Search Legislation

The Medical Food (Wales) Regulations 2000

What Version

 Help about what version

Opening Options

 Help about opening options

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Citation, commencement and application

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.

Interpretation

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); “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.

Restrictions on sale

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.

Enforcement

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

Offences and penalties

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.

Defence in relation to exports

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.

Application of various provisions of the Food Safety Act 1990

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).

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

14th July 2000

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area. The revised version is currently only available in English.

Original (As Enacted or Made) - English:The original English language version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Original (As Enacted or Made) - Welsh:The original Welsh language version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources