
1 

(1) These Regulations may be cited as the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Scotland) Regulations 2009 and come into force on 1st January 2010.
(2) These Regulations extend to Scotland only.
2 

(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; 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) Any expression used both in these Regulations and in the Commission Regulation has the meaning that it bears in the Commission Regulation.
3 

(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.
4 
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 of the Act 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) , as it applies for the purpose of section 14 or 15;
(d) section 30(8) (analysis etc. of samples);
(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) , in so far as it relates to offences under section 33(1) as applied by sub-paragraph (e);
(h) section 35(2) and (3) , 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) ; and
(k) section 44 (protection of officers acting in good faith).
5 

(1) The Tryptophan in Food (Scotland) Regulations 2005  are amended in accordance with the following paragraphs.
(2) In regulation 2 (interpretation)—
(a) in paragraph (1) for the definition  “Directive 2001/15/EC” substitute 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;”; and
(b) after paragraph (2) insert the following paragraph—“
(3) The reference in regulation 5(2) to the Annex to Regulation 953/2009 is a reference to that Annex as amended from time to time.”.
(3) For regulation 5(2)(c) (exceptions from prohibitions) substitute—“
(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 following Regulations are revoked—
(a) the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Scotland) Regulations 2002 ;
(b) the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes)(Scotland) Amendment Regulations 2004 ; and
(c) the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Scotland) Amendment Regulations 2006 .
SHONA ROBISON
Authorised to sign by the Scottish Ministers
St Andrew's House,
Edinburgh

SCHEDULE
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  (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 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  Food Standards Scotland, 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   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 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   assimilated  law, and until the adoption of such specifications, generally acceptable purity criteria recommended by international bodies shall apply.