Opinion of the Economic and Social Committee on the "Proposal for a European Parliament and Council Directive 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"

(2001/C 14/11)

On 13 July 2000 the Council, acting under Article 152 of the EC Treaty, decided to consult the Economic and Social Committee on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was instructed to prepare the Committee's work on this subject, adopted its opinion on 6 October 2000. The rapporteur was Mr David Evans.

At its 376th plenary session, held on 19 October 2000 the Committee adopted the following opinion by 93 votes in favour with 1 abstention.

1. The Commission Proposal

1.1. Council Directive 96/22/EC requires Member States to prohibit the use of oestrogenic, andropenic and gestagenic substance on farm animals, except for "therapeutic purposes and zootechnical treatment(1)". Imports from third countries of animals or animal products which have been treated with these substances for growth promotion purposes are also prohibited.

1.2. In February 1998 the WTO ruled that the ban on import was not compatible with EU rules. The Commission therefore initiated a complementary risk assessment in accordance with the WTO Agreement on the application of Sanitary and Phytosanitary measures. Six hormonal substances were subject to this assessment: oestradiol 17 ß, testosterone, progesterone, trenbolone acetate, zeranol, melengestrol acetate.

1.3. On 30 April 1999 the Scientific Committee on Veterinary measures relating to Public Health (SCVPH) issued an opinion concerning the assessment of potential adverse effects on human health of hormone residues in beef. The major conclusions 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 had 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 were the group of greatest concern. 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) could be established for any of the six hormones when administered to bovine animals for growth promotion purposes.

1.4. As regards oestradiol 17 the SCVPH considered there to be a substantial body of recent evidence suggesting 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 made it impossible to give a quantitative estimate of the risk.

1.5. Subsequent to this SCVPH opinion, further scientific information became available from the UK Veterinary Products Committee, the Committee on Veterinary Medical Products of the EC, and the Joint FAO/WHO Expert Committee on Food Additives. The SCVPH reviewed this further information and on 3 May 2000 concluded that it did not provide convincing data and arguments requiring revision of the conclusions drawn in the opinion of 30 April 1999.

1.5.1. Under existing provisions of Community law, the EMEA is required to examine requests by an interested manufacturer to establish a Maximum Residues Limits for veterinary medicinal products used for therapeutic or zootechnical purposes.

1.5.1.1. EMEA has evaluated oestradiol 17 ß upon the request of producers within the strict context of defined conditions of use, and concluded that it was not necessary to set an MRL for oestradiol 17 ß; for therapeutical purposes.

1.5.1.2. The SCVPH has examined the question in a much broader context and this explains the different conclusions.

1.5.1.3. The Commission proposal represents an approach based on risk management, which takes into account the alternatives of oestradiol 17 ß, the lack of possible control in case of misuse and the opinion of both scientific committees.

1.6. In the light of all the available scientific evidence, the opinions expressed by the responsible EU and other scientific advisory bodies, and the need to avoid any unnecessary risks to consumers, the Commission proposes:

1) to definitively ban the use of oestradiol 17 ß and its ester-like derivatives in farm animals and only to allow its administration to non-farm animals for therapeutic purposes;

2) to continue provisional ban on the use of the other five hormones until more complete scientific information becomes available. The use of those substances may however still be authorised for "therapeutical purposes and zootechnical treatment" under the conditions of Directive 96/22 EC.

1.7. This proposal will mean that imports of beef and beef products, from countries where oestradiol 17 ß and its ester-like derivatives can be legally used for therapeutical zootechnical purposes, will be subject to strict controls and monitoring which will mean that no imports are possible in some cases, if sufficient guarantees are not provided to the EU according to the provisions foreseen by Council Directive 96/23/EC(2).

2. WTO Implications

2.1. An important aspect of this new proposal concerns the continuing WTO dispute between the EU and the USA/Canada over the use of hormones in fattening cattle.

2.2. In 1996 the USA and Canada held formal consultations with the EU under the WTO dispute settlement mechanism regarding the EC ban on imports of meat treated with hormones. These talks led to the setting-up of WTO panels which in August 1997 delivered the opinion that the EC measures were not in conformity with WTO rules. The EU objected to these conclusions and asked that they be reviewed by the Appellate Body.

