Artikelen bij COM(2023)224 - Verlening van dwanglicenties voor crisisbeheersing

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dossier COM(2023)224 - Verlening van dwanglicenties voor crisisbeheersing.
document COM(2023)224 EN
datum 27 april 2023

Article 1 - Subject matter

This Regulation has the objective to ensure that in crises the Union has access to crisis-relevant products. To this end, this Regulation lays down rules on the procedure and conditions for the granting of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.

Article 2 - Scope

1.This Regulation establishes Union compulsory licensing of the following intellectual property rights in force in one or more Member States:

(a)patents, including published patent applications;

(b)utility models; or

(c)supplementary protection certificates;

2.This Regulation is without prejudice to the rules laid down by other Union legal acts regulating copyright and related rights, including Directive 2001/29, Directive 2009/24 and the sui generis rights granted by Directive 96/9/EC on the legal protection of databases.

Article 3 - Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)‘crisis-relevant products’ means products or processes that are indispensable for responding to a crisis or emergency or for addressing the impacts of a crisis or emergency in the Union;

(b)‘relevant activities’ means the acts of making, using, offering for sale, selling or importing.

(c)‘rights-holder’ means a holder of any of the intellectual property rights referred to in Article 2(1);

(d)‘protected invention’ means any invention protected by any of the intellectual property rights referred to in Article 2(1);

(e)‘Union compulsory licence’ means a compulsory licence granted by the Commission to exploit a protected invention of crisis-relevant products for any of the relevant activities in the Union;

(f)‘customs authorities’ means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013 of the European Parliament and of the Council 13 ;

Article 4 - Union compulsory licence

The Commission may grant a Union compulsory licence where a crisis mode or an emergency mode listed in the Annex to this Regulation has been activated or declared in accordance with one of the Union acts listed in that Annex.

Article 5 - General conditions of a Union compulsory licence

1.The Union compulsory licence shall

(a)be non-exclusive and non-assignable, except with that part of the enterprise or goodwill which enjoys such compulsory licence;

(b)have a scope and duration that is limited to the purpose for which the compulsory licence is granted and limited to the scope and duration of the crisis or emergency mode in the framework of which it is granted;

(c)be strictly limited to the relevant activities of crisis-relevant products in the Union;

(d)only be granted against payment of an adequate remuneration to the rights-holder;

(e)be limited to the territory of the Union;

(f)only be granted to a person deemed to be in a position to exploit the protected invention in a manner that permits the proper carry out of the relevant activities of the crisis-relevant products and in accordance with the obligations referred to in Article 10.

2.A Union compulsory licence for an invention protected by a published patent application shall cover a patent granted based on that application, provided that the granting of that patent takes place while the Union compulsory licence is valid.

3.A Union compulsory licence for an invention protected by a patent shall cover a supplementary protection certificate issued with reference to that patent, provided that the transition from patent protection to protection conferred by a supplementary protection certificate takes place while the Union compulsory licence is valid.

Article 6 - Advisory body

1.When the Commission considers the granting of a Union compulsory licence, it shall without undue delay consult an advisory body.

2.The advisory body referred to in paragraph 1 shall be the advisory body competent for the Union crisis or emergency mechanism as listed in Annex I to this Regulation (the ‘competent advisory body’). For the purposes of the present Regulation, the competent advisory body shall assist and advise the Commission as regards the following tasks:

(a)the gathering of crisis-relevant information, market intelligence and the analysis of those data;

(b)the analysis of the crisis-relevant information gathered by Member States or the Commission and aggregated data received by other crisis-relevant bodies at Union and international level;

(c)the facilitation of exchanges and sharing of information with other relevant bodies and other crisis-relevant bodies at Union and national level, as well as at international level, where appropriate;

(d)the identification of the rights protecting the crisis-relevant product;

(e)the establishment of whether there is a need to grant a Union compulsory licence;

(f)the identification and consultation of the representatives of right holders or their representatives as well as potential licensees and consulting other economic operators, and the industry;

(g)the establishment, if relevant, of whether the criteria for termination or modification of the Union compulsory licence set out in Article 15 have been fulfilled.

