The Medical Food (Wales) Regulations 2000

Citation, commencement and application E+W

1.  These Regulations may be cited as the Medical Food (Wales) Regulations 2000, shall come into force on 1st November 2001 and shall apply to Wales.

Commencement Information

I1 Reg. 1 in force at 1.11.2001, see reg. 1

Interpretation E+W

2.  In these Regulations —

• “the Act” (“y Ddeddf”) means the Food Safety Act 1990;

• “the Directive” (“y Gyfarwyddeb”) means Commission Directive 1999/21/EC on dietary foods for special medical purposes(1) [F1 as amended by the Act of the European Community concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded]

• “medical food” (“bwyd meddygol”) 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” (“gwerthu”) includes possess for sale and offer, expose or advertise (otherwise than by means of a label or wrapper) for sale.

Textual Amendments

F1 Words in reg. 2 inserted (31.10.2004) by The Food Safety (Act of Accession concerning the Czech Republic and other States) (Consequential Amendments) (Wales) Regulations 2004 (S.I. 2004/2731), regs. 1, 6(2)

Commencement Information

I2 Reg. 2 in force at 1.11.2001, see reg. 1

Restrictions on sale E+W

3.—(1) No person shall sell a medical food unless —

(a) its formulation and composition, and the instructions for use, are such as to ensure compliance 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) No person who, in respect of medical food of a particular type —

(a) is a designated notifier, that is to say a manufacturer or an importer covered by Article 5 of the Directive, but

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

(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 Article 5 of the Directive in respect of the food.

Commencement Information

I3 Reg. 3 in force at 1.11.2001, see reg. 1

Enforcement E+W

4.  Each food authority shall enforce and execute these Regulations in its area.

Commencement Information

I4 Reg. 4 in force at 1.11.2001, see reg. 1

Offences and penalties E+W

5.  If any person —

(a) contravenes regulation 3(1) above, or

(b) without reasonable excuse contravenes regulation 3(2) above,

he or she shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Commencement Information

I5 Reg. 5 in force at 1.11.2001, see reg. 1

Defence in relation to exports E+W

6.  In any proceedings for an offence under regulation 3(1) above it shall be a defence for the person charged to prove that the food in respect of which the offence is alleged to have been committed was intended for export to a country (other than a Member State) which has legislation analogous to these Regulations and that the food complies with that legislation.

Commencement Information

I6 Reg. 6 in force at 1.11.2001, see reg. 1

Application of various provisions of the Food Safety Act 1990 E+W

7.  The following provisions of the Act shall apply for the purposes of these Regulations and, unless the context otherwise requires, any reference in those provisions to the Act or Part thereof shall be construed for the purposes of these Regulations as a reference to these Regulations:

(a) section 2 (extended meaning of “sale” etc.);

(b) section 3 (presumptions that food is intended for human consumption);

(c) section 20 (offences due to fault of another person);

(d) section 21 (defence of due diligence) as it applies for the purposes of section 8, 14 or 15 of the Act;

(e) section 22 (defence of publication in the course of business);

(f) section 30(8) (which relates to documentary evidence);

(g) section 33 (obstruction etc. of officers);

(h) section 35(1) to (3) (punishment of offences) in so far as it relates to offences under section 33(1) and (2) as applied by paragraph (g) above;

(i) section 36 (offences by bodies corporate); and

(j) section 44 (protection of officers acting in good faith).

Commencement Information

I7 Reg. 7 in force at 1.11.2001, see reg. 1

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998(2)

Jane Davidson

The Deputy Presiding Officer, National Assembly for Wales