Common position (EC) No 12/2003

adopted by the Council on 20 February 2003

with a view to the adoption Directive 2003/.../EC of the European Parliament and of the Council of...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

(2003/C 90 E/01)

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(1),

Having regard to the opinion of the Economic and Social Committee(2),

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

(1) Article 3(a) of Directive 96/22/EC(4) requires Member States to prohibit the administration to farm animals of substances having, inter alia, an oestrogenic, androgenic or gestagenic action. Nevertheless administration of those substances to farm animals may be authorised but only if they are used for therapeutic purposes or zootechnical treatment, in accordance with the provisions of Articles 4, 5 and 7 of that Directive.

(2) Article 11(2) of Directive 96/22/EC requires Member States to prohibit the importation from third countries of farm or aquaculture animals to which substances or products referred to in Article 3(a) of that Directive have been administered, unless those products were administered in compliance with the provisions and requirements laid down in Articles 4, 5 and 7 thereof as well as of meat or products obtained from animals the importation of which is prohibited under Article 3(a) thereof.

(3) In the light of the results of a dispute settlement case brought before the World Trade Organisation (WTO) by the United States of America and by Canada (the Hormones Case)(5) and recommendations made in that respect by the WTO Dispute Settlement Body on 13 February 1998, the Commission immediately initiated a complementary risk assessment, in accordance with the requirements of the Agreement on the Application of Sanitary and Phytosanitary Measures (WTO-GATT 1994)(6) as interpreted by the Appellate Body in the Hormones Case, of the six hormonal substances (oestradiol 17β, testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate) whose administration for animal growth promotion purposes is prohibited by Directive 96/22/EC.

(4) In parallel, the Commission initiated and funded a number of specific scientific studies and research projects on these six hormones in order to obtain as much as possible of the missing scientific information, as identified in the interpretations and findings of the WTO panel and Appellate Body reports in the Hormones Case. Moreover, the Commission addressed specific requests to the United States of America, Canada and other third countries, which authorise the use of these six hormones for animal growth promotion, and published an open call for documentation(7) requesting any interested party, including the industry, to provide any relevant and recent scientific data and information in their possession to be taken into account in the complementary risk assessment.

(5) On 30 April 1999, as requested by the Commission, the Scientific Committee on Veterinary Measures relating to Public Health (SCVMPH) issued an opinion concerning the assessment of potential adverse effects to human health from hormone residues in bovine meat and meat products. The major conclusions of that opinion were, first, that, as concerns excess intake of hormone residues and their metabolites, and in view of the intrinsic properties of hormones and the epidemiological findings, a risk to the consumer has been identified with different levels of conclusive evidence for the six hormones evaluated. Second, for the six hormones endocrine, developmental, immunological, neurobiological, immunotoxic, genotoxic and carcinogenic effects could be envisaged and, of the various susceptible risk groups, prepubertal children is the group of greatest concern and, third, in view of the intrinsic properties of the hormones and taking into account epidemiological findings, no threshold levels and, therefore, no Acceptable Daily Intake (ADI) can be established for any of the six hormones evaluated when they are administered to bovine animals for growth promotion purposes.

(6) As regards, in particular, the use of oestradiol 17β, with the aim of promoting growth, the SCVMPH assessment is that a substantial body of recent evidence suggests that it has to be considered as a complete carcinogen, as it exerts both tumour initiating and tumour promoting effects and that the data currently available does not make it possible to give a quantitative estimate of the risk.

(7) As regards the other five hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate), the SCVMPH assessment is that, in spite of the individual toxicological and epidemiological data available, which were taken into account, the current state of knowledge does not make it possible to give a quantitative estimate of the risk to consumers.

(8) Subsequent to the opinion of the SCVMPH of 30 April 1999, new and more recent scientific information under consideration on some of the six hormones was made available to the Commission from the United Kingdom's Veterinary Products Committee, in October 1999, the Committee on Veterinary Medicinal Products of the European Community (CVM), in December 1999, and the Joint FAO/WHO Expert Committee on Food Additives (JECFA), in February 2000. The CVM has noted in particular that oestradiol 17β has a carcinogenic effect only after prolonged exposure and at levels which are considerably higher than those needed for a physiological (oestrogenic) response. All this latest scientific information was brought to the attention of the SCVMPH, which reviewed it and, on 3 May 2000, concluded that it did not provide convincing data and arguments requiring revision of the conclusions drawn in its opinion of 30 April 1999. The SCVMPH confirmed in its opinion of 10 April 2002 its previous opinion's validity, after revising it in the light of the most recent scientific data.

