Title, commencement and interpretation

1. —(1) These Regulations may be cited as the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004.

(2) These Regulations come into force on 31st March 2004.

(3) In these Regulations “the principal Regulations” means the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2002( 4 ).

Amendment of the principal Regulations

2. The principal Regulations shall be amended in accordance with regulations 3 to 7.

3. In regulation 2(1) (interpretation), in the definition of “Directive 2001/15” there shall be inserted at the end the words “, as amended by Commission Directive 5 ) and as read with Commission Directive 6 ) derogating from Directive

4. In regulation 3 (restrictions on sale) —

(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. ” .

5. In Schedule 1 (substances which may be added for specific nutritional purposes in designated PNU foods) —

(a) there shall be inserted in Category 2 (Minerals) under the heading “CALCIUM” after the entry “- oxide”, the entry “- sulphate”; and

(b) there shall be inserted in Category 4 (Carnitine and taurine) after the entry “L-carnitine hydrochloride” the entry “L-arnitine-–tartrate”.

6. For Schedule 2 (additional substances which may be added for specific nutritional purposes in foods for special medical purposes) there shall be substituted the contents of Schedule 1 to these Regulations.

7. After Schedule 2 there shall be inserted as Schedule 3 the contents of Schedule 2 to these Regulations.

Regulation 6

SCHEDULE 1 REVISED SCHEDULE 2 TO BE SUBSTITUTED IN THE PRINCIPAL REGULATIONS

Regulation 3(1)(a)

“ SCHEDULE 2 ADDITIONAL SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN FOODS FOR SPECIAL MEDICAL PURPOSES

Regulation 7

SCHEDULE 2 NEW SCHEDULE 3 TO BE INSERTED IN THE PRINCIPAL REGULATIONS

Regulation 3(5)

“ SCHEDULE 3 SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN DESIGNATED PNU FOODS IN ACCORDANCE WITH THE DEROGATION IN REGULATION 3(5)

Category 1. Vitamins

VITAMIN E:

• D–alpha tocopheryl polyethylene glycol 1000 succinate

Category 2. Minerals

BORON:

• boric acid

• sodium borate

CALCIUM:

• amino acid chelate

• pidolate

MAGNESIUM:

• amino acid chelate

• pidolate

IRON:

• ferrous hydroxide

• ferrous pidolate

• amino acid chelate

COPPER:

• amino acid chelate

ZINC:

• amino acid chelate

MANGANESE:

• amino acid chelate

SELENIUM:

• enriched yeast

CHROMIUM:

• amino acid chelate ”