1.—(1) These Regulations may be cited as the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Scotland) Amendment Regulations 2004 and shall come into force on 31st March 2004.
(2) These Regulations extend to Scotland only.
(3) In these Regulations “the principal Regulations” means the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Scotland) Regulations 2002(1).
2. The principal Regulations are amended in accordance with regulations 3 to 7.
3. In regulation 2(1) (interpretation), in the definition of “Directive 2001/15” insert at the end “, as amended by Commission Directive 2004/5/EC(2) and as read with Commission Directive 2004/6/EC(3) derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products”.
4. In regulation 3 (restrictions on sale)–
(a)for paragraph (1) substitute–
“(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.”;
(b)in paragraph (2) for “paragraph (1)” substitute “this regulation”; and
(c)at the end insert–
“(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)in Category 2 (Minerals) under the heading “CALCIUM”, after “- oxide” insert “-sulphate”; and
(b)in Category 4 (Carnitine and taurine) after “L-carnitine hydrochloride” insert “L carnitine-L-tartrate”.
6. For Schedule 2 (additional substances which may be added for specific nutritional purposes in foods for special medical purposes) substitute the content of Schedule 1 to these Regulations.
7. After Schedule 2 insert as Schedule 3 the content of Schedule 2 to these Regulations.
TOM McCABE
Authorised to sign by the Scottish Ministers
St Andrew’s House, Edinburgh
8th March 2004