(9) As regards, in particular, oestradiol 17β, this substance can potentially be used in all farm animals and residue intake for all segments of the human population and in particular the susceptible groups at high risk can therefore be especially relevant. Avoiding such intake is important to safeguard human health. Furthermore, the routine use of the above substances for animal growth promotion purposes is likely to lead to increased concentration of those substances in the environment.

(10) Taking into account the results of the risk assessment and all other available pertinent information, it has to be concluded that, in order to achieve the chosen level of protection in the Community from the risks posed, in particular to human health, by the routine use of these hormones for growth promotion and the consumption of residues found in meat derived from animals to which these hormones had been administered for growth promotion, it is necessary to maintain the permanent prohibition laid down in Directive 96/22/EC on oestradiol 17β and to continue provisionally to apply the prohibition to the other five hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate). Furthermore, according to Article 7 of 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(8), the provisional prohibition of these five hormones should apply while the Community seeks more complete scientific information from any source, which could shed light and clarify the gaps in the present state of knowledge of these substances.

(11) However, the use of certain of the above substances, where this is necessary, for therapeutic purposes or zootechnical treatment may continue to be authorised as it is not likely to constitute a hazard for public health due to the nature and the limited duration of the treatments, the limited quantities administered and the strict conditions laid down in Directive 96/22/EC in order to prevent any possible misuse.

(12) However, in the light of the existing information it is appropriate to limit as far as reasonably achievable the exposure to oestradiol 17β and only authorise those treatments for which no viable effective alternatives exist and which are not likely to present an unacceptable risk to public health. In general, there are alternative treatments or strategies available to replace most of the uses of oestradiol 17β for therapeutic or zootechnical purposes. Nonetheless, studies appear to show that at present no viable effective alternatives exist in all the Member States for certain treatments which are currently authorised (foetus maceration or mummification, pyometra in cattle and oestrus induction in cattle, horses, sheep or goats). The use of oestradiol 17β for such treatments does not seem to pose an unacceptable risk if appropriate measures are taken to avoid any abusive use. It therefore appears necessary to maintain the possibility of authorising the treatments mentioned above under strict and verifiable conditions so as to prevent any possible misuse and any unacceptable risk for public health. It is necessary to review within a given time the provisions concerning treatments of farm animals with oestradiol 17β.

(13) The proposed amendments to Directive 96/22/EC are necessary to achieve the chosen level of health protection from the residues in meat of farm animals treated with these hormones for growth promotion purposes, whilst respecting the general principles of food law set out in Regulation (EC) No 178/2002 and the international obligations of the Community. Moreover, there is no other means that is reasonably available at present, taking into account technical and economic feasibility, which is significantly less restrictive on trade and can achieve equally effectively the chosen level of health protection. In addition, minor drafting amendments are equally necessary in particular in view of the replacement of a number of Directives by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(9),

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 96/22/EC is hereby amended as follows:

1. Articles 2 and 3 shall be replaced by the following:

"Article 2

Member States shall prohibit:

(a) the placing on the market of the substances listed in Annex II, List A for administering to animals of all species;

(b) the placing on the market of the substances listed in Annex II, List B of this Directive for administering to animals, the flesh and products of which are intended for human consumption, for purposes other than those provided for in point 2 of Article 4 and in Article 5a.

Article 3

Member States shall prohibit, for substances listed in Annex II, and shall provisionally prohibit, for substances listed in Annex III:

(a) the administering of those substances to farm or aquaculture animals, by any means whatsoever;

(b) the holding, except under official control, of animals referred to in point (a) on a farm, the placing on the market or slaughter for human consumption of farm animals which contain the substances referred to in Annex II and Annex III or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with Articles 4, 5 or 5a;

(c) the placing on the market for human consumption of aquaculture animals to which substances referred to above have been administered and of processed products derived from such animals;

(d) the placing on the market of meat from animals referred to in (b);

(e) the processing of the meat referred to in (d).";

2. in Article 4, point 1, the words "oestradiol 17β" shall be deleted;

3. in Article 5, first paragraph, the first sentence shall be replaced by the following:"Notwithstanding Article 3(a) and without prejudice to Article 2, Member States may authorise the administering to farm animals, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic (other than oestradiol 17β and its ester-like derivatives), androgenic or gestagenic action which are authorised in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(10).";

4. the following Article shall be added:

"Article 5a

1. Notwithstanding Article 3(a) and without prejudice to Article 2, Member States may authorise the administering to farm animals of veterinary medicinal products containing oestradiol 17β or its ester-like derivatives for:

- the treatment of foetus maceration or mummification in cattle,

- the treatment of pyometra in cattle, or

- oestrus induction in cattle, horses, sheep or goats,

in accordance with Directive 2001/82/EC.

