14.10.2003 Official Journal of the European Union L 262/17 DIRECTIVE 2003/74/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003 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 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Com- munity, 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 (), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (), Whereas: (1) Article 3(a) of Directive 96/22[EC (*) 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 provi- sions 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 adminis- tered in compliance with the provisions and require- ments 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. (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) (°) 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) (%) as (f) OJ C 337 E, 28.11.2000 and OJ C 180 E, 26.6.2001, p. 190. () O] C 14, 16.1.2001, p. 47. (*) Opinion of the European Parliament of 1 February 2001 (O] C 267, 21.9.2001, p. 53), Council Common Position of 20 February 2003 (O] C 90 E, 15.4.2003, p. 1) and Decision of the European Parlia- ment of 2 July 2003 (not yet published in the Official Journal). Council Decision of 22 July 2003. () OJL 125, 23.5.1996, p. 3. () WT/DS26/R/USA and WT/DS48/R/CAN (panel reports), and AB- 1997-4 (appellate body report). () OJ L 336, 23.12.1994, p. 40. interpreted by the appellate body in the Hormones case, of the six hormonal substances (oestradiol 17, testos- terone, 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 USA, Canada and other third countries, which authorise the use of these six hormones for animal growth promotion, and published an open call for documentation () 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 (SCVPH) 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 prop- erties of hormones and the epidemiological findings, a risk to the consumer has been identified with different levels of conclusive evidence for the six hormones evalu- ated. Secondly, for the six hormones endocrine, develop- mental, immunological, neurobiological, immunotoxic, genotoxic and carcinogenic effects could be envisaged and, of the various susceptible risk groups, prepubertal children constitute 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 17§, with the aim of promoting growth, the SCVPH 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 do not make it possible to give a quantitative estimate of the risk. () O] C 56, 26.2.1999, p. 17.