title: Directive 2008/97/EC of the European Parliament and of the Council of 19 November 2008 amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists (Text with EEA relevance)

text:
               28.11.2008

               EN

               Official Journal of the European Union

               L 318/9

      DIRECTIVE 2008/97/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 19 November 2008
   amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Article 2 of Directive 96/22/EC (3) prohibits, inter alia, the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species.

               (2)

               The reason for that absolute prohibition was that potential abuse or misuse would be more difficult if there were no product authorised for any animal species whatsoever on the market.

               (3)

               However, experience gained in particular with national residue plans submitted under Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (4) has shown that the misuse of product presentations intended for pet animals does not play a role as a source of abuse or misuse. That is partly because it is economically unattractive to use presentations intended for pet animals for growth promotion in food-producing animals.

               (4)

               Moreover, the prohibition of thyrostatic substances has harmful consequences for the welfare of pet animals (dogs and cats) due to the lack of an alternative treatment for hyperthyroidism in those animals.

               (5)

               The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market.

               (6)

               It is therefore appropriate to limit the scope of Directive 96/22/EC only to food-producing animals and withdraw the prohibition for pet animals, as well as to adjust the definition of therapeutic treatment.

               (7)

               The Opinion of the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) of 30 April 1999 on the potential risks to human health from hormone residues in bovine meat and meat products (which was reviewed on 3 May 2000 and confirmed on 10 April 2002) concluded that there is a substantial body of recent evidence suggesting that oestradiol 17ß has to be considered as a complete carcinogen, as it exerts both tumour-initiating and tumour-promoting effects, and that the data currently available do not make it possible to give a quantitative estimate of the risk to human health. As a result, Directive 96/22/EC was amended by Directive 2003/74/EC so as to, inter alia, prohibit permanently the use of oestradiol 17β as a growth promoter and reduce substantively all other circumstances in which it can be administered to all farm animals for therapeutic or zootechnical purposes pending further examination of the factual and scientific situation and the veterinary practices in the Member States.

               (8)

               Article 11a of Directive 96/22/EC required the Commission to present a report by 14 October 2005 concerning the availability of alternative veterinary medicinal products to those containing oestradiol 17β for food-producing animals for therapeutic purposes. The Commission sought expert advice and established the relevant scientific report, which was forwarded to the European Parliament and the Council on 11 October 2005. That Report concludes that oestradiol 17β is not essential in the production of food-producing animals because the use of the available alternatives (especially prostaglandins) by practising veterinarians is already quite common in the Member States and that the complete prohibition of the use of oestradiol 17β for food-producing animals would have no, or only a negligible, impact on farming and animal welfare.

               (9)

               Proper compliance with the relevant legislation and the elimination of inappropriate use of unauthorised substances can be enhanced by means of objective information and awareness campaigns.

               (10)

               A temporary exemption was provided for the use of oestradiol 17β for oestrus induction in cattle, horses, sheep or goats until 14 October 2006. Since effective alternative products exist and are already used, and in order to ensure the high level of health protection chosen in the Community, that exemption should not be renewed.

               (11)

               Directive 96/22/EC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 96/22/EC is hereby amended as follows:

               1.

               In Article 1(2), point (b) shall be replaced by the following:

                           ‘(b)

                           “therapeutic treatment” shall mean the administering — under Article 4 of this Directive — to an individual farm animal of an authorised substance to treat, after examination by a veterinarian, a fertility problem — including the termination of unwanted gestation — and, in the case of beta-agonists, to induce tocolysis in cows when calving as well as to treat respiratory problems, navicular disease and laminitis and to induce tocolysis in equidae;’.

               2.

               Article 2 shall be replaced by the following:
               ‘Article 2
               Member States shall prohibit the placing on the market of the substances listed in Annex II for administering to any animals, the meat and products of which are intended for human consumption, for purposes other than those provided for in point 2 of Article 4.’.

               3.

               In Article 4, point 2(i) shall be replaced by the following:

                           ‘(i)

                           allyl trenbolone, administered orally, or beta-agonists to equidae, provided they are used in accordance with the manufacturer’s instructions;’.

               4.

               Article 5a shall be deleted.

               5.

               In Articles 3, 6, 7, 8, 11 and 14 a, the references to Article 5a shall be deleted.

               6.

               In Article 11, paragraph 1 shall be replaced by the following:
               ‘1.   Third countries whose legislation authorises the placing on the market and administration of stilbenes, stilbene derivatives, their salts and esters, or of thyrostatic substances for administering to all species of animals the meat and products of which are intended for human consumption may not appear on any of the lists of countries provided for under Community legislation from which Member States are authorised to import farm or aquaculture animals or meat or products obtained from such animals.’.

               7.

               Article 11a shall be replaced by the following:
               ‘Article 11a
               With regard to the substances listed in Annex III, the Commission shall seek additional information, taking into account recent scientific data from all possible sources, and keep the measures applied under regular review with a view to the timely presentation to the European Parliament and to the Council of any necessary proposals.’.

               8.

               The following Article shall be inserted:
               ‘Article 11b
               The Commission, in collaboration with the Member States, shall set up an information and awareness campaign on the complete ban on the use of oestradiol 17β in food-producing animals, aimed at farmers and veterinary organisations in the EU as well as the relevant organisations outside the EU which are directly or indirectly involved in the export to the EU of food of animal origin falling within the scope of this Directive.’.

               9.

               Annex II shall be replaced by the text appearing in the Annex to this Directive.

         Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2009. They shall forthwith communicate to the Commission the text of such laws, regulations and administrative provisions together with a table showing the correlation between them and this Directive.
   When they are adopted by Member States, these measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Strasbourg, 19 November 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J.-P. JOUYET

      (1)  OJ C 10, 15.1.2008, p. 57.

      (2)  Opinion of the European Parliament of 5 June 2008 (not yet published in the Official Journal) and Council Decision of 20 October 2008.

      (3)  OJ L 125, 23.5.1996, p. 3.

      (4)  OJ L 125, 23.5.1996, p. 10.

      ANNEX

            ‘ANNEX II
            List of prohibited substances:

                        List A: prohibited substances

                                    —

                                    Thyrostatic substances,

                                    —

                                    Stilbenes, stilbene derivatives, their salts and esters,

                                    —

                                    Oestradiol 17β and its ester-like derivatives.

                        List B: prohibited substances with derogations

                                    —

                                    Beta-agonists’


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32001L0104

Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)

Official Journal L 006 , 10/01/2002 P. 0050 - 0051

Directive 2001/104/EC of the European Parliament and of the Councilof 7 December 2001amending Council Directive 93/42/EEC concerning medical devices(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the Economic and Social Committee,Acting in accordance with the procedure laid down in Article 251 of the Treaty(1),Whereas:(1) This Directive aims at including in the scope of Directive 93/42/EEC(2) only medical devices which incorporate, as an integral part, substances derived from human blood or human plasma. Medical devices incorporating other substances derived from human tissues remain excluded from the scope of the said Directive.(2) The essential aim of any rules governing the production, distribution or use of medical devices must be to safeguard public health.(3) National provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonised in order to guarantee free movement of such devices within the internal market,HAVE ADOPTED THIS DIRECTIVE:Article 1Article 1(5) of Directive 93/42/EEC is hereby amended as follows:(a) point (c) shall be replaced by the following: "(c) medicinal products covered by Directive 65/65/EEC, including medicinal products derived from blood as covered by Directive 89/381/EEC;";(b) point (e) shall be replaced by the following: "(e) human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells, with the exception of devices referred to in paragraph 4a;".Article 2Implementation, transitional provisions1. Before 13 December 2001, Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof.Member States shall apply these measures with effect from 13 June 2002.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.3. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 16 of Directive 93/42/EEC for conformity assessment take account of all relevant information regarding the characteristics and performance of devices incorporating stable derivatives of human blood or human plasma, including in particular the results of any pertinent tests and verification already carried out under the pre-existing national law, regulations or administrative provisions in respect of such devices.4. For a period of five years following the entry into force of this Directive, Member States shall accept the placing on the market of devices incorporating stable derivatives of human blood or human plasma which conform to the rules in force in their territory on the date on which this Directive enters into force. For a further period of two years, the said devices may be put into service.Article 3This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 7 December 2001.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentI. Durant(1) Opinion of the European Parliament delivered on 23 October 2001 (not yet published in the Official Journal) and Council Decision of 3 December 2001.(2) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Directive 2000/70/EC of the European Parliament and of the Council (OJ L 313, 13.12.2000, p. 22).