3.The advisory body shall cooperate and coordinate closely, where appropriate, with other relevant crisis-related bodies and with intellectual property offices at Union and national level. 

4.For the purpose of the present Regulation, the Commission:

(a)shall ensure participation and invite representatives of other crisis-relevant bodies at Union level as observers to the relevant meetings of the advisory body in order to ensure coherence with the measures implemented through other Union mechanisms; and

(b)may invite representatives of the European Parliament, representatives of economic operators, right holders, potential licensees, stakeholder organisations, social partners and experts to attend meetings of the advisory body as observers.

5.In the absence of any existing competent advisory body, the tasks referred to in paragraph 2 shall be performed by an ad hoc advisory body set up by the Commission (the ‘ad hoc advisory body’). The Commission shall chair the ad hoc advisory body and ensure its secretariat. Each Member State shall have the right to be represented in the ad hoc advisory body.

6.The Commission shall adopt an implementing act laying down the rules of procedure for the ad hoc advisory body referred to in paragraph 5. The rules of procedure shall specify that the ad hoc advisory body shall not be set up for a period exceeding the duration of the crisis or emergency. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24 (3).

Article 7 - Procedure for granting a Union compulsory licence

1.The competent or, where relevant ad hoc, advisory body referred to in Article 6 shall provide the Commission with an opinion without undue delay. That opinion shall be issued in accordance with the rules of procedure of the advisory body and shall contain an assessment of the need for a Union compulsory licence and the conditions for such licence. The opinion shall take account of the following:

(a)the nature of the crisis or emergency;

(b)the scope of the crisis or emergency and how it is expected to evolve;

(c)the shortage of crisis-relevant products and the existence of other means than a Unioncompulsory licence that could adequately and swiftly remedy such shortage.

2.The opinion of the advisory body shall not be binding on the Commission. The Commission may set a time limit for the advisory body to submit its opinion. The time limit shall be reasonable and appropriate to the circumstances of the situation, taking particular account of the urgency of the matter.

3.Before the granting of a Union compulsory licence, the Commission shall give the rights-holder and the licensee an opportunity to comment on the following:

(a)the possibility to reach a voluntary licensing agreement with manufacturers on intellectual property rights for the purpose of manufacturing, using and distributing the crisis-relevant products;

(b)the need to grant the Union compulsory licence;

(c)the conditions under which the Commission intends to grant the Union compulsory licence, including the amount of the remuneration.

4.The Commission shall notify the rights-holder and the licensee as soon as possible of the fact that a Union compulsory licence may be granted. Wherever the identification of the rights-holders is possible and does not cause significant delay, the Commission shall notify them individually.

5.When the Commission considers the granting of a Union compulsory licence, it shall without undue delay publish a notice to inform the public about the initiation of the procedure under this article. This notice shall also include, where already available and relevant, information on the subject of the compulsory licence and an invitation to submit comments in accordance with paragraph 3. The notice shall be published in the Official Journal of the European Union.

6.When assessing whether a Union compulsory licence is to be granted, the Commission shall consider the following:

(a)the opinion referred to in paragraph 2;

(b)the rights and interests of the rights-holder and the licensee;

(c)existing national compulsory licences reported to the Commission in accordance with Article 22.

7.Where the Commission finds that the requirements for a Union compulsory licence are met, the Commission shall grant it by means of an implementing act. The implementing act shall be adopted in accordance with the advisory procedure referred to in Article 24(2). On duly justified imperative grounds of urgency relating to the impacts of the crisis, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 24(4). In case of procedure under Article 24(4), the implementing act shall remain in force for a period not exceeding 12 months.

8.When adopting the implementing act, the Commission shall ensure the protection of confidential information. While respecting the confidentiality of the information, the Commission shall ensure that any information relied on for the purpose of its decision is disclosed to an extent that allows to understand the facts and considerations that led up to the adoption of the implementing act.

