Legal provisions of COM(2011)525 - Electronic identification of bovine animals and deletion of the provisions on voluntary beef labelling

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2011)525 - Electronic identification of bovine animals and deletion of the provisions on voluntary beef labelling.
document COM(2011)525 EN
date May 15, 2014

Contents

Article 1

Regulation (EC) No 1760/2000 is amended as follows:

(1)in Article 1, the second sentence of paragraph 2 is deleted;

(2)in Article 2, the first indent is replaced by the following:

‘—“animal” means a bovine animal within the meaning of Article 2(2), points (b) and (c) of Directive 64/432/EEC, including animals taking part in cultural and sporting events,’;

(3)in the first paragraph of Article 3, point (a) is replaced by the following:

‘(a)means of identification to identify animals individually;’;

(4)Article 4 is replaced by the following:

‘Article 4

Obligation to identify animals

1. All animals on a holding shall be identified by at least two means of identification listed in Annex I and in compliance with rules adopted pursuant to paragraph 3 and approved by the competent authority. At least one of the means of identification shall be visible and bear a visible identification code.

The first subparagraph shall not apply to animals that were born before 1 January 1998 and that are not intended for intra-Union trade. Those animals shall be identified by at least one means of identification.

In order to ensure the adaptation to technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b concerning the addition of means of identification to the list set out in Annex I, whilst ensuring their interoperability.

The means of identification shall be allocated to the holding, distributed and applied to the animals in a manner determined by the competent authority.

The two means of identification, authorised in accordance with the delegated and implementing acts adopted pursuant to paragraph 3 and this paragraph and which are applied to one animal, shall bear the same unique identification code, which, together with the registration of the animals, makes it possible to identify the animal individually and the holding on which it was born.

2. By way of derogation from paragraph 1, where the characters forming the animal’s identification code do not permit the application of an electronic identifier with the same unique identification code, the Member State concerned may allow that, under the supervision of its competent authority, the second means of identification may bear a different code, provided each of the following conditions are fulfilled:

(a)the animal is born before the date of entry into force of the implementing acts referred to in point (c) of the second subparagraph of paragraph 3;

(b)full traceability is ensured;

(c)the individual identification of the animal, including the holding on which it was born, is possible;

(d)the animal is not intended for intra-Union trade.

3. To ensure adequate traceability and adaptability to technical progress and optimal functioning of the identification system, the Commission shall adopt delegated acts in accordance with Article 22b concerning the requirements for the means of identification set out in Annex I, and the transitional measures required for the introduction of a particular means of identification.

On the basis of the relevant ISO standards or other international technical standards adopted by recognised international standard-setting organisations, with the understanding that those international standards are able to guarantee, at the very least, a higher level of performance and reliability than ISO standards, the Commission shall lay down, by means of implementing acts, the necessary rules concerning:

(a)the format and design of the means of identification;

(b)technical procedures for the electronic identification of bovine animals; and

(c)the configuration of the identification code.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).

4. As from 18 July 2019, the Member States shall ensure that the necessary infrastructure is in place in order to provide for the identification of animals on the basis of an electronic identifier as an official means of identification in accordance with this Regulation.

As from 18 July 2019, Member States may introduce national provisions making the use of an electronic identifier compulsory as one of the two means of identification provided for in paragraph 1.

Member States that make use of the option under the second subparagraph shall provide the Commission with the text of such national provisions and make this information available on the internet. The Commission shall assist the Member States in making this information available to the public by providing, on its website, the links to the relevant websites of the Member States.

5. By way of derogation from paragraph 1, bovine animals intended for cultural and sporting events, other than fairs and exhibitions, may be identified by alternative means of identification offering equivalent identification standards to those provided for in paragraph 1.

Holdings making use of alternative means of identification referred to in the first subparagraph shall be registered in the computerised database provided for in Article 5.

The Commission shall, by means of implementing acts, lay down the necessary rules concerning such registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).

In order to ensure traceability based on the identification standards equivalent to those provided for in paragraph 1, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b concerning the requirements for the alternative means of identification referred to in the first subparagraph, including transitional measures required for their introduction.

The Commission may lay down, by means of implementing acts, the rules concerning the format and design of the alternative means of identification, referred to in the first subparagraph, including transitional measures required for their introduction. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).