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31990L0547

Council Directive 90/547/EEC of 29 October 1990 on the transit of electricity through transmission grids

Official Journal L 313 , 13/11/1990 P. 0030 - 0033 Finnish special edition: Chapter 12 Volume 2 P. 0105  Swedish special edition: Chapter 12 Volume 2 P. 0105

*****COUNCIL  DIRECTIVE  of 29 October 1990  on the transit of electricity through transmission grids  (90/547/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the European Council has recognized, at its successive meetings, in particular in Rhodes, the need for a single internal market in energy and whereas the achievement of the internal market more specifically in the electricity sector will help the further development of the Community's energy objectives;  Whereas there must be greater integration of the European energy market if the single inertnal market is to be achieved; whereas electricity is an essential component of the Community's energy balance;  Whereas the achievement of the internal market for energy, more particularly in the electricity sector, must take into account the objective of economic and social cohesion, that is to say, in concrete terms, guarantee an optimum supply of electricity to all the citizens of all the Community regions, with a view to improving and harmonizing the living conditions and development bases in particular in the least-favoured regions;  Whereas energy polices, more than any other measure contributing to the achievement of the internal market, must not be implemented with the sole aim of reducing costs and maintaining competition, but must also take account of the need to ensure the security of supplies and the compatibility of energy production methods with the environment;  Whereas to attain that objective, account should be taken of the specific characteristics of the electricity sector;  Whereas there is increasing trade in electricity each year between high-voltage electricity grids in Europe; whereas the European Community's security of electricity supply would be improved and costs reduced by coordinating the building and operation of the interconnections required for such trade;  Whereas the exchange of electricity between electricity grids which is based on contracts with a minimum duration of one year is so great that requests for transactions and their consequences should be systematically known to the Commission;  Whereas it is possible and desirable to increase electricity transfers between grids and also take account of the imperatives of security and quality of electricity supply; whereas studies show that such greater electricity transfers between grids can minimize the cost of investment and fuels involved in electricity generation and transmission and ensure optimum use of the means of production and infrastructure;  Whereas there are still obstacles to such trade; whereas, provided that they are not due to the nature of technology used or the nature of the grids themselves, such obstacles can be reduced by making the transit of electricity through grids compulsory and introducing an appropriate system for monitoring compliance with this obligation;  Whereas this obligation and monitoring system concern the transit of electricity involved in trade with is in the Community interest, i.e. transit through high-voltage grids;  Whereas the contract conditions concerning the transit of electricity between grids must be negotiated between the responsible entities; whereas the conditions of transit should be fair and should not bring about, directly or indirectly, conditions contrary to Community competition rules;  Whereas, in order to facilitate the conclusion of transit contracts, the Commission is providing for the creation of a conciliation procedure under which submission must be made at the request of one of the parties, without the result of that procedure having legally binding effect;  Whereas it is necessary to approximate the provisions taken by the Member States which affect the transit of electricity;  Whereas the establishment of an internal electricity market will stimulate the dynamic process of better integration of national electricity grids, and whereas in this context special infrastructure measures and programmes should therfore be implemented to accelerate the efficient and socially advantageous linking-up of outlying areas and islands in the Community to the interconnected grid;  Whereas the interconnection of major European grids over which trade must be coordinated extends over a geographical territory which does not coincide with the Community's frontiers; whereas there is an obvious advantage in seeking cooperation with third countries involved in the interconnected European network,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Member States shall take the measures necessary to facilitate transit of electricity between high-voltage grids in accordance with the conditions laid down in this Directive.  Article 2  1. Every transaction for the transport of electricity under the following conditions shall constitute transit of electricity between grids, within the meaning of this Directive, without prejudice to any special arrangements concluded between the Community and third countries:  (a) transmission is carried out by the entity or entities responsible in each Member State for a high-voltage electricity grid, with the exception of distribution grids, in a Member State's territory which contributes to the efficient operation of European high-voltage interconnections;  (b) the grid of origin or final destination is situated in the Community;  (c) the transport involves the crossing of one intra-Community frontier at least.  2. The high-voltage electricity transmission grids and the entities responsible for them in the Member States, which are listed in the Annex, shall be covered by the provisions of this Directive. This list shall be updated after consultation with the Member State concerned whenever necessary by decision of the Commission, within the context of the objectives of this Directive and in particular taking into account paragraph 1 (a).  Article 3  1. Contracts involving transit of electricity between transmission grids shall be negotiated between the entities responsible for the grids concerned and for the quality of service provided and, where appropriate, with the entities responsible in the Member States for importing and exporting electricity.  2. The conditions of transit shall, pursuant to the rules of the Treaty, be non-discriminatory and fair for all the parties concerned, shall not include unfair clauses or unjustified restrictions and shall not endanger security of supply and quality of service, in particular taking full account of the utilization of reserve production capacity and the most efficient operation of existing systems.  3. Member States shall take the measures necessary to ensure that the entities under their jurisdiction referred to in the Annex act without delay to:  - notify the Commission and the national authorities concerned of any request for transit in connection with contracts for the sale of electricity of a minimum of one year's duration,  - open negotiations on the conditions of the electricity transit requested,  - inform the Commission and the national authorities concerned of the conclusion of a transit contract,  - inform the Commission and the national authorities concerned of the reasons for the failure of the negotiations to result in the conclusion of a contract within 12 months following communication of the request. 4. Each the entities concerned may request that the conditions of transit be subject to conciliation by a body set up and chaired by the Commission and on which the entities responsible for transmission grids in the Community are represented.  Article 4  If the reasons for the absence of agreement on a request for transit appear unjustified or insufficient, the Commission, acting on a complaint from the requesting body or on its own initiative, shall implement the procedures provided for by Community law.  Article 5  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1991. They shall forthwith inform the Commission thereof.  Article 6  This Directive is addressed to the Member States.  Done at Luxembourg, 29 October 1990.  For the Council  The President  A. BATTAGLIA  (1) OJ No C 8, 13. 1. 1990, p. 4.  (2) OJ No C 113, 7. 5. 1990, p. 91 and Decision of 10 October 1990 (not yet published in the Official Journal).  (3) OJ No C 75, 26. 3. 1990, p. 23.  ANNEX  List of entities and grids in the Community covered by the Directive  1.2.3 //  //  //  // Member State  // Entity  // Grid  //  //  //  // Germany   // Badenwerk AG Bayernwerk AG Berliner Kraft und Licht AG (Bewag) Energie-Versorgung Schwaben AG (EVS) Hamburgische Elektrizitaetswerke (HEW) Preussen-Elektra AG RWE Energie AG Vereinigte Elektrizitaetswerke Westfalen AG (VEW)   // Interconnection grids   // Belgium   // CPTE - Société pour la coordination de la production et du transport de l'électricité   // Coordinating body for public supply grid  // Denmark   // ELSAM   // Public supply grid (Jutland)   //  // ELKRAFT   // Public supply grid (Seeland)   // Spain  // Red Eléctrica de España S.A.   // Public supply grid  // France   // Électricité de France   // Public supply grid  // Greece   // Dimósia Epicheírisi Ilektrismoý (DEI)   // Public supply grid   // Ireland   // Electricity Supply Board  // Public supply grid   // Italy   // ENEL   // Public supply grid   // Luxembourg   // CEGEDEL   // Public supply grid  // Netherlands   // SEP   // Public supply grid   // Portugal  // EDP   // Public supply grid   // United Kingdom  // National Grid Company Scottish Power Scottish Hydro-Electric Northern Ireland Electricity   // High voltage transmission grids   //    //   //