Article 8 - Content of the Union compulsory licence

1.The Union compulsory licence shall specify the following:

(a)the patent, patent application, supplementary protection certificate or utility model for which the licence is granted or, where the identification of those rights would significantly delay the granting of the licence, the non-proprietary name of the products which are to be manufactured under the licence;

(b)the right-holder, provided they can be identified with reasonable efforts having regard to the circumstances, including the urgency of the situation;

(c)the licensee, in particular the following information:

(1)name, trade name and registered trade mark;

(2)contact details;

(3)unique identification number in the country where the licensee is established;

(4)where available, the Economic Operators Registration and Identification (EORI) number;

(d)the duration for which the Union compulsory licence is granted;

(e)the remuneration to be paid to the rights-holder determined in accordance with Article 9;

(f)the non-proprietary name of the crisis-relevant product which is to be manufactured under the Union compulsory licence and its commodity code (CN code) under which the crisis-relevant product is classified, as defined in Council Regulation (EEC) No 2658/87;

(g)the details referred to in Article 10(1)(c), (d) and (e) allowing the identification of the crisis-relevant product manufactured under the Union compulsory licence and, where applicable, any other specific requirement under Union legislation applicable to the crisis-relevant products and allowing its identification.

(h)measures complementing the compulsory licence, which are necessary to achieve the objective of the compulsory licence.

2.By way of derogation from paragraph 1, point (e), the Commission may determine the remuneration after the granting of the licence, by way of an implementing act, where that determination requires, further investigation and consultation. This implementing act shall be adopted in accordance with the rules referred to in Article 7(6) (a) and (b), 7(7) and 7(8).

Article 9 - Remuneration

1.The licensee shall pay an adequate remuneration to the rights-holder. The amount of the remuneration shall be determined by the Commission and specified in the Union compulsory licence.

2.The remuneration shall not exceed 4 % of total gross revenue generated by the licensee through the relevant activities under the Union compulsory licence.

3.When determining the remuneration, the Commission shall consider the following:

(a)the economic value of the relevant activities authorised under the Union compulsory licence.

(b)whether the rights-holder has received public support to develop the invention.

(c)the degree to which development costs have been amortized by the rights-holder.

(d)where relevant, the humanitarian circumstances relating to the granting of the Union compulsory licence. 

4.If the published patent application for which a compulsory licence has been granted does not subsequently lead to the granting of a patent, the rights-holder shall refund the remuneration paid under this article to the licensee.

Article 10 - Obligations to be fulfilled by the licensee

1.The licensee shall be authorised to exploit the protected invention covered by the Union compulsory license only under the following obligations:

(a)the number of crisis-relevant products manufactured under the Unioncompulsory licence does not exceed what is necessary to meet the needs of theUnion;

(b)the relevant activities are carried out solely for the supply of the crisis-relevant products in the Union market;

(c)the products manufactured under the Union compulsory licence are clearlyidentified, through specific labelling or marking, as being manufactured and marketed pursuant to this Regulation.

(d)the products manufactured under the Union compulsory licence can be distinguished from products manufactured and marketed by the rights-holder or under a voluntary licence granted by the rights-holder by way of special packaging, colouring or shaping, provided that such distinction is feasible and does not have a significant impact on the price of the products;

(e)the packaging of the products manufactured under the Union compulsory licence and any associated marking or leaflet indicate that the products are subject to a Union compulsory licence under this Regulation and specify clearly that the products are exclusively for distribution in the Union and are not to be exported.

(f)before the marketing of the products manufactured under the Union compulsory licence, the licensee shall make available on a website the following information:

(1)the quantities of the products manufactured under the Union compulsory licence per Member State of manufacturing;

(2)the quantities of the products supplied under the Union compulsory licence per Member State of supply;

(3)the distinguishing features of the products under the Union compulsory licence.

The address of the website shall be communicated to the Commission. The Commission shall communicate the address of the website to the Member States.

