Explanatory Note

(This note is not part of the Regulations)

These Regulations, which extend to Scotland only, implement Commission Decision 2003/42/EC (O.J. No. L 13, 18.1.03, p.24) –“the Commission Decision” –so far as it relates to trade between Member States of the European Community and imposes new or changed obligations on the United Kingdom.

The Commission Decision amends Annex II to Council Directive 92/118/EEC (O.J. No. L 62, 15.3.93, p.49) by–

(a)imposing new requirements relating to collagen intended for human consumption; and

(b)modifying in minor respects the model commercial document for raw material destined to the production of gelatine intended for human consumption contained in Commission Decision 1999/724/EC amending Annex II to Council Directive 92/118/EEC 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 (O.J. No. L 290, 12.11.99, p.32).

The provisions of Directive 92/118/EEC relating to intra–Community trade are implemented by the Products of Animal Origin (Import and Export) Regulations 1996 (S.I. 1996/3124). These Regulations amend the 1996 Regulations to give effect to the changes made by the Commission Decision (regulation 3).

The Commission Decision requires collection centres and tanneries which supply raw materials for the manufacture of collagen for human consumption for intra-Community trade and establishments producing collagen for human consumption for intra-Community trade to be authorised for this purpose and the Regulations give power to food authorities to issue, suspend, withdraw and cancel authorisations of collection centres and tanneries which supply raw materials for the manufacture of collagen, and authorisations of establishments producing collagen, for human consumption (regulations 4, 5, 6, 7 and 8). The Food Standards Agency is required to maintain a register of establishments so authorised (regulation 9). These Regulations are enforced by the food authority in its area and powers contained in regulation 6(2) to (6) of the Products of Animal Origin (Import and Export) Regulations 1996 are applied to such enforcement (Regulation 10).

A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations have on business costs, has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.