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

PART 1 E+W Preliminary

Modifications etc. (not altering text)

C1 Pt. 1 applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(b), Sch. 2 (with regs. 7, 8)

Title, application and commencement E+W

1.  The title of these Regulations is the Materials and Articles in Contact with Food (Wales) Regulations 2012, they apply in relation to Wales and come into force on 20 November 2012.

Interpretation E+W

2.—(1) In these Regulations—

“the Act” (“y Ddeddf”) means the Food Safety Act 1990;

F1 ...

F2 ...

“Regulation 1935/2004” (“Rheoliad 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 M1 ;

“Regulation 1895/2005” (“Rheoliad 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 M2 ;

“Regulation 2023/2006” (“Rheoliad 2023/2006”) means Commission Regulation (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food M3 ;

“Regulation 450/2009” (“Rheoliad 450/2009”) means Commission Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with food M4 ;

[F3 “Regulation 10/2011” (“Rheoliad 10/2011”) means Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food;]

[F4 “Regulation 2018/213” (“Rheoliad 2018/213”) means Commission Regulation (EU) 2018/213 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials;]

“authorised officer” (“swyddog awdurdodedig”) 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” (“awdurdod bwyd”) does not include a port health authority;

“port health authority” (“awdurdod iechyd porthladd”) means, in relation to any port health district constituted by order under section 2(3) of the Public Health (Control of Disease) Act 1984 M5 , a port health authority for that district constituted by order under section 2(4) of that Act;

“preparation” (“paratoi”) includes manufacture and any form of treatment or process, and “prepare” (“paratoi”) 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 [F5 , 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 F6 ... or Regulation 10/2011 is a reference to that Regulation F7 ... as amended from time to time.

Textual Amendments

F1 Words in reg. 2(1) omitted (31.12.2020) by The Food and Feed Regulated Products (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/425), regs. 1(3), 3(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 2(1) omitted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2022 (S.I. 2022/1362), regs. 1, 2(2)(a)

F3 Words in reg. 2(1) substituted (14.9.2017) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 3

F4 Words in reg. 2(1) inserted (6.9.2018) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2018 (S.I. 2018/913), regs. 1(3), 3(a)

F5 Words in reg. 2(2) substituted (6.9.2018) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2018 (S.I. 2018/913), regs. 1(3), 3(b)

F6 Words in reg. 2(3) omitted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2022 (S.I. 2022/1362), regs. 1, 2(2)(b)(i)

F7 Words in reg. 2(3) omitted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2022 (S.I. 2022/1362), regs. 1, 2(2)(b)(ii)

Marginal Citations

M1 OJ No. L338, 13.11.2004, p.4, amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council (OJ No. L188, 18.7.2009, p.14).

M2 OJ No. L302, 19.11.2005, p.28.

M3 OJ No. L384, 29.12.2006, p.75.

M4 OJ No. L135, 30.5.2009, p.3.

M5 1984 c. 22.

Scope E+W

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 E+W General Requirements for Materials and Articles

Offences of contravening specified provisions of Regulation 1935/2004 E+W

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) (F8 ... 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.

Textual Amendments

F8 Word in reg. 4(3) omitted (31.12.2020) by virtue of S.I. 2019/425, reg. 3(2A) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(2), 2(3)(a))

Offence of contravening Article 4 of Regulation 2023/2006 E+W

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 E+W

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

F9 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) in respect of Articles [F10 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.

Textual Amendments

F9 Reg. 6(1)(a) omitted (31.12.2020) by virtue of S.I. 2019/425, reg. 3(2B)(a) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(2), 2(3)(a))

F10 Word in reg. 6(1)(b) substituted (31.12.2020) by S.I. 2019/425, reg. 3(2B)(b) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(2), 2(3)(a))

PART 3 E+W Requirements for Active and Intelligent Materials and Articles

Offences of contravening specified provisions of Regulation 450/2009 E+W

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.

F11 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Reg. 7(2) omitted (14.9.2017) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 4

Competent authorities for the purposes of Regulation 450/2009 E+W

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 E+W Requirements for Ceramic Articles

Modifications etc. (not altering text)

C2 Pt. 4 applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(b), Sch. 2 (with regs. 7, 8)

Interpretation of this Part E+W

9.  In this Part—

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

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

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

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

F12 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F12 Reg. 9(b) omitted (31.12.2020) by virtue of The Food and Feed Regulated Products (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/425), regs. 1(3), 3(3); 2020 c. 1, Sch. 5 para. 1(1)

Limits for lead and cadmium and declaration of compliance E+W

[F13 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 and/or cadmium extracted during the test carried out under the conditions laid down in Schedule 3 and Schedule 4 do not exceed the following limits—

	Lead (Pb)	Cadmium (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 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%.]

Textual Amendments

F13 Reg. 10 substituted (31.12.2020) by The Food and Feed Regulated Products (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/425), regs. 1(3), 3(4); 2020 c. 1, Sch. 5 para. 1(1)

[F14 10A.— (1) A person who places on the market a ceramic article which is not yet in contact with foodstuffs must provide a written declaration [F15 complying with paragraph (2)] to accompany the article at the marketing stages up to and including the retail stage.

(2) The declaration must be issued by the manufacturer or by a seller in [F16 Great Britain] and must contain the information laid down in Schedule 5.

(3) A person who manufactures or, in the course of a business, imports into [F17 Great Britain] a ceramic article must on request make available to an authorised officer appropriate documentation to demonstrate that the ceramic article complies with the migration limits for lead and cadmium set out in regulation 10 including—

(a) the results of the analysis carried out;

(b) the test conditions;

(c) the name and the address of the laboratory that performed the testing.

(4) Paragraphs (1), (2) and (3) do not apply in relation to a ceramic article which is second-hand.

