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WELSH STATUTORY INSTRUMENTS

2007 No. 3252 (W.287)
FOOD, WALES
The Materials and Articles in Contact with Food (Wales) Regulations 2007

	Made	13 November 2007
	Laid before the National Assembly for Wales	14 November 2007
	Coming into force
	for the purpose of regulations 5, 7 and 14(3)	1 August 2008
	for all other purposes	6 December 2007

CONTENTS

PART 1
Preliminary

1.	Title, application and commencement

2.	Interpretation

3.

Scope

PART 2
General Requirements for Materials and Articles

4.	Enforcement of Regulation 1935/2004

5.	Enforcement of Regulation 2023/2006

6.	Competent authorities for the purposes of Regulation 1935/2004

7.	Competent authority for the purposes of Regulation 2023/2006

PART 3
Requirements for Vinyl Chloride

8.	Limits and migration limits

9.	Methods of Analysis

PART 4
Requirements for Regenerated Cellulose Film

10.	Controls and limits

11.	Migration limits for regenerated cellulose film coated with plastics

12.	Saving and transitional provisions and defences

PART 5
General

13.	Offences and penalties

14.	Enforcement

15.	Offences by corporate bodies or Scottish partnerships

16.	Offences due to the act or default of a third party

17.	Time limit for prosecutions

18.	General defences

19.	Procedure where a sample is to be analysed

20.	Secondary analysis by the Government Chemist

21.	Application of various provisions of the Act

22.	Amendment of the Ceramic Articles in Contact with Food (Wales) Regulations 2006

23.	Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990

24.	Consequential amendments to the 2006 Regulations

25.	Revocations

The Welsh 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), and 48(1) of the Food Safety Act 1990[1], as read with paragraph 1A of Schedule 2 to the European Communities Act 1972[2].

     These Regulations make provision for a purpose mentioned in section 2(2) of the 1972 Act and it appears to the Welsh Ministers that it is expedient for certain references to a Community instrument or to an Annex to a Community instrument as specified in regulation 2(4) to be construed as references to that instrument or Annex as amended from time to time.

     In accordance with section 48(4A) of the 1990 Act they have 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[3], there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

PART 1
Preliminary
Title, application and commencement
     1. The title of these Regulations is the Materials and Articles in Contact with Food (Wales) Regulations 2007, apply in relation to Wales and come into force —

Interpretation
2. —(1) In these Regulations —

"the Act" ("the Act") means the Food Safety Act 1990;

"the 2006 Regulations" ("Rheoliadau 2006") means the Plastic Materials and Articles in Contact with Food (Wales) Regulations 2006[

4

Cyfarwyddeb 2002/72/EC

5

Cyfarwyddeb 2007/42/EC

6

Rheoliad 1935/2004

7

Rheoliad 2023/2006

8

swyddog awdurdodedig

awdurdod bwyd

mewnforio

plastigion

awadurdod iechyd porthladd

paratoad

caen cellwlos atgynyrchiedig

gwerthu

    (2) Except in regulations 5 and 7, any reference in these Regulations to a numbered Article is a reference to the Article bearing that number in Regulation 1935/2004.

    (3) Expressions used in these Regulations and in Regulation 1935/2004 or Regulation 2023/2006 bear the same meaning in these Regulations as they bear in those Regulations.

    (4) Any reference to Regulation 2023/2006 or to an Annex of Directive 2002/72/EC or of Directive 2007/42/EC is a reference to that Regulation or that Annex as amended from time to time.

Scope
     3. The provisions of these Regulations do not apply to those materials and articles specified in sub-paragraphs (a), (b) and (c) of Article 1(3).

PART 2
General Requirements for Materials and Articles
Enforcement of Regulation 1935/2004
4. Subject to the provisions of Article 27 (transitional arrangements), any person who contravenes any of the following provisions of Regulation 1935/2004 is guilty of an offence —

Enforcement 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
6. The following bodies are designated as the competent authorities for the purposes of the provisions of Regulation 1935/2004 as specified below —

(a) in respect of Articles 9 and 13, the Food Standards Agency;

(b) in respect of Articles 16(1) and 17(2), the Food Standards Agency and the authority having responsibility for enforcement pursuant to regulation 14(1).

