The Genetically Modified Organisms (Deliberate Release) (Wales) (Amendment) Regulations 2005

Made: 12 July 2005

Coming into force: 15 July 2005

The National Assembly for Wales, being designated[^f00001] for the purpose of section 2(2) of the European Communities Act[^f00002] in relation to the control and regulation of the deliberate release, placing on the market and transboundary movements of genetically modified organisms, in exercise of the powers conferred on it by that section, makes the following Regulations—

Title, commencement and application

1

The title of these Regulations is the Genetically Modified Organisms (Deliberate Release) (Wales) (Amendment) Regulations 2005, they come into force on 15 July 2005 and they apply in relation to Wales.

Amendment of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002

2

• (1) The Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002[^f00003] are amended in accordance with the following provisions of this Regulation.

• (2) In regulation 2—

• (a) The following definition is substituted for the definition of “the Deliberate Release Directive”—

• “the Deliberate Release Directive” (“y Gyfarwyddeb Gollyngiadau Bwriadol”) means Council Directive 2001/18/EC[^f00004] on the deliberate release into the environment of genetically modified organisms as amended by the Food and Feed Regulation and Council Regulation (EC) No. 1830/2003[^f00005];

; and

• (b) The following definitions are inserted in the appropriate place in accordance with the alphabet—

• “the Food and Feed Regulation” (“y Rheoliad Bwyd a Bwyd Anifeiliaid”) means Council Regulation (EC) No 1829/2003[^f00006] on genetically modified food and feed;
• “genetically modified feed” (“bwyd anifeiliaid a addaswyd yn enentig”) means — feed containing, consisting of or produced from genetically modified organisms; or genetically modified organisms for feed use;
• “genetically modified food” (“bwyd a addaswyd yn enetig”) means — food containing or consisting of genetically modified organisms; food produced from, or containing ingredients produced from, genetically modified organisms; or genetically modified organisms for food use;

• (3) In regulation 16—

• (a) In paragraph (a), the words “and in accordance with the limitations and conditions to which the use of that product is subject” are inserted after the words “has approval”;

• (b) The following paragraph is substituted for paragraph (f)—

(f) a genetically modified novel food or genetically modified novel food ingredient within the scope of Council Regulation (EC) No 258/75[^f00007], as amended by the Food and Feed Regulation and Council Regulation 1882/2003[^f00008], is marketed; and

; and

• (c) The following paragraph is inserted after paragraph (f)—

(g) genetically modified food or feed authorised under the Food and Feed Regulation is marketed.

• (4) The following regulation is inserted after regulation 18—

Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (18A) (1) Subject to paragraph (2), the marketing of traces of a genetically modified organism or combination of genetically modified organisms in products intended for direct use as food or feed or for processing shall be exempted from the requirements of section 108(1)(a) of the Act (to carry out a risk assessment) and of section 111(1)(a) of the Act (to obtain consent) provided that the conditions set out in article 47 of the Food and Feed Regulation are met. (2) Paragraph (1) shall cease to have effect on 18 April 2007.

• (5) The following paragraph is substituted for paragraph (2) of regulation 22—

(2) the National Assembly for Wales shall not grant or refuse consent to release genetically modified organisms before the end of the period specified for representations in accordance with regulations 21(b) and (f) above and, if any comments referred to in regulation 21(f) are received within that period, before it has considered those comments.

Signed

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[^f00009].

D. Elis-Thomas — The Presiding Officer of the National Assembly — 12 July 2005

Explanatory note

(This note is not part of the Regulations)

These Regulations amend the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002 (the 2002 Regulations).

The amendments to the 2002 Regulations give effect in Wales to the consequential amendments made to Council Directive 2001/18/EC (OJ No. L106, 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 1830/2003 (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 2(2)(a) and 2(3)(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 2(3)(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 2(3)(c)); and

• (d) provide that, until 18 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 2(4)).

• (e) clarify that the National Assembly for Wales must not grant or refuse to consent to release genetically modified organisms before the end of the latest date on which the representations mentioned in regulations 21(c) and (f) of the 2002 Regulations can be made (regulation 2(5)).

A Regulatory Appraisal has been prepared. Copies can be obtained from the Food and Market Development Division, National Assembly for Wales, Cathays Park, Cardiff CF10 3NQ.

Footnotes

[^f00001]: S.I. 2003/2901.

[^f00002]: 1972 c. 68.

[^f00003]: S.I. 2002/3188.

[^f00004]: OJ No L106, 17.4.2001, p.1.

[^f00005]: OJ No L268, 18.10.2003, p.24.

[^f00006]: OJ No L258, 18.10.2003, p.1.

[^f00007]: OJ No L43, 14.2.1997, p.1.

[^f00008]: OJ No L284, 31.10.2003, p.1.

[^f00009]: 1998 c. 38.