 of the Agreement, in relation to the favourable opinion regarding the comprehensive roadmap shall be based on the draft Decision of that Committee referred to in Article 1(1).": "regulatory", "During the transition period set out in paragraph 1:                            (a)                          the reasons for non-certification of any interoperability constituents shall be properly identified in the verification procedure for the subsystem referred to in paragraph 1; and                                    (b)                          national safety authorities shall report in their annual report, as referred to in Article 18 of Directive 2004/49/EC, on the use of non-certified \u201cfriction element for wheel tread brakes\u201d interoperability constituents in the context of authorisation procedures.": "regulatory", "During the transition period set out in paragraph 1:                            (a)                          the reasons for non-certification of any interoperability constituents shall be properly identified in the verification procedure for the subsystem referred to in paragraph 1; and                                    (b)                          the national safety authorities shall report in their annual report, as referred to in Article 18 of Directive 2004/49/EC, on the use of non-certified \u201cfriction element for wheel tread brakes\u201d interoperability constituents in the context of authorisation procedures.\u2019                                    (3)                  The following Article 9a is inserted:                \u2018The EC-type or EC design examination certificate for the \u201cfriction element for wheel tread brakes\u201d interoperability constituent shall be valid for 10 years.": "regulatory", "The Commission shall deliver an opinion on the innovative solution proposed.": "regulatory", "The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.": "constitutive", "Before taking a decision to reject an economic operator from a given procurement procedure, the contracting authority shall give the economic operator the opportunity to submit its observations, unless the rejection has been justified in accordance with point (a) of paragraph\u00a01 by an exclusion decision taken with regard to the economic operator, following an examination of its observations.": "regulatory", "Final recipients shall provide financial intermediaries with a signed declaration of honour confirming that they are not in one of the situations referred to in points (a), (b), (c) and (d) of Article\u00a0106(1) or points (b) and (c) of Article\u00a0107(1).\u2019.": "regulatory", "In all procedures involving negotiation, the contracting authority shall negotiate with tenderers the initial and any subsequent tenders or parts thereof, except their final tenders, in order to improve their content.": "regulatory", "In carrying out this verification, the authorising officer shall exercise his or her powers as foreseen under Article\u00a066 and shall not go beyond what is foreseen in the terms and conditions of the procurement documents and contractual provisions.": "regulatory", "In order to protect the Union's financial interests, the Commission shall set up and operate an early detection and exclusion system.": "regulatory", "In the absence of a final judgment or, where applicable, a final administrative decision in the cases referred to in points (c), (d) and (f) of paragraph\u00a01, or in the case referred to in point (e) of paragraph\u00a01, the contracting authority shall exclude an economic operator on the basis of a preliminary classification in law of a conduct referred to in those points, having regard to established facts or other findings contained in the recommendation of the panel referred to in Article\u00a0108.": "regulatory", "Subject to exceptions and conditions to be specified in the delegated acts adopted pursuant to this Regulation, in the case of contracts the value of which exceeds the thresholds referred to in paragraph\u00a01, the contracting authority shall not sign the contract or framework contract with the successful tenderer until a standstill period has elapsed.": "regulatory", "The Commission shall ensure by appropriate means and in application of Article\u00a095 that tenderers may enter the contents of the tenders and any supporting evidence in an electronic format (\u201ce-procurement\u201d), except in duly justified cases specified in the delegated acts adopted in accordance with Article\u00a0210.": "regulatory", "The Commission shall transmit the information referred to in paragraph\u00a03 of this Article without delay to its authorising officers and those of its executive agencies, all other institutions, bodies, European offices and agencies in order to allow them to carry out the necessary verification in respect of their ongoing procurement procedures and existing contracts.": "regulatory", "The Member\u00a0States shall cooperate with the Commission by informing it of the measures they have taken to act on those observations so that the Commission may take them into account when drawing up its own report.": "regulatory", "The contracting authority shall evaluate all requests to participate or tenders not rejected during the opening phase laid down in paragraph\u00a04 on the basis of the criteria specified in the procurement documents with a view to awarding the contract or to proceeding with an electronic auction.": "regulatory", "The contracting authority shall follow the rules of the restricted procedure for procurement through a dynamic purchasing system.": "regulatory", "The contracting authority shall not award a contract for a given procurement procedure to an economic operator who:                            (a)                          is in an exclusion situation established in accordance with Article\u00a0106;                                    (b)                          has misrepresented the information required as a condition for participating in the procedure or has failed to supply that information;                                    (c)                          was previously involved in the preparation of procurement documents where this entails a distortion of competition that cannot be remedied otherwise.": "regulatory", "The panel shall notify the requesting contracting authority without delay of its revised recommendation, following which the contracting authority shall review its decision.": "regulatory", "The panel shall simultaneously make the same notification to the other contracting authorities;                                    (c)                          before adopting any recommendation, the panel shall give the economic operator and the notified contracting authorities the opportunity to submit observations.": "regulatory", "When carrying out the necessary verification in respect of its ongoing grant procedures and existing agreements in accordance with Article\u00a0108(4), the authorising officer shall ensure that the applicant or beneficiary has been given the opportunity to present its observations before adopting any measure adversely affecting its rights.\u2019;                                    (b)                          paragraph\u00a05 is deleted;                                    (c)                          paragraph\u00a06 is replaced by the following:                        \u20186.": "regulatory", "Where the contracting authority envisages taking a more severe decision than what has been recommended by the panel, it shall ensure that such a decision is taken with due respect for the right to be heard and for the rules of personal data protection.": "regulatory", "While the procurement procedure is under way, all contacts between the contracting authority and candidates or tenderers shall satisfy conditions ensuring transparency, equal treatment and good administration, as set out in Article\u00a096.": "regulatory", "As far as practicable, fishing vessels using purse seines for small pelagic species or surrounding nets without purse line for pelagic species shall avoid encircling sea turtles.": "regulatory", "By 1 October of each year, Member States shall communicate to the Commission their plans and programmes to ensure compliance with Article 16l through adequate monitoring and reporting, in particular of the monthly catches and fishing effort deployed.": "regulatory", "Fishing vessels shall not bring seabirds ashore except within the framework of national plans for the conservation of seabirds or to secure assistance for the recovery of harmed individual seabirds, and provided that the competent national authorities have been duly and officially informed, prior to the fishing vessel concerned returning to port, of the intention to bring such seabirds ashore.": "regulatory", "Masters of fishing vessels shall not bring ashore sea turtles unless as part of a specific rescue or national conservation programme or unless this is otherwise required in order to rescue, and secure assistance for the recovery of, harmed and comatose individual sea turtles and provided that the competent national authorities concerned have been duly and officially informed prior to the fishing vessel concerned returning to port.": "regulatory", "Member States shall set up adequate monitoring systems in order to collect reliable information on the impact on cetacean populations in the Black Sea of fishing vessels targeting picked dogfish with bottom-set gillnets, and shall submit that information to the Commission.": "regulatory", "The Commission shall inform the Executive Secretary of the GFCM of the measures adopted pursuant to paragraphs 2 and 5.": "regulatory", "The Commission shall promptly transmit the information referred to in paragraphs 3, 4 and 5 to the Executive Secretary of the GFCM.": "regulatory", "Without prejudice to Article 15(5) of Regulation (EC) No 1224/2009, masters of fishing vessels shall record in the fishing logbook referred to in Article 14 of that Regulation the following information:                            (a)                          any event of incidental catch and release of seabirds;                                    (b)                          any event of incidental catch and release of sea turtles;                                    (c)                          any event of incidental catch and release of monk seals;                                    (d)                          any event of incidental catch and release of cetaceans;                                    (e)                          any event of incidental catch and, where required, release of sharks and rays of the species listed in Annex II or Annex III to the Protocol to the Barcelona Convention.": "regulatory", "They shall issue authorisations only where an operator:                    (a)                  proves the existence of a contract relating to the provision of the goods; and                            (b)                  certifies in writing that, in respect of the categories and countries concerned:                            (i)                          the operator has not already been granted an authorisation under this Regulation; or                                    (ii)                          the operator has been granted an authorisation under this Regulation but has used at least 50 per cent of the quantity allocated.": "regulatory", "Supervisory measures        Without prejudice to any other supervisory powers conferred on them, competent authorities shall, in particular,                    1.                  require, where appropriate, regulated entities or mixed financial holding companies to:                            (a)                          perform intra-group transactions of the financial conglomerate at arm's length or notify intra-group transactions which are not performed at arm's length;                                    (b)                          approve intra-group transactions of the financial conglomerate through specified internal procedures with the involvement of its management body as referred to in Article 3(1) of Directive 2013/36/EU of the European Parliament and of the Council                         (                           5                          )                        , or of its administrative, management or supervisory body as referred to in Article 40 of Directive 2009/138/EC of the European Parliament and of the Council                         (                           6                          )                        ;                                    (c)                          report more frequently than required under Article 7(2) and Article 8(2) of Directive 2002/87/EC on significant risk concentration and significant intra-group transactions;                                    (d)                          establish additional reporting on significant risk concentration and significant intra-group transactions of the financial conglomerate;                                    (e)                          strengthen the risk management processes and internal control mechanisms of the financial conglomerate;                                    (f)                          present or improve plans to restore compliance with supervisory requirements and to set a deadline for implementation thereof;                                    2.                  shall define appropriate thresholds in order to identify and overview significant risk concentration and significant intra-group transactions;                This Regulation shall enter into force on the twentieth day following that of its publication in the         Official Journal of the European Union        .": "regulatory", "The coordinator and the other relevant competent authorities shall agree on the form and content of the significant intra-group transactions report, including language, remittance dates and channels of communication.": "regulatory", "The coordinator and the other relevant competent authorities shall agree on the form and content of the significant risk concentration report, including language, remittance dates and channels of communication.": "regulatory", "The coordinator and the other relevant competent authorities shall at least require regulated entities or mixed financial holding companies to report on the following:                    (a)                  the dates and amounts of the significant transactions, names and company register numbers or other identification numbers of the relevant group entities and counterparties, including legal entity identifier (LEI), where applicable;                            (b)                  a brief description of the significant intra-group transactions according to the types of transactions set out in paragraph 1;                            (c)                  the total volume of all significant intra-group transactions of a specific financial conglomerate within a given reporting period;                            (d)                  information on how conflicts of interests and risks of contagion at the level of the financial conglomerate regarding significant intra-group transactions are managed, taking into consideration the financial conglomerate's strategy to combine activities in the banking, insurance and investment services sectors, or a sectoral own risks self-assessment including a consideration on the management of conflicts of interests and risks of contagion regarding significant intra-group transactions.": "regulatory", "The coordinator and the other relevant competent authorities shall at least require regulated entities or mixed financial holding companies to report the following:                    (a)                  a description of the significant risk concentration according to the types of risks set out in paragraph 1;                            (b)                  the break-down of the significant risk concentration by counterparties and groups of interconnected counterparties, geographical areas, economic sectors, currencies, identifying the names, company register numbers or other identification numbers of the relevant group companies of the financial conglomerate and their respective counterparties, including LEI, where applicable;                            (c)                  the total amount of each significant risk concentration at the end of a specific reporting period valued according to the applicable sectoral rules;                            (d)                  if applicable, the amount of significant risk concentration