6. Member States shall communicate to each other and to the Commission a model of the means of identification used in their territory. They shall make this information available on the internet. The Commission shall assist the Member States in making this information available to the public by providing, on its website, the links to the relevant websites of the Member States.’;

(5)the following Articles are inserted:

‘Article 4a

Time period for the application of the means of identification

1. The means of identification provided for in Article 4(1) shall be applied to the animal before the expiry of a maximum period, to be determined by the Member State in which the animal was born. The maximum period shall be calculated from the date of birth of the animal and shall not exceed 20 days.

By way of derogation from the first subparagraph, for reasons related to the physiological development of the animals, that period may, for the second means of identification, be extended up to 60 days following the birth of the animal.

No animal may leave the holding where it was born before the two means of identification have been applied to that animal.

2. To enable the application of the means of identification in special circumstances involving practical difficulties, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b to determine the special circumstances under which the Member States may extend the maximum periods for the application of the means of identification as provided for in the first and second subparagraphs of paragraph 1. Member States shall inform the Commission of each use of that option.

Article 4 - b Identification of animals from third countries

1. Any animal subject to veterinary checks, pursuant to Directive 91/496/EEC, entering the Union from a third country and intended for a holding of destination within the territory of the Union, shall be identified at the holding of destination with the means of identification provided for in Article 4(1).

The original identification applied to the animal in the third country of origin shall be recorded in the computerised database provided for in Article 5 together with the unique identification code of the means of identification allocated to the animal by the Member State of destination.

The first subparagraph shall not apply to animals destined directly for a slaughterhouse situated in a Member State, provided that the animals are slaughtered within 20 days following those veterinary checks pursuant to Directive 91/496/EEC.

2. The means of identification of animals referred to in Article 4(1) shall be applied within a maximum period to be determined by the Member State in which the holding of destination is located. That period shall not exceed 20 days following the veterinary checks referred in paragraph 1.

By way of derogation from the first subparagraph, for reasons related to the physiological development of the animals, that period may, for the second means of identification, be extended up to 60 days following the birth of the animal.

In all cases, the two means of identification referred to in the first subparagraph of Article 4(1) shall be applied to the animals before they leave the holding of destination.

3. Where the holding of destination is situated in a Member State that has introduced national provisions under the second subparagraph of Article 4(4) to make the use of an electronic identifier compulsory, the animals shall be identified with that electronic identifier in the holding of destination in the Union, within a period to be determined by the Member State of destination. That period shall not exceed 20 days following the veterinary checks referred in paragraph 1.

By way of derogation from the first subparagraph, for reasons related to the physiological development of the animals, that period may, for the second means of identification, be extended up to 60 days following the birth of the animal.

In all cases, the electronic identifier shall be applied to the animals before they leave the holding of destination.

Article 4 - c Identification of animals moved from one Member State to another

1. Animals moved from one Member State to another shall retain the original means of identification applied to them pursuant to Article 4(1).

However, by way of derogation from the first subparagraph, starting from 18 July 2019, the competent authority of the Member State of destination may allow:

(a)the replacement of one of the means of identification by an electronic identifier without changing the original unique identification code of the animal;

(b)the replacement of both means of identification by two new means of identification which shall both bear the same, new unique identification code. This derogation may be applied until five years after 18 July 2019, where the characters forming the identification code of an animal’s conventional ear tag do not permit the application of an electronic identifier with the same unique identification code, and provided that the animal is born before the date of entry into force of the implementing acts referred to in point (c) of the second subparagraph of Article 4(3).

2. Where the holding of destination is situated in a Member State that has introduced national provisions to make the use of an electronic identifier compulsory, the animals shall be identified with that electronic identifier at the latest in the holding of destination within a maximum period to be determined by the Member State where that holding of destination is located. That maximum period shall not exceed 20 days from the date of arrival of the animals on the holding of destination.

By way of derogation from the first subparagraph, for reasons related to the physiological development of the animals, that period may, for the second means of identification, be extended up to 60 days following the birth of the animal.

In all cases, the electronic identifier shall be applied to the animals before they leave the holding of destination.

However, the first subparagraph shall not apply to animals destined directly for a slaughterhouse situated in the territory of the Member State that has introduced national provisions to make the use of an electronic identifier compulsory.

Article 4 - d Removal, modification or replacement of means of identification

No means of identification may be removed, modified or replaced without the permission of the competent authority. Such permission may only be granted where the removal, modification or replacement do not compromise the traceability of the animal and where its individual identification, including the holding on which it was born, is possible.

