FSA Consultation Letter, 3 March 2003
The purpose of the Regulations is to transpose into English law the requirements of the Commission Decision (2003/42/EC) of 10 January amending Council Directive 92/118/EEC as regards requirements for collagen. It is anticipated that similar proposals will be consulted on separately in Scotland, Wales and Northern Ireland. Responses are requested by: 23 May 2003
In May 2001 the EU Scientific Steering Committee published a report and opinion on the safety with respect to TSE risks of collagen produced from ruminant hides. This was followed in late 2001 by the Commission's proposed draft Decision setting out the conditions for intra-Community trade and imports from third countries of collagen for human consumption and associated raw materials.
The UK was fully involved in negotiation of the final Decision, the text of which was unanimously agreed by the Member States at the meeting of the Standing Committee on the Food Chain and Animal Health on 19 November 2002.
A parallel Commission Decision (1999/724/EC) setting out the conditions for intra-Community trade and imports from third countries of raw materials and gelatine for human consumption came into force on 1 June 2000.
This Decision was implemented into English law by the Gelatine (Intra-Community Trade) (England) Regulations 2001 (S.I. No. 1553), the format of which has largely been followed in the draft Collagen and Gelatine (Intra-Community Trade) (England) Regulations 2003.
Requirements of the Regulations
The draft Regulations implement in England the requirements of the Commission Decision that collagen intended for human consumption may be traded with EU Member States only if specified hygiene requirements applicable to the production, storage and transport of collagen and the raw materials for its production are complied with.
The hygienic manufacture of collagen for the national market only will continue to be covered by the Food Safety (General Food Hygiene) Regulations 1995, as amended. Defra will separately implement the third country import controls laid down in the Decision. Collagen for pharmaceutical use, cosmetics, medical devices or other technical use is not covered by this Decision.
The draft Regulations also implement a minor amendment made by Decision 2003/42/EC to the wording of the commercial document required under paragraph 1 of Part III of the Annex to Decision 1999/724/EC on gelatine.
The Regulations implement the requirements of the Decision largely by adding the Decision to the list in Schedule 3, paragraph 12 of the Products of Animal Origin (Import and Export) Regulations 1996. Schedule 3 lists the Community measures relevant to intra-Community trade and as so amended will give effect to all relevant requirements contained in the Commission Decision in relation to collagen traded with Member States.
The remainder of the Regulations sets out the specific requirements for the authorisation etc. of collection centres and tanneries supplying raw materials for use in the manufacture of collagen for human consumption, as required under paragraph 4 of part III of the Annex to the Decision.
A more detailed breakdown of the Regulations is available from the FSA, although for a full understanding the Regulations should be read in conjunction with the Decision, and with Commission Decision 1999/724/EC on gelatine. Copies of these documents, if required, can be found on the EUR-Lex website.
Authorisation of establishments and enforcement
Local food authorities will be responsible for enforcing the Collagen Regulations. The draft Regulations give food authorities in England powers to issue, suspend, withdraw and cancel authorisations. Persons aggrieved by a decision to refuse authorisation, or to suspend or withdraw authorisation, have the right to appeal to a magistrate's court. The Food Standards Agency will be required to maintain a register of authorised premises.
Guidance to Accompany the Regulations
The Agency will issue general guidance to facilitate the consistent application and enforcement of the Regulations.