Statutory Instruments
2012 No. 2619
Food, England
The Materials and Articles in Contact with Food (England) Regulations 2012
Made
17th October 2012
Laid before Parliament
22nd October 2012
Coming into force
20th November 2012
The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 16(2), 17(1) and (2), 26(1)(a), 2(a) and (3), 31 and 48(1) of the Food Safety Act 1990 , and now vested in him , as read with paragraph 1A of Schedule 2 to the European Communities Act 1972 .
These Regulations make provision for a purpose mentioned in section 2(2) of the 1972 Act and it appears to the Secretary of State that it is expedient for certain references to Commission Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food or to any Annex to the other EU instruments specified in regulation 2(3) to be construed as references to that Regulation or that Annex as amended from time to time.
In accordance with section 48(4A) of the 1990 Act he has 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.
PART 1Preliminary
Title, application and commencement
1. These Regulations may be cited as the Materials and Articles in Contact with Food (England) Regulations 2012, apply in relation to England only and come into force on 20th November 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 282/2008” means Commission Regulation (EC) No. 282/2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No. 2023/2006;
“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 ;
“Regulation 2018/213” means Commission Regulation (EU) No. 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 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” does not include the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and the Middle Temple) nor a port health authority;
“port health authority” means —
in relation to the London port health district (within the meaning given to that phrase for the purposes of the Public Health (Control of Disease) Act 1984 by section 7(1) of that Act), the Common Council of the City of London; and
in relation to any port health district constituted by order under section 2(3) of the Public Health (Control of Disease) Act 1984, a port health authority for that district constituted by order under section 2(4) of that Act;
“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 282/2008, 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 an ... instrument defined in regulation 2(1) is a reference to that ... instrument as amended from time to time.
Scope
3. The provisions of these Regulations do not apply in relation to those materials and articles specified in paragraph (3) of Article 1 (purpose and subject matter) of Regulation 1935/2004.
PART 2General 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) 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.
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 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) ..., the Food Standards Agency; and
(b)in respect of Articles16 (declaration of compliance) and 17(2) (traceability), the Food Standards Agency, each food authority in its area and each port health authority 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 food authority in its area.
PART 3Requirements 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, each food authority in its area and each port health authority in its district.
PART 4Requirements 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 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; ...
(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Limits for lead and cadmium and declaration of compliance
10.—(1)The quantities of lead and cadmium transferred from ceramic articles must not exceed the limits set out in paragraph (4) as read with paragraphs (3) and (5).
(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 ceramic articles must be determined by means of a test, the conditions of which are specified in Schedule 2, using the method of analysis described in Schedule 3.
(3)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/dm2 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 thus obtained must be related as appropriate to the surface area or the volume of the vessel alone.
(4)A ceramic article is to be recognised as satisfying the requirements of these Regulations relating to such articles if the quantities of lead and/or cadmium extracted during the test carried out under the conditions laid down in Schedule 2 and Schedule 3 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/dm2 0,07 mg/dm2. 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.
(5)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 2 and Schedule 3 and the average quantities of lead and/or cadmium extracted from those articles do not exceed the limits set, with none of those articles exceeding those limits by more than 50 %.
10A.—(1)No person may place on the market a ceramic article that does not comply with the requirements of regulation 10(1) as read with regulation 10(2).
(2)At the marketing stages up to and including the retail stage, ceramic articles which are not yet in contact with foodstuffs must be accompanied by a written declaration in accordance with Article 16 of Regulation 1935/2004. That declaration is to be issued by the manufacturer or by a seller in Great Britain and must contain the information laid down in Schedule 4.
(3)Appropriate documentation to demonstrate that the ceramic articles comply with the migration limits for lead and cadmium set out in regulation 10 must be made available by the manufacturer or the importer to the competent authorities on request. That documentation must contain the results of the analysis carried out, the test conditions and the name and the address of the laboratory that performed the testing.
(4)The documentation specified in paragraph (3) 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.