Any replacement of an identification code shall be recorded in the computerised database provided for in Article 5, together with the unique identification code of the original means of identification of the animal.’;

(6)Article 5 is replaced by the following:

‘Article 5

The competent authority of the Member States shall set up a computerised database in accordance with Articles 14 and 18 of Directive 64/432/EEC.

Member States may exchange electronic data between their computerised databases from the date on which the Commission recognises the full operability of the data exchange system. The exchange shall be done in such a way that data protection is guaranteed and any abuse prevented in order to protect the interests of the keeper.

In order to ensure the electronic exchange of information between Member States, the Commission shall adopt delegated acts in accordance with Article 22b to lay down the rules concerning the data to be exchanged between computerised databases of Member States.

The Commission shall by means of implementing acts lay down the technical conditions and modalities for such exchange and recognise the full operability of the data exchange system. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).’;

(7)Article 6 is replaced by the following:

‘Article 6

1. Where a Member State does not exchange electronic data with other Member States, in the framework of the electronic exchange system referred to in Article 5, the following applies:

(a)the competent authority of that Member State shall, for each animal that is intended for intra-Union trade, issue a passport based on the information contained in the computerised database set up in that Member State;

(b)each animal for which a passport is issued shall be accompanied by that passport whenever the animal is moved from one Member State to another;

(c)upon arrival of the animal at the holding of destination, the passport accompanying the animal shall be surrendered to the competent authority of the Member State where the holding of destination is located.

2. In order to allow for the tracing of animal movements back to the holding of origin situated in a Member State, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b to lay down rules concerning the information from the computerised database to be included in the animal passport, including transitional measures required for their introduction.’;

(8)the following Article is inserted:

‘Article 6a

This Regulation shall not prevent national provisions by a Member State concerning the issuing of passports for animals not intended for intra-Union trade.’;

(9)Article 7 is amended as follows:

(a)paragraph 1 is amended as follows:

(i)the second indent is replaced by the following:

‘—report to the competent authority all movements to and from the holding and all births and deaths of animals of the holding, together with the dates of those events, within a maximum period fixed by the Member State concerned; that maximum period shall be at least three days and not exceed seven days following the occurrence of one of those events; Member States may request the Commission to extend the maximum period of seven days.’;

(ii)the following subparagraph is added:

‘To take into account practical difficulties in exceptional cases, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b to determine the exceptional circumstances in which Member States may extend the maximum period of seven days provided for in the second indent of the first subparagraph, together with the maximum length of that extension, which shall not exceed 14 days following the period of seven days referred to in the second indent of the first subparagraph.’;

(b)paragraph 2 is replaced by the following:

‘2.   To ensure the adequate and effective traceability of bovine animals when put out to seasonal grazing, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b concerning the Member States or part of Member States where special rules for seasonal grazing shall apply, including the time period, specific obligations of the keepers, and rules on the holding registration and registration of movements of such bovine animals, including transitional measures required for their introduction.’;

(c)the following paragraphs are added:

‘5.   By way of derogation from paragraph 4, keeping a register shall be optional for any keeper who:

(a)has access to the computerised database provided for in Article 5 which already contains the information to be included in the register; and

(b)enters the up-to-date information, or has it entered, directly into the computerised database provided for in Article 5.

6. To ensure the accuracy and reliability of the information to be included in the holding register provided for in this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b to lay down the necessary rules concerning that information, including transitional measures required for their introduction.’;

(10)Article 8 is deleted;

(11)the following Article is inserted:

‘Article 9a

Training

Member States shall ensure that any person responsible for the identification and registration of animals has received instructions and guidance on the relevant provisions of this Regulation and of any delegated and implementing acts adopted by the Commission pursuant to this Regulation.

Whenever the relevant provisions are amended, the corresponding information shall be made available to the person referred to in the first subparagraph.

Member States shall ensure that appropriate training courses are available.

The Commission shall facilitate the exchange of best practices to improve the quality of information and training across the Union.’;

(12)Article 10 is deleted;

(13)Article 12 is replaced by the following:

‘Article 12

For the purposes of this Title, the following definitions apply:

(1)“beef” means all products falling within CN codes 0201, 0202, 0206 10 95 and 0206 29 91;

(2)“labelling” means the attachment of a label to an individual piece or pieces of meat or to their packaging material, or, in the case of non-pre-wrapped products, the supply of appropriate information in written and visible form to the consumer at the point of sale;

(3)“organisation” means a group of operators from the same or different parts of the beef trade;

(4)“minced meat” means any boned meat that has been minced into fragments and contains less than 1 % salt and that falls within CN codes 0201, 0202, 0206 10 95 and 0206 29 91;

