Food PART 1 Preliminary Citation, extent and commencement 1 These Regulations may be cited as the Materials and Articles in Contact with Food (Scotland) Regulations 2012, extend to Scotland only and come into force on 22nd December 2012. Interpretation 2 1 In these Regulations— “ the Act ” means the Food Safety Act 1990; ... ... “ Regulation 1935/2004 ” means Regulation (EC) No. 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/ EEC and 89/109/EEC ; “ Regulation 1895/2005 ” means Commission Regulation (EC) No. 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food ; “ Regulation 2023/2006 ” means Commission Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food; “ Regulation 450/2009 ” means Commission Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with food ; “ Regulation 10/2011 ” means Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food , as amended by Commission Regulation (EU) 2016/1416 ; “Regulation 2018/213” means Commission Regulation (EU) No. 2018/21 3 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No. 10/2011 as regards the use of that substance in plastic food contact materials; “ authorised officer ” means any person, whether or not an officer of the authority concerned, who is authorised in writing by an authority having responsibility for execution and enforcement under regulation 20 to act in matters arising under these Regulations; “ food authority ” means an authority in terms of section 5(2) of the Act; and “ preparation ” includes manufacture and any form of treatment or process, and “ prepare ” is to be construed accordingly. 2 Expressions used in these Regulations and in Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009, Regulation 10/2011, or Regulation 2018/213 bear the same meaning in these Regulations as they bear in those Regulations. 3 Any reference in these Regulations to Regulation 2023/2006 ... or Regulation 10/2011 is a reference to that Regulation ... as amended from time to time. Scope 3 These Regulations do not apply in relation to those materials and articles specified in Article 1(3) (purpose and subject-matter) of Regulation 1935/2004. PART 2 General requirements for materials and articles Offences of contravening specified provisions of Regulation 1935/2004 4 1 No person may place on the market or use, in the course of a business in connection with the storage, preparation, packaging, sale or service of food any material or article that does not comply with the requirements of Article 3(1) (general requirements) or Article 4(1), (2), (3) or (4) (special requirements for active and intelligent materials and articles). 2 No person may place on the market any material or article that does not comply with the requirements of Article 3(2), 4(5) or (6) or 15(1), (3), (4), (7) or (8) as read with Article 15(2) (labelling). 3 Any person who contravenes paragraph (1) or (2) or Article 11(4) or (5) ( ... authorisation) or 17(2) (traceability) commits an offence. 4 In this regulation a reference to a numbered Article is a reference to that Article in Regulation 1935/2004. Offence of contravening Article 4 of Regulation 2023/2006 5 Any person who fails to comply with the requirements of Article 4 (conformity with good manufacturing practice) of Regulation 2023/2006 commits an offence. Competent authorities for the purposes of Regulation 1935/2004 and Regulation 2023/2006 6 1 The following bodies are designated as the competent authorities for the purposes of the provisions of Regulation 1935/2004 specified below— a in respect of Article 9 (application for authorisation of a new substance) ..., Food Standards Scotland ; and b in respect of Articles 16 (declaration of compliance) and 17(2) (traceability), Food Standards Scotland and each food authority in its area. 2 The competent authority for the purposes of Articles 6(2) (quality control system) and 7(3) (documentation) of Regulation 2023/2006 is each food authority in its area. PART 3 Requirements for active and intelligent materials and articles Offences of contravening specified provisions of Regulation 450/2009 7 1 Subject to the transitional provisions contained in Article 14 (entry into force and application) of Regulation 450/2009, any person who places on the market any active or intelligent material or article which does not comply with the requirements of Article 4 of that Regulation commits an offence . 2 Any person who fails to comply with the requirements of Article 13 (supporting documentation) of Regulation 450/2009 commits an offence. Competent authorities for the purposes of Regulation 450/2009 8 The competent authorities for the purposes of Article 13 of Regulation 450/2009 are Food Standards Scotland and each food authority in its area. PART 4 Requirements for ceramic articles Interpretation of this Part 9 In this Part— a “ ceramic article ” means an article, to which Regulation 1935/2004 applies by virtue of its Article 1(2) as read with its Article 1(3), which— i is manufactured from a mixture of inorganic materials with a generally high argillaceous or silicate content to which small quantities of organic materials may have been added; ii is first shaped with the shape thus obtained having been permanently fixed by firing; and iii may be glazed, enamelled and/or decorated; and b . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Limits for lead and cadmium and declaration of compliance 10 1 The quantities of lead and cadmium transferred from a ceramic article must not exceed the limits set out in paragraph (5) as read with paragraphs (4) and (6). 2 Unless it is demonstrated that the materials used to make the ceramic article did not contain lead or cadmium, the quantities of lead and cadmium transferred from a ceramic article must be determined by means of a test, the conditions of which are specified in Schedule 3, using the method of analysis described in Schedule 4. 3 No person may place on the market a ceramic article that does not comply with the requirements of paragraph (1) as read with paragraph (2). 4 Where a ceramic article consists of a vessel fitted with a ceramic lid, the lead or cadmium limits (or both) which may not be exceeded (mg/dm 2 or mg/litre) must be that which applies to the vessel alone. The vessel alone and the inner surface of the lid must be tested separately and under the same conditions. The sum of the two lead or cadmium extraction levels obtained by this method must be related as appropriate to the surface area or the volume of the vessel alone. 5 A ceramic article is to be recognised as satisfying the requirements of these Regulations relating to such articles if the quantities of lead or cadmium (or both) extracted during the test carried out under the conditions laid down in Schedule 3 and Schedule 4 do not exceed the following limits— Pb Cd Category 1— Articles which cannot be filled and articles which can be filled, the internal depth of which, measured from the lowest point to the horizontal plane passing through the upper rim, does not exceed 25 mm. 0,8 mg/dm 2 0,07 mg/dm 2 Category 2— All other articles which can be filled. 4,0 mg/l 0,3 mg/l Category 3— Cooking ware; packaging and storage vessels having a capacity of more than three litres. 1,5 mg/l 0,1 mg/l 6 However, where a ceramic article does not exceed the above quantities by more than 50%, that article is nevertheless to be recognised as satisfying the requirements of these Regulations relating to such articles if at least three other articles with the same shape, dimensions, decoration and glaze are subjected to a test carried out under the conditions laid down in Schedule 3 and Schedule 4 and the average quantities of lead or cadmium (or both) extracted from those articles do not exceed the limits set, with none of those articles exceeding those limits by more than 50%. 10A 1 A person who places on the market a ceramic article which is not yet in contact with foodstuffs must provide a written declaration in accordance with Article 16 of Regulation 1935/2004 to accompany the article at the marketing stages up to and including the retail stage. 2 The declaration must be issued by the manufacturer or by a seller in Great Britain and must contain the information laid down in Schedule 5. 3 A person who manufactures or, in the course of a business, imports into Great Britain a ceramic article must on request make available to an authorised officer appropriate documentation to demonstrate that the ceramic article complies with the migration limits for lead and cadmium set out in regulation 10 including— a the results of the analysis carried out, b the test conditions, and c the name and the address of the laboratory that performed the testing. 4 Paragraphs (1), (2) and (3) do not apply in relation to a ceramic article which is second-hand. 5 The documentation specified in paragraph (3)(a), (b) and (c) is not required where documentary evidence is provided to show that the materials used to make the ceramic article did not contain lead or cadmium. PART 5 Requirements for regenerated cellulose film Interpretation of this Part 11 1 In this Part— a “ regenerated cellulose film ” means a thin sheet material obtained from refined cellulose derived from unrecycled wood or cotton, with or without the addition of suitable substances, either in the mass or on one or both surfaces, but does not include synthetic casings of regenerated cellulose; b “ URCF ” means uncoated regenerated cellulose film; c “ CRCF ” means coated regenerated cellulose film with coating derived from cellulose; and d “ PRCF ” means coated regenerated cellulose film with coating consisting of plastics. 2 This Part applies to regenerated cellulose film which— a constitutes a finished product in itself; or b is part of a finished product containing other materials, and is intended to come into contact with food or, by being used for that purpose, does come into contact with food. 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Controls and limits 12 1 URCF and CRCF may be manufactured using only the substances or groups of substances listed in schedule 6 (list of substances authorised in the manufacture of regenerated cellulose film) and subject to the restrictions set out in that schedule but, by way of derogation, substances other than those listed in schedule 6 may be used when these substances are employed either as— a dyes and pigments; or b adhesives, provided that there is no trace of migration of the substances, detectable by a validated method, into or on to foodstuffs. 2 PRCF may be manufactured, prior to coating, using only substances or groups of substances listed in the first part of schedule 6 and subject to the restrictions set out in that part. 3 The coating to be applied to PRCF may be manufactured using only substances or groups of substances authorised under Regulation 10/2011 and subject to the restrictions in the authorisations concerned . 4 Materials and articles made of PRCF must comply with Article 12 (overall migration limit) as read with Article 17 (expression of migration test results) and Article 18 (rules for assessing compliance with migration limits) of Regulation 10/2011. 5 Printed surfaces of regenerated cellulose film must not come into contact with foodstuffs. 6 Any material or article made of regenerated cellulose film that is not by its nature clearly intended to come into contact with food must, at a marketing stage other than the retail stage, be accompanied by a written declaration attesting that it complies with the legislation applicable to it. 7 Where special conditions of use are indicated, the material or article made of regenerated cellulose film must be labelled accordingly. 8 No person may place on the market any regenerated cellulose film which has been manufactured in contravention of the requirements of paragraphs (1) to (4), or which fails to comply with paragraphs (5), (6) or (7). PART 6 Requirements for plastic materials and articles Interpretation of Part 6 and Schedule 1 13 In this Part and in Schedule 1 any reference to a numbered Article or Annex is a reference to that Article of or Annex to Regulation 10/2011. Offences of contravening specified provisions of Regulation 10/2011 14 1 Subject to the transitional arrangements set out in Article 22(5) and Article 23 , any person who places on the market a plastic material or article that fails to comply with a requirement of Regulation 10/2011 specified in column 1 of Schedule 1 commits an offence. 2 Any person who fails to comply with the second sentence of Article 8 (general requirements on substances) or, subject to transitional arrangements set out in Article 22(1), (2) and (3) , with Article 16 (supporting documents) commits an offence. Competent authorities for the purposes of Regulation 10/2011 15 The competent authorities for the purposes of Regulation 10/2011— a Article 8 (general requirement on substances), and b Article 16(1) (supporting documents), are Food Standards Scotland and each food authority in its area. PART 7 Requirements for certain epoxy derivatives Restrictions on the use of certain epoxy derivatives (BADGE, BFDGE and NOGE ) 16 1 In this Part— a any reference to a numbered Article or Annex is a reference to that Article or Annex in Regulation 1895/2005; and b paragraphs (2) and (3) are subject to Article 1(3) (scope) . 2 Subject to Article 6(1), (2) and (4) (transitional provisions) , no person may place on the market or use, in the course of a business in connection with the storage, preparation, packaging, sale or service of food— a any material or article in contravention of Article 3 (prohibition on use or presence of BFDGE) or Article 4 (prohibition on use or presence of NOGE); or b any material or article that fails to comply with the restrictions contained in Article 2 (BADGE) as read with Annex I (specific migration limit for BADGE and certain of its derivatives). 3 Subject to Article 6(3) , no person may place on the market any material or article which fails to comply with the requirements of Article 5 (written declaration) . 4 Any person who contravenes paragraph (2) or (3) commits an offence. Competent authorities for the purposes of Regulation 1895/2005 17 The competent authority for the purpose of Article 6(4) is each food authority in its area. PART 7A Requirements for bisphenol A Interpretation of Part 7A 17A In this Part any reference to a numbered Article is a reference to that Article so numbered in Regulation 2018/213. Offences of contravening specified provisions of Regulation 2018/213 17B Subject to Article 6, no person shall place on the market any varnished or coated material or article that does not comply with the requirements of Article 2. Competent authorities for the purposes of Regulation 2018/213 17C The national competent authority for the purposes of Article 4(3) is Food Standards Scotland and each food authority in its area. PART 8 Requirements for vinyl chloride Requirements for vinyl chloride 18 1 Materials and articles, other than those materials and articles controlled by Regulation 10/2011, which are manufactured with vinyl chloride polymers or copolymers— a must not contain vinyl chloride monomer in a quantity exceeding 1 milligram per kilogram of the material or article; and b must be manufactured in such a way that they do not transfer to foods with which they are in contact any quantity of vinyl chloride exceeding 0.01 milligrams of vinyl chloride per kilogram of food. 2 No person may— a place on the market; or b use in the course of a business in connection with the storage, preparation, packaging, selling or service of food, any material or article that does not comply with paragraph (1). PART 9 Enforcement Offences and penalties 19 1 Any person who contravenes the provisions of regulation 10(3) or (4), 12(8) , 17B or 18(2) commits an offence. 