(5)Paragraphs (2) and (3) do not apply in relation to a ceramic article which is second-hand.
PART 5Requirements 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 5 (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 5 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 5 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 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) or (7) .
PART 6Requirements for Plastic Materials and Articles
Interpretation of Part 6 and the Schedule
13. In this Part and in the Schedule 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(4) and (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 the Schedule is guilty of an offence.
(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Competent authorities for the purposes of Regulation 10/2011
15.The competent authorities for the purposes of Articles 8 and 16(1) of and Annex 1, Table 3 (notes on verification of compliance), Notes (23) and (27) to Regulation 10/2011 are the Food Standards Agency, each food authority in its area and each port health authority in its district.
PART 6ARequirements for Recycled Plastic Materials and Articles
Interpretation of this Part
15A.In this Part any reference to a numbered Article is a reference to that Article of Regulation 282/2008.
Offences of contravening Article 3(1) of Regulation 282/2008
15B.Subject to the transitional provisions contained in Article 14, any person who places on the market a material or article that fails to comply with Article 3(1) (requirements for plastic materials and articles) is guilty of an offence.
Competent authorities for the purposes of Regulation 282/2008
15C.The competent authorities for the purposes of Article 10 are the Food Standards Agency and each food authority in its area.
PART 7Requirements 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) 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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 food authority in its area and each port health authority in its district.
PART 7ARequirements for bisphenol A
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 Article 2 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 food authority in its area.
PART 8Requirements 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).
(3)The criteria applicable to the method of determining the level of vinyl chloride in materials and articles and of determining vinyl chloride released by materials and articles are as set out in paragraphs (4), (5), and (6).
(4)The level of vinyl chloride in materials and articles and the level of vinyl chloride released by materials and articles to foodstuffs are determined by means of gas-phase chromatography using the ‘headspace’ method;
(5)For the purposes of determining vinyl chloride released by materials and articles to foodstuffs, the detection limit is 0.01 mg/kg;
(6)Vinyl chloride released by materials and articles to foodstuffs is in principle determined in the foodstuffs. When the determination in certain foodstuffs is shown to be impossible for technical reasons, competent authorities may permit determination by simulants for these particular foodstuffs.
PART 9Enforcement
Offences and penalties
19.—(1)Any person who contravenes regulation 10A(1), 12(8) or 18(2) is guilty of an offence.
(2)Any person who fails to comply with a compliance notice served on them under regulation 19A is guilty of an offence.
(3)Any person who intentionally obstructs a person acting in the execution of Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 282/2008, Regulation 450/2009, Regulation 10/2011, Regulation 2018/213 or these Regulations is guilty of an offence.
(4)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 (3) is guilty of an offence.
(5)Any person who, in purported compliance with any requirement under paragraph (4), knowingly or recklessly supplies information that is false or misleading in any material particular is guilty of an offence.
(6)A person guilty of an offence is liable—
(a)in the case of an offence created by regulation 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 or to a term of imprisonment not exceeding six months or both;
(b)in the case of an offence created by paragraphs (1), (2), (3), (4) or (5) of this regulation or by regulation 4(3), 5, 7(1), 14(1), 15B or 16(4) on summary conviction to a fine.
(7)Nothing in paragraph (3) or (4) is to be construed as requiring a person to answer any question or give any information if to do so might incriminate that person.
Compliance notices
19A.—(1)If an authorised officer has reasonable grounds for believing that any person has not complied with, is not complying with, or is not likely to comply with a provision specified in regulation 19B (which provisions concern declarations of compliance with legislative requirements or supporting documentation), the officer may serve a compliance notice on that person.
(2)A compliance notice must state—
(a)the reason for the service of the notice and the steps the person on whom the notice has been served must take;
(b)the date and, if appropriate, the time by which each step must be taken;
(d)that a failure to comply with the notice is an offence; and
(e)the details of the right to appeal against the notice under regulation 19C.