2.In the event of a failure by the licensee to fulfil the obligations laid down in paragraph 1 of this Article the Commission may:

(a)terminate the Union compulsory licence in accordance with Article 14(3); or

(b)impose fines or periodic penalties on the licensee in accordance with Articles 15 and 16.

3.The European Anti-Fraud Office (OLAF) in cooperation with the relevant national authorities of the Member States may, at the request of the rights-holder or on its own initiative, request access to books and records kept by the licensee, for the purpose of checking whether the content and the conditions of the Union compulsory licence, and in general the provisions of this Regulation, have been complied with.

4.The Commission is empowered to adopt implementing acts establishing rules for the specific labelling or marking referred to in paragraph 1, point (c), and for the packaging, colouring and shaping referred to in point (d) as well as rules for their use and, where relevant, their positioning on the product. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24(2).

Article 11 - Prohibition of export

The export of products manufactured under a Union compulsory licence is prohibited.

Article 12 - Customs control

1.The application of this article is without prejudice to other Union legal acts governing the export of products, in particular Articles 46, 47 and 267 of Regulation (EU) No 952/2013 14 .

2.Customs authorities shall rely on the Union compulsory license and modifications thereof to identify products that may fall under the prohibition laid down in Article 11. For that purpose, risk information as regards each Union compulsory licence and any modification thereof shall be entered in the relevant customs risk management system. Customs authorities shall take such risk information into consideration when they carry out controls on products placed under the customs procedure ‘export’ in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.

3.Where customs authorities identify a product that may fall under the prohibition laid down in Article 11, they shall suspend its export. Customs authorities shall immediately notify the Commission of the suspension and provide it with all relevant information to enable it to establish whether the product was manufactured under a Union compulsory license. To assess whether the suspended products correspond to the Union compulsory license, the Commission may consult the relevant rights-holder. 

4.Where the export of a product has been suspended in accordance with paragraph 3, the product shall be released for export provided that all the other requirements and formalities under Union or national law relating to such export have been fulfilled, and either of the following conditions is fulfilled:

(a)the Commission has not requested the customs authorities to maintain the suspension within 10 working days after it was notified thereof;

(b)the Commission has informed the customs authorities that the product is not manufactured under a Union compulsory licence.

5.Where the Commission concludes that a product manufactured under a Union compulsory licence does not comply with the prohibition laid down in Article 11, customs authorities shall not authorise its release for export. The Commission shall inform the concerned rights-holder of such non-compliance.

6.Where the release for export of a product has not been authorised:

(a)where appropriate in view of the crisis or emergency context, the Commission may require customs authorities to oblige the exporter to take specific actions at their own costs, including supplying them to designated Member States, if need be, after rendering them compliant with Union law. 

(b)in all other cases, customs authorities may take any necessary measure to ensure that the product concerned is disposed of in accordance with national law consistent with Union law. Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly.

Article 13 - Relations between rights-holder and licensee

1.The relations between the rights-holder and the licensee who has been granted a Union compulsory license shall act and cooperate with each other in good faith when performing rights and obligations under this Regulation.

2.In compliance with the good faith obligation, the rights-holder and the licensee shall make their best efforts to fulfil the objective of the Union compulsory licence, taking into account each other's interests. 

Article 14 - Review and termination of the Union compulsory licence

1.The Commission shall review the Union compulsory licence upon reasoned request by the rights-holder or the licensee or on its own initiative and shall, where needed, modify the specifications referred to in Article 8 by means of an implementing act. Where necessary, the Union compulsory licence shall be modified to indicate the complete list of rights and rights-holders covered by the compulsory licence.

2.Where necessary, the Commission shall decide upon reasoned request by the rights-holder or the licensee or on its own initiative on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.

3.A Union compulsory licence may be terminated by the Commission by means of an implementing act where the circumstances which led to it cease to exist and are unlikely to recur or where the licensee fails to comply with the obligations laid down in this Regulation.

4.When the Commission considers modifying, adopting additional measures as referred to in paragraph 2, or terminating the Union compulsory licence, it may consult the advisory body referred to in Article 6.

5.When terminating the Union compulsory licence, the Commission may require that the licensee, within a reasonable period of time, arrange for any goods in its possession, custody, power or control to be redirected or otherwise disposed of in the manner determined by the Commission in consultation with the rights-holder and at the expense of the licensee.

6.The implementing acts referred to in paragraph 1, 2 and 3 shall be adopted in accordance with the rules referred to in Article 7(6) (a) and (b), 7(7) and 7(8).

Article 15 - Fines

1.The Commission may by decision impose on the licensee or the rights-holder fines not exceeding 6 % of their respective total turnover in the preceding business year where, intentionally or negligently:

(a)the licensee fails to comply with its obligations under Article 9(1) or Article 10(1);

(b)the rights-holder or the licensee fail to comply with the principle of good faith and cooperation referred to in Article 13; or

(c)the rights-holder or the licensee fail to comply with any obligation resulting from the additional measures complementing the Union compulsory licence as referred to in Articles 8(1)(h) and 14(2), as specified in the relevant implementing act.

2.In fixing the amount of the fine, regard shall be had to the gravity, to the recurrence of the infringement and to the duration of the infringement.

Article 16 - Periodic penalty payments

1.The Commission may, by decision, impose on the licensee or the rights-holder periodic penalty payments not exceeding 5 % of their respective average daily turnover in the preceding business year per day and calculated from the date appointed by the decision, in order to compel:

(a)the licensee to put an end to an infringement of its obligations under Article 10(1);

(b)the licensee and the rights-holder to put an end to the infringement of Article 13; or

(c)the rights-holder or the licensee to comply with any obligation resulting from the additional measures complementing the Union compulsory licence as referred to in Articles 8(1)(h) and 14(2), as specified in the relevant implementing act.

2.Where the licensee or the rights-holder have satisfied the obligation which the periodic penalty payment was intended to enforce, the Commission may fix the definitive amount of the periodic penalty payment at a figure lower than that which would arise under the original decision.

Article 17 - Limitation period for the imposition of fines and periodic penalty payments

1.The powers conferred on the Commission by Articles 15 and 16 shall be subject to a limitation period of five years.

2.Time shall begin to run on the day on which the infringement is committed. However, in the case of continuing or repeated infringements, time shall begin to run on the day on which the infringement ceases.

3.Any action taken by the Commission or by a competent authority of the Member States for the purpose of the investigation or proceedings in respect of an infringement shall interrupt the limitation period for the imposition of fines or periodic penalty payments.

4.Each interruption shall start time running afresh. However, the limitation period for the imposition of fines or periodic penalty payments shall expire at the latest on the day on which a period equal to twice the limitation period has elapsed without the Commission having imposed a fine or a periodic penalty payment. That period shall be extended by the time during which the limitation period has been suspended pursuant to paragraph 5.

5.The limitation period for the imposition of fines or periodic penalty payments shall be suspended for as long as the decision of the Commission is the subject of proceedings pending before the Court of Justice of the European Union.

Article 18 - Limitation period for the enforcement of fines and periodic penalty payments

1.The power of the Commission to enforce decisions taken pursuant to Articles 15 and 16 shall be subject to a limitation period of five years. 

2.Time shall begin to run on the day on which the decision becomes final.

3.The limitation period for the enforcement of penalties shall be interrupted:

(a)by notification of a decision varying the original amount of the fine or periodic penalty payment or refusing an application for variation;

(b)by any action of the Commission, or of a Member State acting at the request of the Commission, designed to enforce payment of the fine or periodic penalty payment.

4.Each interruption shall start time running afresh.

5.The limitation period for the enforcement of penalties shall be suspended for so long as:

(a)time to pay is allowed;

(b)enforcement of payment is suspended pursuant to a decision of the Court of Justice of the European Union or to a decision of a national court.