2 Any person who intentionally obstructs any person acting in the execution of Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009, Regulation 10/2011 , Regulation 2018/213 or these Regulations commits an offence. 3 Any person who, without reasonable excuse, fails to provide any assistance or information that a person may reasonably require for the performance of their functions under the Regulations mentioned in paragraph (2) or fails to comply with regulation 10(6) commits an offence. 4 Any person who, in purported compliance with any requirement mentioned in paragraph (3), knowingly or recklessly supplies information that is false or misleading in any material particular, commits an offence. 5 Any person who commits an offence under these Regulations is liable— a in the case of an offence created by paragraph (1) or (4) or regulation 4(3), 5, 7(1), 14(1) or 16(4)— i on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or both; or ii on summary conviction to a fine not exceeding the statutory maximum; and b in the case of an offence created by paragraph (2) or (3) or regulation 7(2) or 14(2), on summary conviction to a fine not exceeding level 5 on the standard scale. 6 Nothing in paragraph (2) or (3) is to be construed as requiring any person to answer any question or give any information if to do so might incriminate them. Execution and enforcement 20 1 Each food authority in its area must execute and enforce— a Regulation 1935/2004, Regulation 1895/2005, Regulation 450/2009 , Regulation 10/2011 and Regulation 2018/213 ; b the provisions of Regulation 2023/2006 specified in regulation 5; and c these Regulations. 2 Food Standards Scotland may also execute and enforce— a Articles 16 and 17(2) of Regulation 1935/2004; ... b Article 13 of Regulation 450/2009, c Article 16(1) of Regulation 10/2011, and d Article 4(3) of Regulation 2018/213. Offences by corporate bodies or Scottish partnerships 21 1 Where an offence under these Regulations which has been committed by a body corporate is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of— a any director, manager, secretary or other similar officer of the body corporate; or b any person purporting to act in such a capacity, that individual as well as the body corporate is deemed to have committed that offence and liable to be proceeded against and punished accordingly. 2 Where an offence under these Regulations which has been committed by a Scottish partnership is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of a partner, that partner as well as the partnership shall be deemed to have committed that offence and liable to be proceeded against and punished accordingly. Offences due to the act or default of a third party 22 Where the commission by any person of an offence under these Regulations is due to the act or default of some other person, that other person has also committed the offence; and a person may be charged with and convicted of the offence whether or not proceedings are taken against the first mentioned person. Time limit for prosecutions 23 1 No prosecution for an offence under these Regulations is to be begun after the expiry of 3 years from the commission of the offence or one year from its discovery by the prosecutor, whichever is the earlier. 2 Paragraph (1) does not apply to an offence under regulation 7(2), 14(2) , 19(2), (3) or (4) . General defences 24 1 In any proceedings for an offence under these Regulations it is, subject to paragraph (5), a defence to prove that the person accused (“the accused”) took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by the accused or by a person under the control of the accused. 2 Without prejudice to the generality of paragraph (1), a person accused of an offence under regulation 4(3), 7(1), 14(1), 16(4) , 17B or 19(1) who did not import or prepare the material or article in respect of which the offence is alleged to have been committed is to be taken to have established the defence provided by paragraph (1) if the requirements of paragraphs (3) or (4) are satisfied. 3 The requirements of this paragraph are satisfied if it is proved that— a the commission of the offence was due to the act or default of some other person who was not under the control of the accused, or to reliance on information supplied by such a person; b either— i the accused carried out all such checks of the material or article in question as were reasonable in all the circumstances, or ii it was reasonable in all the circumstances for the accused to rely on checks carried out by the person who supplied the accused with that material or article; and c the accused did not know and had no reason to suspect at the time the offence was committed that the act or omission would amount to an offence under these Regulations. 4 The requirements of this paragraph are satisfied if the offence is one of placing on the market and it is proved that— a the commission of the offence was due to the act or default of some other person who was not under the control of the accused, or to reliance on information supplied by such a person; b the placing on the market of which the offence consisted was not done under the name or mark of the accused; and c the accused did not know and could not reasonably be expected to know at the time the offence was committed that the act or omission would amount to an offence under these Regulations. 