(3)An authorised officer may serve a notice on a person withdrawing, varying or suspending a compliance notice.
19B.The provisions are—
(a)paragraphs (2) and (3) of regulation 10A;
(b)paragraph (6) of regulation 12;
(c)Article 16 of Regulation 1935/2004;
(d)Article 5 of Regulation 1895/2005;
(e)Articles 10(3) and 12 of Regulation 282/2008;
(f)Articles 12 and 13 of Regulation 450/2009;
(g)the second sentence of Article 8, Article 15 as read with Annex 4 and Article 16 of Regulation 10/2011;
(h)Article 4 of Regulation 2018/213.
Appeal against a compliance notice
19C.—(1)Any person served with a compliance notice may appeal against that notice to a magistrates’ court.
(2)The procedure on appeal to a magistrates’ court is by way of complaint for an order, and the Magistrates’ Courts Act 1980 applies to the proceedings.
(3)The period within which an appeal may be brought is one month from the date on which the compliance notice was served on the person wishing to appeal and the making of a complaint for an order is deemed for the purposes of this paragraph to be the bringing of the appeal.
(4)A compliance notice is not suspended pending an appeal unless—
(a)an authorised officer suspends it under regulation 19A(3); or
(b)the court directs that it be suspended.
(5)The court may—
(a)confirm the notice or any requirement contained in it;
(b)vary the notice or any requirement contained in it; or
(c)revoke the notice or any requirement contained in it.
Execution and enforcement
20.—(1)Each food authority in its area is to execute and enforce Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 282/2008, Regulation 450/2009, Regulation 10/2011, Regulation 2018/213 and these Regulations.
(2)Each port health authority in its district is to execute and enforce Regulation 1935/2004, Regulation 1895/2005, Regulation 450/2009, Regulation 10/2011, Regulation 2018/213 and these Regulations.
(3)The Food Standards Agency may execute and enforce the provisions of—
(a)Articles 16 and 17(2) of Regulation 1935/2004;
(b)Article 10 of Regulation 282/2008;
(c)Article 13 of Regulation 450/2009;
(d)Article 8 and 16(1) of and Annex 1, Table 3 (notes on verification of compliance), Notes (23) and (27) to Regulation 10/2011; and
(e)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 shall be deemed to be guilty of 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 be guilty of 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 shall be 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
23.—(1) No prosecution for an offence under these Regulations shall be begun after the expiry of three 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 19(3) or (4) .
General defences
24.—(1) In any proceedings for an offence under these Regulations it shall, subject to paragraph (5), be 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), 15B, 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 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 shall not without leave of the court be entitled to rely on that defence 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 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 shall 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 shall divide the sample into parts by putting the containers into three lots, and each lot shall be treated as being a part.
(3) The authorised officer shall —
(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)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 25(1),
paragraphs (2) to (7) apply.
(2) The authorised officer —
(a)may of the officer's own volition; or
(b)shall —
(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 shall 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 shall 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 shall 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 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);
(b)section 30(8) (analysisetc. 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 282/2008, 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 282/2008, 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” is to be deemed to include references to “placed on the market” and “placing on the market” respectively;
(b)section 44 (protection of officers acting in good faith).
PART 10General and supplementary
Consequential amendment to the Food Safety (Sampling and Qualifications) Regulations 1990
28. In the Food Safety (Sampling and Qualifications) Regulations 1990 , in Schedule 1 (provisions to which those Regulations do not apply) —
(a)omit the title and reference of the Plastic Materials and Articles in Contact with Food (England) Regulations 2009 ; and
(b)for the title and reference of the Materials and Articles in Contact with Food (England) Regulations 2010 substitute the title and reference of these Regulations.
Amendment to the Food Labelling Regulations 1996
29.—(1)The Food Labelling Regulations 1996 are amended in accordance with paragraph (2).
