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 1 — Preliminary

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; andin 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 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) 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 Articles 16 (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 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, each food authority in its area and each port health authority in its district.

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 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 %.

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 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 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) or (7).

PART 6 — Requirements for Plastic Materials and Articles

Interpretation of Part 6 and the Schedule

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 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 ... Regulation 10/2011 are the Food Standards Agency, each food authority in its area and each port health authority 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) 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 8 — 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).

• (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;