taking into account risk mitigation techniques and risk weighting factors;                            (e)                  information on how conflicts of interests and risks of contagion at the level of the financial conglomerate regarding significant risk concentration are managed, taking into consideration the financial conglomerate's strategy to combine activities in the banking, insurance and investment services sectors, or a sectoral own risks self-assessment including a consideration on the management of conflicts of interests and risks of contagion regarding significant risk concentration.": "regulatory", "Germany shall ensure that this Decision is implemented within four months following the date on which it is notified.": "regulatory", "Reporting        The EUSR shall regularly provide the HR and the EEAS with oral and written reports.": "regulatory", "The EUSR shall contribute to the unity, consistency and effectiveness of the Union's action and shall help ensure that all Union instruments and Member States' actions are engaged consistently, to attain the Union's policy objectives.": "regulatory", "The EUSR shall provide regular briefings to Member States' missions and the Union delegations.": "regulatory", "The EUSR, in close coordination with the Head of the Union delegation in Tel Aviv and the Union Representative Office in Jerusalem, shall provide the Heads of the European Union Police Mission in the Palestinian Territory (EUPOL COPPS) and of the European Union Border Assistance Mission for the Rafah Crossing Point (EU BAM Rafah) with local political guidance.": "regulatory", "The PSC shall maintain a privileged link with the EUSR and shall be the EUSR's primary point of contact with the Council.": "regulatory", "They shall make every effort to assist the EUSR in the implementation of the mandate.": "regulatory", "A member of temporary staff shall carry out his duties and conduct himself solely with the interests of the Agency in mind; he shall neither seek nor take instructions from any government, authority, organisation or person outside the Agency.": "regulatory", "A member of temporary staff shall not, without permission from the AACC, disclose on any grounds whatsoever, in any legal proceedings, information of which he has knowledge by reason of his duties.": "regulatory", "A member of temporary staff shall notify the AACC of any changes in a permitted outside activity or assignment, which occur after the member of temporary staff has sought the permission of the AACC under paragraph\u00a01.": "regulatory", "A reasoned decision shall be given by the AACC authority in accordance with the procedure laid down in regard to disciplinary matters.": "regulatory", "Article\u00a0106        Before being engaged, a member of the contract staff shall be medically examined by a medical officer authorised by the Agency in order that the Agency may be satisfied that he fulfils the requirements of Article\u00a0105(3)(d).": "regulatory", "Article\u00a0158        The secretary shall draw up minutes of meetings of the Disciplinary Board.": "regulatory", "Article\u00a016        If the spouse of member of temporary staff is in gainful employment, the member of temporary staff shall inform the AACC.": "regulatory", "Article\u00a031        Members of temporary staff shall be entitled to exercise the right of association; they may in particular be members of trade unions or staff associations.": "regulatory", "Article\u00a035        Any decision requiring damage suffered by the Agency as a result of serious misconduct to be made good, as provided for in Article\u00a026, shall be taken by the AACC after observing the formalities provided for in cases of dismissal for serious misconduct.": "regulatory", "Article\u00a073        In the event of the death of a member of temporary staff, a member of temporary staff's spouse or dependent child, or any other dependent person within the meaning of Article\u00a02 of Annex IV who lived as part of the member of temporary staff's household, the Agency shall reimburse the costs involved in transporting the body from the member of temporary staff's place of employment to his place of origin.": "regulatory", "Article\u00a090        Members of temporary staff shall contribute one third of the cost of financing the pension scheme.": "regulatory", "At the request of the member of temporary staff, the immediate superior shall be obliged to give such orders in writing.": "regulatory", "Before such appropriate measures are adopted by the AACC, the Steering Board shall adopt general provisions for giving effect to this paragraph.": "regulatory", "If he has used up his annual leave, he shall forfeit his remuneration for an equivalent period.": "regulatory", "If necessary, the AACC shall take the measures referred to in Article\u00a012(2).": "regulatory", "If the AACC decides to close the case without imposing any disciplinary penalty, it shall so inform the staff member concerned in writing without delay.": "regulatory", "If, over a period of\u00a012 months, a member of temporary staff is absent for up to three days because of sickness for a total of more than\u00a012 days, he shall produce a medical certificate for any further absence because of sickness.": "regulatory", "In the latter case, the practitioner's fees shall be payable by the Agency up to a maximum amount fixed for a period of no more than three years by the AACC.": "regulatory", "It shall bring to the notice of the competent bodies of the Agency any difficulty having general implications concerning the interpretation and application of these Staff Regulations.": "regulatory", "It shall contribute to the smooth running of the service by providing a channel for the expression of opinion of the staff.": "regulatory", "Members of temporary staff shall refrain from any form of psychological or sexual harassment.": "regulatory", "Members of the temporary staff shall not be exempt from fulfilling their private obligations or from complying with the laws and police regulations in force.": "regulatory", "Member\u00a0States participating in the Agency shall jointly guarantee payment of such benefits in accordance with the scale laid down for financing such expenditure.": "regulatory", "Section D              Public holidays            Article\u00a056        A list of public holidays shall be drawn up by the Agency.": "regulatory", "Should it recommend dismissal or, in exceptional circumstances, extension of the probationary period, the report and the comments shall be transmitted immediately by the immediate superior of the member of the contract staff to the AACC.": "regulatory", "Subject to paragraph\u00a02, if the immediate superior confirms the orders and the member of temporary staff believes that such confirmation does not constitute a reasonable response to the grounds of his concern, the member of temporary staff shall refer the question in writing to the hierarchical authority immediately above.": "regulatory", "The AACC shall decide whether to grant this request.": "regulatory", "The AACC shall lay down such provisions as it deems necessary for applying this Article.": "regulatory", "The AACC shall notify the person concerned of its reasoned decision within four months from the date on which the complaint was lodged.": "regulatory", "The AACC shall notify the person concerned of its reasoned decision within four months from the date on which the request was made.": "regulatory", "The AACC shall take any appropriate measure, and may in particular relieve the member of temporary staff from responsibility in this matter.": "regulatory", "The Agency shall ensure that such complaints are handled confidentially and, where warranted by the circumstances, before the expiry of the deadlines set out in Article\u00a0168.": "regulatory", "The Chairman shall ensure that the decisions of the Disciplinary Board are implemented and shall bring all information and documents relating to the case to the attention of each of its members.": "regulatory", "The Staff Committee shall represent the interests of the staff vis-\u00e0-vis the Agency and maintain continuous contact between the Agency and the staff.": "regulatory", "The Staff Committee shall submit to the competent bodies of the Agency suggestions concerning the organisation and operation of the service and proposals for the improvement of staff working conditions or general living conditions.": "regulatory", "The chairman and members of the Disciplinary Board shall be completely independent in the performance of their duties.": "regulatory", "The national departments with responsibility for employment and unemployment, acting in accordance with their national legislation, and the Agency shall cooperate with each other in an effective manner in order to ensure that this Article is properly applied.": "regulatory", "The same pension entitlement shall apply to children who fulfil the above conditions in the event of the death or remarriage of the spouse in receipt of a survivor's pension.": "regulatory", "They shall be subject to the weighting for the country in question if it is inside the Union or to a weighting equal to\u00a0100 if the country of residence is outside the Union.": "regulatory", "Those members of temporary staff shall manage their working time in agreement with their superiors.": "regulatory", "When privileges and immunities are in dispute, the member of the temporary staff concerned shall immediately inform the Agency.": "regulatory", "Where a case is withdrawn from the Disciplinary Board, the Chairman shall deliver an opinion on the penalty considered.": "regulatory", "Where persons covered by these Staff Regulations, who consider themselves wronged because the principle of equal treatment as set out in this Article has not been applied to them, establish facts from which it may be presumed that there has been direct or indirect discrimination, the onus shall be on the Agency to prove that there has been no breach of the principle of equal treatment.": "regulatory", "Notifications        Member States shall notify the Commission by 31 March each year of the following information for the previous calendar year:                    (a)                  decisions to grant, refuse or withdraw recognition of producer organisations, associations of producer organisations or interbranch organisations, including the date of the decision and the names and the sectors concerned and a summary of the reasons for refusals and withdrawals of recognition;                            (b)                  in respect of recognised producer organisations and recognised associations of producer organisations, the value of marketable production.": "regulatory", "The Member State referred to in paragraph 1 shall make available all relevant information upon request of another Member State in which members of such organisation or association are located.": "regulatory", "A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes\u00a0V,\u00a0VII and\u00a0VIII and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.": "regulatory", "A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.": "regulatory", "A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.": "regulatory", "A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.": "regulatory", "At all times and for each conformity assessment procedure and each kind of PPE for which it has been notified, a conformity assessment body shall have at its disposal the necessary:                    (a)                  personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;                            (b)                  descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures.": "regulatory", "Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.": "regulatory", "Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.": "regulatory", "In order to take into account technical progress and knowledge or new scientific evidence with respect to the category of a specific risk, the Commission shall be empowered to adopt delegated acts in accordance with Article\u00a043 in order to amend Annex\u00a0I by reclassifying the risk from one category to another.": "regulatory", "In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following:                    (a)                  failure of the PPE to meet requirements relating to the health or safety of persons; or                            (b)                  shortcomings in the harmonised standards referred to in Article\u00a014 conferring a presumption of conformity.": "regulatory", "In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.": "regulatory", "Member States shall lay down the rules on penalties applicable to infringements by economic operators of the provisions of this Regulation.": "regulatory", "The Commission shall ensure that the list is kept up to date.": "regulatory", "The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.": "regulatory", "The economic operator shall ensure that corrective action is taken in respect of all the PPE concerned that he has made available on the market throughout the Union.": "regulatory", "The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.": "regulatory", "The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.": "regulatory", "The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph\u00a03.": "regulatory", "They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.": "regulatory", "They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.": "regulatory", "Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article\u00a024, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.": "regulatory", "Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article\u00a024.": "regulatory", "Where the market surveillance authorities of one Member State have sufficient reason to believe that PPE covered by this Regulation presents a risk to the health or safety of persons, they shall carry out an evaluation in relation to the PPE concerned covering all relevant requirements laid down in this Regulation.": "regulatory", "Where the national measure is considered justified and the non-compliance of the PPE is attributed to shortcomings in the harmonised standards referred to in point\u00a0(b) of Article\u00a038(5) of this Regulation, the Commission shall apply the procedure provided for in Article\u00a011 of Regulation\u00a0(EU) No\u00a01025/2012.": "regulatory", "Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the PPE being made available on their national market, to withdraw the PPE from that market or to recall it.": "regulatory", "Without prejudice to Article\u00a038, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:                    (a)                  the CE marking has been affixed in violation of Article\u00a030 of Regulation\u00a0(EC) No\u00a0765/2008 or of Article\u00a017 of this Regulation;                            (b)                  the CE marking has not been affixed;                            (c)                  the identification number of the notified body involved in the production control phase has been affixed in violation of Article\u00a017 or has not been affixed;                            (d)                  the EU declaration of conformity has not been drawn up or has not been drawn up correctly;                            (e)                  the technical documentation is either not available or not complete;                            (f)                  the information referred to in Article\u00a08(6) or Article\u00a010(3) is absent, false or incomplete;                            (g)                  any other administrative requirement provided for in Article\u00a08 or Article\u00a010 is not fulfilled.": "regulatory", "Implementing Regulation (EU) No 1030/2014 is amended as follows:                    (1)                  Article 1 is replaced by the following:                \u2018Uniform format                G-SIIs shall report the information used to identify G-SIIs (indicators, ancillary data and memorandum items) to the relevant authority in electronic format using the template in the Annex to this Regulation, taking into consideration the further specifications of the underlying data and the instructions issued by the relevant authority each year.": "regulatory", "The panel shall be convened at the request of any contracting authority, as referred to in Article\u00a0117.": "regulatory", "Manufacturers shall provide the technical documentation containing the information set out in point 5(c) of Annex II to this