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31982L0003

Council Directive 82/3/EEC of 21 December 1981 amending Directive 75/130/EEC on the establishment of common rules for certain types of combined road/rail carriage of goods between Member States

Official Journal L 005 , 09/01/1982 P. 0012 - 0012 Spanish special edition: Chapter 07 Volume 3 P. 0035  Portuguese special edition Chapter 07 Volume 3 P. 0035

*****COUNCIL  DIRECTIVE  of 21 December 1981  amending Directive 75/130/EEC on the establishment of common rules for certain types of combined road/rail carriage of goods between Member States  (82/3/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 75 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas Directive 75/130/EEC (3), as amended by Directive 79/5/EEC (4), applies on an experimental basis until 31 December 1981 to combined transport in the case of containers of 20 feet and more and swap bodies which have no supports;  Whereas the inaugural effect of Directive 75/130/EEC, as far as this transport is concerned, during the period which has elapsed must be considered to have been positive; whereas that Directive should therefore be applied on a permanent basis with regard to this transport,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Article 8 of Directive 75/130/EEC is hereby deleted.  Article 2  Member States shall take the measures necessary to comply with this Directive. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 21 December 1981.  For the Council  The President  N. RIDLEY  (1) Opinion delivered on 18 December 1981 (not yet published in the Official Journal).  (2) Opinion delivered on 25 November 1981 (not yet published in the Official Journal).  (3) OJ No L 48, 22. 2. 1975, p. 31.  (4) OJ No L 5, 9. 1. 1979, p. 33.


title: Commission Directive 2009/8/EC of 10 February 2009 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed (Text with EEA relevance)

text:
               11.2.2009

               EN

               Official Journal of the European Union

               L 40/19

      COMMISSION DIRECTIVE 2009/8/EC
   of 10 February 2009
   amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8(1) thereof,
   Whereas:

               (1)

               Coccidiostats and histomonostats are substances intended to kill or inhibit protozoa, which may, inter alia, be authorised for use as feed additives in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (2). Authorisations of coccidiostats and histomonostats as feed additives lay down specific conditions for use such as the target animal species or categories for which the additives are intended.

               (2)

               Feed business operators may produce within one establishment a broad range of feeds and different types of products may have to be manufactured after each other in the same production line. It may happen that unavoidable traces of a product remain in the production line and end up in the beginning of the production of another feed product. This transfer from one production lot to another is called ‘carry-over’ or ‘cross-contamination’ and may occur for instance when coccidiostats or histomonostats are used as authorised feed additives. This may result in the contamination of feed produced subsequently by the presence of technically unavoidable traces of those substances in ‘non-target feed’, i.e. in feed for which the use of coccidiostats or histomonostats are not authorised, such as feed intended for animal species or categories not provided for in the additive authorisation. This unavoidable cross-contamination may occur at all stages of production and processing of feed but also during storage and transport of feed.

               (3)

               Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (3) provides for specific requirements for feed businesses using coccidiostats and histomonostats in the production of feed. In particular, the operators concerned have to take all appropriate measures concerning facilities and equipment, production, storage and transport in order to avoid any cross-contamination, and this in accordance with the obligations provided for in Articles 4 and 5 of the above mentioned Regulation. The establishment of maximum levels of unavoidable carry-over of coccidiostats and histomonostats in non-target feed in accordance with Directive 2002/32/EC should not interfere with the primary obligation of operators to apply good manufacturing practices aiming at avoiding this cross-contamination. Continued effort is therefore still needed by the operators concerned in order to avoid the presence of such undesirable substances in animal feed.

               (4)

               Taking into account the application of good manufacturing practices, the maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed should be established following the ALARA (As Low As Reasonably Achievable) principle. For the purpose of enabling the feed manufacturer to manage the above mentioned unavoidable carry-over, a carry-over rate of approximately 3 % compared to the authorised maximum content should be considered as regards feed for less sensitive non-target animal species, while a carry-over rate of approximately 1 % compared to the authorised maximum content should be retained for feed intended to sensitive non-target animal species and ‘withdrawal feed’, i.e. feed used for the period before slaughter. The carry-over rate of 1 % should also be considered for cross-contamination of other feed for target species to which no coccidiostats or histomonostats are added, and as regards non-target feed for ‘continuous food-producing animals’, such as dairy cows or laying hens, where there is evidence of transfer from feed to food of animal origin. If feed materials are fed directly to the animals or if complementary feedingstuffs are used, their use in a daily ration should not lead to the animal being exposed to a higher levels of an coccidiostat or histomonostat than the corresponding maximum levels of exposure where only complete feedingstuffs are used in a daily ration.

               (5)

               In order to prevent the adoption by Member States of national rules addressing the issue of unavoidable carry-over of authorised coccidiostats or histomonostats in non-target feed and their resulting presence in derived foodstuffs, which would hinder the functioning of the internal market, it is necessary to adopt harmonised Community rules in this matter.

               (6)

               The unavoidable carry-over in non-target feed of active substances contained in authorised coccidiostats and histomonostats should be considered as undesirable substances in animal feed within the meaning of Directive 2002/32/EC and their presence should not endanger animal health, human health or the environment. Therefore, maximum levels for these substances in animal feed should be established within Annex I of the said Directive in order to prevent undesirable and harmful effects.

               (7)

               Where MRLs have been laid down in the frame of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (4) or in the frame of Regulation (EC) No 1831/2003, compliance with those provisions should be ensured when establishing maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed.

               (8)

               The occurrence of unavoidable carry-over of coccidiostats and histomonostats in non-target feed, even below maximum levels that should be set under Directive 2002/32/EC, may result in the presence of residues of these substances in food products of animal origin. Therefore, in order to protect public health, and insofar there is no maximum residue limit (MRL) yet fixed for the specific food concerned, maximum tolerances for the presence of active substances contained in coccidiostats and histomonostats have been established by Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed (5), in the context of Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (6).

               (9)

               On a request from the Commission, the European Food Safety Authority (the Authority) adopted several opinions (7) on the risks involved for animal health and public health as the consequence of unavoidable carry-over of coccidiostats or histomonostats authorised as feed additives into non-target feed. For each coccidiostat or histomonostat authorised as feed additive, the Authority’s assessment took into account hypothetical carry-over rates of 2 %, 5 % and 10 % from feed produced with the highest authorised dose of the coccidiostats or histomonostats into the afterwards produced non-target feed.

               (10)

               Considering the conclusions of the individual scientific opinions, it can be stated that generally the Authority concluded that the presence of the coccidiostats or histomonostats authorised as feed additives, in non-target feed at levels resulting from an unavoidable carry-over, and taking into account all prevention measures, is unlikely to result in adverse animal health effects and that the risk to consumers, health from the ingestion of residues in products from animals exposed to cross-contaminated feed is negligible.

