The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Wales) Regulations 2023

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations authorise the placing on the market, in Wales, of specified genetically modified food and feed products for the purposes of Regulation (EC) No 1829/2003 on genetically modified food and feed (EUR 2003/1829). These Regulations also modify the “authorisation holders” for 18 existing authorisations under EUR 2003/1829.

Part 2 of these Regulations (regulation 3 and Schedules 1 to 8) contains the authorisation, in relation to Wales, for the placing on the market of products containing, consisting of, or produced from the specified genetically modified organisms—

• Schedule 1 is a new authorisation for genetically modified soybean DAS-81419-2 × DAS-44406-6;

• Schedule 2 is a new authorisation for genetically modified soybean DAS-81419-2;

• Schedule 3 is a new authorisation for genetically modified soybean SYHT0H2;

• Schedule 4 is a new authorisation for genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and listed sub-combinations;

• Schedule 5 is a new authorisation for genetically modified maize 1507 × MIR162 × MON 810 × NK603 and listed sub-combinations;

• Schedule 6 is a new authorisation for genetically modified cotton GHB614 × T304-40 × GHB119;

• Schedule 7 renews the authorisation for genetically modified maize MON 88017 × MON 810;

• Schedule 8 renews an authorisation for genetically modified oilseed rape GT73. This renewal is limited to products (other than food) containing or consisting of genetically modified oilseed rape GT73. It does not cover products “produced from” that genetically modified organism.

Part 3 of these Regulations (regulations 4 to 21) amends, in relation to Wales, 18 retained EU Decisions containing existing authorisations for genetically modified food and feed. The amendments all relate to changes to the names and addresses of the respective authorisation holders, and their representatives in Great Britain.

Part 4 of these Regulations (regulation 22) revokes, in relation to Wales, the retained EU Decision containing the previous authorisation for the products now authorised by Schedule 7.

The authorisations granted by these Regulations are valid for a period of ten years in accordance with Articles 7(4) and 19(4) of EUR 2003/1829. This is subject to Articles 11(4) and 23(4) of EUR 2003/1829, which provide for an extension of the authorisation period in certain circumstances where an application for renewal has been submitted.

In each Schedule, paragraph 4 specifies the methods for detection, including sampling, which have been validated for use in relation to the authorised products. The documents referred to have been published at https://gmo-crl.jrc.ec.europa.eu/method-validations.

Information on the authorisations granted by these Regulations is required to be entered in the register of genetically modified food and feed referred to in Article 28(1) of EUR 2003/1829 (“the Register”).

The authorisations granted by these Regulations are required to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(1)(e) of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms (EUR 2003/1946).

Further information on the authorisations granted by these Regulations including in relation to the Register, the monitoring plans required by paragraph 5 of each Schedule, or the information notified pursuant to the Cartagena Protocol, can be obtained from the Food Standards Agency, 11th Floor, Southgate House, Wood Street, Cardiff, CF10 1EW or by writing to [e-mail].

The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, it was not considered necessary to carry out a regulatory impact assessment as to the likely costs and benefits of complying with these Regulations.