Food PART 1 Preliminary Citation and commencement 1 These Regulations may be cited as the Materials and Articles in Contact with Food Regulations (Northern Ireland) 2012 and come into operation on 20th November 2012. Interpretation 2 1 In these Regulations — “ Directive 84/500/ EEC ” means Council Directive 84/500/EEC on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs as last amended by Commission Directive 2005/31/EC ; “ Directive 2007/42/EC ” means Commission Directive 2007/42/EC relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs ; “ 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 as last amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council ; “ 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 , subject to paragraph 3, Commission Regulation (EC) No. 10/2011 on plastic materials and articles intended to come into contact with foods as last amended by Commission Regulation ( EU ) 2018/831 ; “Regulation 2018/213” means Commission Regulation ( EU ) 2018/213 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 district council having responsibility for execution and enforcement under regulation 20, who is authorised by that district council in writing to act in matters arising under these Regulations; “ the Order ” means the Food Safety (Northern Ireland) Order 1991; and “ preparation ” includes manufacture and any form of treatment or process. 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 to Regulation 2023/2006 or to any Annex to Directive 2007/42/EC or Regulation 10/2011 is a reference to that Regulation or that Annex as amended from time to time. 4 The Interpretation Act (Northern Ireland) 1954 applies to these Regulations as it applies to an Act of the Assembly. Scope 3 The provisions of 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 A person must not 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 A person must not 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) (Community authorisation) or 17(2) (traceability) is guilty of an offence. 4 In this regulation a reference to a numbered Article is a reference to that Article in Regulation 1935/2004. Offences 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 is guilty of 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 Articles 9 (application for authorisation of a new substance) and 13 (competent authorities of Member States), the Food Standards Agency; and b in respect of Articles 16(1) (declaration of compliance) and 17(2) (traceability), the Food Standards Agency and each district council in its district. 2 The competent authority for the purposes of Article 6(2) (quality control system) and 7(3) (documentation) of Regulation 2023/2006 is each district council in its district. 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 is guilty of an offence . 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competent authorities for the purposes of Regulation 450/2009 8 The competent authorities for the purposes of Article 13 of Regulation 450/2009 are the Food Standards Agency and each district council in its district. PART 4 Requirements for Ceramic Articles Interpretation of this Part 9 1 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 1(3) that — 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 any reference to a numbered Article or Annex is a reference to that Article of or Annex to Directive 84/500/EEC . Limits for lead and cadmium and declaration of compliance 10 1 The quantities of lead or cadmium transferred from a ceramic article must not exceed the limits laid down in Article 2(4) as read with Article 2(3) and (5). 2 Unless it is demonstrated that the materials used to make the ceramic article did not contain lead or cadmium, compliance with paragraph (1) is to be determined by testing and analysis in accordance with Annexes I and II. 3 A person must not place on the market a ceramic article that does not comply with the requirements of paragraph (1) as read with paragraph (2). 4 A person who places on the market a ceramic article that is not yet in contact with food must provide a written declaration complying with paragraph (5) to accompany the article at the marketing stages up to and including the retail stage. 5 The declaration must be issued by the manufacturer or by a person established within the EU who placed the ceramic article on the market and must contain the information laid down in Annex III. 6 A person who manufactures or, in the course of business, imports into the EU a ceramic article must on request make available to an authorised officer appropriate documentation to demonstrate compliance with the requirements of paragraph (1) including — a the results of analysis carried out; b the test conditions; and c the name and address of the laboratory that performed the testing. 7 Paragraphs (4), (5) and (6) do not apply in relation to a ceramic article which is second-hand. 8 The documentation specified in paragraph (6)(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 Except in regulation 12(3), any reference in this Part to a numbered Annex is a reference to that Annex to Directive 2007/42/EC . Controls and limits 12 1 URCF and CRCF may be manufactured using only the substances or groups of substances listed in Annex II (list of substances authorised in the manufacture of regenerated cellulose film) and subject to the restrictions set out in that Annex but, by way of derogation, substances other than those listed in Annex II 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 Annex II 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 listed in Annex I to Regulation 10/2011 and subject to the restrictions in that Annex. 4 Materials and articles made of PRCF must comply with Article 12 (overall migration limit) as read with Articles 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 A person must not 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) or (7) . PART 6 Requirements for Plastic Materials and Articles Interpretation of Part 6 and the Schedule 13 Except in regulation 14(1), any reference in this Part and in Schedule 1 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 2 of Commission Regulation (EU) No 1282/2011 , Article 2 of Commission Regulation (EU) No 1183/2012 , Article 2 of Commission Regulation (EU) No 202/2014 , Article 2 of Commission Regulation (EU) No 2015/174 , Article 2 of Commission Regulation ( EU ) 2016/1416, Article 2 of Commission Regulation ( EU ) 2017/752; Article 2 of Commission Regulation ( EU ) 2018/79; Article 6 of Commission Regulation ( EU ) 2018/213 and Article 2 of Commission Regulation ( EU ) 2018/831, , 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 is guilty of an offence. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competent authorities for the purposes of Regulation 10/2011 15 1 The competent authorities for the purposes of Articles 8 and 16(1) of Regulation 10/2011 are the Food Standards Agency and each district council in its district. 