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Foods for Special Medical Purposes (Scotland) Regulations 2000

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Restrictions on sale

3.—(1) No person shall sell a dietary food in Scotland unless–

(a)its formulation, composition and instructions for use comply with Article 3 of the Directive as read with the Annex thereto;

(b)the name under which it is sold complies with Article 4(1) of the Directive; and

(c)it is labelled in accordance with Article 4(2) to (5) of the Directive.

(2) The manufacturer or importer of a dietary food–

(a)shall provide the notification to the competent authority called for by Article 5 of the Directive in respect of that dietary food; and

(b)shall not sell that dietary food in Scotland unless notification has been provided in accordance with sub-paragraph (a) above.

(3) For the purposes of paragraph (2) above the competent authority shall be–

(a)in respect of a dietary food manufactured in Scotland or imported into Scotland from outside the United Kingdom, the Food Standards Agency;

(b)in respect of a dietary food manufactured in, or imported from outside the United Kingdom into, any other part of the United Kingdom, the authority designated as the competent authority for that part for the purposes of Article 5 of the Directive.

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