The Genetically Modified Organisms (Deliberate Release) (Scotland) Amendment Regulations 2004

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (S.S.I. 2002/541) (“the 2002 Regulations”).

The amendments to the 2002 Regulations give effect in Scotland to the consequential amendments made to Directive 2001/18/EC of the European Parliament and the Council (O.J. No. L 106, 17.4.02, p.1) on the deliberate release into the environment of genetically modified organisms (the “Deliberate Release Directive”) by Council Regulation (EC) No 1829/2003 (OJ No. L286, 18.10.03, p. 1) on genetically modified food and feed (the “Food and Feed Regulation”).

These amending Regulations–

(a) update references to relevant EC legislation (Regulations 3 and 4(b));

(b) provide that, where products have been approved in accordance with legislative provisions other than those contained in the 2002 Regulations, those products are only exempt from the requirements of sections 108(1)(a) and 111(1)(a) of the Environmental Protection Act 1990 if they have been marketed in accordance with any conditions or limitations imposed upon the consent that has been issued in relation to that product (Regulation 4(a));

(c) provide for the marketing of genetically modified food and feed that has been authorised under the Food and Feed Regulation without the need for a marketing consent under section 111(1)(a) of the Environmental Protection Act 1990 (“the Act”), or an additional risk assessment under section 108(1)(a) of the Act (Regulation 4(c)); and

(d) provide that, until 18^th April 2007, the placing on the market of traces of a genetically modified organism or a combination of genetically modified organisms in products intended for direct use as food or feed or for processing is exempt from the requirements of section 111(1)(a) of the Act (to obtain a marketing consent) and of section 108(1)(a) of the Act (to carry out a risk assessment) provided the conditions specified in article 47 of the Food and Feed Regulation are met (Regulation 5).

(e) clarify that the Scottish Ministers must not grant or refuse consent to release genetically modified organisms before any comments mentioned in regulation 20(f) of the 2002 Regulations have been considered. (Regulation 6).

A Regulatory Impact Assessment for these Regulations has been prepared and a copy has been placed in the Scottish Parliament Information Centre. Copies can be obtained from the Scottish Executive Environment and Rural Affairs Department, GM Team, Victoria Quay, Edinburgh EH6 6QQ.