Medical Food (England) Regulations 2000
| Jurisdiction | UK Non-devolved |
2000 No. 845
FOOD, ENGLAND
The Medical Food (England) Regulations 2000
Made 21th March 2000
Laid before Parliament 31th March 2000
Coming into force 1st November 2001
The Minister of Agriculture, Fisheries and Food and the Secretary of State, acting jointly in exercise of the powers conferred on them by sections 6(4), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 19901and of all other powers enabling them in that behalf, after consultation in accordance with section 48(4) of that Act with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations, hereby make the following Regulations:
Title, commencement and extent
1. These Regulations may be cited as the Medical Food (England) Regulations 2000, shall come into force on 1st November 2001 and shall apply to England.
Interpretation
2. In these Regulations–
“the Act” means the Food Safety Act 1990;
“the Directive” means Commission Directive 1999/21/ECon dietary foods for special medical purposes2;
“food authority” does not include–
(a) the council of a district of a non-metropolitan county except where the county functions have been transferred to that council pursuant to a structural change, or
(b) the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner and the Middle Temple);
“medical food” means food coming within the classification of dietary foods for special medical purposes for which compositional and labelling requirements are laid down in the Directive; and
“sell” includes possess for sale and offer, expose or advertise (otherwise than by means of a label or wrapper) for sale.
Restrictions on sale
3.—(1) No person shall sell a medical food unless–
(a)
(a) its formulation and composition comply with Article 3 of the Directive as read with the Annex thereto and its instructions for use are such that its use in accordance with those instructions would so comply;
(b)
(b) the name under which it is sold complies with Article 4(1) of the Directive; and
(c)
(c) it is labelled in accordance with Article 4(2) to (5) of the Directive.
(2) No person who, in respect of medical food of a particular type–
(a)
(a) is a designated notifier, that is to say a manufacturer or an importer covered by Article 5 of the Directive, but
(b)
(b) has failed to comply with the requirement to notify the competent authority referred to in that Article,
shall sell a medical food of that type.
(3) For the purposes of paragraph (2) above the competent authority is–
(a)
(a) in respect of medical food manufactured in England, or imported into England from outside the United Kingdom, the Food Standards Agency;
(b)
(b) in respect of medical food manufactured in (or imported from outside the United Kingdom into) other territory within the United Kingdom, the authority duly designated in that territory as the competent authority for the purposes of...
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