2009 No. 3254 (W.283)
FOOD, WALES
The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2009
Made 8 December 2009
Laid before the National Assembly for Wales 10 December 2009
Coming into force 1 January 2010

The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 16(1)(e), 17(2), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990 and now vested in them.
1990 c. 16.
Functions of the Secretary of State, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I.1999/672) and thereafter transferred to the Welsh Ministers by paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (2006 c. 32).
These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Welsh Ministers 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 uses to be construed as a reference to that Annex as amended from time to time.
1972 c. 68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (2006 c. 51).
OJNo. L269, 14.10.2009, p.9.
In accordance with section 48(4A) of the Food Safety Act 1990, the Welsh Ministers have 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 safety there has been open and transparent public consultation during the preparation and evaluation of these Regulations.
OJNo. L31, 1.2.2002, p.1, as last amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny — Part Four (OJNo. L188, 18.7.2009, p.14).

1 Title, application and commencement
The title of these Regulations is The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2009, they apply in relation to Wales and come into force on 1 January 2010.

2 Interpretation
1 In these Regulations—
“the Act” (“y Ddeddf”) means the Food Safety Act 1990;
“the Commission Regulation” (“Rheoliad y Comisiwn”) 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” (“awdurdod bwyd”) has the meaning that it bears by virtue of section 5(1A) of the Act; and
“specified provision” (“darpariaeth benodedig”) 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 1984, to a port health authority; or
1984 c. 22; section 7(3)(d) was substituted by paragraph 27 of Schedule 3 to the Food Safety Act 1990.
(b) by an order under section 6 of the Public Health Act 1936, to a joint board for a united district,
1936 c. 49; section 6 is to be read with paragraph 1 of Schedule 3 to the Food Safety Act 1990.
any reference in these Regulations to a food authority is 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.

3 Offences, penalties and execution and enforcement
1 Any person who contravenes any of the specified provisions is guilty of an offence.
2 A person guilty of an offence under paragraph (1) will be liable on summary conviction to a fine not exceeding level 5 on the standard scale.
3 Each food authority must execute and enforce these Regulations within its area.

4 Application of various sections of the Act
The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part thereof is 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), as it applies for the purpose of section 14 or 15;
Section 21 was amended by S.I.2004/3279.
(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” is deemed to be a reference to any such requirement as is mentioned in that subsection as applied by paragraph (e);
(g) section 35(1) (punishment of offences), in so far as it relates to offences under section 33(1) as applied by paragraph (e);
Section 35(1) is amended by the Criminal Justice Act 2003 (2003 c. 44), Schedule 26, paragraph 42, from a date to be appointed.
(h) section 35(2) and (3), in so far as it relates to offences under section 33(2) as applied by paragraph (f);
Section 35(3) was amended by S.I.2004/3279.
(i) section 36 (offences by bodies corporate);
(j) section 36A (offences by Scottish partnerships); and
Section 36A was inserted by the Food Standards Act 1999 (1999 c. 28), Schedule 5, paragraph 16.
(k) section 44 (protection of officers acting in good faith).

5 Amendment to the Tryptophan in Food (Wales) Regulations 2005
1 The Tryptophan in Food (Wales) Regulations 2005 are amended in accordance with the following paragraphs.
S.I.2005/3111 (W.231).
2 In paragraph (1) of regulation 2 (interpretation), for the definition “Directive 2001/15/EC” there is substituted the following definition—

““Regulation 953/2009” (“Rheoliad 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;”

.

6 Revocation
The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2002 are revoked.
S.I.2002/2939 (W.280).
Gwenda Thomas Deputy Minister for Social Services under authority of the Minister for Health and Social Services, one of the Welsh Ministers 8 December 2009

THE SCHEDULE Specified Provisions
Regulations 2(1) and 3(1)
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 uses.
Article 3(1)	Requirement that the use of substances added for specific nutritional purposes will 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 Food Standards Agency, the manufacturer or, where appropriate, the importer will 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 will 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 will 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 will apply.
OJNo. L124, 20.5.2009, p.21.

(This note is not part of the Regulations)
1 These Regulations, which apply in relation to Wales, make provision for the execution and enforcement of Commission Regulation (EC) No. 953/2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (OJNo. L269, 14.10.2009, p.9) (“the Commission Regulation”). The Commission Regulation repeals and replaces Commission Directive 2001/15/EC on substances that may be added for specific nutritional purposes in food for particular nutritional uses (OJNo. L52, 22.2.2001, p.19) and Commission Directive 2004/6/EC derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products (OJNo. L15, 22.1.2004, p.31).
2 These Regulations—
(a) provide that a person who contravenes specified provisions of the Commission Regulation set out in the Schedule to these Regulations is guilty of an offence (regulation 3(1));
(b) provide penalties for offences (regulation 3(2));
(c) specify the enforcement authority (regulation 3(3));
(d) provide for the application of specified provisions of the Food Safety Act 1990 (1990 c. 16) for the purposes of these Regulations (regulation 4);
(e) make consequential amendments to the Tryptophan in Food (Wales) Regulations 2005 (S.I.2005/3111 (W.231)) (regulation 5); and
(f) revoke the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2002 (S.I.2002/2939 (W.280)) (regulation 6).
3 Article 3(2) of the Commission Regulation refers to the competent authorities referred to in Article 11 of Directive 2009/39/EC of the European Parliament and of the Council on foodstuffs intended for particular nutritional uses (OJNo. L124, 20.5.2009, p.21). The Notification of Marketing of Food for Particular Nutritional Uses (Wales) Regulations 2007 (S.I.2007/1040 (W.100)) provide at regulation 3 that the Food Standards Agency is the competent authority in respect of food for a particular nutritional use manufactured in Wales or imported into Wales from outside the United Kingdom.