5 If in any case the defence provided by this regulation involves the allegation that the commission of the offence was due to the act or default of another person, or to reliance on information supplied by another person, the accused is not without leave of the court entitled to rely on that defence unless— a at least 7 clear days before the hearing; and b where the accused has previously appeared before the court in connection with the alleged offence, within one month of the first such appearance, the accused has served on the prosecutor a written notice giving such information identifying or assisting in the identification of that other person as was then in the possession of the accused. Procedure where a sample is to be analysed 25 1 An authorised officer who has procured a sample under section 29 of the Act and who considers it should be analysed must divide the sample into 3 parts. 2 If the sample consists of sealed containers and opening them would, in the opinion of the authorised officer, impede a proper analysis, the authorised officer must divide the sample into parts by putting the containers into 3 lots, and each lot is to be treated as being a part. 3 The authorised officer must— a if necessary place each part in a suitable container and seal it; b mark each part or container; c as soon as is reasonably practicable, give one part to the owner and notify the owner in writing that the sample will be analysed; d submit one part for analysis in accordance with section 30 of the Act; and e retain one part for future submission under regulation 26. Secondary analysis by the Government Chemist 26 1 Where a sample has been retained under regulation 25(3)(e) and— a a decision has been made to send a report to the procurator fiscal or proceedings have been commenced against a person for an offence under these Regulations; and b the result of the analysis carried out in accordance with regulation 25(3)(d) is to be adduced as evidence, paragraphs (2) to (8) apply. 2 The authorised officer— a may of the officer's own volition; or b must— i if requested by the prosecutor; ii if the court so orders; or iii (subject to paragraph (6)) if requested by the accused, send the retained part of the sample to the Government Chemist for analysis. 3 The Government Chemist must analyse the part sent under paragraph (2) and send to the authorised officer a certificate specifying the results of the analysis. 4 Any certificate of the results of analysis transmitted by the Government Chemist must be signed by or on behalf of the Government Chemist, but the analysis may be carried out by any person under the direction of the person who signs the certificate. 5 The authorised officer must immediately on receipt supply the prosecutor and the accused with a copy of the Government Chemist's certificate of analysis. 6 Where a request is made under paragraph (2)(b)(iii) the authorised officer may give notice in writing to the accused requesting payment of a fee specified in the notice to defray some or all of the Government Chemist's charges for performing the functions under paragraph (3), and in the absence of agreement by the accused to pay the fee specified in the notice the authorised officer may refuse to comply with the request. 7 Any certificate transmitted by or on behalf of the Government Chemist in accordance with paragraph (4) is to be taken as sufficient evidence of the facts stated therein unless any party to the proceedings requests that the person by whom the certificate is signed be called as a witness. 8 In this regulation, “ the accused ” includes a person in respect of whom an authorised officer intends to submit a report to the procurator fiscal. Application of various provisions of the Act 27 1 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 of it is to be construed as a reference to these Regulations— a section 2 (extending meaning of “sale” etc ); and b section 30(8) (analysis etc. of samples) . 2 In the application of section 32 of the Act (powers of entry) for the purposes of these Regulations, the reference to the Act in subsection (1) is to be construed as including a reference to Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009 , Regulation 10/2011 or Regulation 2018/213 , as appropriate. 3 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 is to be construed as including a reference to Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009 , Regulation 10/2011 or Regulation 2018/213 , as appropriate, and to these Regulations— a section 3 (presumptions that food intended for human consumption) with the modifications that the references to “sold” and “sale” are to be deemed to include references to “placed on the market” and “placing on the market” respectively; and b section 44 (protection of officers acting in good faith). PART 10 General and supplementary Consequential amendment to the Food Safety (Sampling and Qualifications) Regulations 1990 28 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amendment to the Food Labelling Regulations 1996 29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Revocations 30 The Regulations specified in Schedule 2 are revoked. MICHAEL MATHESON Authorised to sign by the Scottish Ministers St Andrew's House, Edinburgh