               (11)

               Taking into account the Authority’s opinions and the currently different approaches applied in the Member States to address the unavoidable cross-contamination, it is proposed to set maximum levels for feed as laid down in the Annexes to this Directive, in order to ensure a proper functioning of the internal market and to protect animal and public health.

               (12)

               The establishment of maximum levels of undesirable substances in animal feed should take place through an adaptation of Annex I of Directive 2002/32/EC, as provided for in Article 8(1) of that Directive. When adapting the technical provisions in Annex I of Directive 2002/32/EC, developments in scientific and technical knowledge have been taken into account through the consideration of scientific opinions of the Authority and of the development of analytical methods in feed. The provisions provided in Annex should be reviewed by 1 July 2011 at the latest to take account of developments in scientific and technical knowledge.

               (13)

               The maximum levels set in the Annex to this Directive should be continuously adapted to the conditions of use provided for in the authorisations of coccidiostats and histomonostats as feed additives. In view of the occurrence of a possible time gap between the authorisation – or modification, suspension or revocation of the authorisation – of a coccidiostat or histomonostat as feed additive and the consequent amendment to the maximum levels laid down in the Annexes to this Directive, the latter should be considered as without prejudice to the levels of coccidiostats or histomonostats authorised as feed additives in the frame of Regulation (EC) No 1831/2003.

               (14)

               Due to the fact that the unavoidable carry-over of coccidiostats or histomonostats into non-target feed may result in the presence of these substances as contaminants in derived food, it is appropriate to take a comprehensive and integrated approach to address the issue through the simultaneous adoption and application of this Directive setting maximum levels for the unavoidable carry-over of coccidiostats or histomonostats into non-target feed and the Commission Regulation setting maximum levels for the resulting presence of these substances in food.

               (15)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTVE:
   Article 1
   Annex I to Directive 2002/32/EC is amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2009 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. 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. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 10 February 2009.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 140, 30.5.2002, p. 10.

      (2)  OJ L 268, 18.10.2003, p. 29.

      (3)  OJ L 35, 8.2.2005, p. 1.

      (4)  OJ L 224, 18.8.1990, p. 1.

      (5)  See page 7 of this Official Journal.

      (6)  OJ L 37, 13.2.1993, p. 1.

      (7)  Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission on Cross-contamination of non-target feedingstuffs by lasalocid authorised for use as a feed additive, The EFSA Journal (2007) 553, 1-46.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/CONTAM_ej553_lasalocid_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by narasin authorised for use as a feed additive, The EFSA Journal (2007) 552, 1-35.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/CONTAM_ej552_narasin_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by maduramicin authorised for use as a feed additive, The EFSA Journal (2008) 594, 1-30.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej594_maduramicin_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by semduramicin authorised for use as a feed additive, The EFSA Journal (2008) 593, 1-27.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej593_semduramicin_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by salinomycin authorised for use as a feed additive, The EFSA Journal (2008) 591, 1-38.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej591_salinomycin_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by monensin authorised for use as a feed additive, The EFSA Journal (2008) 592, 1-40.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej592_monensin_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by halofuginone hydrobromide authorised for use as a feed additive, The EFSA Journal (2008) 657, 1-31.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej657_halofuginone_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by decoquinate authorised for use as a feed additive, The EFSA Journal (2008) 656, 1-26.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej656_decoquinate_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by robenidine authorised for use as a feed additive, The EFSA Journal (2008) 655, 1-29.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej655_robenidine_en,0.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by nicarbazin authorised for use as a feed additive, The EFSA Journal (2008) 690, 1-34.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej690_nicarbazin_en.pdf?ssbinary=true
   Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by diclazuril authorised for use as a feed additive, The EFSA Journal (2008) 716, 1-31.
   http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej716_diclazuril_en.pdf?ssbinary=true

      ANNEX
      The following points are added in Annex I to Directive 2002/32/EC:

                     ‘Undesirable substances

                     Products intended for animal feed (1)

                     Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 %

                                 1.

                                 Lasalocid sodium

                     Feed materials

                     1,25

                     Compound feed for

                                 —

                                 dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 12 weeks) and chickens reared for laying (> 16 weeks);

                     1,25

                                 —

                                 chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 12 weeks) for the period before slaughter in which the use of lasalocid sodium is prohibited (withdrawal feed);

                     1,25

                                 —

                                 other animal species.

                     3,75

                     Premixtures for use in feed in which the use of lasalocid sodium is not authorised.

                         (2)

                                 2.

                                 Narasin

                     Feed materials

                     0,7

                     Compound feed for

                                 —

                                 turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks);

                     0,7

                                 —

                                 chickens for fattening for the period before slaughter in which the use of narasin is prohibited (withdrawal feed);

                     0,7

                                 —

                                 other animal species.

                     2,1

                     Premixtures for use in feed in which the use of narasin is not authorised.

                         (2)

                                 3.

                                 Salinomycin sodium

                     Feed materials

                     0,7

                     Compound feed for

                                 —

                                 equine species, turkeys, laying birds and chickens reared for laying (> 12 weeks);

                     0,7

                                 —

                                 chickens for fattening, chickens reared for laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed);

                     0,7

                                 —

                                 other animal species.

                     2,1

                     Premixtures for use in feed in which the use of salinomycin sodium is not authorised.

                         (2)

                                 4.

                                 Monensin sodium

                     Feed materials

                     1,25

                     Compound feed for

                                 —

                                 equine species, dogs, small ruminants (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 16 weeks);

                     1,25

                                 —

                                 chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (withdrawal feed);

                     1,25

                                 —

                                 other animal species.

                     3,75

                     Premixtures for use in feed in which the use of monensin sodium is not authorised.

                         (2)

                                 5.

                                 Semduramicin sodium

                     Feed materials

                     0,25

                     Compound feed for

                                 —

                                 laying birds and chickens reared for laying (> 16 weeks);

                     0,25

                                 —

                                 chickens for fattening for the period before slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed);

                     0,25

                                 —

                                 other animal species.

                     0,75

                     Premixtures for use in feed in which the use of semduramicin sodium is not authorised.

                         (2)

                                 6.

                                 Maduramicin ammonium alpha

                     Feed materials

                     0,05

                     Compound feed for

                                 —

                                 equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks);

                     0,05

                                 —

                                 chickens for fattening and turkeys (< 16 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed);

                     0,05

                                 —

                                 other animal species.

                     0,15

                     Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised.

                         (2)

                                 7.

                                 Robenidine hydrochloride

                     Feed materials

                     0,7

                     Compound feed for

                                 —

                                 laying birds and chickens reared for laying (> 16 weeks);

                     0,7

                                 —

                                 chickens for fattening, rabbits for fattening and breeding and turkeys for the period before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed);

                     0,7

                                 —

                                 other animal species.

                     2,1

                     Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised.

                         (2)

                                 8.

                                 Decoquinate

                     Feed materials

                     0,4

                     Compound feed for

                                 —

                                 laying birds and chickens reared for laying (> 16 weeks);

                     0,4

                                 —

                                 chickens for fattening for the period before slaughter in which the use of decoquinate is prohibited (withdrawal feed);

                     0,4

                                 —

                                 other animal species.

                     1,2

                     Premixtures for use in feed in which the use of decoquinate is not authorised.

                         (2)

                                 9.

                                 Halofuginone hydrobromide

                     Feed materials

                     0,03

                     Compound feed for

                                 —

                                 laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 12 weeks);

                     0,03

                                 —

                                 chickens for fattening and turkeys (< 12 weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed);

                     0,03

                                 —

                                 other animal species other than chickens reared for laying (< 16 weeks).

