This Regulation shall enter into force on the day following its publication in the Official Journal of the European Communities.
It shall apply from 1 July 2001.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 May 2001.
For the European Parliament
The President
N. Fontaine
For the Council
The President
M. Winberg
(1) OJ C 45, 19.2.1999, p. 2 and
OJ C 120 E, 24.4.2001, p. 89.
(2) OJ C 258, 10.9.1999, p. 19.
(3) Opinion of the European Parliament of 17 May 2000 (OJ C 59, 23.2.2001, p. 93), Common Position of the Council of 12 February 2001 (OJ C 88, 19.3.2001, p. 1) and Decision of the European Parliament of 3 May 2001.
(4) OJ L 184, 17.7.1999, p. 23.
(5) Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (OJ L 395, 30.12.1989, p. 13). Directive as last amended by Council Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49).
(6) Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (OJ L 224, 18.8.1990, p. 29). Directive as last amended by Council Directive 92/118/EEC.
(7) Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, p. 1).
(8) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121 29.7.1964, p. 1977/64). Directive as last amended by Directive 2000/20/EC of the European Parliament and of the Council (OJ L 163, 4.7.2000, p. 35).
(9) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). Directive as last amended by Commission Decision 94/953/EC (OJ L 371, 31.12.1994, p. 14).
(10) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ L 268, 24.9.1991, p. 56). Directive as last amended by Directive 96/43/EC (OJ L 162, 1.7.1996, p. 1).
(11) Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).
(12) Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (OJ L 378, 31.12.1982, p. 58). Directive as last amended by Commission Decision 2000/556/EC (OJ L 235, 19.9.2000, p. 27).
(13) Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (OJ L 268, 14.9.1992, p. 1). Directive as last amended by Directive 96/23/EC (OJ L 23.5.1996, p. 10).
(14) Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(1) to Directive 89/662/EEC and, as regards pathogens, in Directive 90/425/EEC (OJ L 62, 15.3.1993, p. 49). Directive as last amended by Commission Decision 1999/724/EC (OJ L 290, 12.11.1999, p. 32).
ANNEX I
SPECIFIC DEFINITIONS
For the purpose of this Regulation:
(a) "indigenous case of BSE" means a case of bovine spongiform encephalitis which has not been clearly demonstrated to be due to infection prior to importation as a live animal, embryo or ovum;
(b) "discrete adipose tissue" means internal and external body fat removed during the slaughter and cutting process, in particular fresh fat from the heart, caul, kidneys and mesentery of bovine animals, and fat from cutting rooms;
(c) "cohort" means a group of bovine animals which were either born in the same herd as, and within 12 months preceding or following the birth of, the affected cattle or reared together with the affected animal at any time during the first year of their life and which may have consumed the same feed as that which the affected animal consumed during the first year of its life;
(d) "landfill site" means a waste disposal site as defined by Directive 1999/31/EC(1).
(1) Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999, p. 1).
ANNEX II
DETERMINATION OF BSE STATUS
CHAPTER A
The BSE status of a Member State or a third country or of one of their regions, hereinafter referred to as "country or region", shall be determined on the basis of the following criteria:
(a) the outcome of a risk analysis identifying all the potential factors for the appearance of BSE referred to in Chapter B and their development over time;
(b) an education programme for veterinarians, breeders and those who transport, trade in and slaughter bovine animals, which seeks to encourage them to report all cases of neurological manifestations in adult bovine animals;
(c) the compulsory reporting and examination of all bovine animals showing clinical signs of BSE;
(d) a system of continuous surveillance and monitoring of BSE with particular reference to the risks described in Chapter B, taking account of the guidelines in the table of Chapter A of Annex III or in accordance with the appropriate international standards; reports on the number of examinations carried out and the results thereof must be kept for at least seven years;
(e) the examination in an approved laboratory of samples of encephala or other tissues collected under the surveillance system mentioned in point (d).
CHAPTER B
The risk analysis referred to in Chapter A(a) shall be based on the following factors:
- the consumption by bovine animals of meat and bone meal or greaves derived from ruminants;
- the importation of meat and bone meal or greaves potentially contaminated by a TSE or animal feed containing meat and bone meal or greaves;
- the importation of animals or ova/embryos potentially infected by a TSE;
- the epidemiological status of the country or region in regard to animal TSEs;
- the extent of knowledge about the structure of the bovine, ovine and caprine population in the country or region;
- the source of animal waste, the parameters of the processes for treating such waste and the methods of producing animal feed.