Explanatory Note
(This note is not part of the Regulations)
These Regulations, which apply to Wales, make provision to enforce Commission Delegated Regulation (EU) 2016/127 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 infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (OJ No. L 25, 2.2.2016, p. 1, “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 3 provides that each food authority must execute and enforce these Regulations within its area. Regulation 2(1) contains a definition of “food authority”.
Regulation 4 and Schedule 2 apply, with modifications, certain provisions of the Food Safety Act 1990 (c. 16) for the purposes of these Regulations.
Regulation 5 and Schedule 3 make provision for revocations and savings as a consequence of these Regulations. The Infant Formula and Follow-on Formula (Wales) Regulations 2007 (S.I. 2007/3573 W. 316) (“the 2007 Regulations”) and the provisions which amend those Regulations are revoked. The 2007 Regulations implement Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ No. L 401, 30.12.2006, p. 1) and Council Directive 95/52/EEC on infant formulae and follow-on formulae intended for export to third countries (OJ No. L 179, 1.7.1992, p. 129). Article 13 of the Delegated Regulation repeals that Directive with effect from 22 February 2020, and from 22 February 2021 in the case of infant formula and follow-on formula manufactured from protein hydrolysates.
Regulation 5 of these Regulations further provides for the revocations to be saved for the purposes of the transitional arrangements in that regulation. Those transitional arrangements provide that where infant formula or follow-on formula has been placed on the market or labelled prior to the date of application of the Delegated Regulation (22 February 2020 or, in the case of infant formula or follow-on formula manufactured from protein hydrolysates, 22 February 2021), it may continue to be marketed until stocks are exhausted, provided that certain requirements are met.
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.