                     0,09

                     Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised.

                         (2)

                                 10.

                                 Nicarbazin

                     Feed materials

                     0,5

                     Compound feed for

                                 —

                                 equine species, laying birds and chickens reared for laying (> 16 weeks);

                     0,5

                                 —

                                 chickens for fattening for the period before slaughter in which the use of nicarbazin (in combination with narasin) is prohibited (withdrawal feed);

                     0,5

                                 —

                                 other animal species.

                     1,5

                     Premixtures for use in feed in which the use of nicarbazin (in combination with narasin) is not authorised.

                         (2)

                                 11.

                                 Diclazuril

                     Feed materials

                     0,01

                     Compound feed for

                                 —

                                 laying birds, chickens reared for laying (> 16 weeks) and turkeys for fattening (> 12 weeks);

                     0,01

                                 —

                                 rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed);

                     0,01

                                 —

                                 other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening and turkeys for fattening (< 12 weeks).

                     0,03

                     Premixtures for use in feed in which the use of diclazuril is not authorised.

                         (2)

         (1)  Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition.

         (2)  The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50 % of the maximum levels established in the feed when the instructions for use of the premixture are followed.’


title: Commission Directive 2006/83/EC of 23 October 2006 adapting Directive 2002/4/EC on the registration of establishments keeping laying hens, covered by Council Directive 1999/74/EC, by reason of the accession of Bulgaria and Romania

text:
               20.12.2006

               EN

               Official Journal of the European Union

               L 362/97

         COMMISSION DIRECTIVE 2006/83/EC
   of 23 October 2006
   adapting Directive 2002/4/EC on the registration of establishments keeping laying hens, covered by Council Directive 1999/74/EC, by reason of the accession of Bulgaria and Romania
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty of Accession of Bulgaria and Romania, and in particular Article 4(3) thereof,
   Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,
   Whereas:

               (1)

               Pursuant to Article 56 of the Act of Accession, where acts which remain valid beyond 1 January 2007 require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary adaptations are to be adopted by the Commission in all cases where the Commission adopted the original act.

               (2)

               The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties reached political agreement on a set of adaptations to acts adopted by the Institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

               (3)

               Commission Directive 2002/4/EC of 30 January 2002 on the registration of establishments keeping laying hens, covered by Council Directive 1999/74/EC (1) should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2002/4/EC is amended as set out in the Annex.
   Article 2
   1.   Member States shall adopt and publish, by the date of accession of Bulgaria and Romania to the European Union at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from the date of accession of Bulgaria and Romania to the European Union.
   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. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the fields covered by this Directive.
   Article 3
   This Directive shall enter into force subject to, and on the date of, the entry into force of the Treaty of Accession of Bulgaria and Romania.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 23 October 2006.

            For the Commission

         Olli REHN

            Member of the Commission

      (1)  OJ L 30, 31.1.2002, p. 44.

      ANNEX
      AGRICULTURE
      VETERINARY AND PHYTOSANITARY LEGISLATION

         VETERINARY LEGISLATION

      32002 L 0004: Commission Directive 2002/4/EC of 30 January 2002 on the registration of establishments keeping laying hens, covered by Council Directive 1999/74/EC (OJ L 30, 31.1.2002, p. 44), as amended by:

                  —

                  12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

            The list in Part 2.2 of the Annex is replaced by the following:

                     ‘AT

                     Austria

                     BE

                     Belgium

                     BG

                     Bulgaria

                     CY

                     Cyprus

                     CZ

                     Czech Republic

                     DE

                     Germany

                     DK

                     Denmark

                     EE

                     Estonia

                     EL

                     Greece

                     ES

                     Spain

                     FI

                     Finland

                     FR

                     France

                     HU

                     Hungary

                     IE

                     Ireland

                     IT

                     Italy

                     LT

                     Lithuania

                     LU

                     Luxembourg

                     LV

                     Latvia

                     MT

                     Malta

                     NL

                     Netherlands

                     PL

                     Poland

                     PT

                     Portugal

                     RO

                     Romania

                     SE

                     Sweden

                     SI

                     Slovenia

                     SK

                     Slovakia

                     UK

                     United Kingdom.’


Avis juridique important

|

31993L0070

Eleventh Commission Directive 93/70/EEC of 28 July 1993 establishing Community analysis methods for official control of feedingstuffs

Official Journal L 234 , 17/09/1993 P. 0017 - 0021 Finnish special edition: Chapter 3 Volume 52 P. 0132  Swedish special edition: Chapter 3 Volume 52 P. 0132

