2009 No. 3051
The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009
Made
Laid before Parliament
Coming into force
The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 16(1)(a) and (f), 17(2), 26(1)(a) and (3) and 48(1) of the Food Safety Act 19901 and now vested in him2 as read with paragraph 1A of Schedule 2 to the European Communities Act 19723.
These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for any reference to the Annex to Commission Regulation (EC) No. 953/2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses4 to be construed as a reference to that Annex as amended from time to time.
In accordance with section 48(4A) of the Food Safety Act 1990, the Secretary of State has had regard to relevant advice given by the Food Standards Agency.
As required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety5 there has been open and transparent public consultation during the preparation and evaluation of these Regulations.
Title application and commencement1
These Regulations may be cited as the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009, apply in relation to England only and come into force on 1 January 2010.
Interpretation2
1
In these Regulations—
“the Act” means the Food Safety Act 1990;
“the Commission Regulation” means Commission Regulation (EC) No. 953/2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses;
“food authority” has the meaning that it bears by virtue of section 5(1) of the Act, except that it does not include the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and Middle Temple); and
“specified provision” means any provision of the Commission Regulation that is specified in Column 1 of the Schedule and whose subject-matter is described in Column 2 of the Schedule.
2
Subject to paragraph (3), any expression other than one defined in paragraph (1) that is used both in these Regulations and in the Act has the meaning it bears in the Act.
3
Any expression used both in these Regulations and in the Commission Regulation has the meaning that it bears in the Commission Regulation.
4
Where any functions under the Act are assigned—
a
by an order under section 2 or 7 of the Public Health (Control of Disease) Act 19846, to a port health authority;
b
by an order under section 6 of the Public Health Act 19367, to a joint board for a united district; or
c
by an order under paragraph 15(6) of Schedule 8 to the Local Government Act 19858, to a single authority for a metropolitan county,
any reference in these Regulations to a food authority shall be construed, so far as relating to those functions, as a reference to the authority to whom they are so assigned.
5
In these Regulations any reference to the Annex to the Commission Regulation is a reference to that Annex as amended from time to time.
Offences, penalties and execution and enforcement3
1
Any person who contravenes any of the specified provisions shall be guilty of an offence.
2
A person guilty of an offence under paragraph (1) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.
3
Each food authority shall execute and enforce these Regulations within its area.
Application of various sections of the Food Safety Act 19904
The following provisions of the Act shall apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part thereof shall be construed as a reference to these Regulations—
a
section 3 (presumptions that food intended for human consumption);
b
section 20 (offences due to fault of another person);
c
section 21 (defence of due diligence)9, as it applies for the purpose of section 14 or 15;
d
section 30(8) (which relates to documentary evidence);
e
section 33(1) (obstruction etc. of officers);
f
section 33(2), with the modification that the reference to “any such requirement as is mentioned in subsection (1)(b) above” shall be deemed to be a reference to any such requirement as is mentioned in that subsection as applied by sub-paragraph (e);
g
section 35(1) (punishment of offences)10, in so far as it relates to offences under section 33(1) as applied by sub-paragraph (e);
h
section 35(2) and (3)11, in so far as it relates to offences under section 33(2) as applied by sub-paragraph (f);
i
section 36 (offences by bodies corporate);
j
section 36A (offences by Scottish partnerships)12; and
k
section 44 (protection of officers acting in good faith).
Amendment to the Tryptophan in Food (England) Regulations 20055
1
The Tryptophan in Food (England) Regulations 200513 are amended in accordance with the following paragraphs.
2
In paragraph (1) of regulation 2 (interpretation), for the definition “Directive 2001/15/EC” there is substituted the following definition—
“Regulation 953/2009” means Commission Regulation (EC) No. 953/2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses;
3
In regulation 5 (exceptions from prohibitions), for sub-paragraph (c) of paragraph (2) there is substituted the following sub-paragraph—
c
laevorotatory tryptophan, its sodium, potassium, calcium or magnesium salts or its hydrochloride, added in compliance with Regulation 953/2009 to any food for a particular nutritional use referred to in the Annex to that Regulation;
Revocation6
The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 200214 are revoked.
Signed by authority of the Secretary of State for Health
THE SCHEDULESpecified Provisions
Provision of the Commission Regulation | Subject matter |
|---|---|
Article 2(1) | Requirement that among the substances belonging to the categories appearing in the Annex to the Commission Regulation, only those listed in that Annex, complying with the relevant specifications as necessary may be added for specific nutritional purposes in the manufacture of foodstuffs for particular nutritional uses covered by Directive 2009/39 of the European Parliament and the Council on foodstuffs intended for particular nutritional uses15. |
Article 3(1) | Requirement that the use of substances added for specific nutritional purposes shall result in the manufacture of safe products that fulfil the particular nutritional requirements of the persons for whom they are intended, as established by generally accepted scientific data. |
Article 3(2) | Requirement that upon request by the competent authority referred to in Article 11 of Directive 2009/39, the manufacturer or, where appropriate, the importer shall produce the scientific work and the data establishing that the use of the substances complies with Article 3(1) of the Commission Regulation. If such work and data are contained in a readily available publication, a mere reference to that publication shall suffice. |
Article 4(2) | Requirement that purity criteria established by Community legislation which apply to the substances listed in the Annex to the Commission Regulation when they are used in the manufacture of foodstuffs for purposes other than those covered by the Commission Regulation shall also apply to those substances when they are used for purposes covered by the Commission Regulation. |
Article 4(3) | Requirement that for substances listed in the Annex to the Commission Regulation for which purity criteria are not established by Community legislation, and until the adoption of such specifications, generally acceptable purity criteria recommended by international bodies shall apply. |
(This note is not part of the Regulations)