The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Wales) Regulations 2024

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make provision, in relation to Wales, on regulated food product authorisations.

Part 2 of these Regulations (regulations 2 and 3 and Schedules 1 to 3) is made in exercise of powers in Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (EUR 2008/1331). Regulation 2 and Schedule 1 update, in relation to Wales, the domestic list of food additives approved for use in foods in Annex 2 of Regulation (EC) No 1333/2008 on food additives (EUR 2008/1333). Regulation 3 and Schedules 2 and 3 amend, in relation to Wales, Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 (EUR 2012/231).

The amendments made in Part 2 of these Regulations provide for—

• the authorisation, in relation to Wales, of the placing on the market and use of the food additive E 960b steviol glycosides from fermentation (Yarrowia lipolytica);

• the authorisation, in relation to Wales, of a new production method for an existing authorised additive: E 960c enzymatically produced steviol glycosides. The specification for the existing production method in the Annex to EUR 2012/231 is renumbered as E 960c(i). The specification for the new production method is inserted as “E 960c(ii) rebaudioside M, AM and D produced via enzymatic conversion of highly purified steviol glycosides from Stevia leaf extracts”;

• the authorisation, in relation to Wales, of a new use (edible ices) for the food additive E 476 polyglycerol polyricinoleate, and an amendment to an existing authorised use (sauces);

• the introduction of a maximum residue limit of 0.1 mg/kg for residues of ethylene oxide applying to all authorised food additives;

• minor miscellaneous corrections to Annex 2 to EUR 2008/1333.

Part 3 of these Regulations is also made in exercise of powers in EUR 2008/1331. Regulation 4 removes, in relation to Wales, 22 flavouring substances from the domestic list of authorised flavouring substances in Annex 1 to Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (EUR 2008/1334). Regulation 5 makes transitional provision to allow existing products containing these substances to continue to be marketed and used until their date of minimum durability (‘best before’ date) or ‘use by’ date.

Part 4 of these Regulations (regulation 6 and Schedules 4 to 8) is made in exercise of powers in Regulation (EU) 2015/2283 on novel foods (EUR 2015/2283). Part 4 updates, in relation to Wales, the list of authorised novel foods in the Annex to Commission Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (EUR 2017/2470)—

• Schedule 4 inserts a new entry, authorising the placing on the market of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food for use in the specified food categories.

• Schedule 5 inserts a new entry, authorising the placing on the market of cetylated fatty acids as a novel food for use in food supplements for adults only.

• Schedule 6 inserts a new entry, authorising the placing on the market of 3-fucosyllactose (3-FL) (from a strain of Escherichia coli K-12 DH1) as a novel food for use in the specified food categories.

• Schedule 7 inserts a new entry, authorising the placing on the market of lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture as a novel food for use in the specified food categories.

• Schedule 8 corrects errors in existing entries—

  • In Table 1 only, the existing entry for “bovine milk basic whey protein isolate” is replaced to address formatting errors in the existing entry.

  • In Table 2 only, the specification for Xylo-oligosaccharides is amended to add the parameter for “Dry material (%)”, which was missing from the existing entry.

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.