(This note is not part of the Regulations)
1. These Regulations, which apply in relation to Wales, amend the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2002 as amended (“the principal Regulations”).
2. These Regulations implement Commission Directive 2006/34/EC (OJ No. L83, 22.3.2006, p.14) amending the Annex to Directive 2001/15/EC as regards the inclusion of certain substances.
3. The principal Regulations apply to food for most particular nutritional uses (definition of “designated PNU food” in regulation 2(1) of those Regulations). Those Regulations restrict the sale of such food where there has been added to it for a specific nutritional purpose a substance falling within one of the following six categories: vitamins; minerals; amino acids; carnitine and taurine; nucleotides; choline and inositol. In such a case the substance must be listed under the relevant category in Schedule 1 or, as regards foods for special medical purposes, Schedule 1 or 2. There is a time-limited derogation as respects substances listed in Schedule 3 (regulation 3(5) of those Regulations).
4. These Regulations—
(a)add certain substances to the list in the categories of vitamins and minerals which may be added for specific nutritional purposes in designated PNU foods (without any time limit) (regulation 4);
(b)add a substance in the minerals category to the list of substances which may be added for specific nutritional purposes in foods for special medical purposes (without any time limit) (regulation 5);
(c)update the definition of “Directive 2001/15” (regulation 3).
5. These Regulations also amend the Notification of Marketing of Food for Particular Nutritional Uses (England and Wales) Regulations 2002 in so far as they apply in relation to Wales to remove unnecessary wording from regulation 6 of those Regulations (regulation 6).
6. A full regulatory appraisal has been prepared for these Regulations and has been placed in the Library of the National Assembly for Wales along with a copy of the transposition note relating to these Regulations. Copies are also available from the Food Standards Agency, 11th Floor, Southgate House, Cardiff CF10 1EW.