
1 
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 

(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
(b) by an order under section 6 of the Public Health Act 1936 , to a joint board for a united district,
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 

(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.
3A. 

(1) Section 10(1) and (2) of the Act (improvement notices) applies, with the modification (in the case of section 10(1)) specified in Part 1 of Schedule 2, for the purposes of—
(a) enabling an improvement notice to be served on a person requiring the person to secure compliance with the specified provisions contained in Schedule 1; and
(b) making the failure to comply with a notice referred to in subparagraph (a) an offence.
(2) Section 32(1) to (8) of the Act (powers of entry) applies, with the modification (in the case of section 32(1)) specified in Part 2 of Schedule 2, for the purposes of enabling an authorised officer of an enforcement authority—
(a) to exercise a power of entry to ascertain whether food that does not comply with one or more of the specified provisions contained in Schedule 1 is, or has been, sold; and
(b) to exercise a power of entry to ascertain whether there is any evidence of any contravention of the specified provisions contained in Schedule 1.
(3) Section 35 of the Act (punishment of offences) applies, with the modification specified in Part 3 of Schedule 2, for the purpose of specifying the punishment of an offence committed under paragraph (1)(b).
(4) Section 37(1), (3), (5) and (6) of the Act (appeals) applies, with the modification (in the case of section 37(1), (5) and (6)) specified in Part 4 of Schedule 2, for the purpose of enabling a decision to serve a notice referred to in paragraph (1)(a) to be appealed.
(5) Section 39 of the Act (appeals against improvement notices) applies, with the modification (in the case of section 39(3)) specified in Part 5 of Schedule 2, for the purpose of dealing with appeals against a decision to serve a notice referred to in paragraph (1)(a).
4 
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;
(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);
(h) section 35(2) and (3) , in so far as it relates to offences under section 33(2) as applied by paragraph (f);
(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).
5 

(1) The Tryptophan in Food (Wales) Regulations 2005  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” (“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 
The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2002  are revoked.
Gwenda Thomas
Deputy Minister for Social Services under authority of the Minister for Health and Social Services, one of the Welsh Ministers

Schedule 1
Regulations 2(1), 3(1), and 3A(1) and (2)

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  (foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability).
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 Secretary of State, the Welsh Ministers or Food Standards Scotland , 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  assimilated  law  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  assimilated  law, and until the adoption of such specifications, generally acceptable purity criteria recommended by international bodies will apply.
SCHEDULE 2
Regulation 3A
PART 1
1. 
For section 10(1) (improvement notices) substitute—“
(1) If an authorised officer of an enforcement authority has reasonable grounds for suspecting that a person is failing to comply with the provisions specified in Schedule 1 of the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2009, the authorised officer may, by a notice served on that person (in this Act referred to as an “improvement notice”)—
(a) state the officer’s grounds for suspecting that the person is failing to comply or, as the case may be, that the food does not comply with the relevant provision;
(b) specify the matters which constitute the failure to so comply;
(c) specify the measures which, in the officer’s opinion, the person must take in order to secure compliance; and
(d) require the person to take those measures, or such measures that are at least equivalent to them, within such period as may be specified in the notice.”
PART 2
2. 
For paragraphs (a) to (c) of section 32(1) (powers of entry) substitute—“
(a) to enter any premises within the authority’s area for the purpose of ascertaining whether there has been any contravention of the provisions specified in Schedule 1 of the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2009; and
(b) to enter any business premises, whether within or outside the authority’s area, for the purpose of ascertaining whether there is on the premises any evidence of any contravention of that regulation;”.
PART 3
3. 
In section 35 (punishment of offences), after subsection (1), insert—“
(1A) A person guilty of an offence under section 10(2), as applied by regulation 3A(1) of the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2009, is liable, on summary conviction, to a fine.”
PART 4
4. 
For section 37(1) (appeals) substitute—“
(1) Any person who is aggrieved by a decision of an authorised officer of an enforcement authority to serve an improvement notice under section 10(1) as applied and modified by regulation 3A(1) of, and Part 1 of Schedule 2 to, the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) Regulations 2009, may apply to the magistrates’ court.”
5. 
For section 37(5) substitute—“
(5) The period within which such an appeal as is mentioned in subsection (1) above may be brought shall be—
(a) one month from the date on which notice of the decision was served on the person desiring to appeal; or
(b) the period specified in the improvement notice,whichever ends the earlier; and in the case of such an appeal, the making of the complaint shall be deemed for the purposes of this subsection to be the bringing of the appeal.”
6. 
In section 37(6)—
(a) for “(3) or (4)” substitute “(1)”; and
(b) in paragraph (a), omit “or to the sheriff”.
PART 5
7. 
In section 39(3) (appeals against improvement notices), omit “for want of prosecution”.