23.6.1999 Official Journal of the European Communities L 156/1 (Acts whose publication is obligatory) COUNCIL REGULATION (EC) No 1308/1999 of 15 June 1999 amending Regulation (EC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission ('), Having regard to the opinion of the European Parlia- ment (%), Having regard to the opinion of the Economic and Social Committee (%), Whereas: (1)  since the adoption of Council Regulation (EEC) No 2377/90 (%), the regulatory environment for veter- inary medicinal products has altered radically, in particular as a result of the entry into force of Council Regulation (EC) No 2309/93 of 22 July laying down Community procedures for the authorisation and supervision of medicinal prod- ucts for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (°) and of the amendments made by Directive 93/40/EEC (°) to Council Directive 81/ 851/EEC of 28 September 1981 on the approxima- tion of the laws of the Member States relating to veterinary medicinal products (’), and to Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (%), (") OJ C 131, 12.5.1999, p. 14. () Opinion delivered on 4 May 1999 (not yet published in the Official Journal). () Opinion deliverd on 28 April 1999. (not yet published in the Official Journal). (") OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 2728/98 (O] L 343, 18.12.1998, p. 8). () OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regulation (EEC) No 649/98 (O] L 88, 24.3.1998, p. 7). () OJ L 214, 24.8.1993, p. 31. ) OJ L 317, 6.11.1981, p. 1. () OJ L 317, 6.11.1981, p. 16. ) the Committee for Veterinary Medicinal Products is henceforth responsible to the European Agency for the Evaluation of Medicinal Products and it falls to that Agency, through that Committee, to issue an opinion on the maximum residue limits of veterinary medicinal products which are acceptable in foodstuffs of animal origin in accordance with Regulation (EEC) No 2377/90; 3) Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (°) establishes the fees payable to the Agency for examining applications for the establishment, amendment and extension of maximum residue limits; (4 it is necessary, consequently, to amend Regulation (EEC) No 2377/90 by conferring on the Agency the task of dealing with applications for the estab- lishment, amendment and extension of maximum residue limits and by aligning the decision-making process with respect to the authorisation and super- vision of medicinal products for veterinary use with that introduced by Regulation (EEC) No 2309/93; (5)  the Agreement on the application of sanitary and phytosanitary measures which emerged from the multilateral negotiations of the Uruguay Round, approved on behalf of the Community by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the Euro- pean Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986 to 1994) (') creates transparency obligations as regards () OJ L 35, 15.2.1995, p. 1. Regulation as amended by Regula- tion (EC) No 2743/98 (O] L 345, 19.12.1998, p. 3). (% OJ L 336, 23.12.1994, p. 1.