(2) In regulation 2(1) (interpretation), for the definition of “ingredient” substitute the following definition —
““ingredient” means —
any substance, including any additive or food enzyme and any constituent of a compound ingredient, which is used in the preparation of a food and which is still present in the finished product, even if in altered form; or
any released active substance within the meaning of Article 3(f) of Commission Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with food,
and a “compound ingredient” shall be composed of two or more such substances;.”.
(3) Paragraphs (1) and (2) expire on 13th December 2014.
Statutory Review
30.—(1) The Food Standards Agency must from time to time —
(a)carry out a review of the operation and effect of regulations 1 to 27;
(b)set out the conclusions of the review in a report; and
(c)publish the report.
(2) In carrying out the review the Food Standards Agency must, so far as is reasonable, have regard to the operation of the relevant assimilated instruments .
(3) The report must in particular —
(a)set out the objectives intended to be achieved by the regulatory system established by these Regulations;
(b)assess the extent to which those objectives are achieved; and
(c)assess whether those objectives remain appropriate and, if they do, the extent to which they could be achieved with a system that imposes less regulation.
(4) The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.
(5) Reports under this regulation are afterwards to be published at intervals not exceeding five years.
(6) In this regulation “the relevantassimilated instruments” means ... Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009 and Regulation 10/2011.
Revocations
31. The following Regulations are revoked —
(a)The Ceramic Articles in Contact with Food (England) Regulations 2006 ;
(b)The Plastic Materials and Articles in Contact with Food (England) Regulations 2009;
(c)The Materials and Articles in Contact with Food (England) Regulations 2010;
(d)The Plastic Materials and Articles in Contact with Food (England) (Amendment) Regulations 2011
Signed by authority of the Secretary of State for Health.
Anna Soubry
Parliamentary Under-Secretary of State,
Department of Health
Regulation 14(1)
THE SCHEDULESpecified provisions of Regulation 10/2011
| Specified provision | Subject matter |
|---|---|
| Article 4(e), as read with Articles 17 and 18 | Prohibition on placing on the market plastic materials or articles if they do not meet specified compositional and declaration requirements |
| Article 5(1) and Annex I, as read with Article 6 | Requirement, subject to certain derogations, to use only authorised substances in the manufacture of plastic layers in plastic materials and articles |
| Article 8, first sentence | General quality and purity standards that must be observed for substances used in the manufacture of plastic layers in plastic materials and articles |
| Article 9 as read with Annex I | Particular restrictions and specifications for substances used in the manufacture of plastic layers in plastic materials and articles |
| Article 10 as read with Annex II | General restrictions on plastic materials and articles |
| Article 11(1) and Annex 1, as read with Article 11(3) and (4) | Specific limits on the degree to which constituents of plastic materials and articles are permitted to migrate into foods |
| Article 12 | Overall limits on the permitted level of migration of the constituents of plastic materials and articles into food simulants |
| Article 13(1),(3),(4) and (5) and Annex I as read with Article 13(2) | Particular restrictions and specifications for the composition of each plastic layer in plastic multi-layer materials and articles |
| Article 14(1) and (5) and Annex 1, as read with Article 14(2),(3) and (4) | Particular restrictions and specifications for the composition of each plastic layer in multi-material multi-layer materials and articles |
| . . . | . . . |
Regulation 10
SCHEDULE 2BASIC RULES FOR DETERMINING THE MIGRATION OF LEAD AND CADMIUM
1.Test liquid
4 % (v/v) acetic acid, in a freshly prepared aqueous solution.
2.Test conditions
(a)Carry out the test at a temperature of 22 ± 2 °C for a duration of 24 ± 0,5 hours.
(b)When the migration of lead is to be determined, cover the sample by an appropriate means of protection and expose it to the usual lighting conditions in a laboratory. When the migration of cadmium or of lead and cadmium is to be determined, cover the sample so as to ensure that the surface to be tested is kept in total darkness.
