Foods for Special Medical Purposes (Scotland) Regulations 2000

Scottish Statutory Instruments

2000 No. 130

FOOD

Foods for Special Medical Purposes (Scotland) Regulations 2000

Made

28th April 2000

Laid before the Scottish Parliament

9th May 2000

Coming into force

1st November 2001

The Scottish Ministers, in exercise of the powers conferred on them by sections 6(4), 16(1)(a), (e) and (f), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990M1 and of all other powers enabling them in that behalf, and 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:

Marginal Citations

M1 1990 c.16; section 6(4) of the Act was amended by the Deregulation and Contracting Out Act 1992 (c.40), Schedule 9, paragraph 6. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998 (c.46).

Citation, commencement and extent S

1.—(1) These Regulations may be cited as the Foods for Special Medical Purposes (Scotland) Regulations 2000 and shall come into force on 1st November 2001.

(2) These Regulations extend to Scotland only.

Interpretation S

2.  In these Regulations–

• “the Act" means the Food Safety Act 1990;

• [F1 “the Directive” means Commission Directive 1999/21/EC on dietary foods for special medical purposes M2 as amended by–

  (a)

  the Act 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 Slovak Republic and the adjustments to the Treaties on which the European Union is founded;

  (b)

  Commission Directive 2006/82/EC adapting Directive 91/321 on infant formulae and follow on formulae and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania; and

  (c)

  Commission Directive 2006/141/EC on infant formulae and follow on formulae and amending Directive 1991/21/EC]

• [F2 “dietary food” means—

  (a)

  food coming within the classification of dietary foods for special medical purposes for which compositional labelling requirements are laid down in the Directive and which has been developed to satisfy the nutritional needs of infants, or

  (b)

  food coming within the classification of dietary foods for special purposes for which compositional and labelling requirements are laid down in the Directive and which has been labelled or placed on the market before 22nd February 2019, and]

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

Textual Amendments

F1 Words in reg. 2 substituted (11.1.2008) by The Infant Formula and Follow-on Formula (Scotland) Regulations 2007 (S.S.I. 2007/549), regs. 1(b)(ii), 30(2)

F2 Words in reg. 2 substituted (22.2.2019) by The Foods for Specific Groups (Medical Foods) (Miscellaneous Amendments) (Scotland) Regulations 2018 (S.S.I. 2018/392), regs. 1(1), 3(2)

Marginal Citations

M2 O.J. No. L91, 7.4.1999, p.29, as corrected by a corrigendum published on 5th January 2000 (O.J. No. L2, 5.1.2000, p.79)

Restrictions on sale S

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 [F3 Food Standards Scotland];

(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.

Textual Amendments

F3 Words in reg. 3(3)(a) substituted (1.4.2015) by The Food (Scotland) Act 2015 (Consequential and Transitional Provisions) Order 2015 (S.S.I. 2015/100), arts. 1(2), 2, sch. para. 7

Enforcement S

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

Offences and penalties S

5.  If any person contravenes regulation 3(1) and (2) above, he 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 S

F4 6.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F4 Reg. 6 revoked (1.1.2006) by The Official Feed and Food Controls (Scotland) Regulations 2005 (S.S.I. 2005/616), reg. 1(b), sch. 6

Application of various sections of the Food Safety Act 1990 S

7.  The following provisions of the Act shall apply for the purposes of these Regulations and any reference in these 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 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).

[F5 Transitional arrangements S

8.   In respect of any contravention before 1st January 2010, no person commits an offence under regulation 5(a) consisting of a contravention of regulation 3(1)(a) where the action that would otherwise constitute the offence consists of selling a medical food the composition of which fails to comply with Article 3 of the Directive as read with the row relating to manganese set out in the second part of Table 1 (minerals) in the Annex to the Directive if the composition of that medical food would have complied with Article 3 of the Directive as read with the row relating to manganese set out in the second part of Table 1 (minerals) in the Annex to the Directive as it stood before it was amended by Commission Directive 2006/141/EC on infant formulae and follow on formulae and amending Directive 1999/21/EC.]

Textual Amendments

F5 Reg. 8 inserted (4.11.2008) by The Infant Formula and Follow-on Formula (Scotland) Amendment Regulations 2008 (S.S.I. 2008/322), regs. 1, 3

SUSAN C DEACON

A member of the Scottish Executive

St. Andrew’s House, Edinburgh

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which come into force on 1st November 2001, implement Commission Directive 1999/21/EC on dietary foods for special medical purposes (O.J. No. L91, 7.4.1999, p.29) and extend to Scotland only.

Article 1(2) of the Directive classifies such foods as foods specially processed or formulated for the dietary management of specified types of patients under medical supervision whose treatment calls for a special diet, and regulation 2 of these Regulations defines dietary food as food within that classification.

Article 2 of the Directive calls for member States to ensure that such food may only be marketed if it complies with the Directive, and Articles 3 and 4 of the Directive lay down requirements for formulation, composition and instructions for use of such food, and for its naming and labelling, and regulation 3(1) of these Regulations prohibits the sale of dietary food unless those criteria are met.

Article 5 of the Directive requires notification to competent authorities of placing on the market of products covered by the Directive when manufactured, or imported from outside the European Community. Regulation 3(2) of these Regulations imposes that notification requirement, and regulation 3(3) specifies which authorities are to be recipients of the notification. For dietary foods manufactured in Scotland, or imported into Scotland from outside the United Kingdom, the Food Standards Agency is the relevant authority.

Enforcement responsibilities, offences and penalties and application of provisions of the Food Safety Act 1990 (c.16) are set out in regulations 4, 5 and 7 of these Regulations. The Regulations also provide a defence in relation to exports in accordance with Articles 2 and 3 of Council Directive 89/397/EEC (O.J. No. L186, 30.6.89, p.23) on the Official Control of Foodstuffs (regulation 6).