(a) for paragraph (1) there shall be substituted the following paragraph  - 

    " (1) Subject to paragraph (5), no person shall sell any designated PNU food being a food to which a substance falling within one of the categories mentioned in paragraph (2) has been added for a specific nutritional purpose unless  - 


(a) that substance is listed under that category  - 


(i) in the case of any food for special medical purposes, in Schedule 1 or 2; and

(ii) in any other case, in Schedule 1;



(b) that substance complies with the relevant purity criteria referred to in paragraph (3); and

(c) in the case of a substance listed in Schedule 2, the conditions of use (if any) set out in that Schedule relating to that substance are met."; and



(b) there shall be inserted at the end the following paragraph  - 

    " (5) The restrictions in paragraph (1) shall not apply until 1st January 2007 in the case of a substance falling within one of the categories mentioned in paragraph (2) and listed under that category in Schedule 3 if  - 


(a) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance in the manufacture of any designated PNU food; and

(b) that substance was used in the manufacture of a food for a particular nutritional use which was on sale in the European Community on 11th February 2004.".

(a) Commission Directive 2004/5/EC (OJ No. L14, 21.1.2004, p.19) amending Directive 2001/15/EC to include certain substances in the Annex; and

(b) Commission Directive 2004/6/EC (OJ No. L15, 22.1.2004, p.31) derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products.

     3. The principal Regulations apply to food for most particular nutritional uses (definition of "designated PNU foods" in regulation 2(1) of those Regulations). Where there has been added to that food for a specific nutritional purpose a substance falling within one of the following categories: vitamins; minerals; amino acids; carnitine and taurine; nucleotides; choline and inositol, those Regulations prohibit (in most cases from 1st April 2004) the sale of such food unless the substance is listed under the relevant category in Schedule 1 or, in the case of foods for special medical purposes, Schedule 1 or 2.

     4. These Regulations  - 

(a) allow until 1st January 2007, subject to conditions, the sale of designated PNU foods to which there has been added a substance listed in new Schedule 3 to the principal Regulations (regulations 4(b) and 7 and Schedule 2);

(b) add another substance to the list of substances in the category minerals and in the category carnitine and taurine which may be added for specific nutritional purposes in designated PNU foods (regulation 5);

(c) add six substances to the list of substances in the category amino acids which may be added for specific nutritional purposes in foods for specific medical purposes (regulation 6 and Schedule 1); impose a condition of use in the case of one of these substances (regulation 4(a) and Schedule 1); and in implementation of the Annex to Directive 2001/15/EC (OJ No. L52, 22.2.2001, p.19) provide that for amino acids also the sodium, potassium, calcium and magnesium salts, as well as their hydrochlorides may be used (Schedule 1);

(d) update the definition of "Directive 2001/15" (regulation 3).

     5. A full regulatory impact assessment of the effect that these Regulations will have on the costs of business has been prepared and placed in the Library of each House of Parliament together with a Transposition Note setting out how the main elements of Directives 2004/5/EC and 2004/6/EC are transposed in these Regulations. Copies may be obtained from the Food Labelling and Standards Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH.