The Materials and Articles in Contact with Food (Scotland) Regulations 2012

Made: 22nd November 2012

Laid before the Scottish Parliament: 23rd November 2012

Coming into force: 22nd December 2012

The Scottish Ministers make 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 , paragraph 1A of Schedule 2 to the European Communities Act 1972 and all other powers enabling them to do so.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Scottish Ministers 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 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 Food Safety Act 1990, the Scottish Ministers have had regard to relevant advice given by the Food Standards Agency .

There has been consultation 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 .

PART 1 — Preliminary

Citation, extent and commencement

1

These Regulations may be cited as the Materials and Articles in Contact with Food (Scotland) Regulations 2012, extend to Scotland only and come into force on 22nd December 2012.

Interpretation

2

• (1) In these Regulations—

• “the Act” means the Food Safety Act 1990;

• ...

• ...

• “Regulation 1935/2004” means Regulation (EC) No. 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC ;

• “Regulation 1895/2005” means Commission Regulation (EC) No. 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food ;

• “Regulation 2023/2006” means Commission Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food;

• “Regulation 450/2009” means Commission Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with food ;

• “Regulation 10/2011” means Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food , as amended by Commission Regulation (EU) 2016/1416;

• “Regulation 2018/213” means Commission Regulation (EU) No. 2018/213 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” means an authority in terms of section 5(2) of the Act; and

• “preparation” includes manufacture and any form of treatment or process, and “prepare” is to be construed accordingly.

• (2) Expressions used in these Regulations and in Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009, Regulation 10/2011, or Regulation 2018/213 bear the same meaning in these Regulations as they bear in those Regulations.

• (3) Any reference in these Regulations to Regulation 2023/2006 ... or Regulation 10/2011 is a reference to that Regulation ... as amended from time to time.

Scope

3

These Regulations do not apply in relation to those materials and articles specified in Article 1(3) (purpose and subject-matter) of Regulation 1935/2004.

PART 2 — General requirements for materials and articles

Offences of contravening specified provisions of Regulation 1935/2004

4

• (1) No person may place on the market or use, in the course of a business in connection with the storage, preparation, packaging, sale or service of food any material or article that does not comply with the requirements of Article 3(1) (general requirements) or Article 4(1), (2), (3) or (4) (special requirements for active and intelligent materials and articles).

• (2) No person may place on the market any material or article that does not comply with the requirements of Article 3(2), 4(5) or (6) or 15(1), (3), (4), (7) or (8) as read with Article 15(2) (labelling).

• (3) Any person who contravenes paragraph (1) or (2) or Article 11(4) or (5) (... authorisation) or 17(2) (traceability) commits an offence.

• (4) In this regulation a reference to a numbered Article is a reference to that Article in Regulation 1935/2004.

Offence of contravening Article 4 of Regulation 2023/2006

5

Any person who fails to comply with the requirements of Article 4 (conformity with good manufacturing practice) of Regulation 2023/2006 commits an offence.

Competent authorities for the purposes of Regulation 1935/2004 and Regulation 2023/2006

6

• (1) The following bodies are designated as the competent authorities for the purposes of the provisions of Regulation 1935/2004 specified below—

• (a) in respect of Article 9 (application for authorisation of a new substance) ..., Food Standards Scotland; and

• (b) in respect of Articles 16 (declaration of compliance) and 17(2) (traceability), Food Standards Scotland and each food authority in its area.

• (2) The competent authority for the purposes of Articles 6(2) (quality control system) and 7(3) (documentation) of Regulation 2023/2006 is each food authority in its area.

PART 3 — Requirements for active and intelligent materials and articles

Offences of contravening specified provisions of Regulation 450/2009

7

• (1) Subject to the transitional provisions contained in Article 14 (entry into force and application) of Regulation 450/2009, any person who places on the market any active or intelligent material or article which does not comply with the requirements of Article 4 of that Regulation commits an offence .

• (2) Any person who fails to comply with the requirements of Article 13 (supporting documentation) of Regulation 450/2009 commits an offence.

Competent authorities for the purposes of Regulation 450/2009

8

The competent authorities for the purposes of Article 13 of Regulation 450/2009 are Food Standards Scotland and each food authority in its area.

PART 4 — Requirements for ceramic articles

Interpretation of this Part

9

In this Part—

• (a) “ceramic article” means an article, to which Regulation 1935/2004 applies by virtue of its Article 1(2) as read with its Article 1(3), which—

• (i) is manufactured from a mixture of inorganic materials with a generally high argillaceous or silicate content to which small quantities of organic materials may have been added;

• (ii) is first shaped with the shape thus obtained having been permanently fixed by firing; and

• (iii) may be glazed, enamelled and/or decorated; and

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Limits for lead and cadmium and declaration of compliance

10

• (1) The quantities of lead and cadmium transferred from a ceramic article must not exceed the limits set out in paragraph (5) as read with paragraphs (4) and (6).

• (2) Unless it is demonstrated that the materials used to make the ceramic article did not contain lead or cadmium, the quantities of lead and cadmium transferred from a ceramic article must be determined by means of a test, the conditions of which are specified in Schedule 3, using the method of analysis described in Schedule 4.

• (3) No person may place on the market a ceramic article that does not comply with the requirements of paragraph (1) as read with paragraph (2).

• (4) Where a ceramic article consists of a vessel fitted with a ceramic lid, the lead or cadmium limits (or both) which may not be exceeded (mg/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 obtained by this method must be related as appropriate to the surface area or the volume of the vessel alone.

• (5) A ceramic article is to be recognised as satisfying the requirements of these Regulations relating to such articles if the quantities of lead or cadmium (or both) extracted during the test carried out under the conditions laid down in Schedule 3 and Schedule 4 do not exceed the following limits—

	Pb	Cd
Category 1— Articles which cannot be filled and articles which can be filled, the internal depth of which, measured from the lowest point to the horizontal plane passing through the upper rim, does not exceed 25 mm.	0,8 mg/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

• (6) However, where a ceramic article does not exceed the above quantities by more than 50%, that article is nevertheless to be recognised as satisfying the requirements of these Regulations relating to such articles if at least three other articles with the same shape, dimensions, decoration and glaze are subjected to a test carried out under the conditions laid down in Schedule 3 and Schedule 4 and the average quantities of lead or cadmium (or both) extracted from those articles do not exceed the limits set, with none of those articles exceeding those limits by more than 50%.

PART 5 — Requirements for regenerated cellulose film

Interpretation of this Part

11

• (1) In this Part—

• (a) “regenerated cellulose film” means a thin sheet material obtained from refined cellulose derived from unrecycled wood or cotton, with or without the addition of suitable substances, either in the mass or on one or both surfaces, but does not include synthetic casings of regenerated cellulose;

• (b) “URCF” means uncoated regenerated cellulose film;

• (c) “CRCF” means coated regenerated cellulose film with coating derived from cellulose; and

• (d) “PRCF” means coated regenerated cellulose film with coating consisting of plastics.

• (2) This Part applies to regenerated cellulose film which—

• (a) constitutes a finished product in itself; or

• (b) is part of a finished product containing other materials,

and is intended to come into contact with food or, by being used for that purpose, does come into contact with food.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Controls and limits

12

• (1) URCF and CRCF may be manufactured using only the substances or groups of substances listed in schedule 6 (list of substances authorised in the manufacture of regenerated cellulose film) and subject to the restrictions set out in that schedule but, by way of derogation, substances other than those listed in schedule 6 may be used when these substances are employed either as—

• (a) dyes and pigments; or

• (b) adhesives,

provided that there is no trace of migration of the substances, detectable by a validated method, into or on to foodstuffs.

• (2) PRCF may be manufactured, prior to coating, using only substances or groups of substances listed in the first part of schedule 6 and subject to the restrictions set out in that part.

• (3) The coating to be applied to PRCF may be manufactured using only substances or groups of substances authorised under Regulation 10/2011 and subject to the restrictions in the authorisations concerned.

• (4) Materials and articles made of PRCF must comply with Article 12 (overall migration limit) as read with Article 17 (expression of migration test results) and Article 18 (rules for assessing compliance with migration limits) of Regulation 10/2011.

• (5) Printed surfaces of regenerated cellulose film must not come into contact with foodstuffs.

• (6) Any material or article made of regenerated cellulose film that is not by its nature clearly intended to come into contact with food must, at a marketing stage other than the retail stage, be accompanied by a written declaration attesting that it complies with the legislation applicable to it.

• (7) Where special conditions of use are indicated, the material or article made of regenerated cellulose film must be labelled accordingly.

• (8) No person may place on the market any regenerated cellulose film which has been manufactured in contravention of the requirements of paragraphs (1) to (4), or which fails to comply with paragraphs (5), (6) or (7).

PART 6 — Requirements for plastic materials and articles

Interpretation of Part 6 and Schedule 1

13

In this Part and in Schedule 1 any reference to a numbered Article or Annex is a reference to that Article of or Annex to Regulation 10/2011.

Offences of contravening specified provisions of Regulation 10/2011

14

• (1) Subject to the transitional arrangements set out in Article 22(5) and Article 23 , any person who places on the market a plastic material or article that fails to comply with a requirement of Regulation 10/2011 specified in column 1 of Schedule 1 commits an offence.

• (2) Any person who fails to comply with the second sentence of Article 8 (general requirements on substances) or, subject to transitional arrangements set out in Article 22(1), (2) and (3) , with Article 16 (supporting documents) commits an offence.

Competent authorities for the purposes of Regulation 10/2011

15

The competent authorities for the purposes of Regulation 10/2011—

• (a) Article 8 (general requirement on substances), and

• (b) Article 16(1) (supporting documents),

are Food Standards Scotland and each food authority in its area.

PART 7 — Requirements for certain epoxy derivatives

Restrictions on the use of certain epoxy derivatives (BADGE, BFDGE and NOGE)

16

• (1) In this Part—

• (a) any reference to a numbered Article or Annex is a reference to that Article or Annex in Regulation 1895/2005; and

• (b) paragraphs (2) and (3) are subject to Article 1(3) (scope) .

• (2) Subject to Article 6(1), (2) and (4) (transitional provisions) , no person may place on the market or use, in the course of a business in connection with the storage, preparation, packaging, sale or service of food—

• (a) any material or article in contravention of Article 3 (prohibition on use or presence of BFDGE) or Article 4 (prohibition on use or presence of NOGE); or

• (b) any material or article that fails to comply with the restrictions contained in Article 2 (BADGE) as read with Annex I (specific migration limit for BADGE and certain of its derivatives).

• (3) Subject to Article 6(3) , no person may place on the market any material or article which fails to comply with the requirements of Article 5 (written declaration) .

• (4) Any person who contravenes paragraph (2) or (3) commits an offence.

Competent authorities for the purposes of Regulation 1895/2005

17

The competent authority for the purpose of Article 6(4) is each food authority in its area.

PART 8 — Requirements for vinyl chloride

Requirements for vinyl chloride

18

• (1) Materials and articles, other than those materials and articles controlled by Regulation 10/2011, which are manufactured with vinyl chloride polymers or copolymers—

• (a) must not contain vinyl chloride monomer in a quantity exceeding 1 milligram per kilogram of the material or article; and

• (b) must be manufactured in such a way that they do not transfer to foods with which they are in contact any quantity of vinyl chloride exceeding 0.01 milligrams of vinyl chloride per kilogram of food.

• (2) No person may—

• (a) place on the market; or

• (b) use in the course of a business in connection with the storage, preparation, packaging, selling or service of food,

any material or article that does not comply with paragraph (1).

PART 9 — Enforcement

Offences and penalties

19

• (1) Any person who contravenes the provisions of regulation 10(3) or (4), 12(8) , 17B or 18(2) commits an offence.

• (2) Any person who intentionally obstructs any person acting in the execution of Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009, Regulation 10/2011 , Regulation 2018/213 or these Regulations commits an offence.

• (3) Any person who, without reasonable excuse, fails to provide any assistance or information that a person may reasonably require for the performance of their functions under the Regulations mentioned in paragraph (2) or fails to comply with regulation 10(6) commits an offence.

• (4) Any person who, in purported compliance with any requirement mentioned in paragraph (3), knowingly or recklessly supplies information that is false or misleading in any material particular, commits an offence.