2.3. The Appellate Body reported in February 1998, arguing that although scientific studies submitted by the EU showed a general risk of cancer, they were not "sufficiently specific to the case in hand" to be relevant. The Appellate Body did however say that a WTO member:

- has the right to choose the level of health protection it deems appropriate;

- is not obliged to assess risk in a quantitative form in order to be able to take measures;

- is not obliged to follow majority and mainstream scientific views. Minority or divergent views can also be taken into account.

2.4. It also dealt with the issue of growth promotion hormones as against naturally-occurring hormones, pointed out that WTO rules permit members to take provisional measures when the scientific information is insufficient, and recommended the EU to bring its measures into conformity with its obligations under the SPS Agreement.

2.5. The EU was subsequently given until 13 May 1999 to implement these recommendations. A few days after this date, both the USA and Canada sought WTO authorisation of counter measures and this was implemented in July 1999.

3. Comments

3.1. The proposed directive is fully supported by the latest scientific information available, is based on risk assessment in accordance with the SPS provisions and is intended to regularise the EU's position under the WTO rules by applying a total ban on 17 ß oesteradiol, and provisional bans on the other substances. The Committee fully supports the Commission proposal.

3.2. However, the Committee would like to acquire supporting evidence for the Commission's decision to allow the administration of oestradiol 17 ß to non-farm animals, like pets for example. In this context, and with regard to recital 12 of the proposal, the Committee understands that Commission's intention is to give priority to the control of hormones in farm animals and to consider pet animals at a later stage. The current text is ambiguous and allows for misleading conclusions or misuse.

3.3. Our overriding concern in looking at this proposal must be with the safety of the EU consumer and particularly the more vulnerable groups identified in the latest scientific information. The proposal depends on a balanced assessment of the risks involved in the use of these substances, both for therapeutic and zootechnical purposes, where there are animal health and welfare issues involved, as well as potential economic ones, and for growth promotion purposes where the motivation is purely economic. In making this proposal, the Commission and its advisory bodies have had to take into account both the complex scientific data and changing practices in animal husbandry, not only in the EU but in third countries. Research on these matters is continuous and the Committee emphasises the need for the Commission to keep the legislation under review in the light of further knowledge.

3.4. There are important international trade implications, and we are concerned about the effectiveness of the EU controls, which inevitably are very complex, over imports from third countries where these substances may be used, for whatever the stated purpose. The Committee therefore calls on the Commission to examine the systems which apply to the verification and control over meat imported from third countries, and to ensure that these are fully consistent with the priority which must be given to consumer safety.

3.5. As regards oestradiol 17 ß, this substance can potentially be used in all farm animals and residue intake can be relevant for all segments of the human population, and especially the groups at high risk (such as very young children). Avoiding such intake is important to safeguard human health. It is relevant that the residues resulting from the use of this substance cannot be detected through the routine analytical methods at present available. It is also relevant that there are alternatives available, though these may be subject to different controls in the different EU Member States. The Committee fully supports therefore the Commission proposal not to allow the use of this substance.

3.6. As regards the other five substances the Committee also supports the Commission proposal, but considers there is a need for further examination of the balance of risks and benefits involved in their use. In particular, while recognising that zootechnical use (which is primarily concerned with the synchronising of oestrus for insemination purposes) is subject to licensing and scrutiny, we believe it should be subject to further consideration. We question whether:

- this use is consistent with the precautionary principle;

- imports from third countries where these substances are used for therapeutic or zootechnical treatment are subject to harmonised and systematic controls;

- across the EU the administration of such substances is properly registered at the farm records so as to allow for monitoring by the competent authorities; in addition, we wonder whether appropriate controls take place and, if not, we strongly recommend that the Commission takes the necessary measures to this end.

Brussels, 19 October 2000.

The President

of the Economic and Social Committee

Göke Frerichs

(1) Zootechnical treatment shall mean the administering to an individual farm animal of any substance under Article 5 of this Directive for synchronising oestrus and preparing donors and recipients for the implantation of embryos, after examination of the animal by a veterinarian or, in accordance with the second paragraph of Article 5 under his responsibility (see Directive 96/22/EC Article 1 c).

(2) OJ L 125, 23.5.1996, p. 10-32.