Regulation.": "regulatory", "CHAPTER 2          ORGANISATION AND RESPONSIBILITIES          Corporate Management Board        The Corporate Management Board shall take the overall responsibility for the governance of IT security as a whole within the Commission.": "regulatory", "In case of a major IT security incident, the Directorate-General for Informatics shall be the contact point for the management of the crisis situations by coordinating the IT security incidents crisis management groups.": "regulatory", "Regular communications shall take place between the Directorate-General for Informatics and the Directorate-General for Human Resources and Security to exchange information and coordinate the handling of security incidents, in particular any IT security incident that may require a formal inquiry.": "regulatory", "The Directorate-General for Informatics shall develop emergency procedures to be approved by the ISSB.": "regulatory", "The Directorate-General for Informatics shall regularly report on major IT security incidents affecting the Commission's CIS to the ISSB.": "regulatory", "The ISSB shall monitor and review the overall implementation of this decision and report on it to the Corporate Management Board.": "regulatory", "The ISSB shall review and report biannually to the Corporate Management Board on governance matters as well as on IT-security-related issues, including serious IT security incidents.": "regulatory", "Member States shall take the necessary measures to prevent the entry into, or transit through, their territories of the persons designated by the Committee as:                            (a)                          engaging in or providing support for acts that undermine the peace, stability or security of the CAR, including acts that threaten or impede the stabilization and reconciliation process or that fuel violence;                                    (b)                          acting in violation of the arms embargo established in paragraph\u00a054 of UNSCR 2127 (2013) and Article\u00a01 of this Decision, or as having directly or indirectly supplied, sold, or transferred to armed groups or criminal networks in the CAR, or as having been the recipient of arms or any related materiel, or any technical advice, training, or assistance, including financing and financial assistance, related to violent activities of armed groups or criminal networks in the CAR;                                    (c)                          involved in planning, directing, or committing acts that violate international human rights law or international humanitarian law, as applicable, or that constitute human rights abuses or violations, in the CAR, including, targeting of civilians, ethnic- or religious-based attacks, attacks on schools and hospitals, and abduction and forced displacement;                                    (d)                          involved in planning, directing or committing acts involving sexual and gender-based violence in the CAR;                                    (e)                          recruiting or using children in armed conflict in the CAR, in violation of applicable international law;                                    (f)                          providing support for armed groups or criminal networks through the illicit exploitation or trade of natural resources, including diamonds, gold, wildlife as well as wildlife products in or from the CAR;                                    (g)                          obstructing the delivery of humanitarian assistance to the CAR, or access to, or distribution of, humanitarian assistance in the CAR;                                    (h)                          involved in planning, directing, sponsoring, or conducting attacks against United Nations missions or international security presences, including Minusca, the Union missions and French operations which support them;                                    (i)                          being leaders of an entity designated by the Committee, or having provided support to, or acted for or on behalf of, or at the direction of a person or an entity designated by the Committee, or an entity owned or controlled by a person or entity designated by the Committee,                        as listed in the Annex to this Decision.\u2019.": "regulatory", "The Head of the RCC shall issue instructions to all RCC staff.": "regulatory", "They shall keep the Head of the Union Delegation in the place where they are located duly informed.": "regulatory", "Fruiting plants shall be visually inspected in the most appropriate periods of the year taking into account climatic and growing conditions of plants of the genera or species concerned.": "regulatory", "The Commission shall provide information on the financial aspects of the projects referred to in Article 1(2).": "regulatory", "The FRS shall perform this task under the responsibility of the HR.": "regulatory", "The HR shall report to the Council on the implementation of this Decision on the basis of regular reports prepared by the FRS.": "regulatory", "The High Representative (HR) shall be responsible for the implementation of this Decision.": "regulatory", "The staff of the competent authorities referred to in Article 35 who deal with requests concerning unaccompanied minors shall have received, and shall continue to receive, appropriate training concerning the specific needs of minors.": "regulatory", "The application of exemptions granted to the companies specifically mentioned in paragraph 1 of this Article or authorised by the Commission in accordance with Article 2(2) shall be conditional upon presentation to the customs authorities of the Member States of a valid commercial invoice issued by the producer or consignor, on which shall appear a declaration dated and signed by an official of the entity issuing such invoice, identified by his/her name and function.": "regulatory", "A data reporting services provider shall promptly notify the competent authority of its home Member State of any planned significant changes to the IT system prior to their implementation.": "regulatory", "A data reporting services provider shall use systems and facilities that are appropriate and robust enough to ensure continuity and regularity in the performance of the services provided referred to in Directive 2014/65/EU.": "regulatory", "APAs and CTPs shall perform periodic reconciliations between the trade reports they receive and the trade reports that they publish, verifying the correct publication of the information.": "regulatory", "An APA shall refer to the transaction identification code in any subsequent communication with the reporting firm in relation to a specific trade report.": "regulatory", "An ARM shall have in place adequate policies, arrangements and technical capabilities to receive transaction reports from clients and to transmit information back to clients.": "regulatory", "An ARM shall have in place policies, arrangements and technical capabilities to comply with the technical specification for the submission of transaction reports required by the competent authority of its home Member State and by other competent authorities to whom the ARM sends transaction reports.": "regulatory", "An ARM shall perform periodic reconciliations at the request of the competent authority of its home Member State or the competent authority to whom the ARM submits transaction reports between the information that the ARM receives from its client or generates on the client's behalf for transaction reporting purposes and data samples of the information provided by the competent authority.": "regulatory", "An ARM shall promptly notify the client of the details of the error or omission and provide an updated transaction report to the client.": "regulatory", "An ARM shall set up and maintain appropriate arrangements to identify transaction reports that are incomplete or contain obvious errors caused by clients.": "regulatory", "Where an APA determines that a trade report it receives is incomplete or contains information that is likely to be erroneous, it shall not publish that trade report and shall promptly alert the investment firm submitting the trade report.": "regulatory", "Where an APA publishes a trade report which is a duplicate, it shall insert the code \u2018DUPL\u2019 in a reprint field to enable recipients of the data to differentiate between the original trade report and any duplicates of that report.": "regulatory", "Where an ARM becomes aware of errors or omissions caused by the ARM itself, it shall promptly submit a correct and complete report.": "regulatory", "Any decision relating to a specific individual which is taken under these Staff Regulations shall at once be communicated in writing to the member of temporary staff concerned.": "regulatory", "A member of the temporary staff engaged for a period of not less than one year shall receive an installation allowance as provided for in Article\u00a05 of Annex IV amounting, for an expected period of service of:                     not less than one year but less than two years,                  to one third                  of the rate laid down in Article\u00a05 of Annex IV                    not less than two years but less than three years,                  to two thirds                    three years or more,                  to three thirds                2.": "regulatory", "The report shall be communicated to the member of temporary staff.": "regulatory", "After green harvesting, Member States shall verify that the area concerned has been harvested in total and the harvested product has been denatured.": "regulatory", "An operational programmes shall be submitted for approval by a producer organisation to the competent authority of the Member State in which the producer organisation has its headquarters, by 15 September of the year preceding that in which the programme is to be implemented.": "regulatory", "Before a non-harvesting operation takes place, Member States shall verify by an on-the-spot check that the area concerned has been well maintained, that no partial harvest has already taken place, that the product is well developed and would in general be sound, fair and of marketable quality.": "regulatory", "Checks        Without prejudice to specific provisions of this Regulation or other Union legislation, Member States shall introduce checks and measures to ensure the proper application of Regulation (EU) No 1308/2013, Delegated Regulation (EU) 2017/891 and this Regulation.": "regulatory", "In particular, Member States shall ensure that:                    (a)                  all eligibility criteria established by Union or national legislation or the national strategy or national framework can be checked;                            (b)                  the competent authorities of the Member State responsible for carrying out checks have a sufficient number of suitably qualified and experienced staff to carry out the checks effectively; and                            (c)                  provision is made for checks to avoid irregular duplicated financing of measures under Regulation (EU) No 1308/2013 in the fruit and vegetables sector and under other Union or national schemes.": "regulatory", "Member States shall carry out administrative and on-the-spot checks with regard to the recognition criteria which apply to all recognised producer organisations and associations of producer organisations at least once every five years even if the producer organisations or the associations of producer organisations do not implement an operational programme.": "regulatory", "Member States shall carry out on-the-spot checks at the premises of producer organisations, associations of producer organisations and their subsidiaries, where applicable, to ensure compliance with the conditions for recognition, for granting an aid or the balance thereof for the year concerned as referred to in Article 9(1), which shall supplement the administrative checks.": "regulatory", "Payment of the aid        Member States shall pay the aid by 15 October of the year following the year of implementation of the programme.": "regulatory", "Prior to the approval of an operational programme under Article 33 of Delegated Regulation (EU) 2017/891, Member States shall verify, by all the appropriate means, including through on-the-spot checks, the operational programme submitted for approval and the request for amendment, where applicable.": "regulatory", "The Member State in which a transnational producer organisation has its head office shall have overall responsibility for the organisation of checks on that organisation in respect of the operational programme and operational fund and for the application of administrative penalties where such checks demonstrate that obligations have not been met.": "regulatory", "Less significant credit institutions shall start reporting information in accordance with paragraphs 4 and 5 from the next reporting reference date for quarterly reporting where the total value of the assets of a less significant credit institution exceeds, on a consolidated basis, EUR 3\u00a0billion, on four consecutive reporting reference dates for quarterly reporting.": "regulatory", "NCAs shall decide when credit institutions have to report supervisory financial information in order for them to meet this deadline.\u2019;                            (13)                  the heading of Title III is replaced by the following:                \u2018TITLE III                  REPORTING BY LESS SIGNIFICANT CREDIT INSTITUTIONS ON A CONSOLIDATED AND ON AN INDIVIDUAL BASIS AND BY LESS SIGNIFICANT BRANCHES ON AN INDIVIDUAL BASIS                \u2019;                            (14)                  Chapter I of Title III is replaced by the following:                \u2018                 CHAPTER I                      Reporting on a consolidated basis                    Format and frequency of reporting on a consolidated basis for less significant credit institutions                1.": "regulatory", "Significant credit institutions, other than those referred to in paragraph 1, which are not part of a significant supervised group and are subject to national accounting frameworks based on Directive 86/635/EEC shall report supervisory financial information to the relevant NCA.": "regulatory", "Supervisory financial reporting by these credit institutions shall take place with the frequency specified in Article 9 of Implementing Regulation (EU) No 680/2014 and shall include the common minimum information specified in Annex I.