Explanatory Note
(This note is not part of the Regulations)
1. These Regulations, which extend to England only, implement in relation to England Commission Decision 2003/42/EC amending Council Directive 92/118/EEC as regards requirements for collagen (OJ No. L13, 18.1.2003, p.24) as amended by Commission Decision 2003/503/EC (OJ No. L170, 9.7.2003, p.30) – “the Commission Decision” – so far as it relates to trade between Member States of the European Community.
2. The provisions of Council Directive 92/118/EEC (OJ No. L62, 15.3.93, p.49) which relate to intra-Community trade are implemented in relation to Great Britain as a whole by the Products of Animal Origin (Import and Export) Regulations 1996 (S.I. 1996/3124, as already amended, “the 1996 Regulations”).
3. The Commission Decision amends Annex II to Council Directive 92/118/EEC by —
(a)amending the current commercial document for raw material destined for the production of gelatine for human consumption which is contained in Chapter IV of that Annex; and
(b)inserting into that Annex new requirements relating to collagen intended for human consumption.
4. These Regulations amend the 1996 Regulations to give effect to the amendment described in paragraph 3(a), and to the requirements referred to in paragraph 3(b) which relate to —
(a)production establishments;
(b)the raw materials which may be used in production and the conditions attaching to their use;
(c)transport and storage of such raw materials;
(d)the process of production;
(e)appropriate measures to be taken to ensure that production batches meet specified criteria; and
(f)packaging, storage and transport (regulation 3(3)).
5. In implementation of the remainder of the requirements referred to in paragraph 3(b), these Regulations also —
(a)by means of an amendment to paragraph 9 of Schedule 3 to the 1996 Regulations —
(i)disapply in respect of establishments producing collagen intended for human consumption the registration requirements in regulation 11 of the 1996 Regulations which would otherwise apply in relation to them, and
(ii)continue to disapply in respect of such establishments the notification requirements in regulation 12 of those Regulations (regulation 3(2)); and
(b)give power to food authorities in England, and subject to a right of appeal, to grant, suspend, withdraw or cancel authorisations of —
(i)collection centres and tanneries which supply raw materials for the production of collagen intended for human consumption, and
(ii)establishments which produce collagen intended for human consumption (regulations 4–8).
6. The Food Standards Agency is required to maintain a register of premises authorised by food authorities under regulations 4 and 5 and food authorities are required to give the Agency certain information about authorisations granted by them (regulation 9).
7. These Regulations provide for their enforcement by the relevant food authority and, for the purposes of such enforcement, apply regulation 6(2) to (6) of the 1996 Regulations (regulation 10).
8. A Regulatory Impact Assessment has been prepared in relation to these Regulations and placed in the Library of each House of Parliament. Copies may be obtained from the Microbiological Safety Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.