PART 4Amendments to retained direct EU legislation
CHAPTER 1EU Regulations
Commission Regulation (EC) No 65/20046
1
Commission Regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms is amended as follows.
2
For Article 1 substitute—
Article 1
1
This Regulation applies to genetically modified organisms, hereinafter ‘GMOs’, authorised for placing on the market in accordance with Regulation 1829/2003 of the European Parliament and of the Council and—
a
in England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002,
b
in Wales, the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002,
c
in Scotland, the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002,
d
in Northern Ireland, the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003,
and applications for placing on the market under such legislation.
2
This Regulation does not apply to medicinal products authorised under the Human Medicines Regulations 2012 or the Veterinary Medicines Regulations 2013, or applications for authorisation under those Regulations.
3
In Article 2(2), after “Biosafety clearing house” insert “established by the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the “Biosafety clearing house”)”.
4
In Article 3—
a
in point (b), for the words from “Commission” to “original application” substitute “Secretary of State”;
b
for point (c) substitute—
c
for GMOs authorised under Regulation (EC) No 1829/2003, the unique identifier must be recorded in the register maintained in accordance with Article 28 of that Regulation.
5
Omit Articles 4 to 6.
6
After Article 7, omit the words from “This Regulation” to “Member States.”.
7
In the Annex—
a
in Section A, in paragraph 1, in the first subparagraph, omit “under Community legislation”;
b
in section B, for “endorsed at Community level” substitute “implemented in the United Kingdom”.