These Regulations, which apply to Wales, amend the Food for Specific Groups (Information and Compositional Requirements) (Wales) Regulations 2016 (S.I. 2016/639 (W. 175)) (“the 2016 Regulations”) in order to provide for the enforcement in domestic law of the provisions of Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants (OJ No. L 25, 2.2.2016, p. 30) (“the Delegated Regulation”).

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 (c. 68) and references in them to provisions of the Delegated Regulation are to be construed as references to such provisions as they are amended from time to time.

Regulation 4 of these Regulations amends regulation 2 of the 2016 Regulations so that references in the 2016 Regulations to the Delegated Regulation are to the Delegated Regulation as it applies to food for special medical purposes including that developed to satisfy the nutritional requirements of infants.

Regulation 6 of these Regulations substitutes a new regulation 7 of the 2016 Regulations to provide new transitional arrangements which ensure that stocks of food for special medical purposes which were labelled or placed on the market before the date of application of provisions of the Delegated Regulation may continue to be marketed until those stocks are exhausted.

Regulation 7 of these Regulations amends the table in Schedule 1 to the 2016 Regulations to include further provisions into the definition of “specified EU requirement”.

These Regulations also make amendments to the 2016 Regulations to correct drafting errors and to provide further clarity. Regulation 8 inserts new paragraphs 6A and 7A in Part 3 of Schedule 3 to the 2016 Regulations to provide clarity regarding the application of section 35 of the Food Safety Act 1990 to the 2016 Regulations and regulation 5 corrects a drafting error in regulation 4(5) of the 2016 Regulations.

Regulation 9 of these Regulations contains revocations and savings provisions. Regulation 9 of, and the Schedule to, these Regulations revoke the Medical Food (Wales) Regulations 2000 (S.I. 2000/1866 (W. 125)) and provisions which amend them. The Medical Food (Wales) Regulations 2000 implement Commission Directive 1999/21/EC on dietary foods for special medical purposes developed to satisfy the nutritional requirements of infants (OJ No. L 91, 7.4.1999, p. 29, as corrected by a corrigendum published on 5 January 2000 (OJ No. L 2, 5.1.2000, p. 79)).

Regulation 9 of these Regulations further provides for the revocations to be saved for the purposes of the transitional provisions in regulation 7 of the 2016 Regulations as substituted by these Regulations, and for the purposes of the transitional provisions in regulation 5(3) of the Infant Formula and Follow-on Formula (Wales) Regulations 2020 (S.I. 2020/**** W. **)).

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.