31.5.2001 Official Journal of the European Communities L1471 (Acts whose publication is obligatory) REGULATION (EC) No 999/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof, Having regard to the proposal from the Commission ('), Having regard to the opinion of the Economic and Social Committee (%), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (%), Whereas: (1)  Several distinct transmissible spongiform encephalo- pathies (TSEs) have for a number of years been recog- nised as occurring separately in humans and animals. Bovine spongiform encephalopathy (BSE) was first recognised in bovine animals in 1986 and in the following years was recognised as occurring in other species of animal. A new variant of Creutzfeldt-Jakob Disease (CJD) was described in 1996. Evidence continues to grow of the similarity between the BSE agent and that of the new variant of Creutzfeld-Jakob Disease. (2)  Since 1990 the Community has adopted a series of measures to protect human and animal health from the risk of BSE. Those measures have been based on the safeguard provisions of Directives on animal-health measures. It is appropriate, in view of the magnitude of the risk posed to human and animal health by certain TSEs, to adopt specific rules for their prevention, control and eradication. () O] C 45, 19.2.1999, p. 2 and O] C 120 E, 24.4.2001, p. 89. () O] C 258, 10.9.1999, p. 19. (’) Opinion of the European Parliament of 17 May 2000 (O] C 59, 23.2.2001, p. 93), Common Position of the Council of 12 February 2001 (O] C 88, 19.3.2001, p. 1) and Decision of the European Parliament of 3 May 2001. () This Regulation directly concerns public health and is relevant to the functioning of the internal market. It covers products which are included in Annex I to the Treaty as well as products which are not. Consequently, it is appropriate to choose Article 152(4)(b) of the Treaty as the legal basis. The Commission has obtained scientific opinions, in particular from the Scientific Steering Committee and the Scientific Committee on Veterinary Measures relating to Public Health, on several aspects of TSEs. Those opin- ions include advice on measures to reduce the potential risk for humans and animals resulting from exposure to infected animal products. These rules should apply to the production and placing on the market of live animals and products of animal origin. However, it is not necessary for them to apply to cosmetic or medicinal products, medical devices or their starting materials or intermediate products, for which other specific rules, in particular on the non-use of specified risk material, apply. Nor should they apply to products of animal origin which do not pose a risk to animal or human health since they are intended for purposes other than the production of food, feed or fertiliser. It is appropriate to ensure that products of animal origin excluded from the scope of this Regulation are kept separate from those covered by it unless they meet at least the same health standards as the latter. Provision should be made for safeguard measures to be taken by the Commission in cases where a risk from a TSE has not been adequately addressed by the competent authority of a Member State or third country. A procedure should be established for the determination of the epidemiological status of a Member State, a third country and of one of their regions, hereinafter referred to as ‘countries or regions’ with respect to BSE, on the basis of the incident propagation and human exposure