\u2019;                            (10)                  Article 7(3) is replaced by the following:                \u20183.": "regulatory", "Information on shareholders        An applicant seeking authorisation as an investment firm in accordance to Title II of Directive 2014/65/EU shall provide to the competent authority the following information on its shareholders:                    (a)                  the list of persons with a direct or indirect qualifying holding in the investment firm, and the amount of these holdings and, for indirect holdings, the name of the person through which the stake is held and the name of the final holder;                            (b)                  for persons with a qualifying holding (direct or indirect) in the investment firm the documentation required from proposed acquirers for the acquisition and increases in qualifying holdings in investment firms in accordance with Articles 3, 4 and 5 of Commission Delegated Regulation 2017/1946 of 11 July 2017 supplementing Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for an exhaustive list of information to be included by proposed acquirers in the notification of a proposed acquisition of a qualifying holding in an investment firm                 (                   4                  )                ;                            (c)                  for corporate shareholders that are members of a group, an organisational chart of the group indicating the main activities of each firm within the group, identification of any regulated entities within the group and the names of the relevant supervisory authorities as well as the relationship between the financial entities of the group and other non-financial group entities.": "regulatory", "Data from a clinical trial started before the date referred to in the second paragraph of Article 99 shall only be submitted in an application dossier if that clinical trial is registered in a public register which is a primary or partner registry of, or a data provider to, the WHO ICTRP or if the results of that clinical trial have been published in an independent peer-reviewed scientific publication.": "regulatory", "Data from a clinical trial started as from the date referred to in the second paragraph of Article 99 shall only be submitted in an application dossier if that clinical trial has been registered prior to its start in a public register which is a primary or partner registry of, or a data provider to, the WHO ICTRP.": "regulatory", "If the applicant finds that the data have been processed in breach of this Regulation or of Directive 95/46/EC, in particular because they are incomplete or inaccurate, he or she shall be entitled to have them corrected or erased.": "regulatory", "It shall perform this task under the control of the High Representative.": "regulatory", "By 30 June of each year, the Commission shall submit to the European Parliament and to the Council a report on the implementation of this Decision in the preceding year, including an evaluation of that implementation.": "regulatory", "If the financing needs of Georgia decrease fundamentally during the period of the disbursement of the Union's macro-financial assistance compared to the initial projections, the Commission, acting in accordance with the advisory procedure referred to in Article\u00a07(2), shall reduce the amount of the assistance or suspend or cancel it.": "regulatory", "Progress in attaining those objectives shall be regularly monitored by the Commission.": "regulatory", "The Commission shall be assisted by a committee.": "regulatory", "When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication.": "regulatory", "Member States shall provide those metadata to the Commission (Eurostat) not later than 3 months after transmission of the pre-checked microdata.": "regulatory", "Member States shall transmit the pre-checked microdata within 9 months after the end of the national period for collecting the data.": "regulatory", "After the expiry of the submission period referred to in paragraph 1, Member States shall inform the non-eligible applicants on the non-eligibility of their applications pursuant to the decision on the eligibility criteria adopted by Member States in accordance with Article 4.": "regulatory", "Checks concerning the declarations        As regards the declarations referred to in Articles 31 to 34 of Delegated Regulation (EU) 2018/273, Member States shall carry out any checks and take any measures necessary to ensure the accuracy of those declarations.": "regulatory", "Member States shall automatically grant authorisations within three months as from the submission of the application.": "regulatory", "Member States shall determine the maximum acceptable percentages for losses from evaporation during warehousing, processing operations or changes in product category.": "regulatory", "Member States shall notify the Commission by 1 November of each year of:                    (a)                  the applications for authorisations for new plantings, the authorisations effectively granted during the previous wine year pursuant to Article 7(1) or (2) of this Regulation, and the authorisations refused by the applicants as well as those granted to other applicants before 1 October pursuant to Article 7(3) of this Regulation.": "regulatory", "Member States shall submit to the Commission by 1 March of each year:                    (a)                  the communication on wine-growing areas referred to in Article 145(3) of Regulation (EU) No 1308/2013, concerning the situation on 31 July of the previous wine year.": "regulatory", "Producers shall submit the production declaration referred to in Article 31 of the Delegated Regulation (EU) 2018/273 as regards the production of the current wine year by 15 January of each year.": "regulatory", "The ERC-CWS shall draw up and update on a yearly basis the list of the Member States laboratories designated for the preparation of samples and the measurements for the analytical databank.": "regulatory", "The designated laboratories shall meet the general criteria for the operation of testing laboratories set out in ISO/IEC 17025:2005, and shall in particular take part in a system of proficiency tests covering methods of isotopic analysis.": "regulatory", "Where Member States decide to limit the total area available for new plantings to be allocated in the form of authorisations in accordance with Article 63(2) and (3) of Regulation (EU) No 1308/2013, they shall make public such decisions and the underlying reasons by 1 March of the respective year.": "regulatory", "Where support under a certain coupled support measure may also be granted under another coupled support measure, or under a measure implemented under other Union measures and policies, Member States shall ensure that the farmer concerned may receive support aiming at addressing the same difficulty, as referred to in Article\u00a052(3) of Regulation (EU) No 1307/2013 and as defined for that coupled support measure, under only one such measure per sector, region, specific type of farming or specific agricultural sector that is targeted in accordance with that provision.\u2019;                            (6)                  in Article 67(3), point (c) is replaced by the following:                            \u2018(c)                          for each affected measure, a justification that a transfer is consistent with the production-limiting character of the scheme referred to in Article 52(6) of Regulation (EU) No 1307/2013 and that the decisions notified to the Commission pursuant to Article 54 of that Regulation and paragraphs 1 and 2 of this Article do not become void.\u2019;                                    (7)                  Annex I is replaced by the text set out in the Annex to this Regulation.": "regulatory", "Food business operators or their representatives shall give prior notification of the estimated date and time of physical arrival of consignments of food referred to in Article 1(1) to the competent authorities at the designated point of entry and of the nature of the consignment.": "regulatory", "In respect of amounts stemming from the provisional measures established by Council Decisions (EU) 2015/1523                               (                                 *1                                )                              and (EU) 2015/1601                               (                                 *2                                )                              , with a view to enhancing solidarity and in accordance with TFEU, Member States shall allocate at least 20\u00a0% of those amounts to actions under the national programmes for the transfer of applicants for international protection or of beneficiaries of international protection, for resettlement or other ad hoc humanitarian admissions, as well as for preparatory measures for the transfer of applicants for international protection following their arrival in the Union, including arrival by sea, or for the transfer of beneficiaries of international protection.": "regulatory", "At the time of its creation, the originator shall indicate, where possible, whether the EUCI can be downgraded or declassified on a given date or following a specific event.": "regulatory", "However, they shall ensure that individual pieces of information are given the appropriate classification level.": "regulatory", "If the department has compiled classified information from various sources it shall first seek the consent of any other parties that provided source material, including in Member States, other EU bodies, third countries or international organisations.": "regulatory", "Meeting organisers shall endeavour to group CONFIDENTIEL UE/EU CONFIDENTIAL and SECRET UE/EU SECRET items consecutively on the agenda in order to facilitate the smooth functioning of the meeting.": "regulatory", "Meeting organisers shall prepare a complete list of participants prior to the meeting.": "regulatory", "Meeting organisers shall remind participants that any comments sent in on a CONFIDENTIEL UE/EU CONFIDENTIAL or SECRET UE/EU SECRET agenda item must not be sent through email, or through other means that have not been appropriately accredited in accordance with Article 11 of this Decision.": "regulatory", "Otherwise, the originator shall review the information and assess the risks at least every 5 years in order to determine whether the original classification level is still appropriate.": "regulatory", "Staff shall bear in mind that when large amounts of classified information are stored on removable storage media the device may warrant a higher classification level.": "regulatory", "The Chair shall ensure that unauthorised portable electronic devices have been left outside the meeting room.": "regulatory", "The Commission department that creates a classified document shall be responsible for deciding whether it can be downgraded or declassified.": "regulatory", "The initial recipients shall be responsible for informing any subsequent addressees to whom they have sent or copied the original CONFIDENTIEL UE/EU CONFIDENTIAL or SECRET UE/EU SECRET information.": "regulatory", "When creating CONFIDENTIEL UE/EU CONFIDENTIAL or SECRET UE/EU SECRET information, Commission staff shall use CIS accredited for the corresponding classification level or for a higher classification level.": "regulatory", "When hand-carrying either paper documents or removable storage media classified as CONFIDENTIEL UE/EU CONFIDENTIAL or SECRET UE/EU SECRET, staff shall comply with all of the following additional measures:                          \u2014                        When travelling by public transport the classified information shall be placed in a briefcase or bag that is kept in the bearer's personal custody.": "regulatory", "Where these are not available, staff shall seek the advice of the Commission security authority.": "regulatory", "An authorisation for transit of goods listed in Annex II shall be granted by the competent authority of the Member\u00a0State where the natural or legal person, entity or body transporting the goods within the customs territory of the Union is resident or established, as listed in Annex I.": "regulatory", "As regards brokering services the competent authorities shall in particular receive details of the location of the goods in the originating third country, a clear description of the goods and the quantity involved, third parties involved in the transaction, the third country of destination, the end-user in that country and its exact location.": "regulatory", "Each Member\u00a0State shall appoint a representative to that group.": "regulatory", "If no application for an authorisation is made within six months of the detention, or if the competent authority dismisses such an application, the customs authorities shall dispose of the detained goods in accordance with applicable national law.": "regulatory", "If that person, entity or body is not resident or established in a Member\u00a0State, an authorisation shall be granted by the competent authority of the Member\u00a0State in which the entry of goods into the customs territory of the Union takes place.": "regulatory", "It shall communicate the points on which supplementary information needs to be provided.": "regulatory", "The Commission shall forward its questions to the other Member\u00a0States.": "regulatory", "A manufacturer which is subject to a derogation in accordance with this Article shall notify the Commission immediately of any change which affects or may affect its eligibility for a derogation.": "regulatory", "By 28 February of each year, each Member State shall determine and transmit to the Commission the information listed in Parts A of Annexes II and III in respect of the preceding calendar year.": "regulatory", "By 31\u00a0December 2020, the Commission shall review Directive 1999/94/EC considering the need to provide consumers with accurate, robust and comparable information on the fuel consumption, CO               2              emissions and air pollutant emissions of new passenger cars placed on the market, as well as evaluate the options for introducing a fuel economy and CO               2              emissions label for new light commercial vehicles.": "regulatory", "Manufacturers included in a pool shall jointly inform the Commission of any change of pool manager or of its financial status, in so far as this may affect its ability to meet the requirement to pay any excess emissions premium imposed on the pool in accordance with Article 8, and of any changes to the membership of the pool or the dissolution of the pool.": "regulatory", "Manufacturers shall ensure that the CO               2              emission and fuel consumption values recorded in the certificates of conformity correspond to the CO               2              emissions from, and fuel consumption of, vehicles in-service as determined in accordance with Regulation (EU) 2017/1151.": "regulatory", "The Commission shall adopt, by means of implementing acts, detailed provisions for a procedure to approve the innovative technologies or innovative technology packages referred to in paragraph 1 of this Article.": "regulatory", "The Commission shall consider any notifications from manufacturers and shall, by 31\u00a0October, either confirm or amend the provisional calculations under paragraph 4.": "regulatory", "The Commission shall notify each manufacturer of its provisional calculation for that manufacturer.": "regulatory", "Type-approval authorities shall without delay report to the Commission deviations found in the CO               2              emissions of vehicles in-service as compared to the specific emissions of CO               2              indicated in the certificates of conformity as a result of verifications performed in accordance with Article 13.": "regulatory", "By 30 September each year, from the starting years set out in point 1 of Part B of Annex I, manufacturers of heavy-duty vehicles shall report those data for each new heavy-duty vehicle with a date of simulation falling within the preceding reporting period of 1 July to 30 June to the Commission in accordance with the reporting procedure set out in Annex II.": "regulatory", "By 30 September each year, starting in 2020, the competent authorities of the Member States shall report those data of the previous reporting period of 1 July to 30 June to the Commission in accordance with the reporting procedure set out in Annex II.": "regulatory", "The Commission shall determine, by means of implementing acts, the procedures for performing the verifications referred to in paragraph 2 of this Article.": "regulatory", "The Commission shall monitor and assess the real-world representativeness of the CO               2              emissions and energy consumption values determined within the framework of Regulation (EC) No\u00a0595/2009.": "regulatory", "The Commission shall publish the adjusted reference CO               2              emissions values and shall apply those values for the calculation of the manufacturer specific CO               2              emissions targets applicable in the reporting periods starting from the date of application of the delegated acts adjusting the values.": "regulatory", "With regard to 2019, manufacturers shall report the data for each new heavy-duty vehicle with a date of simulation falling within the period 1 January 2019 to 30 June 2020.": "regulatory", "At the same time, Member States shall also transmit this emissions data to the Commission.": "regulatory", "For the implementation of this Regulation, the Union shall provide grants to the NSIs and other national authorities as referred to in Article 5(2) of Regulation (EC) No 223/2009, for:                          (a)                        the development and/or implementation, and the improvement of timeliness, of data collection, data collection methods, sampling frames and data processing for statistics under this Regulation, for the first four years of the data collection for each domain covered by this Regulation;                                  (b)                        the development of methodologies for statistics under this Regulation, including the participation of the Member States in representative feasibility and pilot studies referred to in Article 14;                                  (c)                        the collection and production of statistics on ad hoc subjects required