Article 19 - Right to be heard and access to the file

1.Before adopting a decision pursuant to Article 15 or 16, the Commission shall give the licensee or the rights-holder the opportunity of being heard on the alleged infringement which is to be made subject to a fine or periodic penalty payments.

2.The licensee or the rights-holder may submit its observations on the alleged infringement within a reasonable period set by the Commission, which may not be less than 14 days.

3.The Commission shall base its decisions only on objections on which the parties concerned have been able to comment.

4.The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to have access to the Commission's file under the terms of a negotiated disclosure, subject to the legitimate interest of the licensee or the rights-holder or other person concerned in the protection of their commercially sensitive information and trade secrets. The Commission shall have the power to adopt decisions setting out such terms of disclosure in case of disagreement between the parties. The right of access to the file of the Commission shall not extend to confidential information and internal documents of the Commission, other competent authorities or other public authorities of the Member States. In particular, the right of access shall not extend to correspondence between the Commission and those authorities. Nothing in this paragraph shall prevent the Commission from disclosing and using information necessary to prove an infringement.

5.If the Commission considers it necessary, it may also hear other natural or legal persons. Applications to be heard on the part of such persons shall, where they show a sufficient interest, be granted.

Article 20 - Publication of decisions

1.The Commission shall publish the decisions it adopts pursuant to Article 15 and Articles 16. Such publication shall state the names of the parties and the main content of the decision, including any fines or penalties imposed.

2.The publication shall have regard to the rights and legitimate interests of the licensee, the rights-holder or any third parties in the protection of their confidential information.

Article 21

Review by the Court of Justice of the European Union

In accordance with Article 261 TFEU, the Court of Justice of the European Union has unlimited jurisdiction to review decisions by which the Commission has imposed fines or periodic penalty payments. It may cancel, reduce or increase the fine or periodic penalty payment imposed.

Article 22 - Reporting on national compulsory licences

When a national compulsory licence has been granted for the purpose of addressing a national crisis or emergency, the Member State shall notify the Commission of the granting of the licence and of the specific conditions attached to it. The information provided shall include the following:

(a)the purpose of the national compulsory licence and its legal basis in national law;

(b)the name and address of the licensee;

(c)the products concerned and, to the extent possible, the concerned intellectual property rights and rights-holders;

(d)the remuneration to be paid to the rights-holder;

(e)the quantity of products to be supplied under the licence;

(f)the duration of the licence.

Article 23 - Amendments to Regulation (EC) No 816/2006

Regulation (EC) No 816/2006 is amended as follows:

(a)The following Article 18a is inserted:

“Article 18a

Union compulsory licence

1. The Commission may grant a compulsory licence where the activities of manufacture and sale for export spread across different Member States and would therefore require compulsory licences for the same product in more than one Member State.

2. Any person may submit an application for a compulsory licence under paragraph 1. The application shall fulfil the requirements laid down in Article 6 (3) and shall specify the Member States to be covered by the compulsory licence.

3. The compulsory licence granted in accordance with paragraph 1 shall be subject to the conditions set out in Article 10 and shall specify that it is applicable to the whole territory of the Union.

4. In the event of an application referred to in paragraph 2 under this Article, the competent authority referred to in Articles 1 to 11, 16 and 17 shall be the Commission.

5. The Commission is empowered to adopt implementing acts in order to:

(a) grant a compulsory licence;

(b) reject the application for a compulsory licence;

(c) amend or terminate the compulsory licence.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 18b (2). On duly justified imperative grounds of urgency relating to the impacts of the public health problems, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18b (3).”

(b)The following Article 18b is inserted:

“Article 18b
Committee Procedure

1. The Commission shall be assisted by a committee (‘the Compulsory Licensing Committee’). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 thereof, shall apply.”

Article 24 - Committee Procedure

1.The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3.Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

4.Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 thereof, shall apply.

Article 25 - Evaluation

The Commission shall, by the last day of the third year following the granting of the Union compulsory licence in accordance with Article 7, present an evaluation report to the Council, the European Parliament and the European Economic and Social Committee on the application of this Regulation.

Article 26 - 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.