The Collagen and Gelatine (Intra-Community Trade) (England) (No. 2) Regulations 2003

Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations, which apply in relation to England only, implement in relation to England Commission Decision 2003/721/EC amending Council Directive 92/118/EEC as regards requirements for collagen intended for human consumption and repealing Decision 2003/42/EC (OJ No. L260, 11.10.2003, p.21) – “the new Decision” – so far as it relates to trade between Member States of the European Community.

2.  Commission Decision 2003/42/EC as amended (revoked by the new Decision) was implemented in relation to England, in so far as it related to trade between Member States of the European Community, by the Collagen and Gelatine (Intra-Community Trade) (England) Regulations 2003 (S.I. 2003/1736). With effect from 23rd December 2003 these Regulations revoke those Regulations and the amendments made by them to the Products of Animal Origin (Import and Export) Regulations 1996 (S.I. 1996/3124 as already amended, “the 1996 Regulations”) (regulations 3 and 4).

3.  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 1996 Regulations.

4.  With effect from 31st December 2003 the new Decision amends Annex II to Council Directive 92/118/EEC by —

(a)amending, in the same manner as the revoked Decision previously did, the 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 requirements relating to collagen intended for human consumption which are the same as those previously inserted into it by the revoked Decision, save as regards one minor particular in the commercial document model for raw material destined for the production of collagen.

5.  With effect from 31st December 2003 these Regulations amend the 1996 Regulations to give effect to the amendment described in paragraph 4(a), and to the requirements referred to in paragraph 4(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 5(3)).

6.  In implementation of the remainder of the requirements referred to in paragraph 4(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 establishments the notification requirements in regulation 12 of those Regulations (regulation 5(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 6–10).

7.  The Food Standards Agency is required to maintain a register of premises authorised by food authorities under regulations 6 and 7 and food authorities are required to give the Agency certain information about authorisations granted by them (regulation 11).

8.  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 12).

9.  A full regulatory impact assessment of the effect that this instrument will have on the costs of business has been prepared and placed on 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.