3.Filling
(a)Samples which can be filled—
Fill the article with a 4 % (v/v) acetic acid solution to a level no more than1 mm from the overflow point; the distance is measured from the upper rimof the sample. Samples with a flat or slightly sloping rim should be filled so that the distance between the surface of the liquid and the overflow point is no more than 6 mm measured along the sloping rim.
(b)Samples which cannot be filled—
The surface of the sample which is not intended to come into contact with foodstuffs is first covered with a suitable protective layer able to resist the action of the 4 % (v/v) acetic acid solution. The sample is then immersed in a recipient containing a known volume of acetic acid solution in such a way that the surface intended to come into contact with foodstuffs is completely covered by the test liquid.
4.Determination of the surface area
The surface area of the articles in Category 1 is equal to the surface area of the meniscus formed by the free liquid surface obtained by complying with the filling requirements set out in paragraph 3 above.
Regulation 10
SCHEDULE 3METHODS OF ANALYSIS FOR DETERMINATION OF THE MIGRATION OF LEAD AND CADMIUM
1.Object and field of application
The method allows the specific migration of lead and/or cadmium to be determined.
2.Principle
The determination of the specific migration of lead and/or cadmium is carried out by an instrumental method of analysis that fulfils the performance criteria of paragraph 4.
3.Reagents
All reagents must be of analytical quality, unless otherwise specified.
Where reference is made to water, it means distilled water or water of equivalent quality.
(a)4 % (v/v) acetic acid, in aqueous solution.
Add 40 ml of glacial acetic acid to water and make up to 1 000 ml.
(b)Stock solutions
Prepare stock solutions containing 1 000 mg/litre of lead and at least 500 mg/litre of cadmium respectively in a 4 % acetic acid solution, as referred to in paragraph (a).
4.Performance criteria of the instrumental method of analysis
(a)The detection limit for lead and cadmium must be equal to or lower than— 0,1 mg/litre for lead; 0,01 mg/litre for cadmium.
The detection limit is defined as the concentration of the element in the 4 % acetic acid solution, as referred to in paragraph 3(a) which gives a signal equal to twice the background noise of the instrument.
(b)The limit of quantification for lead and cadmium must be equal to or lower than— 0,2 mg/litre for lead; 0,02 mg/litre for cadmium.
(c)Recovery. The recovery of lead and cadmium added to the 4 % acetic acid solution, as referred to in point 3(a), must lie within 80-120 % of the added amount.
(d)Specificity. The instrumental method of analysis used must be free from matrix and spectral interferences.
5.Method
(a)Preparation of the sample
The sample must be clean and free from grease or other matter likely to affect the test.
Wash the sample in a solution containing a household liquid detergent at a temperature of approximately 40 °C. Rinse the sample first in tap water and then in distilled water or water of equivalent quality. Drain and dry so as to avoid any stain. The surface to be tested is not to be handled after it has been cleaned.
(b)Determination of lead and/or cadmium
The sample thus prepared is tested under the conditions laid down in Schedule 2.
Before taking the test solution for determining lead and/or cadmium, homogenise the content of the sample by an appropriate method, which avoids any loss of solution or abrasion of the surface being tested.
Carry out a blank test on the reagent used for each series of determinations.
Carry out determinations for lead and/or cadmium under appropriate conditions.
Regulation 10A
SCHEDULE 4DECLARATION OF COMPLIANCE
1.The written declaration referred to in regulation 10A must contain the following information—
(a)the identity and address of the company which manufactures the finished ceramic article and of the importer who imports it into Great Britain;
(b)the identity of the ceramic article;
(c)the date of the declaration;
(d)the confirmation that the ceramic article meets relevant requirements in these Regulations and Regulation 1935/2004.
2.The written declaration must permit an easy identification of the goods for which it is issued and must be renewed when substantial changes in the production bring about changes in the migration of lead or cadmium or both.
Regulation 12(1)
SCHEDULE5LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM
DESCRIPTION OF REGENERATED CELLULOSE FILM
Regenerated cellulose film is a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.
LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM
Notes:
The percentages in this Schedule, in the first and second parts, are expressed in weight/weight (w/w) and are calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film.
The usual technical denominations are given in square brackets.
The substances used shall be of good technical quality as regards the purity criteria.
First Part: Uncoated regenerated cellulose film
| Denominations | Restrictions |
|---|---|
| A. Regenerated cellulose | Not less than 72% (w/w) |
| B. Additives | |
| 1. Softeners | Not more than 27% (w/w) in total |
| — Bis (2-hydroxyethyl) ether [= diethyleneglycol] | Only for films intended to be coated and then used for foodstuffs which are not moist, namely which do not contain water which is physically free at the surface. The total amount of bis(2-hydroxyethyl)ether and ethanediol present in foodstuffs that have been in contact with film of this type may not exceed 30 mg/kg of the foodstuff. |
| — Ethanediol [= monoethyleneglycol] | |
| — 1.3-butanediol | |
| — Glycerol | |
| — 1.2-propanediol [= 1.2 propyleneglycol] | |
| — Polyethylene oxide [= polyethyleneglycol] | Average molecular weight between 250 and 1200. |
| — 1.2-polypropylene oxide [= 1.2 polypropyleneglycol] | Average molecular weight not greater than 400 and free 1.3-propanediol content not greater than 1% (w/w) in substance. |
| — Sorbitol | |
| — Tetraethyleneglycol | |
| — Triethyleneglycol | |
| — Urea | |
| 2. Other additives | Not more than 1% (w/w) in total. |
| First class | The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm2 of the uncoated film. |
| — Acetic acid and its NH4, Ca, Mg, K and Na salts | |
| — Ascorbic acid and its NH4, Ca, Mg, K and Na salts | |
| — Benzoic acid and sodium benzoate | |
| — Formic acid and its NH4, Ca, Mg, K and Na salts | |
| — Linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also behenic and ricinoleic acids and the NH4, Ca, Mg, K, Na, Al, Zn salts of these acids | |
| — Citric, d- and l-lactic, maleic, l-tartaric acids and their Na and K salts | |
| — Sorbic acid and its NH4, Ca, Mg, K and Na salts | |
| — Amides of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also the amides of behenic and ricinoleic acids | |
| — Natural edible starches and flours | |
| — Edible starches and flours modified by chemical treatment | |
| — Amylose | |
| — Calcium and magnesium carbonates and chlorides | |
| — Esters of glycerol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and/or with adipic, citric, 12-hydroxystearic (oxystearin), ricinoleic acids | |
| — Esters of polyoxyethylene (8 to 14 oxyethylene groups) with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive | |
| — Esters of sorbitol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive | |
| — Mono-and/or di-esters of stearic acid with ethanediol and/or bis (2-hydroxyethyl) ether and/or triethylene glycol | |
| — Oxides and hydroxides of aluminium, calcium, magnesium and silicon and silicates and hydrated silicates of aluminium, calcium, magnesium and potassium | |
| — Polyethylene oxide [= polyethyleneglycol] | Average molecular weight between 1200 and 4000. |
| — Sodium propionate | |
| Second class | The total quantity of the substances may not exceed 1 mg/dm2 of the uncoated film and the quantity of the substance or group of substances in each indent may not exceed 0.2 mg/dm2 (or a lower limit where one is specified) of the uncoated film. |
| — Sodium alkyl (C8-C18) benzene sulphonate | |
| — Sodium isopropyl naphthalene sulphonate | |
| — Sodium alkyl (C8-C18) sulphate | |
| — Sodium alkyl (C8-C18) sulphonate | |
| — Sodium dioctylsulphosuccinate | |
| — Distearate of dihydroxyethyl diethylene triamine monoacetate | Not more than 0.05 mg/dm2 of the uncoated film. |
