(1) Cases T-13/99 Pfizer and T-70/99 Alpharma (nyp in the ECR, both judgments are available at http://curia.eu.int).Google Scholar

(2) Given the limited scope of this study, we will focus on these judgments’ contribution to the European Court of Justice and Court of First Instance's case-law on the precautionary principle. It should however be noted that there are other points of interest in these judgments, particularly with regard to admissibility and to the application of the proportionality principle.Google Scholar

(3) Regulation amending, as regards withdrawal of the authorization of certain antibiotics, Directive 70/524 (OJ 1998 L 351, p. 4).Google Scholar

(4) OJ, English Special Edition 1970 (III), p. 840. This directive lays down Community rules concerning the authorization of additives for incorporation in feeding-stuffs, and is founded on Article 37 EC.Google Scholar

(5) “(T)he prohibition on the use of (…) bacitracin zinc (and) virginiamycin (…) ought to be perceived as an interim protective measure taken as a precaution, which could be reconsidered in the light of the investigations which will have been carried out (…)” (Recital 29 of Regulation 2821/98).Google Scholar

(6) Until 31 December 1998, Sweden was authorized, under Annex XV, Title VII, point E1(4) of its Act of Accession, to maintain its pre-accession legislation concerning the use of antibiotics as additives in feedingstuffs. Before that date, “a decision (had to be) taken in accordance with (…) Directive 70/524 on requests for adaptation presented by the Kingdom of Sweden”.Google Scholar

(7) Article 11 : “ 1. Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that the use of one of the additives listed in Annex I or its use in conditions which may be specified constitutes a danger to animal or human health or the environment although it complies with the provisions of this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision.Google Scholar

2. The Commission shall, as soon as possible, examine the grounds cited by the Member State concerned and consult the Member States within the Standing Committee for Feedingstuffs; it shall then deliver its opinion without delay and take the appropriate measures.Google Scholar

3. Should the Commission consider that amendments to the Directive are necessary in order to mitigate the difficulties mentioned in paragraph 1 and to ensure the protection of human or animal health or the environment, it shall initiate the procedure laid down in Article 24 with a view to adopting these amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force”.Google Scholar

(8) Pfizer at 44.Google Scholar

(9) SCAN was created by Decision 76/791 of 24 September 1976 (OJ 1976 L 279, p. 35), replaced by Commission Decision 97/579 of 23 July 1997 (OJ 1997 L 237, p. 18). According to article 8(1) of Directive 70/524 (as amended by Directive 96/51), its task is to “assist the Commission, at (its) request, on all scientific questions relating to the use of additives in animal nutrition“.Google Scholar

(10) Pfizer at 53.Google Scholar

(11) Ibid.Google Scholar

(12) Established by Council Decision 70/372 of 20 July 1970 (OJ, English Special Edition 1970 (II), p. 534). This Committee, set up under Article 202 EC, is chaired by a representative of the Commission and consisting of representatives of the Member States. Articles 11 and 24 of Directive 70/524 provide that it must be consulted by the Commission both at the stage of risk assessment and of risk management.Google Scholar

(13) Pfizer at 57.Google Scholar

(14) Established by Commission Decision 97/404 of 10 June 1997 (OJ 1997 L 169, p. 85). Its task is notably to assist the Commission to obtain scientific advice in the field of consumer health.Google Scholar

(15) Pfizer at 114, Alpharma at 135. The CFI referred to its judgments in Cases C-180/96 United Kingdom v. Commission [1998] ECR I-2265 and C-157/96 National Farmers’ Union [1998] ECR I-2211.Google Scholar

(16) Pfizer at 142, Alpharma at 155.Google Scholar

(17) Pfizer at 143, Alpharma at 156.Google Scholar

(18) Pfizer at 148, Alpharma at 161.Google Scholar

(19) Pfizer at 154 and 155, Alpharma at 167 and 168.Google Scholar

(20) Pfizer at 159, Alpharma at 172. These principles were already mentioned in the Commission's Communications on the Precautionary Principle (COM/2000/01final) and on Consumer Health and Food Safety (COM/97/183 final).Google Scholar

(21) Pfizer at 160, Alpharma pt. 173.Google Scholar

(22) Pfizer at 162, Alpharma pt. 175.Google Scholar

(23) Pfizer at 196 and 197.Google Scholar

(24) Pfizer at 194.Google Scholar

(25) Pfizer at 199.Google Scholar

(26) Pfizer at 265.Google Scholar

(27) Pfizer at 270, Alpharma at 213.Google Scholar

(28) See supra.Google Scholar

(29) Pfizer at 274 and 275. See also Alpharma at 234 to 236.Google Scholar

(30) Pfizer at 285 to 287, Alpharma at 234 to 236.Google Scholar

(31) Pfizer at 298.Google Scholar

(32) Inter alia conclusions of the Berlin World Health Organization conference (October 1997), the Economic and Social Committee of the European Union (9 September 1998, OJ 1998 C 407, p. 7), the Copenhagen conference on antibiotic resistance (September 1998), as well as reports of national specialist bodies from Sweden, Netherlands and the United Kingdom.Google Scholar

(33) Pfizer at 327.Google Scholar

(34) Pfizer at 329.Google Scholar

(35) Pfizer at 334.Google Scholar

(36) Pfizer at 335.Google Scholar

(37) Pfizer at 338.Google Scholar

(38) Pfizer at 340.Google Scholar

(39) Pfizer at 265.Google Scholar

(40) Pfizer at 365-368.Google Scholar

(41) See also Alpharma at 296-302.Google Scholar

(42) Pfizer at 381.Google Scholar

(43) Pfizer at 382.Google Scholar

(44) Pfizer at 386.Google Scholar

(45) Pfizer at 387.Google Scholar

(46) Pfizer at 166-170, Alpharma at 177-181.Google Scholar

(47) Pfizer at 172, Alpharma at 183.Google Scholar

(48) Pfizer at 393.Google Scholar

(49) Pfizer at 201.Google Scholar