ELEVENTH COMMISSION DIRECTIVE 93/70/EEC of 28 July 1993 establishing Community analysis methods for official control of feedingstuffsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article  2 thereof,  Whereas Directive 70/373/EEC requires official controls on feedingstuffs for the purpose of checking compliance with requirements arising under quality and composition provisions laid down by law, regulation or administrative action, to be carried out  using Community sampling and analysis methods;  Whereas a Community analysis method for the additive halofuginone should be established for use in checking compliance with the conditions for its use in animal nutrition;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:   Article 1  Member States shall require that analyses for halofuginone content for the purposes of official checks on feedingstuffs be made using the method described in the Annex hereto.   Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1994. They shall immediately inform the Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.   Article 3  This Directive is addressed to the Member States.  Done at Brussels, 28 July 1993.  For the Commission René STEICHEN Member of the Commission  (1) OJ No L 170, 3. 8. 1970, p. 2.  (2) OJ No L 362, 31. 12. 1985, p. 8.     ANNEX   DETERMINATION OF HALOFUGINONE  DL-trans-7-bromo-6-chloro-3-[3-(3-hydroxy-2-piperidyl)acetonyl]-quinazolin-4-(3H)-one hydrobromide 1. Purpose and scope  The method is for the determination of halofuginone in feedingstuffs. The lower limit of determination is 1 mg/kg.  2. Principle  After treatment with hot water, halofuginone is extracted as the free base into ethyl acetate and subsequently partitioned as the hydrochloride into an aqueous acid solution. The extract is purified by ion-exchange chromatography. The content of  halofuginone is determined by reserved-phase high-performance liquid chromatography (HPLC) using an UV detector.  3. Reagents 3.1. Acetonitrile, HPLC grade 3.2. Amberlite XAD-2 resin 3.3. Ammonium acetate 3.4. Ethyl acetate 3.5. Acetic acid, glacial 3.6. Halofuginone standard substance (DL-trans-7-brome-6-chloro-3-[3-hydroxy-2-piperidyl)acetonyl] quinazoline-4-(3H)-one hydrobromide, E 764) 3.6.1. Halofuginone stock standard solution, 100 mg/ml  Weight to the nearest 0,1 mg, 50 mg of halofuginone (3.6) in a 500 ml graduated flask, dissolve in ammonium acetate buffer solution (3.18), make up to the mark with the buffer solution and mix. This solution is stable for three weeks at 5 °C if stored  in the dark.  3.6.2. Calibration solutions  Into a series of 100 ml graduated flasks transfer 1,0, 2,0, 3,0, 4,0 and 6,0 ml of the stock standard solution (3.6.1). Make up to the mark with mobile phase (3.21) and mix. These solutions have concentrations of 1,0, 2,0, 3,0, 4,0 and 6,0 mg/ml of  halofuginone respectively. These solutions must be freshly prepared before use.  3.7. Hydrochloric acid (r20 approximately 1,16 g/ml).  3.8. Methanol 3.9. Silver nitrate 3.10. Sodium ascorbate 3.11. Sodium carbonate 3.12. Sodium chloride 3.13. EDTA (ehtylenediaminetetraacetic acid, disodium salt) 3.14. Water, HPLC grade 3.15. Sodium carbonate solution, v = 10 g/100 ml 3.16. Sodium chloride-saturated sodium carbonate solution, v = 5 g/100 ml  Dissolve 50 g of sodium carbonate (3.11) in water, dilute to 1 l and add sodium chloride (3.12) until the solution is saturated.  3.17. Hydrochloric acid, approximately 0,1 mol/l  Dilute 10 ml of HCI (3.7) with water to 1 l.  3.18. Ammonium acetate buffer solution, approximately 0,25  Dissolve 19,3 g of ammonium acetate (3.3) and 30 ml of acetic acid (3.5) in water (3.14) and dilute to 1 l.  3.19. Amberlite XAD-2 resin preparation  Wash an appropriate quantity of Amberlite (3.2) with water until all chloride ions have been removed, as indicated by a silver nitrate (3.20) test performed on the discarded aqueous phase. Then wash the resin with 50 ml of methanol (3.8), discard the  methanol and store the resin under fresh methanol.  3.20. Silver nitrate solution, approximately 0,1 mol/l  Dissolve 0,17 g of silver nitrate (3.9) in 10 ml of water.  3.21. HPLC Mobile phase  Mix 500 ml of acetonitrile (3.1) with 300 ml of ammonium acetate buffer solution (3.18) and 1 200 ml of water (3.14). Adjust the pH to 4,3 using acetic acid (3.5). Filter through a 0,22 mm filter (4.8) and degas the solution (e.g. by ultrasonification  for 10 minutes). This solution is stable for one month, if stored in the dark in a closed container.  4. Apparatus 4.1. Ultrasonic bath 4.2. Rotary film evaporator 4.3. Centrifuge 4.4. HPLC equipment with variable wavelength ultraviolet detector or diode-array detector 4.4.1. Liquid chromatographic column, 300 mm × 4 mm, C 18, 10 mm packaging, or an equivalent column 4.5. Glass column (300 mm × 10 mm) fitted with a sintered-glass filter and a stopcock 4.6. Glass-fibre filters, diameter 150 mm 4.7. Membrane filters, 0,45 mm 4.8. Membrane filters, 0,22 mm 5. Procedure  Note: Halofuginone as the free base is unstable in alkaline and ethyl acetate solutions. It should not remain in ethyl acetate for more than 30 minutes.  5.1. General 5.1.1. A blank feed should be analysed to check that neither halofuginone nor interfering substances are present.  5.1.2. A recovery test should be carried out by analysing the blank feed which has been fortified by addition of a quantity of halofuginone, similar to that present in the sample. To fortify at a level of 3 mg/kg, add 300 ml of the stock standard  solution (3.6.1) to 10 g of the blank feed, mix and wait for 10 minutes before proceeding with the extraction step (5.2).   Note: for the purpose of this method, the blank feed should be similar in type to that of the sample and on analysis halofuginone should not be detected.  5.2. Extraction  Weigh to the nearest 0,1 g, 10 g of the prepared sample, into a 200 ml centrifuge tube, add 0,5 g of sodium ascorbate (3.10), 0,5 g of EDTA (3.13) and 20 ml of water and mix. Place the tube for 5 minutes in a water bath (80 °C). After cooling down to  room temperature, add 20 ml of sodium carbonate solution (3.15) and mix. Add immediately 100 ml of ethyl acetate (3.4) and shake vigorously by hand for 15 seconds. Then place the tube for three minutes in the ultrasonic bath (4.1) and loosen the  stopper. Centrifuge for two minutes and decant the ethyl acetate phase through a glass fibre filter (4.6), into a 500 ml separating funnel. Repeat the extraction of te sample with a second portion of 100 ml of ethyl acetate. Wash the combined extracts  for one minute with 50 ml of sodium chloride-saturated sodium carbonate solution (3.16) and discard the aqueous layer.   Extract the organic layer for 1 min with 50 ml of hydrochloric acid (3.17). Run the lower acid layer into a 250 ml separating funnel. Re-extract the organic layer for 1,5 minutes with a further 50 ml of hydrochlorid acid and combine with the first  extract. Wash the combined acid extracts by swirling for approximately 10 seconds with 10 ml of ethyl acetate (3.4).   Quantitatively transfer the aqueous layer into a 250 ml round-bottomed flask and discard the organic phase. Evaporate all the remaining ethyl acetate from the acid solution using a rotary film evaporator (2.4). The temperature of the water bath should  not exceed 40 °C. Under a vacuum of approximately 25 mbar all of the residual ethyl acetate will be removed within 5 minutes at 38 °C.  5.3. Clean up 5.3.1. Preparation of the Amberlite column  An XAD-2 column is prepared for each sample extract. Transfer 10 g of prepared Amberlite (3.19) into a glass column (4.5) with methanol (3.8). Add a small plug of glass-wool to the top of the resin bed. Drain the methanol from the column and wash the  resin with 100 ml of water, stopping the flow as the liquid reaches the top of the resin bed. Allow the column to equilibrate or 10 minutes before use. Never allow the column to run dry.  5.3.2. Sample clean up  Transfer the extract (5.2) quantitatively to the top of the prepared Amberlite column (5.3.1) and elute, discarding the eluate. The rate of elution should not exceed 20 ml/min. Rinse the round-bottomed flask with 20 ml of hydrochlorid acid (3.17) and  use this to wash the resin column. Blow through any remaining acid solution with a stream of air. Discard the washings. Add 100 ml of methanol (3.8) to the column and allow 5 to 10 ml to elute, collecting the eluate in a 250 ml round-bottomed flask.  Leave the remaining methanol for 10 minutes to equilibrate with the resin and continue the elution at a rate not exceeding 20 ml/min, collecting the eluate in the same round-bottomed flask. Evaporate the methanol on the rotary film evaporator (4.2), the  temperature of the waterbath should not exceed 40 °C. Transfer the residue quantitatively into a 10 ml calibrated flask using the mobile phase (3.21). Make up to the mark with mobile phase and mix. An aliquot is filtered through a membrane filter (4.7).  Reserver this solution for the HPLC determination (5.4) 5.4. HPLC determination 5.4.1. Parameters  The following conditions are offered for guidance, other conditions may be used provided they yield equivalent results.   Liquid chromatographic column (4.4.1)  HPLC Mobile phase (3.21)  Flow rate: 1,5 to 2 ml/min.   Detection wavelength: 243 nm  Injection volume: 40 to 100 ml.   Check the stability of the chromatographic system, injecting the calibration solution (3.6.2) containing 3,0 mg/ml several times, until constant peak heights (or areas) and retention times are achieved.  5.4.2. Calibration graph  Inject each calibration solution (3.6.2) several times and measure the peak heights (areas) for each concentration. Plot a calibration graph using the mean peak heights or areas of the calibration solutions as the ordinates and the corresponding  concentrations in mg/ml as the abscissae.  5.4.3. Sample solution  Inject the sample extract (5.3.2) several times, using the same volume as taken for the calibration solutions and determine the mean peak height (area) of the halofuginone peaks.  6. Calculation of results  Determine the concentration of the sample solution in mg/ml, from the mean height (area) of the halofuginone peaks of the sample solution by reference to the calibration graph (5.4.2).   The content of halofuginone w (mg/kg) of the sample is given by the following formula:   w = c × 10 m  in which:   - c: halofuginone concentration of the sample solution in mg/ml,   - m: mass of the test portion in grams.  7. Validation of the results 7.1. Identity  The identity of the analyte can be confirmed by co-chromatography, or by using a diode-array detector by which the spectra of the sample extract and the calibration solution (3.6.2) containing 6,0 mg/ml are compared.  7.1.1. Co-chromatography  A sample extract is fortified by addition of an appropriate amount of a calibration solution (3.6.2). The amount of added halofuginone should be similar to the estimated amount of halofuginone found in the sample extract.   Only the height of the halofuginone peak should be enhanced after taking into account both the amount added and the dilution of the extract. The peak width, at half of its maximum height, must be within ± 10 % of the original width.  7.1.2. Diode-array detection  The results are evaluated according to the following criteria:   (a) the wavelength of maximum asbsorption of the sample and of the standard spectra, recorded at the peak apex on the chromatogram, must be the same within a margin determined by the resolving power of the detection system. For diode-array detection,  this is typically within ± 2 nm;   (b) between 225 and 300 nm, the sample and standard spectra recorded at the peak apex on the chromatogram, must not be different for those parts of the spectrum within the range 10 to 100 % or relative absorbance. This criterion is met when the same  maxima are present and at no observed point the deviation between the two spectra exceeds 15 % of the absorbance of the standard analyte;   (c) between 225 and 300 nm, the spectra of the upslope, apex and downslope of the peak produced by the sample extract must not be different from each other for those parts of the spectrum within the range 10 to 100 % of relative absorbance. This  criterion is met when the same maxima are present and when at all observed points the deviation between the spectra does not exceed 15 % of the absorbance of the spectrum of the apex.   If one of these criteria is not met the presence of the analyte has not been confirmed.  7.2. Repeatability  The difference between results of two parallel determinations carried out on the same sample must not exceed 0,5 mg/kg for halofuginone contents up to 3 mg/kg.  7.3. Recovery  For the fortified blank sample the recovery should be at least 80 %.  8. Results of a collaborative study  A collaborative study (1) was arranged in which three samples were analysed by eight laboratories.   Results    /* Tables: see OJ */      (1) The Analyst 108, 1983, pp. 1252 to 1256.