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 paragraph 2 is subject to Article 1(3) (scope) . 2 A person must not 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Any person who contravenes paragraph (2) is guilty of an offence. Competent authorities for the purposes of Regulation 1895/2005 17 The competent authority for the purpose of Article 6(4) is each district council in its district. PART 7A Requirements for bisphenol A in varnishes and coatings intended to come into contact with food Interpretation of Part 7A 17A In this Part any reference to a numbered Article is a reference to the Article so numbered in Regulation 2018/213. Offences of contravening specified provisions of Regulation 2018/213 17B Subject to the transitional provisions contained in Article 6, any person who places on the market a material or article that fails to comply with Article 2 is guilty of an offence. Competent authorities for the purposes of Regulation 2018/213 17C The competent authorities for the purposes of Article 4(3) are the Food Standards Agency and each district council in its district. PART 8 Requirements for Vinyl chloride Requirements on materials and articles manufactured with 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 A person must not — 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 regulation 10(3), 12(8) or 18(2) is guilty of an offence. 2 Any person who intentionally obstructs a 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 is guilty of an offence. 3 Any person who, without reasonable excuse, fails to provide any assistance or information a person may reasonably require for the performance of their functions under the Regulations mentioned in paragraph (2) is guilty of an offence. 4 Any person who, in purported compliance with any requirement under paragraph (3), knowingly or recklessly supplies information that is false or misleading in any material particular is guilty of an offence. 5 A person guilty of an offence is liable — a in the case of an offence created by paragraph (1) or (4) or by regulation 4(3), 5, 7(1), 14(1), 16(4) or 17B — i on conviction on indictment to a fine or to a term of imprisonment not exceeding two years or both, or ii on summary conviction to a fine not exceeding level 5 on the standard scale; and b in the case of an offence created by paragraph (2) or (3), 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 a person to answer any question or give any information if to do so might incriminate that person. Enforcement 20 1 Each district council in its district must execute and enforce Regulation 1935/2004, Regulation 1895/2005, Article 4 of Regulation 2023/2006, Regulation 450/2009, Regulation 10/2011 and these Regulations. 2 The Food Standards Agency may also execute and enforce the provisions of — a Articles 16(1) and 17(2) of Regulation 1935/2004; b Article 13 of Regulation 450/2009; and c Article 16(1) of Regulation 10/2011. Offences due to the act or default of a third party 21 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 is guilty of 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 22 1 A prosecution for an offence under these Regulations shall not be commenced after the expiry of three years from the commission of the offence or, one year from its discovery by the prosecution, whichever is the earlier. 2 Paragraph (1) does not apply to an offence under regulation 19(2) or (3) . General defences 23 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 shall 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 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 entitled to rely on that defence, without leave of the court, unless — a at least seven 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 prosecution a notice in writing 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 24 1 An authorised officer who has procured a sample under Article 29 of the Order and who considers it should be analysed must divide the sample into three 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 three lots, and each lot must 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 Article 30 of the Order; and e retain one part for future submission under regulation 25. Secondary analysis by the Government Chemist 25 1 Where a sample has been retained under regulation 24(3)(e) and — a proceedings are intended to be or have been commenced against a person for an offence under these Regulations; and b the prosecution intends to adduce as evidence the result of the analysis mentioned in regulation 24(1), paragraphs (2) to (7) apply. 2 The authorised officer — a may of the officer's own volition; or b must — i if requested by the prosecutor (if a person other than the authorised officer), 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 (if a person other than the authorised officer) 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 In this regulation “ the accused ” includes a person against whom an authorised officer is intending to commence proceedings. Application of various provisions of the Order 26 1 Article 9(1) and (2) of the Order (improvement notices) applies for the purposes of these Regulations with the modification (in the case of Article 9(1)) set out in Schedule 2 Part 1 for the purposes of- a enabling an improvement notice to be served on a person requiring that person to comply with any of the following provisions— i regulations 10(4), 10(6), 12(6); ii Article 16 of Regulation 1935/2004; iii Article 5 of Regulation 1895/2005; iv Articles 12 and 13 of Regulation 450/2009; ... v the second sentence of Article 8, Article 15 as read with Annex IV and Article 16 of Regulation 10/2011; and vi Article 4 of Regulation 2018/213; and b making the failure to comply with a notice referred to in sub-paragraph (a) an offence. 2 The provisions of the Order specified in column 1 of the table in Part 2 to Schedule 2 apply, with the modifications (if any) specified in column 2 of that table. 3 Paragraphs (1) and (2) are without prejudice to the application of the Order to these Regulations for purposes other than those specified in paragraph (1). PART 10 General and supplementary Consequential amendment to the Food Safety (Sampling and Qualifications) Regulations (Northern Ireland) 1991 27 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amendment to the Food Labelling Regulations (Northern Ireland) 1996 28 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Revocations 29 The following are revoked — a The Ceramic Articles in Contact with Food Regulations (Northern Ireland) 2006 ; b The Plastic Materials and Articles in Contact with Food Regulations (Northern Ireland) 2009; c The Materials and Articles in Contact with Food Regulations (Northern Ireland) 2010; d The Plastic Materials and Articles in Contact with Food (Amendment) Regulations (Northern Ireland) 2011 . Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 22nd October 2012. Julie Thompson A senior officer of the Department of Health, Social Services and Public Safety