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	Statutory Instruments of the Scottish Parliament
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"the Directive" means Council Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses[4];

"PNU food" means a food for a particular nutritional use which–

(a) owing to its special composition or process of manufacture, is clearly distinguishable from food intended for normal consumption; and

(b) is sold in such a way as to indicate its suitability for its claimed particular nutritional purpose,

but does not fall within any of the following classifications–

(i) infant formulae and follow-on formulae;

(ii) processed cereal-based foods and baby foods for infants and young children;

(iii) food intended for use in energy-restricted diets for weight reduction;

(iv) dietary foods for special medical purposes;

(v) foods intended to meet the expenditure of intense muscular effort, especially for sportsmen and sportswomen; or

(vi) foods for persons suffering from carbohydrate-metabolism disorders (diabetes);

"particular nutritional use" means the fulfilment of the particular nutritional requirements of–

(a) certain categories of persons whose digestive processes are, or whose metabolism is, disturbed;

(b) certain categories of persons whose physiological condition renders them able to obtain a special benefit from the controlled consumption of any substance in food; or

(c) infants or young children in good health; and

"sell" includes possess for sale and offer, expose or advertise (otherwise than by means of a label or wrapper) for sale.

    (2) Other expressions used in these Regulations and in the Directive have the same meaning in these Regulations as they have in the Directive.

Restriction on sale
     3. —(1) No person who, in respect of a PNU food product of a particular type–

(a) is a manufacturer or an importer referred to in Article 9 of the Directive; and

(b) has failed to comply with–


(i) a requirement to notify the competent authority, as referred to in paragraph 1 or 2 of that Article; or

(ii) a requirement to produce anything to the competent authority, as referred to in paragraph 3 of that Article,



shall sell a PNU food product of that type.

    (2) For the purposes of paragraph (1), the competent authority is–

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

(b) in respect of PNU food manufactured in (or imported from outside the United Kingdom into) another territory within the United Kingdom, the authority duly designated in that territory as the competent authority for the purposes of Article 9 of the Directive in respect of the food.

Declaration
     4. —(1) Where the Food Standards Agency has detailed grounds for establishing that a foodstuff intended for a particular nutritional use which does not belong to one of the groups listed in Annex I to the Directive does not comply with Article 1(2) of the Directive or endangers human health, it may by written declaration suspend or restrict trade in that product.

    (2) Such a declaration shall be published in such manner as the Food Standards Agency thinks fit and shall specify the product concerned.

    (3) A declaration which imposes conditions on trade in any product shall specify those conditions.

    (4) Where a declaration is in force suspending trade in any product, no person shall trade in that product.

    (5) Where a declaration is in force imposing conditions on trade in any product, no person shall trade in that product unless the product complies with conditions specified in the declaration.

    (6) A declaration may be modified, suspended or revoked by a further written declaration published, so far as is practicable, in the same manner and to the same extent as the original declaration.

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

Offences and penalties
     6. If any person without reasonable excuse contravenes regulation 3(1) or regulation 4(4) or (5), that person shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.

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 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 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);

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

(j) section 36A (offences by Scottish partnerships); and

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

Revocation
     8. The Notification of Marketing of Food for Particular Nutritional Uses (Scotland) Regulations 2002[5] are revoked.


LEWIS MACDONALD
Authorised to sign by the Scottish Ministers

St Andrew's House, Edinburgh
1st February 2007

[2] Section 48(4A) was inserted by the 1999 Act, section 40(1) and Schedule 5, paragraph 21.back

[3] O.J. No. L 31, 1.2.02, p.1, as amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council amending Regulation (EC) No. 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (O.J. No. L 245, 29.9.03, p.4) and Commission Regulation (EC) No. 575/2006 of the European Parliament and of the Council as regards the number and names of the permanent Scientific Panels of the European Food Safety Authority (O.J. No. L 100, 8.4.06, p.3).back

[4] O.J. No. L 186, 30.6.89, p.27, as amended by Directive 96/84/EC of the European Parliament and of the Council amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (O.J. No. L 48, 19.2.97, p.20), Directive 1999/41/EC of the European Parliament and of the Council amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (O.J. No. L 172, 8.7.99, p.38) and Regulation (EC) No. 1882/2003 of the European Parliament and of the Council adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty (O.J. No. L 284, 31.10.03, p.1).back

[5] S.S.I. 2002/50.back

 © Crown copyright 2007