Avis juridique important

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31986L0525

Commission Directive 86/525/EEC of 27 October 1986 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 310 , 05/11/1986 P. 0019 - 0022 Finnish special edition: Chapter 3 Volume 22 P. 0035  Swedish special edition: Chapter 3 Volume 22 P. 0035

*****COMMISSION  DIRECTIVE  of 27 October 1986  amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs  (86/525/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 86/403/EEC (2), and in particular Article 7 thereof,  Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes were consolidated by Commission Directive 85/429/EEC (3);  Whereas the use of certain additives hitherto authorized at national level has been widely tested; whereas the studies carried out and the experience gained indicate that these additives may be authorized throughout the Community for the uses specified;  Whereas the manufacture of pet foods requires the use of acidity regulators to modulate the pH of such feedingstuffs; whereas, therefore, this group of additives should be added to the Annexes to the Directive while specifying, on the basis of the intended use, which substances are authorized for use throughout the Community and which are to remain for the time being subject to national authorization;  Whereas it is appropriate to authorize at national level, for a limited period of time, the use of colouring matter 'Brilliant Blue FCF', for the identification of cereals used as feedingstuffs; whereas a decision on the authorization of this additive at Community level should be taken before the expiry of that period;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto.  Article 2  Member States shall, by 30 November 1987 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall immediately inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 27 October 1986.  For the Commission  Frans ANDRIESSEN  Vice-President  (1) OJ No L 270, 14. 12. 1970, p. 1.  (2) OJ No L 233, 20. 8. 1986, p. 16.  (3) OJ No L 245, 12. 9. 1985, p. 1.  ANNEX  1. In Annex I:  (a) in A. Antibiotics, against item No E 715 'Avoparcin', the particulars relating to cattle for fattening are replaced by the following:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 //  //  //  / / Cattle   for fattening   // -   // 15   // 30   // Indicate in the instructions for use: "for supplementary feedingstuffs the maximum dose in the daily ration must not exceed: - for 100 kg bodyweight: 103 mg - above 100 kg: add 4,3 mg for each additional 10 kg bodyweight."'   //    //   //   //   //   //  //   //  (b) In D. Coccidiostats and other medicinal substances, the following item is added:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 // E 768  // Nicarbazin   // Equimolecular complex of 1,3-bis (4-nitro- phenyl) urea and 4,6-dimethyl pyrimidine-2-ol  // Chickens for fattening  // 4 weeks   // 100   // 125   // Use prohibited at least 9 days before slaughter'   //    //   //   //   //   //  //   // (c) Group M 'Acidity regulators' and the following items are added:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 // E 170  // Calcium carbonate   //   //   //   //   //   //   // 296  // DL- and L-Malic acid   //   //   //   //   //   //   // -  // Ammonium dihydrogen orthophosphate   //   //   //   //  //   //   // -   // di Ammonium hydrogen orthophosphate   //  //   //   //   //   //   // E 339 (i)   // Sodium dihydrogen orthophosphate   //   //   //   //   //   //   // E 339 (ii)  // di Sodium hydrogen orthophosphate   //   //   //   //   //  //   // E 339 (iii)   // tri Sodium orthophosphate   //   //  //   //   //   //   // E 340 (i)   // Potassium dihydrogen orthophosphate   //   //   //   //   //   //   // E 340 (ii)  // di Potassium hydrogen orthophosphate   //   //   //   //  //   //   // E 340 (iii)   // tri Potassium orthophosphate  //   //   //   //   //   //   // E 341 (i)   // Calcium tetrahydrogen diorthophosphate   //   //   //   //   //   //  // E 341 (ii)   // Calcium hydrogen orthophosphate   //   //  //   //   //   //   // 350 (i)   // Sodium malate (salt of DL- or L-Malic Acid)   //   //   //   //   //   //   // E 450 (a) (i)   // di Sodium dihydrogen diphosphate   //   //   //   //  //   //   // E 450 (a) (iii)   // tetra Sodium diphosphate  //   // Dogs, cats'   //   //   //   //   // E 450 (a) (iv)  // tetra Potassium diphosphate   //   //   //   //   //   //  // E 450 (b) (i)   // penta Sodium triphosphate   //   //  //   //   //   //   // E 450 (b) (ii)   // penta Potassium triphosphate   //   //   //   //   //   //   // 500 (i)  // Sodium carbonate   //   //   //   //   //   //   // 500 (ii)   // Sodium hydrogen carbonate   //   //   //   //   //  //   // 500 (iii)   // Sodium sesquicarbonate   //   //   //  //   //   //   // 501 (ii)   // Potassium hydrogen carbonate  //   //   //   //   //   //   // 503 (i)   // Ammonium carbonate   //   //   //   //   //   //   // 503 (ii)  // Ammonium hydrogen carbonate   //   //   //   //   //   //  // 507   // Hydrochloric acid   //   //   //   //   //   //  // 510   // Ammonium chloride   //   //   //   //   //   //  // 513   // Sulphuric acid   //   //   //   //   //   //  // 524   // Sodium hydroxide   //   //   //   //   //   //  // 529   // Calcium oxide   //   //   //   //   //   //  // 540   // di calcium diphosphate   //   //   //   //   //  //   //    //   //   //   //   //   //   //  2. In Annex II:  (a) in F. Colouring matters including pigments, the following item is hereby added:  1.2.3.4.5.6.7.8.9 //  //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions  // Period of authorization 1.2.3.4.5.6,7.8.9 //  //  //  //  //  //  //  //  //  //  //  // //  // mg/kg  of complete feedingstuffs  //  //  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8.9 // 4  // Brilliant Blue FCF  // Disodium salt of 4,4-(N-ethyl-p-sulphoben-  zyl-amino)-phenyl (2-sulphoniphenyl)-methy- lene)-(1-(N-ethyl-N-sulphobenzyl) D 2,5-) cyclohexadieneimine  // All species or categories of animals  // -   // -   // -   // Permitted in animal feedingstuffs only in products processed from denatured cereals   // 30. 11. 1987'   //    //   //   //   //   //   //   //  //  (b) in I. Trace elements, the date 3.12.1986 is added in the column headed 'Period of authorization' for Item No 1 'Molybdenum' and Item No 2 'Selenium';  (c) Group M. 'Acidity regulators' and the following items are added:  1.2.3.4.5.6.7.8.9 //  //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions  // Period of authorization 1.2.3.4.5.6,7.8.9 //  //  //  //  //  //  //  //  //  //  //  // //  // mg/kg  of complete feedingstuffs  //  //  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8.9 // E 170   // Calcium carbonate   //   //   //   //   //   //  // 30. 11. 1987   // 296   // DL- and L-Malic acid   //   //  //   //   //   //   // 30. 11. 1987   // -   // Ammonium dihydrogen orthophosphate   //   //   //   //   //   //  // 30. 11. 1987   // -   // di Ammonium hydrogen orthophosphate   //   //   //   //   //   //   // 30. 11. 1987  // E 339 (i)   // Sodium dihydrogen orthophosphate   //   //  //   //   //   //   // 30. 11. 1987   // E 339 (ii)   // di Sodium hydrogen orthophosphate   //   //   //   //   //   //  // 30. 11. 1987   // E 339 (iii)   // tri Sodium orthophosphate   //   //   //   //   //   //   // 30. 11. 1987  // E 340 (i)   // Potassium dihydrogen orthophosphate   //  //   //   //   //   //   // 30. 11. 1987   // E 340 (ii)  // di Potassium hydrogen orthophosphate   //   //   //   //  //   //   // 30. 11. 1987   // E 340 (iii)   // tri Potassium orthophosphate   //   //   //   //   //   //   // 30. 11. 1987  // E 341 (i)   // Calcium tetrahydrogen diorthophosphate   //  //   //   //   //   //   // 30. 11. 1987   // E 341 (ii)  // Calcium hydrogen orthophosphate   //   //   //   //   //  //   // 30. 11. 1987   // 350 (i)   // Sodium malate (salt of DL- or L-Malic Acid)   //   // All pets with the exception of cats and dogs  //  //  //  //  // 30. 11. 1987   // E 450 (a) (i)   // di Sodium dihydrogen diphosphate   //   //   //   //  //   //   // 30. 11. 1987   // E 450 (a) (iii)   // tetra Sodium diphosphate   //   //   //   //   //   //   // 30. 11. 1987   // E 450 (a) (iv)   // tetra Potassium diphosphate   //  //   //   //   //   //   // 30. 11. 1987   // E 450 (b) (i)  // penta Sodium triphosphate   //   //   //   //   //   //  // 30. 11. 1987   // E 450 (b) (ii)   // penta Potassium triphosphate   //   //   //   //   //   //   // 30. 11. 1987  // 500 (i)   // Sodium carbonate   //   //   //   //   //  //   // 30. 11. 1987   // 500 (ii)   // Sodium hydrogen carbonate   //   //   //   //   //   //   // 30. 11. 1987  // 500 (iii)   // Sodium sesquicarbonate   //   //   //   //  //   //   // 30. 11. 1987   // 501 (ii)   // Potassium hydrogen carbonate   //   //   //   //   //   //   // 30. 11. 1987   // 503 (i)   // Ammonium carbonate   //   //   //   //  //   //   // 30. 11. 1987   // 503 (ii)   // Ammonium hydrogen carbonate   //   //   //   //   //   //   // 30. 11. 1987  // 507   // Hydrochloric acid   //   //   //   //   //   //  // 30. 11. 1987   // 510   // Ammonium chloride   //   //  //   //   //   //   // 30. 11. 1987   // 513   // Sulphuric acid   //   //   //   //   //   //   // 30. 11. 1987   // 524  // Sodium hydroxide   //   //   //   //   //   //   // 30. 11. 1987   // 529   // Calcium oxide   //   //   //   //   //   //  // 30. 11. 1987   // 540   // di calcium diphosphate   //  //   //   //   //   //   // 30. 11. 1987'   //    //   //  //   //   //   //   //   //CALCIUM OXIDE   //  //  //  //  //  //  30 . 11 . 1987  540  DI CALCIUM DIPHOSPHATE   //  //  //  //  //  //  30 . 11 . 1987'   //   //  //  //  //  //  //  //  //


title: Directive (EU) 2015/254 of the European Parliament and of the Council of 11 February 2015 repealing Council Directive 93/5/EEC on assistance to the Commission and cooperation by the Member States in the scientific examination of questions relating to food  Text with EEA relevance

text:
               18.2.2015

               EN

               Official Journal of the European Union

               L 43/1

         DIRECTIVE (EU) 2015/254 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 11 February 2015
   repealing Council Directive 93/5/EEC on assistance to the Commission and cooperation by the Member States in the scientific examination of questions relating to food
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national parliaments,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the ordinary legislative procedure (2),
   Whereas:

               (1)

               In the framework of the Regulatory Fitness and Performance Programme (REFIT), the Commission is committed to achieving a simple, clear, stable and predictable regulatory framework for businesses, workers and citizens.

               (2)

               Council Directive 93/5/EEC (3) aims to ensure the smooth running of the Scientific Committee on Food by promoting the scientific support from the Member States to that Committee and by organising cooperation with the relevant national bodies on scientific issues regarding the safety of foodstuffs.

               (3)

               Pursuant to Regulation (EC) No 178/2002 of the European Parliament and of the Council (4), the tasks of the Scientific Committee on Food referred to in Directive 93/5/EEC have been transferred to the European Food Safety Authority (EFSA), and those tasks are currently provided for by Regulation (EC) No 178/2002.

               (4)

               Commission Decision 97/579/EC (5) which established the Scientific Committee on Food has been repealed by Commission Decision 2004/210/EC (6).

               (5)

               Pursuant to Regulation (EC) No 178/2002, EFSA has also become the competent body to promote scientific cooperation with the Member States and relevant national bodies operating in the fields falling within EFSA's mission. In particular, Article 22 of Regulation (EC) No 178/2002 provides that EFSA is to act in close cooperation with the competent bodies in the Member States and that the Member States are to cooperate with EFSA to ensure the accomplishment of its mission.

               (6)

               Directive 93/5/EEC has therefore become obsolete and should be repealed,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 93/5/EEC is repealed.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 February 2016. They shall immediately inform the Commission thereof.
   When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Strasbourg, 11 February 2015.

            For the European Parliament

            The President

         M. SCHULZ

            For the Council

            The President

         Z. KALNIŅA-LUKAŠEVICA

      (1)  OJ C 451, 16.12.2014, p. 157.

      (2)  Position of the European Parliament of 16 December 2014 (not yet published in the Official Journal) and Decision of the Council of 27 January 2015.

      (3)  Council Directive 93/5/EEC of 25 February 1993 on assistance to the Commission and cooperation by the Member States in the scientific examination of questions relating to food (OJ L 52, 4.3.1993, p. 18).

      (4)  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 the procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

      (5)  Commission Decision 97/579/EC of 23 July 1997 setting up Scientific Committees in the field of consumer health and food safety (OJ L 237, 28.8.1997, p. 18).

      (6)  Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment (OJ L 66, 4.3.2004, p. 45).