The treatment must be carried out by the veterinarian himself on farm animals which have been clearly identified. This treatment must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be that provided for in Directive 2001/82/EC:

- type of product administered,

- the nature of the treatment,

- the date of treatment,

- the identity of the animals treated,

- the date of expiry of the withdrawal period.

The register must be made available to the competent authority at its request.

Stockfarmers shall be prohibited from holding on their farms veterinary medicinal products containing oestradiol 17β or its ester-like derivatives.";

5. Article 6(1) shall be replaced by the following:

"1. Hormonal products and beta-agonists the administration of which to farm animals is authorised in accordance with Articles 4, 5 or 5a must meet the requirements of Directive 2001/82/EC.";

6. Article 7(1), first subparagraph, shall be replaced by the following:

"1. For the purpose of trade, Member States may authorise the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in Articles 4, 5 or 5a and may authorise the affixing of the Community stamp to meat from such animals where the conditions laid down in Articles 4, 5 or 5a and the withdrawal periods provided for in the authorisation to place on the market are complied with.";

7. Article 8 shall be amended as follows:

(a) point 1 shall be replaced by the following:

"1. at the time of the import, manufacture, storage, distribution, sale and use of the substances referred to in Articles 2 and 3, their possession is restricted to the persons authorised by national legislation in accordance with Article 68 of Directive 2001/82/EC.";

(b) in point 2(a), the words "Article 2" shall be replaced by "Articles 2 and 3";

(c) in point 2(d), the words "in Articles 4 and 5" shall be replaced by "in Articles 4, 5 and 5a";

(d) footnote 2 shall be deleted and footnote 3 shall become footnote 2;

8. Article 11(2)(a) shall be amended as follows:

(a) in point (i), the words "Article 2(a)" shall be replaced by "Annex II, List A";

(b) point (ii) shall be replaced by the following:

"(ii) to which substances referred to in Annex II, List B and Annex III have been administered, unless those substances were administered in compliance with the provisions and requirements laid down in Articles 4, 5, 5a and 7 and the withdrawal periods allowed in international recommendations have been observed;";

9. the following Article shall be added:

"Article 11a

The Commission shall present within two years from(11) to the European Parliament and the Council a report on the availability of alternative veterinary medicinal products to those containing oestradiol 17β or its ester-like derivatives and present to them the following year any necessary proposals intending to replace in due time these substances.

Likewise, 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 timely presentation to the European Parliament and the Council of any necessary proposals.";

10. the following Article shall be added:

"Article 14a

Notwithstanding Articles 3 and 5a, and without prejudice to Article 2, farm animals for which it can be certified that they have been administered oestradiol 17β or its ester-like derivatives for therapeutic or zootechnical purposes prior to...2002(12) shall be subject to the same provisions as those laid down for the substances authorised in accordance with Article 4(1) as regards therapeutic use and Article 5 as regards zootechnical use.";

11. all references to "Directive 81/851/EEC" and "Directive 81/852/EEC" shall be construed as references to "Directive 2001/82/EC";

12. the Annex to Directive 96/22/EC shall become "Annex I", and Annexes II and III in the Annex to this Directive shall be added.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by...(13) at the latest. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a 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 day of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at...

For the European Parliament

The President

For the Council

The President

(1) OJ C 337 E, 28.11.2000, p. 163 and OJ C 180 E, 26.6.2001, p. 190.

(2) OJ C 14, 16.1.2001, p. 47.

(3) Opinion of the European Parliament of 1 February 2001 (OJ C 267, 21.9.2001, p. 53), Council Common Position of 20 February 2003 and Decision of the European Parliament of...(not yet published in the Official Journal).

(4) OJ L 125, 23.5.1996, p. 3.

(5) WT/DS26/R/USA and WT/DS48/R/CAN (panel reports), and AB-1997-4 (Appellate Body report).

(6) OJ L 336, 23.12.1994, p. 40.

(7) OJ C 56, 26.2.1999, p. 17.

(8) OJ L 31, 1.2.2002, p. 1.

(9) OJ L 311, 28.11.2001, p. 1.

(10) OJ L 311, 28.11.2001, p. 1.

(11) Date of entry into force of this Directive.

