Commission Decision
of 10 January 2003
amending Council Directive 92/118/EEC as regards requirements for collagen
(notified under document number C(2002) 5557)
(Text with EEA relevance)
(2003/42/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to 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(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC(1), as last amended by Directive 2002/33/EC of the European Parliament and of the Council(2), and in particular the second paragraph of Article 15 thereof,
Whereas:
(1) Specific public health conditions for the preparation of collagen intended for human consumption should be laid down. Provided that these conditions are the same for collagen intended for human consumption and collagen not intended for human consumption, and provided that hygiene conditions are also the same, it should be possible to produce and/or store both types of collagen in the same establishment.
(2) The authorisation and registration, inspection and hygiene conditions for the establishments preparing collagen should be set. Certain health conditions contained in Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the production and marketing of meat products and certain other products of animal origin(3), as last amended by Directive 97/76/EC(4), and in Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs(5), are relevant for the preparation of collagen.
(3) Article 2.3.13.7 of the International Animal Health Code (2001) issued by the International Office of Epizootics on BSE recommends that if gelatine and collagen are prepared exclusively from hides and skins, veterinary administrations should authorise their import and transit through their territories without restriction, regardless of the status of the exporting countries.
(4) Under 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(6), as last amended by Commission Regulation (EC) No 1494/2002(7), hides and skins within the meaning of Directive 92/118/EEC, derived from healthy ruminants and collagen derived from such hides and skins are not subject to restrictions on placing on the market.
(5) The Scientific Steering Committee adopted an opinion on the safety of collagen on 10 and 11 May 2001, addressing the question of the safety in relation to transmissible spongiform encephalopathies (hereinafter TSE) of collagen produced from ruminant hides.
(6) The raw material used for the production of collagen consists mainly of bovine connective tissue of hides and tendons, calf skins, sheep skins and pig skins. To ensure the safety of the raw material, it must derive from animals that pass ante and post-mortem inspections as fit for human consumption. Such material must also be collected, transported, stored and handled in the most hygienic ways possible.
(7) To guarantee traceability of the raw material, collection centres and tanneries, which intend to supply the raw material, should be authorised and registered. A model commercial document should also be prescribed to accompany the raw material during transportation and at time of delivery to the collection centres, tanneries and collagen processing plants.
(8) It is appropriate to amend the current commercial document for raw material destined for the production of gelatine for human consumption, to take into account particulars in relation to control procedures in certain Member States.
(9) The standards for the finished product should be fixed to ensure that it is not contaminated with substances or micro-organisms presenting a risk to consumer health. Pending a scientific evaluation of such standards, it is appropriate to include, on a provisional basis, generally accepted standards as regards contamination. The requirements for packaging, storage and transport of the finished product should also be laid down.
(10) It is necessary to lay down specific health rules for the importation of collagen and raw material destined for the production of collagen intended for human consumption. Specimens of health certificates to accompany the imported collagen and raw material destined for the production of collagen for human consumption should be drawn up. It is also necessary for the Commission to recognise conditions offering equivalent guarantees based on a proposal submitted by a third country.
(11) The adoption of specific rules for the production of collagen should be without prejudice to the adoption of rules for the prevention and control of TSE.
(12) Directive 92/118/EEC should therefore be amended accordingly.
(13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
Annex II to Directive 92/118/EEC is amended in accordance with the Annex to this Decision.
This Decision shall apply from 30 June 2003.
It shall not apply to collagen intended for human consumption that was produced or imported before that date.
This Decision is addressed to the Member States.