| — Ammonium, magnesium and potassium lauryl sulphates | |
| — N,N′-distearoyl diaminoethane, N,N′-dipalmitoyl diaminoethane and N,N′-dioleoyl diaminoethane | |
| — 2-heptadecyl-4.4-bis(methylene-stearate) oxazoline | |
| — Polyethylene-aminostearamide ethylsulphate | Not more than 0.1 mg/dm2 of the uncoated film. |
| Third class — Anchoring agent | The total quantity of substances may not exceed 1 mg/dm2 of the uncoated film. |
— Condensation product of melamine-formaldehyde unmodified, or which may be modified with one or more of the following products: butanol, diethylenetriamine, ethanol, triethylenetetramine, tetraethylenepentamine, tri-(2-hydroxyethyl) amine, 3.3′-diaminodipropylamine, 4.4′-diaminodibutylamine | Free formaldehyde content not greater than 0.5 mg/dm2 of the uncoated film. Free melamine content not greater than 0.3 mg/dm2 of the uncoated film. |
| — Condensation product of melamine-urea-formaldehyde modified with tris-(2-hydroxyethyl)amine | Free formaldehyde content not greater than 0.5 mg/dm2 of the uncoated film. Free melamine content not greater than 0.3 mg/dm2 of the uncoated film. |
— Cross-linked cationic polyalkyleneamines: (a) polyamide-epichlorhydrin resin based on diaminopropylmethylamine and epichlorhydrin; (b) polyamide-epichlorhydrin resin based on epichlorhydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine; (c) polyamide-epichlorhydrin resin based on adipic acid, diethylenetriamine and epichlorhydrin, or a mixture of epichlorhydrin and ammonia; (d) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, dimethyl adipate and diethylenetriamine; (e) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, adipamide and diaminopropylmethylamine | |
| — Polyethyleneamines and polyethyleneimines | Not more than 0.75 mg/dm 2 of the uncoated film. |
— Condensation product of urea-formaldehyde unmodified, or which may be modified with one or more of the following products: aminomethylsulphonic acid, sulphanilic acid, butanol, diaminobutane, diaminodiethylamine, diaminodipropylamine, diaminopropane, diethylenetriamine, ethanol, guanidine, methanol, tetraethylenepentamine, triethylenetetramine, sodium sulphite | Free formaldehyde content not greater than 0.5 mg/dm 2 of the uncoated film. |
| Fourth class | The total quantity of substances may not exceed 0.01 mg/dm 2 of the uncoated film. |
| — Products resulting from the reaction of the amines of edible oils with polyethylene oxide | |
| — Monoethanolamine lauryl sulphate |
Second Part: Coated regenerated cellulose film
| Denominations | Restrictions |
|---|---|
| A. Regenerated cellulose | See first part. |
| B. Additives | See first part. |
| C. Coating | |
| 1. Polymers | The total quantity of substances may not exceed 50 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| — Ethyl, hydroxyethyl, hydroxypropyl and methyl ethers of cellulose | |
| — Cellulose nitrate | Not more than 20 mg/dm 2 of the coating on the side in contact with foodstuffs; nitrogen content between 10.8 % (w/w) and 12.2 % (w/w) in the cellulose nitrate. |
| 2. Resins | The total quantity of substances may not exceed 12.5 mg/dm 2 of the coating on the side in contact with foodstuffs and which is used solely for the preparation of regenerated cellulose films with cellulose nitrate based coatings. |
| — Casein | |
| — Colophony and/or its products of polymerization, hydrogenation, or disproportionation and their esters of methyl, ethyl or C 2to C 6polyvalent alcohols, or mixtures of these alcohols | |
| — Colophony and/or its products of polymerization, hydrogenation, or disproportionation condensed with acrylic, maleic, citric, fumaric and/or phthalic acids and/or 2.2 bis (4-hydroxyphenyl) propane formaldehyde and esterified with methyl ethyl or C 2to C 6polyvalent alcohols or mixtures of these alcohols | |
