(This note is not part of the Regulations)
1. These Regulations, which apply to Wales only, implement, in relation to Wales, Commission Decision 2003/721/EC amending Council Directive 92/118/EEC as regards requirements for collagen (OJ No. L260, 11.10.2003, p.21) 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. With effect from 31st December 2003 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. With effect from 31st December 2003 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), with effect from 31st December 2003 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 establishment of regulation 12 of those Regulations (regulation 3(2)) and;
(b)give power to food authorities in Wales, 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 to 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 appraisal of the effect these Regulations have on business costs, has been prepared pursuant to section 65 of the Government of Wales Act 1998 and placed in the Library of the National Assembly for Wales. Copies may be obtained from the Food Standards Agency, 11th Floor, Southgate House, Cardiff CF10 1EW.