Competent authority for the purposes of Regulation 2023/2006
7. The competent authority for the purposes of Article 6(2) and 7(3) of Regulation 2023/2006 is each food authority in its area.

PART 3
Requirements for Vinyl Chloride
Limits and migration limits
8. —(1) Materials and articles which are manufactured with vinyl chloride polymers or copolymers —

(2) No person may —

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

Methods of Analysis
9. —(1) The method used in analysing any sample for the purpose of establishing the quantity of vinyl chloride monomer present in the material or article in order to determine whether it complies with regulation 8(1)(a) is the method specified in the Annex to Commission Directive 80/766/EEC (which lays down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs)[9].

(2) The method used in analysing any food for the purpose of establishing the quantity of vinyl chloride present in the food in order to determine whether a material or article which is or has been in contact with the food complies with regulation 8(1)(b) is the method specified in the Annex to Commission Directive 81/432/EEC (which lays down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs)[10].

PART 4
Requirements for Regenerated Cellulose Film
Controls and limits
10. —(1) This Part applies to regenerated cellulose film which —

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

(2) Except in paragraph (4), any reference in this regulation to Annex II is a reference to Annex II to Directive 2007/42/EC.

(3) Subject to paragraph (5), no person may manufacture any regenerated cellulose film intended to come into contact with food using any substance or group of substances other than the substances named or described —

(b) in the first column of the First Part of Annex II in the case of film to be coated, where the coating will consist of plastics,

and other than in accordance with the conditions and restrictions specified in the corresponding entry in the second column of the appropriate Part of Annex II, as read with the preamble to that Annex.

    (4) No person may manufacture any coating to be applied to film referred to in paragraph (3)(b) using any substance or group of substances except those listed in Annex II, III or IV to Directive 2002/72/EC and other than in accordance with the appropriate requirements, restrictions and specifications contained in those Annexes and in the 2006 Regulations.

    (5) Substances other than those listed in Annex II may be used as colourants or adhesives in the manufacture of a film to which paragraph (3)(a) applies, provided that such film is manufactured in such a way that it does not transfer any colourant or adhesive to food in any detectable quantity.

    (6) Subject to regulation 12 no person may —

any regenerated cellulose film which has been manufactured in contravention of the requirements of paragraphs (3) or (4), or which fails to comply with paragraph (8).

(7) No person may use in the course of a business in connection with the storage, preparation, packaging, serving or selling of food —

(8) Any material or article made of regenerated cellulose film, unless by its nature clearly intended to come into contact with food, at a marketing stage other than the retail stage must be accompanied by a written declaration attesting that it complies with the legislation applicable to it.

Migration limits for regenerated cellulose film coated with plastics
11. —(1) Subject to paragraph (2), no person may manufacture or import any material or article made with regenerated cellulose film coated with plastics which —

(a) is intended to come into contact with food; and

(b) is capable of transferring its constituents to food in quantities exceeding an overall migration limit of 10 milligrams per square decimetre of the surface of the material or article in contact with food.

(2) In the case of any material or article made with regenerated cellulose film coated with plastics which —

(a) is or is comparable to a container or which can be filled with a capacity of not less than 500 millilitres and not more than 10 litres; or

(b) can be filled and for which it is impracticable to estimate the surface area in contact with food; or

(c) is a cap, gasket, stopper or similar device for sealing,

the overall migration limit is to be 60 milligrams of constituents transferred per kilogram of food.

(3) No person may manufacture or import any material or article made with regenerated cellulose film coated with plastics manufactured with any substance listed in Section A or B of Annex II to Directive 2002/72/EC (authorised monomers and other starting substances) which —

(a) is intended to come into contact with food; and

(b) is capable of transferring its constituents to food in quantities exceeding the specific migration limits set out in column 4 of those Sections as read with the general introduction to that Annex.

(4) Where the migration limit for a substance mentioned in paragraph (3) is expressed in milligrams per kilogram, in the case of regenerated cellulose film coated with plastics which —

(a) is or is comparable to a container or which can be filled with a capacity of less than 500 millilitres or more than 10 litres; or

(b) cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the film and the quantity of food in contact with it,

the migration limit is to be divided by the conversion factor of 6 in order to express it in milligrams of constituents transferred per square decimetre of the material or article in contact with food.

    (5) Subject to paragraph (6), the verification of compliance with migration limits is to be conducted in accordance with the provisions of Schedules 2 and 3 of the 2006 Regulations as read with regulation 11 of those Regulations and for the purposes of this paragraph any reference in those provisions to a plastic material or article is to be construed as a reference to regenerated cellulose film coated with plastic.

    (6) Paragraph (5) does not apply in any circumstances to which regulation 9(1) or (2) is applicable.

Saving and transitional provisions and defences
     12. —(1) Notwithstanding the revocation of the Materials and Articles in Contact with Food Regulations 1987[11], in relation to regenerated cellulose film manufactured before 29th April 1994 the defences in regulation 6A of those Regulations apply in relation to offences under these Regulations in like manner as they applied to offences under the equivalent provisions in those Regulations.

    (2) In any proceedings for an offence of contravening regulation 10(3), (4), (6) or (7), or regulation 11(1) or (3) it is a defence to prove that —

12

PART 5
General
Offences and penalties
13. —(1) Any person who —

is guilty of an offence.

(2) Any person guilty of an offence under these Regulations is liable —

(b) in the case of an offence mentioned in paragraph (1)(b) on summary conviction to a term of imprisonment not exceeding 3 months or to a fine not exceeding level 5 on the standard scale or both.

(3) Nothing in paragraph (1)(b) is to be construed as requiring any person to answer any question or give any information if to do so might incriminate him or her.

Enforcement
14. —(1) Each food authority in its area and each port health authority in its district will execute and enforce —

(a) the provisions of Regulation 1935/2004 mentioned in regulation 4, and

(b) subject to paragraph (3), these Regulations.

    (2) The Food Standards Agency may also execute and enforce the provisions of Articles 16(1) and 17(2).

    (3) Each food authority in its area will execute and enforce the provisions of Regulation 2023/2006 mentioned in regulation 5.

Offences by corporate bodies or Scottish partnerships
     15. —(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 person as well as the body corporate is 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 person as well as the partnership is 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
     16. 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
     17. No prosecution for an offence under these Regulations is to 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.

General defences
     18. —(1) In any proceedings for an offence under these Regulations it is, subject to paragraph (5), a defence for the person accused to prove that he or she took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by him or herself or by a person under his or her control.

    (2) Without prejudice to the generality of paragraph (1), a person accused of an offence under regulation 4 or 13(1)(a) who did not —

(a) prepare the material or article in respect of which the offence is alleged to have been committed; nor

(b) import it into the United Kingdom,

is to be taken to have established the defence provided by paragraph (1) if that person satisfies the requirements of paragraphs (3) and (4).

(3) A person satisfies the requirements of this paragraph if that person proves —

(a) that the commission of the offence was due to the act or default of some other person who was not under his or her control, or to reliance on information supplied by such a person;

(b) that either —

(c) that he or she did not know and had no reason to suspect at the time the offence was committed that his or her act or omission would amount to an offence under these Regulations.

(4) A person satisfies the requirements of this paragraph if the offence is one of sale and he or she proves —

(a) that the commission of the offence was due to the act or default of some other person who was not under his or her control, or to reliance on information supplied by such a person;

(b) that the sale of which the offence consisted was not a sale under his or her name or mark; and

(c) that he or she did not know and could not reasonably be expected to know at the time the offence was committed that his or her 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 person accused will 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 he or she has previously appeared before the court in connection with the alleged offence, within one month of his or her first such appearance,

he or she 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 his or her possession.

Procedure where a sample is to be analysed
     19. —(1) An authorised officer who has procured a sample under section 29 of the Act and who considers it should be analysed is to 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 is to divide the sample into parts by putting the containers into three lots, and each lot is to be treated as being a part.

    (3) The authorised officer will —