by the users as provided for in Annex IV, new or revised sets of variables and characteristics implemented for the first time.": "regulatory", "The results of the feasibility and pilot studies referred to in paragraph 1 shall be evaluated by the Commission (Eurostat) in cooperation with Member States and the main users of the data sets.": "regulatory", "They shall not impose significant additional burden or cost on the Member States.": "regulatory", "Where this Regulation confers tasks on NSIs and other national authorities which they did not previously carry out, they shall be granted sufficient financial resources from the Union for the purpose of carrying out those tasks.": "regulatory", "Insurance and reinsurance undertakings shall use the technical information referred to in paragraph 2 when calculating technical provisions and basic own funds for reporting with reference dates from 30 September 2019 until 30 December 2019.": "regulatory", "National customs authorities shall await the publication of the outcome of the reopening investigation before deciding on any claims for repayment and remission of the duties concerned by this Regulation.": "regulatory", "In the case referred in paragraph 1(c), the competent authority of the border control post shall inform through the IMSOC the competent authority of the Member State of destination of the introduction of the samples.": "regulatory", "Germany shall inform the Commission of the amendment of the Swiss\u2010German Agreement pursuant to Article 1 of this Decision and shall notify the Commission of the text of that amendment.": "regulatory", "By way of derogation from paragraph 2, from the date of application of this Decision, the BNB representative to the Supervisory Board shall participate and exercise voting rights in the deliberations for the adoption by the ECB of instructions with regard to the identification of significant supervised entities established in the Republic of Bulgaria pursuant to Article 110 of Regulation (EU) No 468/2014 (ECB/2014/17).": "regulatory", "From 1 October 2020, the ECB shall carry out the tasks in the areas referred to in Article 4(1) and 4(2) and Article 5 of Regulation (EU) No 1024/2013 in relation to supervised entities established in the Republic of Bulgaria.": "regulatory", "Upon notification of instructions addressed by the ECB to BNB with regard to the identification of significant supervised entities established in the Republic of Bulgaria pursuant to Article 110 of Regulation (EU) No 468/2014 (ECB/2014/17), BNB shall appoint sub-coordinators for the relevant joint supervisory teams pursuant to Article 115(3) of Regulation (EU) No 468/2014 (ECB/2014/17) and shall inform the ECB of those appointments without undue delay.": "regulatory", "Upon notification of instructions addressed by the ECB to BNB with regard to the identification of significant supervised entities established in the Republic of Bulgaria pursuant to Article 110 of Regulation (EU) No 468/2014 (ECB/2014/17), BNB shall identify as pending procedures pursuant to Article 48 of Regulation (EU) No 468/2014 (ECB/2014/17) any supervisory procedure formally initiated which requires a decision but cannot be completed before 1 October 2020.": "regulatory", "If the Commission, following a request for prolongation, comes to the conclusion that changes to the regulatory approach as set out under this decision are required, or that other conditions are necessary to increase competition or market integration, sufficient time shall be given for their implementation, giving also sufficient advance notice to other market participants of possible changes to available cross-border capacity.": "regulatory", "For the purposes of giving or withdrawing consent to prolong the storing of the application file, the tool shall inform the applicant on the data that would be retained or erased.": "regulatory", "Member States\u2019 personnel referred to in Article 15(3) whose duties may require access to EUCI classified CONFIDENTIEL UE/EU CONFIDENTIAL or above shall be security cleared to the relevant level or otherwise duly authorised by virtue of their functions, in accordance with national laws and regulations, before being granted access to such EUCI.": "regulatory", "Member States shall inform the applicant within 2 months as from the submission of the application for the extension of the deadline for grubbing up referred to in paragraph 1 and where applications have been refused, applicants shall be informed of the reasons thereof.": "regulatory", "The payments and benefits provided for in this Section shall be suspended if the remuneration which a member of the temporary staff receives in respect of his employment is suspended pursuant to these Staff Regulations.": "regulatory", "In this case, the privileges of the holder shall be limited by the competent authority to performing flight instruction and testing for initial issue of type ratings, the supervision of initial line flying by the operators\u2019 pilots, delivery or ferry flights, initial line flying, flight demonstrations or test flights, as appropriate to the tasks foreseen under this paragraph.": "regulatory", "Member States shall take the measures necessary to ensure the quality of the data and metadata transmitted under this Regulation.": "regulatory", "The Commission (Eurostat) shall also take into account the burden resulting from other ongoing pilot studies in order to limit the number of concurrent pilot studies during the same period of time.": "regulatory", "By way of derogation to the procedure set out in paragraph 4, projects proposed for selection without a call for proposals under point (c) of paragraph 1 shall be assessed by the Commission on the basis of a project summary.": "regulatory", "In case of a negative assessment the Commission shall notify the managing authority of its reasons.\u2019;                                          (7)                      Article 48 is amended as follows:                                (a)                              in paragraph 2, points (ii) and (iii) are replaced by the following:                                        \u2018(ii)                                      costs incurred should be paid before the submission of the final project reports.": "regulatory", "The Commission shall notify its assessment to the managing authority within two months of the document submission date.": "regulatory", "The position to be taken on behalf of the Union within the International Maritime Organization\u2019s Maritime Safety Committee during its 102               nd              session shall be to support the adoption of the amendments to:                          (a)                        Parts A-1, B, B-1, B-2 to B-4 of Chapter II-1 of the International Convention for the Safety of Life at Sea, as laid down in Annex 1 to IMO document MSC 102/3;                                  (b)                        Parts A-1 and B-1 of the International Code of Safety for Ships Using Gases or Other Low-flashpoint Fuels, as laid down in Annex 2 to IMO document MSC 102/3;                                  (c)                        resolution A.658(16) on the use and fitting of retro-reflective materials on life-saving appliances.": "regulatory", "The EGE's discussions shall be confidential.": "regulatory", "Benchmark administrators shall explain, using the template laid down in the Annex to this Regulation, which of the environmental, social and governance (ESG) factors referred to in Annex II to Commission Delegated Regulation (EU) 2020/1816               (                 4                )              they have taken into account when designing their benchmark methodology.": "regulatory", "Any additional information received directly by the Commission shall be made available to the Member States.": "regulatory", "Member States shall designate the competent authorities referred to in this Regulation and identify them on the websites listed in Annex II.": "regulatory", "The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 1 within four weeks of the authorisation.": "regulatory", "The Member States shall immediately inform each other and the Commission of any other relevant information at their disposal which might affect the effective implementation of this Regulation.": "regulatory", "In particular, the Identification Committee shall assist the Commission in identifying and selecting potential members of the EGE and in assessing their availability and willingness to serve as such.": "regulatory", "Minutes shall be drafted by the secretariat under the responsibility of the chairperson.": "regulatory", "The EGE shall establish close links with the Commission departments concerned by issues on which the EGE is working.": "regulatory", "The responsible Commission department shall ask applicants for their consent before including their names on the reserve list.": "regulatory", "The responsible Commission department shall establish a reserve list of suitable candidates that may be used to appoint members\u2019 replacements.": "regulatory", "Supervisory financial information in respect of subsidiaries established in a non-participating Member State or a third country shall be reported in the following manner:                            (a)                          Significant credit institutions applying IFRS on a consolidated basis in accordance with Regulation (EC) No 1606/2002, including those that apply them for supervisory reporting pursuant to Article 24(2) of Regulation (EU) No 575/2013, shall ensure that the supervisory financial information specified in paragraph 1 of Annex II is submitted on an individual basis to the relevant NCA in respect of subsidiaries established in a non-participating Member State or a third country.": "regulatory", "The Commission shall report to the Council on the financial aspects of the projects referred to in Article\u00a01.": "regulatory", "The Commission shall supervise the proper management of the expenditure referred to in paragraph 2.": "regulatory", "The HR shall report to the Council on the implementation of this Decision on the basis of regular quarterly reports prepared by UNODA.": "regulatory", "The technical implementation of the projects referred to in Article\u00a01 shall be carried out by the United Nations Office for Disarmament Affairs (UNODA).": "regulatory", "UNODA shall perform its task under the responsibility of the HR.": "regulatory", "The comparability of Member States\u2019 data and the timely calculation of the required representative and reliable European aggregates, including headline indicators, shall be ensured.": "regulatory", "Each fishing vessel, group of fishing vessels, fishing gear category, operator and/or fishing related activity, for each stock referred to in Article 1, shall be subject to control and inspections according to the level of priority attributed pursuant to paragraph 3.": "regulatory", "It shall be prohibited to directly or indirectly make or be part of any arrangement to make new loans or credit with a maturity exceeding 90 days, after 29\u00a0June 2021, to:                                    (a)                                  the Republic of Belarus, its Government, its public bodies, corporations or agencies; or                                            (b)                                  a major credit or other institution established in Belarus with over 50 % public ownership or control as of 1\u00a0June 2021, as listed in Annex IX; or                                            (c)                                  a legal person, entity or body established outside the Union whose proprietary rights are directly or indirectly owned for more than 50 % by an entity listed in Annex IX; or                                            (d)                                  any natural or legal person, entity or body when acting on behalf or at the direction of a legal person, entity or body referred to in point (c).": "regulatory", "It shall be prohibited to sell, supply, transfer or export, directly or indirectly, dual-use goods and technology, whether or not originating in the Union, to natural or legal persons, entities or bodies in Belarus as listed in Annex V to this Regulation.": "regulatory", "Article\u00a01l                      It shall be prohibited to provide insurance or re-insurance to:                                  (i)                                the Belarusian Government, its public bodies, corporations or agencies; or                                          (ii)                                any natural or legal person, entity or body acting on behalf or at the direction of a legal person, entity or body referred to in point (i).": "regulatory", "The direct or indirect sale, purchase, transportation or brokering of gold and precious metals, as well as of diamonds to, from or for the Government of Syria, its public bodies, corporations and agencies, the Central Bank of Syria, as well as to, from or for persons and entities acting on their behalf or at their direction, or entities owned or controlled by them, shall be prohibited.": "regulatory", "The Commission shall record the applicable retention periods in line with the Common Commission-Level Retention List and shall make available to the data subjects the relevant retention periods for these processing activities in its data protection notice.": "regulatory", "The Commission shall record the reasons for any restriction applied pursuant to this Decision including a reference to the legal ground(s) applied for the restriction and an assessment of the necessity and proportionality of the restriction, taking into account the relevant elements set out in Article\u00a025(2) of Regulation (EU) 2018/1725.": "regulatory", "Member States shall establish appropriate intervals within which vehicles of categories L3e, L4e, L5e and L7e equipped with a combustion engine with a displacement of more than 125 cm                               3                              , are to be subject to a roadworthiness test.\u2019;                                          (3)                      Annexes I and III are amended in accordance with the Annex to this Directive.": "regulatory", "They shall apply the measures necessary to comply with Article\u00a01 and point (2) of the Annex of this Directive from 27\u00a0September 2022.": "regulatory", "A new exporting producer shall provide evidence that:                        (a)                      it did not export the goods described in Article\u00a01(1) originating in the People\u2019s Republic of China during the period of investigation (1\u00a0July 2018 to 30\u00a0June 2019);                                (b)                      it is not related to an exporter or producer subject to the measures imposed by this Regulation; and                                (c)                      it has either actually exported the product concerned or has entered into an irrevocable contractual obligation to export a significant quantity to the Union after the end of the period of investigation.": "regulatory", "Subject to the limitations set out in paragraph 3, and where appropriate for a reasonable fee, passengers shall be entitled to take bicycles on board the train.": "regulatory", "Persons with disabilities or persons with reduced mobility shall be assisted as follows:                          (a)                        the personal assistant, recognised as such in accordance with national practices, may travel with a special tariff and, if applicable, free of charge and be seated, where practicable, next to the person with disabilities;                                  (b)                        where a railway undertaking requires that a passenger needs to be accompanied on board the train in accordance with Article 21(2), the accompanying person shall be entitled to travel free of charge and to be seated, where practicable, next to the person with disabilities or to the person with reduced mobility;                                  (c)                        an assistance dog shall be permitted to accompany them in accordance with any relevant national law;                                  (d)                        for unstaffed trains, station managers or railway undertakings shall provide assistance free of charge, in conformity with the access rules referred to in Article\u00a021(1), during boarding and alighting from a train when there is trained staff on duty at the station;                                  (e)                        on departure from, transit through or arrival at a staffed railway station, the station manager or the railway undertaking shall provide assistance free of charge in such a way that that person is able to board the train, to transfer to a connecting rail service for which he or she has a ticket, or to alight from the train, provided there is trained staff on duty.": "regulatory", "Where a passenger has made a reservation for a bicycle and the carriage of that bicycle is refused without a duly justified reason, the passenger shall be entitled to re-routing or reimbursement in accordance with Article 18, compensation in accordance with Article\u00a019 and assistance in accordance with Article 20(2).": "regulatory", "The acceptance by a person, entity or body in the Union of technical assistance related to goods listed in Annex II supplied from a third country, whether for consideration or not, by any person, entity or body shall be prohibited.": "regulatory", "Any transit of goods listed in Annex II shall be prohibited.": "regulatory", "Where there is no ticket office or no accessible ticketing machine in the station of departure and no other accessible means to purchase a ticket in advance, persons with disabilities shall be permitted to buy tickets on board the train at no extra cost.": "regulatory", "All national enforcement bodies involved shall cooperate to facilitate the resolution of the complaint, including by sharing information, assisting with the translation of documents and providing information on the circumstances of incidents.": "regulatory", "CHAPTER VI            SECURITY, COMPLAINTS AND QUALITY OF SERVICE              Personal security of passengers            In agreement with public authorities, railway undertakings, infrastructure managers and station managers shall take adequate measures in their respective fields of responsibility and adapt them to the level of security defined by the public authorities to ensure passengers\u2019 personal security in railway stations and on trains and to manage risks.": "regulatory", "If a passenger is killed or injured, the railway undertaking as referred to in Article 26(5) of Annex I shall without delay, and in any event not later than 15 days after the establishment of the identity of the natural person entitled to compensation, make such advance payments as may be required to meet immediate economic needs on a basis proportional to the damage suffered.": "regulatory", "In complex cases such as those involving multiple complaints or a number of operators, cross-border travel or accidents on the territory of a Member State other than that which granted the undertaking\u2019s licence, and in particular where it is unclear which national enforcement body is competent, or where it would facilitate or accelerate the resolution of the complaint, national enforcement bodies shall cooperate to identify a lead body, which shall serve as a single point of contact for passengers.": "regulatory", "In such a case, it shall inform the passenger of the reasons for the extension and of the expected time needed to conclude the procedure.": "regulatory", "Passenger complaints about an incident involving a railway undertaking shall be handled by the national enforcement body or any other body designated under paragraph 2 of the Member State that granted that undertaking\u2019s licence.": "regulatory", "Railway undertakings shall establish service quality standards and implement a quality management system to maintain service quality.": "regulatory", "Railway undertakings shall make reasonable efforts to avoid additional connections and to ensure that delay in the total travel time is as short as possible.": "regulatory", "Report            By 7 June 2026, the Commission shall report to the European Parliament and the Council on the implementation and the results of this Regulation.": "regulatory", "The Commission and the bodies designated shall publish that information on their websites.": "regulatory", "The ticket vendors or the tour operators shall be responsible for handling requests and possible complaints of the passenger under paragraph 4.": "regulatory", "They shall monitor their performance pursuant to those standards and provide access to the information on their performance to the national public authorities on request.": "regulatory", "They shall publish their conditions for the transport of bicycles, including up-to-date information on the availability of capacity, by using the telematics applications referred to in Regulation (EU) No 454/2011 on their official websites.": "regulatory", "Where a ticket or tickets are purchased in a single commercial transaction and the ticket vendor or tour operator has combined the tickets on its own initiative, the ticket vendor or tour operator that sold the ticket or tickets shall be liable to reimburse the total amount paid for that transaction for the ticket or tickets and, moreover, to pay compensation equivalent to 75\u00a0% of that amount in the event that the passenger misses one or more connections.": "regulatory", "Where the need for assistance has been notified in advance in accordance with point\u00a0(a) of Article 24, the station manager or the railway undertaking shall ensure that assistance is provided as requested;                                  (f)                        at unstaffed stations, railway undertakings shall provide assistance free of charge on board a train and during boarding and alighting from a train if the train is accompanied by trained staff;                                  (g)                        in the absence of trained accompanying staff on board a train and at a station, station managers or railway undertakings shall make all reasonable efforts to enable persons with disabilities or persons with reduced mobility to have access to travel by rail;                                  (h)                        railway undertakings shall make all reasonable efforts to provide persons with disabilities or persons with reduced mobility with access to the same on-board services as other passengers, where these persons cannot have access to those services independently and safely.": "regulatory", "Where there is no staff on board the train, the railway undertaking shall advise the persons with disabilities whether to and inform them on how to purchase the ticket.": "regulatory", "Article\u00a06c                      Designation of a competent authority responsible for coordinating administrative enquiries                      The contact details of the competent authority responsible for coordinating in each Member State administrative enquiries in relation to taxable persons making use of one of the special schemes shall include the name, department, address, phone number and email address to be used to contact that competent authority.": "regulatory", "G-SIIs shall disclose the information referred to in paragraph 1 in their year-end Pillar 3 report.": "regulatory", "Exporters shall supply the competent authorities with all relevant information required for their application for an export authorisation.": "regulatory", "When applying the conditions under points (i) and (ii), the competent authority shall require adequate information as regards the use of the authorisation granted, including information concerning the purpose of, and the counterparts to, the activities concerned.": "regulatory", "By 31\u00a0December 2024, the Commission shall carry out a mid-term evaluation of this Regulation.": "regulatory", "Entities as referred to in point (a)(ii) of paragraph 1 shall participate as part of a consortium composed of at least two independent entities, at least one of which is established in a Member State.": "regulatory", "For support provided under direct or indirect management, the Commission shall publish the information referred to in Article\u00a038(2) of the Financial Regulation on a publicly available website and shall update that information regularly.": "regulatory", "In compliance with its reporting requirements pursuant to point (h)(iii) of the first subparagraph of Article\u00a041(3) of the Financial Regulation, the Commission shall present to the European Parliament and to the Council information on the core performance indicators listed in Annex V to this Regulation.": "regulatory", "The Commission shall engage with civil society organisations and relevant networks, in particular with a view to preparing and evaluating the work programmes for Union actions financed under the Fund.": "regulatory", "The Commission shall establish the overall amount to be made available for the thematic facility under the annual appropriations of the Union budget.": "regulatory", "The Fund shall provide financial assistance to address urgent and specific needs in the event of duly justified emergency situations.": "regulatory", "To ensure the visibility of Union funding, recipients of Union funding shall refer to the origin of that funding when publicly communicating on the action concerned, and shall display the Union emblem.": "regulatory", "When funding from the thematic facility is provided under direct or indirect management to Member States, the Commission shall ensure that projects affected by a reasoned opinion delivered by the Commission in respect of infringement proceedings under Article\u00a0258 TFEU that put in doubt the legality and regularity of expenditure or the performance of those projects are not selected.": "regulatory", "Without prejudice to existing possibilities for carrying out further audits as referred to in Article\u00a0127 of the Financial Regulation, the managing authority shall draw up the management declaration referred to in point (f) of the first subparagraph of Article\u00a074(1) of Regulation (EU) 2021/1060.": "regulatory", "For that purpose, it shall notify the Commission of a dossier describing the product or substance concerned, giving the reasons for such specific authorisation and explaining why the products and substances authorised under this Regulation are not adequate to be used due to the specific conditions in the relevant area.": "regulatory", "It shall ensure that the dossier is fit to be made publicly available subject to Union and national legislation of the Member States on data protection.": "regulatory", "Where AIFMs consider principal adverse impacts of investment decisions on sustainability factors as described in Article\u00a04(1), point (a) of Article\u00a04 of Regulation (EU) 2019/2088, or as required by paragraphs 3 or 4 of Article\u00a04 of that Regulation, those AIFMs shall take into account such principal adverse impacts when complying with the requirements set out in paragraphs 1 to 3 of this Article.\u2019;                                  (3)                      in Article\u00a022, the following paragraph 3 is added:                      \u20183.": "regulatory", "In the case of an entry in the Internal Market Information System for a refusal decision falling within Article\u00a03(1)(h)(i), the competent authority shall review the entry at least once every 10 years from the date on which the refusal decision was made and shall update the entry, immediately following each such review, to confirm that the refusal decision remains in force or, if the decision has been revoked, to record the revocation date in accordance with paragraph 2.": "regulatory", "Member States having a direct management interest shall submit as soon as possible, but by no later than 1\u00a0May 2022, additional scientific information supporting this exemption for cuckoo ray caught with bottom trawls.": "regulatory", "If it appears that overriding reasons for refusing to disclose the supervisory information referred to in paragraph (1)(c) exist, the Governing Council shall decide on the transmission of supervisory information, following the procedure laid down in Article\u00a026(8) of Regulation (EU) No\u00a01024/2013.": "regulatory", "The addressee shall implement an in-house programme in order to ensure the effective withdrawal from the market of ACS- BN\u00d8\u00d87-1 oilseed rape in breeding and seed production and shall gather data on the presence of that genetically modified organism in the oilseed rape shipments to the Union from Canada.": "regulatory", "Article\u00a01            Spain shall ensure that:                        (a)                      a restricted zone which comprises a protection zone and a surveillance zone is established immediately by the competent authority of that Member State in accordance with Article\u00a021(1) of Delegated Regulation (EU) 2020/687 and under the conditions laid down in that Article;                                (b)                      the protection and surveillance zones referred to in paragraph (a) comprise at least the areas listed in the Annex to this Decision.": "regulatory", "For that purpose, the HR shall enter into the necessary arrangements with the GICHD.": "regulatory", "The Commission shall report on the financial aspects of the project referred to in Article\u00a01.": "regulatory", "The Commission shall supervise the proper management of the expenditure referred to in paragraph 1.": "regulatory", "The HR shall report to the Council on the implementation of this Decision on the basis of regular narrative reports prepared by the GICHD.": "regulatory", "In the above situations, the on-board operator shall not drive the fully automated vehicle and the ADS shall continue to perform the DDT.": "regulatory", "The remote intervention operator shall not drive the fully automated vehicle and the ADS shall continue to perform the DDT.": "regulatory", "Those specifications shall be assessed by the approval authorities or their technical services in accordance with Annex III.": "regulatory", "Unless otherwise agreed between Members pursuant to Regulation (EC) No\u00a0521/2008, all rights and obligations including assets, debts or liabilities of the Members pursuant to Regulation (EC) No\u00a0521/2008 shall be transferred to the Members pursuant to this Regulation.": "regulatory", "Article\u00a054            Compensation            Recipients of the service shall have the right to seek, in accordance with Union and national law, compensation from providers of intermediary services, in respect of any damage or loss suffered due to an infringement by those providers of their obligations under this\u00a0Regulation.": "regulatory", "At the latest when effect is given to the order or, where applicable, at the time provided by the issuing authority in its order, providers of intermediary services shall inform the recipient of the service concerned of the order received and to the effect given to it.": "regulatory", "At the request of the Commission, the Digital Services Coordinators and other competent authorities shall provide the Commission with all necessary information to carry out the tasks assigned to it under this Section.": "regulatory", "Before the adoption of any measures pursuant to the first paragraph of this Article, the Commission shall publish a draft thereof and invite all interested parties to submit their comments within the period set out therein, which shall not be less than one month.": "regulatory", "By 17\u00a0November 2027, and every five years thereafter, the Commission shall evaluate this Regulation, and report to the\u00a0European\u00a0Parliament, the Council and the European Economic and Social Committee.": "regulatory", "Digital Services Coordinators and, where applicable, other competent authorities that do not follow the opinions, requests or recommendations addressed to them adopted by the\u00a0Board shall provide the reasons for this choice, including an explanation on the investigations, actions and the measures that they have implemented, when reporting pursuant to this Regulation or when adopting their relevant decisions, as appropriate.": "regulatory", "Each Member\u00a0State shall ensure that its Digital Services Coordinator has sufficient autonomy in managing its budget within the budget's overall limits, in order not to adversely affect the independence of the Digital Services Coordinator.": "regulatory", "Following the notification pursuant to this paragraph, other Member\u00a0States shall not initiate proceedings for the same infringement as that referred to in the notification.": "regulatory", "For the purpose of paragraph\u00a02, Member\u00a0States and the Board shall send information on the request of the\u00a0Commission.": "regulatory", "If the interview referred to in paragraph 1 is