(5)“trimmings” means small pieces of meat recognised as fit for human consumption produced exclusively during trimming operations during the boning of carcasses and/or the cutting up of meat;

(6)“cut meat” means meat which has been cut into small cubes, slices or other individual portions that do not require further cutting by an operator before being bought by the final consumer and that can be directly used by that consumer. This definition does not cover minced meat and trimmings.’;

(14)Article 13 is amended as follows:

(a)paragraphs 3 and 4 are deleted;

(b)in paragraph 5, the introductory phrase of point (a) is replaced by the following:

‘(a)Operators and organisations shall also indicate on the labels:’;

(c)the following paragraph is added:

‘6.   To avoid unnecessary repetition of the indication on the label of the beef of the Member States or third countries where rearing took place, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b pertaining to a simplified presentation for cases of very short stay of the animal in the Member State or third country of birth or of slaughter.

The Commission shall, by way of implementing acts, adopt rules concerning the maximum size and composition of the group of animals referred to in paragraphs 1 and 2(a), taking into account constraints as regards the homogeneity of the groups of animals where those cut meats and trimmings come from. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).’;

(15)in Article 14, the fourth paragraph is replaced by the following:

‘To ensure conformity with the horizontal rules relating to the labelling in this Section, the Commission shall be empowered to adopt delegated acts in accordance with Article 22b to lay down, on the basis of the experience regarding minced meat, rules equivalent to those in the first three paragraphs of this Article for beef trimmings or cut beef.’;

(16)Article 15 is replaced by the following:

‘Article 15

Compulsory labelling of beef from third countries

By way of derogation from Article 13, beef imported into the territory of the Union for which not all the information provided for in Article 13 is available, shall be labelled with the indication:

“Origin: non-EU” and “Slaughtered in (name of the third country)”.’;

(17)from 13 December 2014:

(a)the heading of Section II of Title II shall be replaced by the words ‘Voluntary labelling’;

(b)Articles 16, 17 and 18 are deleted; and

(c)the following Article is inserted into Section II of Title II:

‘Article 15a

General rules

Food information other than that specified in Articles 13, 14 and 15 which is added to labels voluntarily by operators or organisations marketing beef shall be objective, verifiable by the competent authorities and comprehensible for consumers.

That information shall comply with the horizontal legislation on labelling and in particular Regulation (EU) No 1169/2011 of the European Parliament and of the Council (8).

Where operators or organisations marketing beef do not respect the obligations referred to in the first and the second paragraphs, the competent authority shall apply appropriate penalties as laid down in Article 22.

The Commission shall be empowered to adopt delegated acts in accordance with Article 22b concerning definitions and requirements applicable to terms or categories of terms that may be put on the labels of pre-packed fresh and frozen beef and veal.

(8) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).’;"

(18)Articles 19, 20 and 21 are deleted;

(19)Article 22 is replaced by the following:

‘Article 22

1. Member States shall take all the necessary measures to ensure compliance with the provisions of this Regulation.

The controls provided for shall be without prejudice to any controls which the Commission may carry out pursuant to Article 9 of Regulation (EC, Euratom) No 2988/95.

Any penalties imposed by the Member State on a keeper, operator or organisation marketing beef shall be effective, dissuasive and proportionate.

The competent authority shall carry out each year a minimum number of official checks in relation to identification and registration of animals which shall cover at least 3 % of the holdings.

The competent authority shall immediately increase the minimum rate of official checks referred to in the second subparagraph where it is established that provisions on identification and registration of animals have not been complied with.

The selection of holdings to be inspected by the competent authority shall be made on the basis of a risk analysis.

Each Member State shall submit an annual report to the Commission by 31 August on the implementation of the official checks during the previous year.

2. Notwithstanding paragraph 1, the competent authority shall impose on a keeper the following administrative penalties:

(a)if one or more animals on a holding do not comply with any of the provisions laid down in Title I: a restriction on the movement of all animals to or from the holding of the keeper concerned;

(b)in the case of animals for which the identification and registration requirements laid down in Title I are not fully complied with: an immediate restriction on the movement of those animals only, until those requirements are fully complied with;

(c)if, on one holding, the number of animals for which the identification and registration requirements laid down in Title I are not fully complied with is in excess of 20 %: an immediate restriction on the movement of all the animals present on that holding; in respect of holdings of not more than 10 animals, this measure shall apply if more than two animals are not fully identified in accordance with the requirements laid down in Title I;