(12) Date referred to in the first subparagraph of Article 2(1).

(13) 12 months after the date of entry into force of this Directive.

ANNEX

"ANNEX II

List of prohibited substances:

List A:

- thyrostatic substances,

- stilbenes, stilbene derivatives, their salts and esters;

List B:

- oestradiol 17β and its ester-like derivatives,

- beta-agonists.

ANNEX III

List of provisionally prohibited substances:

Substances having oestrogenic (other than oestradiol 17β and its ester-like derivatives), androgenic or gestagenic action."

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

On 3 July 2000 the Commission submitted its original proposal(1), which it subsequently amended on 6 March 2001(2).

The European Parliament delivered its opinion on that proposal at first reading on 1 February 2001(3).

The Economic and Social Committee delivered an opinion on 19 October 2000(4).

The Committee of the Regions decided not to deliver an opinion.

After examining the opinions delivered, the Council adopted a Common Position on 20 February 2003.

II. OBJECTIVE OF THE PROPOSAL

The aim of the proposed directive is to ensure that the Community rules concerning the use of hormones in stockfarming are in accordance with the general principles of food law set out in regulation (EC) No 178/2002. In particular it aims at ensuring that the high level of health protection mandated by article 152(1) of the Treaty is attained, in conformity with the international obligations of the Community, through measures based on a comprehensive assessment of the available scientific evidence, or, as far as the available evidence on the extent of the harmful effects of certain substances is incomplete, on the precautionary principle.

In order to reach this aim the proposed directive updates Directive 96/22/EC in the light of extensive risk assessments of the available scientific information performed by the Scientific Committee on Veterinary Measures relating to Public Health (SCVMPH) and other pertinent information from relevant sources.

III. ANALYSIS OF THE COMMON POSITION

There is no difference of opinion between the Council, the European Parliament and the Commission regarding the essential elements of the proposed directive and in particular on the need for maintaining a prohibition on the use of oestradiol 17β and its ester-like derivatives for growth promotion purposes and to introduce a temporary precautionary prohibition on the use of other hormones while additional scientific information, necessary for a fuller assessment of the risk, is gathered.

In deciding such measures the Council has taken into account the latest scientific evidence and risk assessments, in particular the opinion of the SCVMPH of April 2002, together with other possible consequences, in particular environmental, of the large scale use of hormones in stockfarming. The recitals of the proposed directive have been modified accordingly.

Contrary to the Commission's proposal, but in accordance with amendments 4, 5, 6, 7, 9, 12, 13 and 14, which have been followed in substance even if using a different drafting, the Council considered preferable to let Parliament and the Council take future risk management decisions concerning the updates of the directive's provisions in the light of the new evidence which the Commission is required to gather taking into account recent scientific data from all possible sources and present to them.

The Council, in agreement with the Commission and Parliament, has decided to maintain the use of certain of the substances, where this is strictly necessary, for therapeutic purposes or zootechnical treatment as this is not likely to constitute an unacceptable hazard for public health due to the nature and the limited duration of the treatments, the limited quantities administered and the strict conditions under which their administration can take place, laid down in Directive 96/22/EC in order to prevent any possible misuse. The Council has, however, considered appropriate, in the light of the existing information to limit as far as reasonably achievable the exposure to oestradiol 17β and only authorise those very few treatments (foetus maceration or mummification, pyometra in cattle and oestrus induction in cattle, horses, sheep or goats) for which no viable and effective alternatives seem presently to be available. Such treatments are not likely to present an unacceptable risk to public health, especially in the light of the new very stringent conditions required to be taken to avoid any possible abusive use. The Council has equally provided for a timely review of the provisions concerning treatments of farm animals with oestradiol 17β.

The Council incorporated amendments 8 and 10 which present useful clarifications but did not incorporate amendments 1, 2, 3, 10 et 11 the content of which is already largely reflected in the proposed directive which the Council, like the Commission, considered would have been made redundant by those additions.

For the sake of clarity the Council added some minor drafting improvements to Directive 96/22/EC, in particular in view of the replacement of a number of Directives by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(5).

IV. CONCLUSIONS

The Council feels that the fact that it has to a very large extent taken account of the European Parliament's position ought to lead to an early adoption of the Directive.

(1) OJ C 337 E, 28.11.2000, p. 163.

(2) OJ C 180 E, 26.6.2001, p. 190.

(3) OJ C 267, 21.9.2001, p. 53.

(4) OJ C 14, 16.1.2001, p. 47.

(5) OJ L 311, 28.11.2001, p. 1.