conducted on other premises than those of the\u00a0Commission, the Commission shall inform the Digital Services Coordinator of the\u00a0Member\u00a0State in the territory of which the interview takes place.": "regulatory", "In addition, the Commission, in cooperation with the Digital Services Coordinators and the\u00a0Board, shall coordinate the assessment of systemic and emerging issues across the Union in relation to very large online platforms or very large online search engines with regard to matters covered by this\u00a0Regulation.": "regulatory", "In fixing the amount of the fine, the Commission shall have regard to the nature, gravity, duration and recurrence of the infringement and, for fines imposed pursuant to paragraph\u00a02, the delay caused to the proceedings.": "regulatory", "It shall be actively involved in the decisions related to risk management, and shall ensure that adequate resources are allocated to the management of the risks identified in accordance with\u00a0Article\u00a034.": "regulatory", "Member States shall ensure that when an order referred to in paragraph\u00a01 is transmitted to the provider, it meets at least the following conditions:                          (a)                        that order contains the following elements:                                  (i)                                a reference to the legal basis under Union or national law for the order;                                          (ii)                                a statement of reasons explaining why the information is illegal content, by reference to one or more specific provisions of Union law or national law in compliance with Union law;                                          (iii)                                information identifying the issuing authority;                                          (iv)                                clear information enabling the provider of intermediary services to identify and locate the illegal content concerned, such as one or more exact URL and, where necessary, additional information;                                          (v)                                information about redress mechanisms available to the provider of intermediary services and to the recipient of the service who provided the content;                                          (vi)                                where applicable, information about which authority is to receive the information about the effect given to the orders;                                          (b)                        the territorial scope of that order, on the basis of the applicable rules of Union and national law, including the Charter, and, where relevant, general principles of international law, is limited to what is strictly necessary to achieve its objective;                                  (c)                        that order is transmitted in one of the languages declared by the provider of intermediary services pursuant to\u00a0Article\u00a011(3) or in another official language of the Member\u00a0States, agreed between the authority issuing the order and that provider, and is sent to the electronic point of contact designated by that provider, in accordance with\u00a0Article\u00a011; where the order is not drafted in the language declared by the provider of intermediary services or in another bilaterally agreed language, the order may be transmitted in the language of the authority issuing the order, provided that it is accompanied by a translation into such declared or bilaterally agreed language of at least the elements set out in points\u00a0(a) and\u00a0(b) of this paragraph.": "regulatory", "Member\u00a0States shall cooperate with the Commission, in particular through their respective Digital Services Coordinators and other competent authorities, where applicable, including by making available their expertise and capabilities.": "regulatory", "Member\u00a0States shall ensure that any of their activities undertaken under the first subparagraph do not affect the ability of their Digital Services Coordinators to certify the bodies concerned in accordance with paragraph\u00a03.": "regulatory", "Member\u00a0States shall ensure that the maximum amount of a periodic penalty payment shall be\u00a05\u00a0% of the average daily worldwide turnover or income of the provider of intermediary services concerned in the preceding financial year per day, calculated from the date specified in the decision concerned.": "regulatory", "Member\u00a0States shall ensure that their Digital Services Coordinators perform their tasks under this Regulation in an impartial, transparent and timely manner.": "regulatory", "Member\u00a0States shall lay down the rules on penalties applicable to infringements of this\u00a0Regulation by providers of intermediary services within their competence and shall take all the necessary measures to ensure that they are implemented in accordance with\u00a0Article\u00a051.": "regulatory", "National courts shall also avoid taking decisions which could conflict with a decision contemplated by the Commission in proceedings it has initiated under this Regulation.": "regulatory", "Providers of intermediary services shall designate a single point of contact to enable recipients of the service to communicate directly and rapidly with them, by electronic means and in a user-friendly manner, including by allowing recipients of the service to choose the means of communication, which shall not solely rely on automated tools.": "regulatory", "Providers of online platforms allowing consumers to conclude distance contracts with traders shall ensure that traders can only use those online platforms to promote messages on or to offer products or services to consumers located in the Union if, prior to the use of their services for those purposes, they have obtained the following information, where applicable to the trader:                          (a)                        the name, address, telephone number and email address of the trader;                                  (b)                        a copy of the identification document of the trader or any other electronic identification as defined by\u00a0Article\u00a03 of Regulation (EU)\u00a0No\u00a0910/2014 of the European\u00a0Parliament and of the\u00a0Council                       (                         40                        )                      ;                                  (c)                        the payment account details of the trader;                                  (d)                        where the trader is registered in a trade register or similar public register, the trade register in which the trader is registered and its registration number or equivalent means of identification in that register;                                  (e)                        a self-certification by the trader committing to only offer products or services that comply with the applicable rules of Union law.": "regulatory", "Providers of online platforms allowing consumers to conclude distance contracts with traders shall make best efforts to assess whether such traders have provided the information referred to in paragraphs\u00a01 and\u00a02 prior to allowing them to offer their products or services on those platforms.": "regulatory", "Providers of online platforms shall ensure that the decisions, referred to in paragraph\u00a05, are taken under the supervision of appropriately qualified staff, and not solely on the basis of automated means.": "regulatory", "Providers of online platforms shall ensure that their internal complaint-handling systems are easy to access, user-friendly and enable and facilitate the submission of sufficiently precise and adequately substantiated complaints.": "regulatory", "Providers of online platforms shall not design, organise or operate their online interfaces in a way that deceives or manipulates the recipients of their service or in a way that otherwise materially distorts or impairs the ability of the recipients of their service to make free and informed decisions.": "regulatory", "Providers of online platforms shall take the necessary technical and organisational measures to ensure that notices submitted by trusted flaggers, acting within their designated area of expertise, through the mechanisms referred to in\u00a0Article\u00a016, are given priority and are processed and decided upon without undue delay.": "regulatory", "Providers of very large online platforms and of very large online search engines shall be subject, at their own expense and at least once a year, to independent audits to assess compliance with the following:                          (a)                        the obligations set out in\u00a0Chapter\u00a0III;                                  (b)                        any commitments undertaken pursuant to the codes of conduct referred to in\u00a0Articles\u00a045 and\u00a046 and the crisis protocols referred to in\u00a0Article\u00a048.": "regulatory", "Providers of very large online platforms and of very large online search engines shall put in place reasonable, proportionate and effective mitigation measures, tailored to the specific systemic risks identified pursuant to\u00a0Article\u00a034, with particular consideration to the impacts of such measures on fundamental rights.": "regulatory", "Providers of very large online platforms or of very large online search engines receiving an audit report that is not \u2018positive\u2019 shall take due account of the operational recommendations addressed to them with a view to take the necessary measures to implement them.": "regulatory", "Providers of very large online platforms or of very large online search engines shall transmit to the Digital Services Coordinator of establishment and the Commission, without undue delay upon completion, and make publicly available at the latest three months after the receipt of each audit report pursuant to\u00a0Article\u00a037(4):                          (a)                        a report setting out the results of the risk assessment pursuant to\u00a0Article\u00a034;                                  (b)                        the specific mitigation measures put in place pursuant to\u00a0Article\u00a035(1);                                  (c)                        the audit report provided for in\u00a0Article\u00a037(4);                                  (d)                        the audit implementation report provided for in\u00a0Article\u00a037(6);                                  (e)                        where applicable, information about the consultations conducted by the provider in support of the risk assessments and design of the risk mitigation measures.": "regulatory", "The Commission shall adopt delegated acts, in accordance with\u00a0Article\u00a087, laying down the detailed methodology and procedures for:                          (a)                        the determination of the estimated costs referred to in paragraph\u00a02;                                  (b)                        the determination of the individual annual supervisory fees referred to in paragraph\u00a05, points\u00a0(b) and\u00a0(c);                                  (c)                        the determination of the maximum overall limit defined in paragraph\u00a05, point\u00a0(c); and                                  (d)                        the detailed arrangements necessary to make payments.": "regulatory", "The Commission shall adopt implementing acts establishing the amount of the annual supervisory fee in respect of each provider of very large online platform or of very large online search engine.": "regulatory", "The Commission shall aim to ensure that the codes of conduct at least address the following:                          (a)                        the transmission of information held by providers of online advertising intermediaries to recipients of the service concerning the requirements set in\u00a0Article\u00a026(1), points\u00a0(b),\u00a0(c) and\u00a0(d);                                  (b)                        the transmission of information held by providers of online advertising intermediaries to the repositories pursuant to\u00a0Article\u00a039;                                  (c)                        meaningful information on data monetisation.": "regulatory", "The Commission shall base its decisions only on objections on which the parties concerned have been able to comment.": "regulatory", "The Commission shall charge providers of very large online platforms and of very large online search engines an annual supervisory fee upon their designation pursuant to\u00a0Article\u00a033.": "regulatory", "The Commission shall consult the Board, and shall support and promote the development and implementation of voluntary standards set by relevant European and international standardisation bodies, at least in respect of the following:                          (a)                        electronic submission of notices under\u00a0Article\u00a016;                                  (b)                        templates, design and process standards for communicating with the recipients of the service in a user-friendly manner on restrictions resulting from terms and conditions and changes thereto;                                  (c)                        electronic submission of notices by trusted flaggers under\u00a0Article\u00a022, including through application programming interfaces;                                  (d)                        specific interfaces, including application programming interfaces, to facilitate compliance with the obligations set out in\u00a0Articles\u00a039 and\u00a040;                                  (e)                        auditing of very large online platforms and of very large online search engines pursuant to\u00a0Article\u00a037;                                  (f)                        interoperability of the advertisement repositories referred to in\u00a0Article\u00a039(2);                                  (g)                        transmission of data between advertising intermediaries in support of transparency obligations pursuant to\u00a0Article\u00a026(1), points\u00a0(b),\u00a0(c) and\u00a0(d);                                  (h)                        technical measures to enable compliance with obligations relating to advertising contained in this Regulation, including the obligations regarding prominent markings for advertisements and commercial communications referred to in\u00a0Article\u00a026;                                  (i)                        choice interfaces and presentation of information on the main parameters of different types of recommender systems, in accordance with\u00a0Articles\u00a027 and\u00a038;                                  (j)                        standards for targeted measures to protect minors online.": "regulatory", "The Commission shall encourage and facilitate the drawing up of voluntary codes of conduct at Union level by providers of online platforms and other relevant service providers, such as providers of online advertising intermediary services, other actors involved in the programmatic advertising value chain, or organisations representing recipients of the service and civil society organisations or relevant authorities to contribute to further transparency for actors in the online advertising value chain beyond the requirements of\u00a0Articles\u00a026 and\u00a039.": "regulatory", "The Commission shall have powers to supervise and enforce this Regulation, other than those laid down in\u00a0Section\u00a05 of\u00a0Chapter\u00a0III thereof, against providers of very large online platforms and of very large online search engines.": "regulatory", "The Commission shall keep the Board and the Digital Services Coordinators informed about the implementation of the action plan, and about its monitoring thereof.": "regulatory", "The Commission shall report to the European\u00a0Parliament and to the Council on a yearly basis following the adoption of decisions in accordance with this Article, and, in any event, three months after the end of the crisis, on the application of the specific measures taken pursuant to those decisions.": "regulatory", "The Commission shall subsequently monitor the implementation of the action plan.": "regulatory", "The Commission shall support the update of the standards in the light of technological developments and the behaviour of the recipients of the services in question.": "regulatory", "The