(d)if the keeper of an animal cannot prove that animal’s identification and traceability: where appropriate, on the basis of an assessment of the animal health and food safety risks, the destruction of the animal without compensation;

(e)if a keeper fails to report to the competent authority the movement of an animal to and from his holding in accordance with the second indent of Article 7(1), the competent authority shall restrict the movement of animals to and from that holding;

(f)if a keeper fails to report to the competent authority the birth or death of an animal in accordance with the second indent of Article 7(1), the competent authority shall restrict the movement of animals to and from that holding;

(g)in cases of persistent failure by a keeper to pay the charge referred to in Article 9, Member States may restrict the movement of animals to and from the holding of that keeper.

3. Notwithstanding paragraph 1, where operators and organisations marketing beef have labelled beef without complying with their obligations laid down in Title II, Member States shall, as appropriate, and in accordance with the principle of proportionality, require the removal of the beef from the market. In addition to the penalties referred to in paragraph 1, Member States may:

(a)if the meat concerned conforms with relevant veterinary and hygiene rules authorise that such beef:

(i)be placed on the market after being properly labelled in accordance with Union requirements; or

(ii)be sent directly for processing into products other than those indicated in the first indent of Article 12;

(b)order the suspension or withdrawal of the approval of the operators and organisations concerned.

4. Experts from the Commission, in conjunction with the competent authorities, shall:

(a)verify that Member States comply with the requirements of this Regulation;

(b)make on-the-spot checks to ensure that the checks are carried out in accordance with this Regulation.

5. A Member State in whose territory an on-the-spot check is made shall provide the experts from the Commission with any assistance they may require in the performance of their tasks. The outcome of the checks made shall be discussed with the competent authority of the Member State concerned before a final report is drawn up and circulated. This report shall, where appropriate, contain recommendations for Member States on the improvement of compliance with this Regulation.’;

(20)the following Articles are inserted:

‘Article 22a

Competent authorities

Member States shall designate the competent authority or authorities responsible for ensuring compliance with this Regulation and any acts adopted by the Commission on its basis.

They shall inform the Commission and the other Member States of the identity of those authorities.

Article 22 - b Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions under this Article.

2. The power to adopt delegated acts referred to in Articles 4(1), 4(3), 4(5), 4a(2), 5, 6(2), 7(1), 7(2), 7(6), 13(6), 14(4) and 15a shall be conferred on the Commission for a period of five years from 17 July 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. 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.

3. The delegation of power referred to in Articles 4(1), 4(3), 4(5), 4a(2), 5, 6(2), 7(1), 7(2), 7(6), 13(6), 14(4) and 15a may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. 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. It shall not affect the validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5. A delegated act adopted pursuant to Articles 4(1), 4(3), 4(5), 4a(2), 5, 6(2), 7(1), 7(2), 7(6), 13(6), 14(4) and 15a shall enter into force only if no objection has been expressed either by the European Parliament or 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. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

(21)Article 23 is replaced by the following:

‘Article 23

Committee procedure

1. The Commission shall be assisted for the implementing acts adopted pursuant to Articles 4(3), 4(5), 5 and 13(6) by the Standing Committee on the Food Chain and Animal Health established by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (9).

That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council (10).

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

Where the opinion of the Committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the Committee so decides or a simple majority of committee members so requests.

(9) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1)."

(10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’;"

(22)the following Article is inserted:

‘Article 23a

Report and legislative developments

No later than:

—18 July 2019 for the voluntary labelling provisions, and

—18 July 2023 for the electronic identification provisions,

the Commission shall submit to the European Parliament and the Council the corresponding reports dealing with the implementation and impact of this Regulation including, in the first case, the possibility of reviewing the voluntary labelling provisions, and, in the second case, the technical and economic feasibility of introducing mandatory electronic identification throughout the Union.

Those reports shall, if necessary, be accompanied by appropriate legislative proposals.’;

(23)the following Annex is inserted:

‘ANNEX I

MEANS OF IDENTIFICATION

A)CONVENTIONAL EAR TAG

WITH EFFECT FROM 18 JULY 2019:

B)ELECTRONIC IDENTIFIER IN THE FORM OF AN ELECTRONIC EAR TAG

C)ELECTRONIC IDENTIFIER IN THE FORM OF A RUMINAL BOLUS

D)ELECTRONIC IDENTIFIER IN THE FORM OF AN INJECTABLE TRANSPONDER’

Article 2

This Regulation shall enter into force on the twentieth 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.