| — Esters derived from bis(2-hydroxyethyl) ether with addition products of betapinene and/or dipentene and/or diterpene and maleic anhydride | |
| — Edible gelatine | |
| — Castor oil and its products of dehydration or hydrogenation and its condensation products with polyglycerol, adipic, citric, maleic, phthalic and sebacic acids | |
| — Natural gum [= damar] | |
| — Poly-beta-pinene [= terpenic resins] | |
| — Urea-formaldehyde resins (see anchoring agents) | |
| 3. Plasticisers | The total quantity of substances may not exceed 6 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| — Acetyl tributyl citrate | |
| — Acetyl tri(2-ethylhexyl) citrate | |
| — Di-isobutyl adipate | |
| — Di-n-butyl adipate | |
| — Di-n-hexyl azelate | |
| — Dicyclohexyl phthalate | Not more than 4.0 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| — 2-ethylhexyl diphenyl phosphate (synonym: phosphoric acid diphenyl 2 ethylhexyl ester) | The amount of 2-ethylhexyl diphenyl phosphate shall not exceed: (a) 2.4 mg/kg of the foodstuff in contact with this type of film; or (b) 0.4 mg/dm2 in the coating on the side in contact with foodstuffs. |
| — Glycerol monoacetate [= monoacetin] | |
| — Glycerol diacetate [= diacetin] | |
| — Glycerol triacetate [= triacetin] | |
| — Di-butyl sebacate | |
| — Di-n-butyl tartrate | |
| — Di-isobutyl tartrate | |
| 4. Other additives | The total quantity of substances may not exceed 6 mg/dm 2 in the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs. |
| 4.1. Additives listed in the first part | Same restrictions as in the first part (however the quantities in mg/dm 2 refer to the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs). |
| 4.2. Specific coating additives | The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm 2 (or a lower limit where one is specified) of the coating on the side in contact with foodstuffs. |
| — 1-hexadecanol and 1-octadecanol | |
| — Esters of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and of ricinoleic acid with ethyl, butyl, amyl and oleyl linear alcohols | |
| — Montan waxes, comprising purified montanic (C 26to C 32) acids and/or their esters with ethanediol and/or 1.3 butanediol and/or their calcium and potassium salts | |
| — Carnauba wax | |
| — Beeswax | |
| — Esparto wax | |
| — Candelilla wax | |
| — Dimethylpolysiloxane | Not more than 1 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| — Epoxidised soya-bean oil (oxirane content 6 to 8 %) | |
| — Refined paraffin and microcrystalline waxes | |
| — Pentaerythritol tetrastearate | |
| — Mono and bis(octadecyldiethyleneoxide)-phosphates | Not more than 0.2 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| — Aliphatic acids (C 8to C 20) esterified with mono- or di-(2-hydroxyethyl)amine | |
| — 2- and 3-tert.butyl-4-hydroxyanisole [= butylated hydroxyanisole — BHA] | Not more than 0.06 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| — 2.6-di-tert.butyl-4-methylphenol [= butylated hydroxytoluene — BHT] | Not more than 0.06 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| — Di-n-octyltin-bis(2-ethylhexyl) maleate | Not more than 0.06 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| 5. Solvents | The total quantity of substances may not exceed 0.6 mg/dm 2 of the coating on the side in contact with foodstuffs. |
| — Butyl acetate | |
| — Ethyl acetate | |
| — Isobutyl acetate | |
| — Isopropyl acetate | |
| — Propyl acetate | |
| — Acetone | |
| — 1-butanol | |
| — Ethanol | |
| — 2-butanol | |
| — 2-propanol | |
| — 1-propanol | |
| — Cyclohexane | |
| — Ethyleneglycol monobutyl ether | |
| — Ethyleneglycol monobutyl ether acetate | |
| — Methyl ethyl ketone | |
| — Methyl isobutyl ketone | |
| — Tetrahydrofuran | |
| — Toluene | Not more than 0.06 mg/dm 2 of the coating on the side in contact with foodstuffs. |