Commission shall take due account of the views submitted by the provider concerned.": "regulatory", "The Commission shall take utmost account of any views of the Board in its decision.": "regulatory", "The Commission shall take utmost account of the recommendation of the Board issued pursuant to this\u00a0Article.": "regulatory", "The Digital Services Coordinator of establishment shall communicate its preliminary position on the alleged infringement no later than one month after the end of the deadline referred to in the first subparagraph to all Digital Services Coordinators, the Commission and the Board.": "regulatory", "The Digital Services Coordinator of establishment shall take the necessary investigatory or enforcement measures to ensure compliance with this Regulation, taking utmost account of the views and request for review by the Commission.": "regulatory", "The Digital Services Coordinators of destination participating in the joint investigation shall be entitled, at the request of or after having consulted the Digital Services Coordinator of establishment, to exercise their investigative powers referred to in\u00a0Article\u00a051(1) in respect of the providers of intermediary services concerned by the alleged infringement, with regard to information and premises located within their territory.": "regulatory", "The Digital Services Coordinators that have received such a request, and, where involved by the Digital Services Coordinator, any other competent authority, shall cooperate sincerely and in a timely manner with the Commission and shall be entitled to exercise their investigative powers referred to in\u00a0Article\u00a051(1) in respect of the provider of the very large online platform or of the very large online search engine at stake, with regard to information, persons and premises located within the territory of their Member\u00a0State and in\u00a0accordance with the request.": "regulatory", "The latter shall remain fully responsible if the information supplied is incomplete, incorrect or misleading.": "regulatory", "The management body shall approve and review periodically, at least once a year, the strategies and policies for taking up, managing, monitoring and mitigating the risks identified pursuant to\u00a0Article\u00a034 to which the very large online platform or the very large online search engine is or might be exposed to.": "regulatory", "The management body shall devote sufficient time to the consideration of the measures related to risk management.": "regulatory", "The provider of the very large online platform or of the very large online search engine or other natural or legal person concerned shall be required to submit to an inspection ordered by decision of the Commission.": "regulatory", "The respective Digital Services Coordinator shall subsequently send the application, together with the supporting documents submitted by the respective researchers and the initial assessment, to the Digital Services Coordinator of establishment.": "regulatory", "They shall ensure that the repository does not contain any personal data of the recipients of the service to whom the advertisement was or could have been presented, and shall make reasonable efforts to ensure that the information is accurate and complete.": "regulatory", "They shall remain free from any external influence, whether direct or indirect, and shall neither seek nor take instructions from any other public authority or any private party.": "regulatory", "Upon a duly substantiated application from researchers, the Digital Services Coordinator of establishment shall grant such researchers the status of \u2018vetted researchers\u2019 for the specific research referred to in the application and issue a reasoned request for data access to a provider of very large online platform or of very large online search engine a pursuant to paragraph\u00a04, where the researchers demonstrate that they meet all of the following conditions:                          (a)                        they are affiliated to a research organisation as defined in\u00a0Article\u00a02, point\u00a0(1), of\u00a0Directive (EU)\u00a02019/790;                                  (b)                        they are independent from commercial interests;                                  (c)                        their application discloses the funding of the research;                                  (d)                        they are capable of fulfilling the specific data security and confidentiality requirements corresponding to each request and to protect personal data, and they describe in their request the appropriate technical and organisational measures that they have put in place to this end;                                  (e)                        their application demonstrates that their access to the data and the time frames requested are necessary for, and proportionate to, the purposes of their research, and that the expected results of that research will contribute to the purposes laid down in paragraph\u00a04;                                  (f)                        the planned research activities will be carried out for the purposes laid down in paragraph\u00a04;                                  (g)                        they have committed themselves to making their research results publicly available free of charge, within a reasonable period after the completion of the research, subject to the rights and interests of the recipients of the service concerned, in accordance with Regulation (EU)\u00a02016/679.": "regulatory", "Upon the receipt of an order to act against one or more specific items of illegal content, issued by the relevant national judicial or administrative authorities, on the basis of the applicable Union law or national law in compliance with Union law, providers of intermediary services shall inform the authority issuing the order, or any other authority specified in the order, of any effect given to the order without undue delay, specifying if and when effect was given to the order.": "regulatory", "Very large online platforms and very large online search engines within the meaning of\u00a0Article\u00a033 shall publish their terms and conditions in the official languages of all the\u00a0Member\u00a0States in which they offer their services.": "regulatory", "When adopting a recommendation to the\u00a0Commission referred to in\u00a0Article\u00a036(1), first subparagraph, the Board shall vote within\u00a048\u00a0hours after the request of the Chair of the\u00a0Board.": "regulatory", "When identifying and applying measures pursuant to point\u00a0(b) of this paragraph, the service provider or providers shall take due account of the gravity of the serious threat referred to in paragraph\u00a02, of the urgency of the measures and of the actual or potential implications for the rights and legitimate interests of all parties concerned, including the possible failure of the measures to respect the fundamental rights enshrined in the\u00a0Charter.": "regulatory", "When sending a simple request for information to the provider of the very large online platform or of the very large online search engine concerned or other person referred to in paragraph\u00a01 of this Article, the Commission shall state the legal basis and the purpose of the request, specify what information is required and set the period within which the information is to be provided, and the fines provided for in\u00a0Article\u00a074 for supplying incorrect, incomplete or misleading information.": "regulatory", "Where a Member\u00a0State has designated several competent authorities pursuant to\u00a0Article\u00a049, it shall ensure that the Digital Services Coordinator draws up a single report covering the activities of all competent authorities and that the Digital Services Coordinator receives all relevant information and support needed to that effect from the other competent authorities concerned.": "regulatory", "Where a provider of hosting services becomes aware of any information giving rise to a suspicion that a criminal offence involving a threat to the life or safety of a person or persons has taken place, is taking place or is likely to take place, it shall promptly inform the law enforcement or judicial authorities of the Member\u00a0State or Member\u00a0States concerned of its suspicion and provide all relevant information available.": "regulatory", "Where an information society service is provided that consists of the transmission in a communication network of information provided by a recipient of the service, the service provider shall not be liable for the automatic, intermediate and temporary storage of that information, performed for the sole purpose of making more efficient or more secure the information's onward transmission to other recipients of the service upon their request, on condition that the provider:                          (a)                        does not modify the information;                                  (b)                        complies with conditions on access to the information;                                  (c)                        complies with rules regarding the updating of the information, specified in a manner widely recognised and used by industry;                                  (d)                        does not interfere with the lawful use of technology, widely recognised and used by industry, to obtain data on the use of the information; and                                  (e)                        acts expeditiously to remove or to disable access to the information it has stored upon obtaining actual knowledge of the fact that the information at the initial source of the transmission has been removed from the network, or access to it has been disabled, or that a judicial or an administrative authority has ordered such removal or disablement.": "regulatory", "Where necessary to meet the objectives set out in\u00a0Article\u00a061(2), the Board shall in particular:                          (a)                        support the coordination of joint investigations;                                  (b)                        support the competent authorities in the analysis of reports and results of audits of very large online platforms or of very large online search engines to be transmitted pursuant to this\u00a0Regulation;                                  (c)                        issue opinions, recommendations or advice to Digital Services Coordinators in accordance with this Regulation, taking into account, in particular, the freedom to provide services of the providers of intermediary service;                                  (d)                        advise the Commission on the measures referred to in\u00a0Article\u00a066 and, adopt opinions concerning very large online platforms or very large online search engines in accordance with this Regulation;                                  (e)                        support and promote the development and implementation of European standards, guidelines, reports, templates and code of conducts in cooperation with relevant stakeholders as provided for in this Regulation, including by issuing opinions or recommendations on matters related to\u00a0Article\u00a044, as well as the identification of emerging issues, with regard to matters covered by this\u00a0Regulation.": "regulatory", "Where several options are available pursuant to paragraph\u00a01 for recommender systems that determine the relative order of information presented to recipients of the service, providers of online platforms shall also make available a functionality that allows the recipient of the service to select and to modify at any time their preferred option.": "regulatory", "Where the Commission considers that the commitments offered by the provider of the very large online platform or of the very large online search engine concerned are unable to ensure effective compliance with the relevant provisions of this Regulation, it shall reject those commitments in a reasoned decision when concluding the proceedings.": "regulatory", "Where the Commission finds that the conditions of paragraph\u00a01 are not met, it shall close the investigation by a decision.": "regulatory", "Where the Commission requires the provider of the very large online platform or of the very large online search engine concerned or other person referred to in paragraph\u00a01 of this\u00a0Article to supply information by decision, it shall state the legal basis and the purpose of the request, specify what information is required and set the period within which it is to be provided.": "regulatory", "Where the complaint falls under the responsibility of another competent authority in its Member\u00a0State, the Digital Services Coordinator receiving the complaint shall transmit it to that authority.": "regulatory", "Where the provider of hosting services cannot identify with reasonable certainty the\u00a0Member\u00a0State concerned, it shall inform the law enforcement authorities of the\u00a0Member\u00a0State in which it is established or where its legal representative resides or is established or inform Europol, or\u00a0both.": "regulatory", "By 15 November each year, Member States shall notify the Commission of the following data for the previous year concerning recognised national and transnational producer organisations and recognised associations thereof, grouped according to the different sectors of agricultural products listed in Article\u00a01(2) of Regulation (EU) No\u00a01308/2013:                              (a)                            the value of marketed production per entity, determined in accordance with Articles 31 and\u00a032 of Commission Delegated Regulation (EU) 2022/126                           (                             *1                            )                          and, where appropriate, for each product or list of products for which the recognition was granted.": "regulatory", "Article\u00a018            Reporting on multilevel climate and energy dialogue referred to in Article\u00a011 of Regulation (EU) 2018/1999            Member States shall report the information on progress in establishing the dialogue referred to in Article\u00a011 of Regulation (EU) 2018/1999, in accordance with the formats set out in Annex XXIII to this Regulation.": "regulatory", "Article\u00a04            Reporting on progress with respect to the energy security dimension            Member States shall report the information on progress towards the objectives, targets and contributions with respect to the energy security dimension referred to in Article\u00a04, point (c) and Article\u00a022, points (a) to (d) of Regulation (EU) 2018/1999 in accordance with the formats set out in Annex V to this Regulation.": "regulatory", "Article\u00a05            Reporting on progress with respect to the internal energy market dimension            Member States shall report the information on progress towards the objectives, targets and contributions with respect to internal energy market dimension referred to in Article\u00a04, point (d) and Article\u00a023(1), points (a) to (g) of Regulation (EU) 2018/1999 in accordance with the formats set out in Annex VI to this Regulation.": "regulatory", "Member States shall complement the reports pursuant to Article\u00a018(1), point (a) with information referred to in Article\u00a010 and Article\u00a011 of this Regulation.": "regulatory", "Member States shall report the information on adaptation referred to in Article\u00a04, point (a)(1) of Regulation (EU) 2018/1999 in accordance with the formats set out in Annex III to this Regulation.": "regulatory", "Member States shall report the information on progress towards the national objectives to phase out energy subsidies, in particular for fossil fuels, referred to in Article\u00a025(d) of Regulation (EU) 2018/1999 in accordance with the formats set out in Annex VIII to this Regulation.": "regulatory", "Member States shall report the information on progress towards the objectives, including progress towards the Union\u2019s climate-neutrality objective set out in Article\u00a02(1) of Regulation (EU) 2021/1119 of the European Parliament and of the Council               (                 3                )              , and towards the targets with respect to greenhouse gas emissions and removals referred to in Article\u00a04, point (a)(1) of Regulation (EU) 2018/1999, in accordance with the formats set out in Annex I to this Regulation.": "regulatory"}