Regulation 6 Amendment of the cases and circumstances in which a marketing consent is required

(1)

In regulation 2 of the 1992 Regulations (Interpretation), there shall be inserted immediately after the definition of “the Commission” the following definition—

““the Contained Use Directive” means Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms^f1;”.

(2)

In paragraph (1) of regulation 10 of the 1992 Regulations (Consent to market products)—

(a)

between the words “cases and circumstances other than” and “the marketing of a product” there shall be inserted “(a)”;

(b)

after the words “the Deliberate Release Directive” there shall be added the following—

“; (b) the marketing of a product containing genetically modified micro-organisms within the meaning of Article 2 of the Contained Use Directive, the conditions of sale for which specify that it is to be used only in conditions of contained use in accordance with the Contained Use Directive; (c) the marketing of a medicinal product for human or veterinary use within the meaning of Council Regulation (EEC) No. 2309/93^f2; (d) the marketing of an additive within the meaning of regulation 2(1) of the Feeding Stuffs Regulations 1991^f3 incorporated in or for incorporation in any feeding stuff within the meaning of regulation 2(1) as aforesaid.”.

Annotations

Footnotes

f1: OJ No. L117, 8.5.90, p.1.
f2: OJ No. L214, 24.8.93, p.1. A Council Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. The Regulation provides for the specific risk assessment of medicinal products containing or consisting of genetically modified organisms.
f3: S.I. 1991/2840, as amended by S.I. 1993/1442, S.I. 1994/499 and S.I. 1994/2510. These Regulations implement Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ No. L270, 14.12.70, p.1.), as amended from time to time, in particular by Council Directive 93/114/EC (OJ No. L334, 31.12.93, p.24.) which provides for the specific risk assessment of additives containing genetically modified organisms.