S.I. No 556 of 2001

European Communities (Guidelines for the Assessment of Additives in Animal Nutrition) (Amendment) Regulations, 2001

I, Joe Walsh, Minister for Agriculture, Food and Rural Development, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 ( No. 27 of 1972 ), for the purpose of giving effect to Council Directive No. 87/153/EEC of 16 February, 1987¹ , as amended by Commission Directive No. 2001/79/EC of 17 September, 2001² , hereby make the following regulations:-

1.       These Regulations may be cited as the European Communities (Guidelines for the Assessment of Additives in Animal Nutrition) (Amendment) Regulations, 2001.

2.       It is hereby prescribed that any dossier which must accompany a request for the inclusion of an additive or a new use of an additive in the Annexes to Council Directive No. 70/524/EEC of 23 November 1970³ , shall be compiled by the person making the request in accordance with the guidelines set out in the Annex to the Council Directive No. 87/153/EEC of 16 February 1987¹ , as amended by Commission Directive No. 2001/79/EC of 17 September, 2001² .

3.       These Regulations shall apply without prejudice to any legislation on -

(a)      good laboratory practice for the purposes of mutual acceptance of data for the evaluation of clinical products, and

(b)      the protection of animals used for experimental or other scientific purposes.

Explanatory Note

(This is not part of the Instrument and does not purport to be a legal interpretation)

These Regulations, which deal with the assessment procedure for granting Community authorisation to additives, implement Council Directive No. 87/153/EEC, as amended by Commission Directive No. 2001/79/EC.

Published by, the Stationery Office, Dublin

¹ OJ No. L 64, 7.3.1987, p. 19

² OJ No. L 267, 6.10.2001, p. 1

³ OJ. No. 270, 14.12.1970, p. 1

¹ OJ No. L 64, 7.3.1987, p. 19

² OJ No. L 267, 6.10.2001, p. 1