(This note is not part of the Regulations)
Regulations 3 to 8 of these Regulations amend the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443) (“the 2002 Regulations”). The 2002 Regulations implement Directive 2001/18/EC relating to the deliberate release of genetically modified organisms (“the 2001 Directive”). These amendments are necessary to implement Commission Directive (EU) 2018/350 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms (O.J. No L 67, 9.3.2018, p. 30) (“the 2018 Directive”).
Regulation 3 amends the definition of the 2001 Directive to reflect the amendments made to it by the 2018 Directive.
The amendments made by regulations 4 to 7 relate to the information to be contained in applications for consent to release genetically modified higher plants in relation to trials (amendments to regulation 11 of, and Schedule 1 to, the 2002 Regulations by regulations 4 and 6 respectively). They also make provision in relation to the information to be included in applications for consent to release genetically modified higher plants for commercial purposes (amendments to regulation 16 of, and Schedule 1A to, the 2002 Regulations by regulations 5 and 7 respectively). These changes are necessary owing to the substitution, by the 2018 Directive, of Annexes III and IIIB to the 2001 Directive.
Regulation 8 makes minor changes to Schedule 3 to the 2002 Regulations.
Regulation 9 amends the Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88) which prospectively amended Schedule 3 to the 2002 Regulations. The purpose of the amendment is to omit a provision in S.I. 2019/88, the effect of which would have been to correct a deficiency which the new provision at paragraph 7 of Schedule 3 (introduced by regulation 8 in these Regulations) now eliminates.
Regulation 10 makes provision requiring the Secretary of State to conduct a review of the operation of these Regulations on a five-yearly basis.
An explanatory memorandum and a transposition note have been laid before Parliament which provides more detail on the way that these Regulations implement the 2018 Directive.
An impact assessment has not been produced for this instrument as no, or no significant, impact on the private or voluntary sector is foreseen.