(5) The documentation specified in paragraph (3)(a), (b) and (c) is not required where documentary evidence is provided to show that the materials used to make the ceramic article did not contain lead or cadmium.]

Textual Amendments

F14 Reg. 10A inserted (31.12.2020) by The Food and Feed Regulated Products (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/425), regs. 1(3), 3(5); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in reg. 10A(1) substituted in earlier amending provision S.I. 2019/425, reg. 3(5) (31.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(2), 2(3)(b)(i)

F16 Words in reg. 10A(2) substituted in earlier amending provision S.I. 2019/425, reg. 3(5) (31.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(2), 2(3)(b)(ii)

F17 Words in reg. 10A(3) substituted in earlier amending provision S.I. 2019/425, reg. 3(5) (31.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(2), 2(3)(b)(iii)

PART 5 E+W Requirements for Regenerated Cellulose Film

Interpretation of this Part E+W

11.—(1) In this Part—

(a) “regenerated cellulose film” (“caen cellwlos atgynyrchiedig”) 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” (“CCAH”) means uncoated regenerated cellulose film;

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

(d) “PRCF” (“CCAP”) 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.

F18 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F18 Reg. 11(3) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2022 (S.I. 2022/1362), regs. 1, 2(3)

Controls and limits E+W

12.—(1) URCF and CRCF may be manufactured using only the substances or groups of substances listed in [F19 Schedule 6] (list of substances authorised in the manufacture of regenerated cellulose film) and subject to the restrictions set out in [F20 that Schedule] but, by way of derogation, substances other than those listed in [F19 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 [F21 Table 1 of Schedule 6 and subject to the restrictions in that Table].

(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)F22 ... or (7).

Textual Amendments

F19 Words in reg. 12(1) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2022 (S.I. 2022/1362), regs. 1, 2(4)(a)(i)

F20 Words in reg. 12(1) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2022 (S.I. 2022/1362), regs. 1, 2(4)(a)(ii)

F21 Words in reg. 12(2) substituted (14.4.2023) by The Food Additives, Food Flavourings, and Novel Foods (Authorisations) and Food and Feed (Miscellaneous Amendments) (Wales) Regulations 2023 (S.I. 2023/343), regs. 1(3), 7 (with reg. 4)

F22 Word in reg. 12(8) omitted (14.9.2017) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 5

PART 6 E+W Requirements for Plastic Materials and Articles

Interpretation of Part 6 and [F23 Schedule 1] E+W

13.   [F24 Except in regulation 14(1), any reference in this Part and in Schedule 1] to a numbered Article or Annex is a reference to that Article of or Annex to Regulation 10/2011.

Textual Amendments

F23 Words in reg. 13 heading substituted (14.9.2017) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 6(a)

F24 Words in reg. 13 substituted (26.7.2018) by The Food and Feed (Miscellaneous Amendments and Revocations) (Wales) Regulations 2018 (S.I. 2018/806), regs. 1(3), 22(2)

Offences of contravening specified provisions of Regulation 10/2011 E+W

14.—(1) Subject to the transitional arrangements set out in [F25 Article 2 of Commission Regulation (EU) No 1282/2011, Article 2 of Commission Regulation (EU) No 1183/2012, Article 2 of Commission Regulation (EU) No 202/2014, Article 2 of Commission Regulation (EU) 2015/174, Article 2 of Commission Regulation (EU) 2016/1416, Article 2 of Commission Regulation (EU) 2017/752, Article 2 of Commission Regulation (EU) 2018/79 [F26 , Article 2 of Commission Regulation (EU) 2018/831 and Article 6 of Regulation 2018/213]] 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 [F27 Schedule 1] is guilty of an offence.

F28 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F25 Words in reg. 14(1) substituted (26.7.2018) by The Food and Feed (Miscellaneous Amendments and Revocations) (Wales) Regulations 2018 (S.I. 2018/806), regs. 1(3), 22(3)

F26 Words in reg. 14(1) substituted (6.9.2018) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2018 (S.I. 2018/913), regs. 1(3), 4

F27 Words in reg. 14(1) substituted (14.9.2017) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 7(a)

F28 Reg. 14(2) omitted (14.9.2017) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 7(b)

Competent authorities for the purposes of Regulation 10/2011 E+W

[F29 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.]

Textual Amendments

F29 Reg. 15 substituted (14.9.2017) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 8

PART 7 E+W Requirements for certain epoxy derivatives

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

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) [F30 paragraph (2) is] subject to Article 1(3) (scope) M6 .

(2) [F31 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).

F32 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Any person who contravenes paragraph (2) F33 ... is guilty of an offence.

Textual Amendments

F30 Words in reg. 16(1)(b) substituted (14.9.2017) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 9(a)

F31 Word in reg. 16(2) substituted (26.7.2018) by The Food and Feed (Miscellaneous Amendments and Revocations) (Wales) Regulations 2018 (S.I. 2018/806), regs. 1(3), 22(4)

F32 Reg. 16(3) omitted (14.9.2017) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 9(b)

F33 Words in reg. 16(4) omitted (14.9.2017) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 9(c)

Marginal Citations

M6 Article 3 contains an exception relating to certain containers and storage tanks and pipelines belonging to them.

Competent authorities for the purposes of Regulation 1895/2005 E+W

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 E+W 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).

[F34 (3) The method of analysis used for checking compliance with paragraph (1) must comply with the criteria 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 milligrams of vinyl chloride per kilogram of food.

(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, a food authority may permit determination by simulants for these particular foodstuffs.]

Textual Amendments

F34 Reg. 18(3)-(6) inserted (31.12.2020) by The Food and Feed Regulated Products (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/425), regs. 1(3), 3(6); 2020 c. 1, Sch. 5 para. 1(1)

PART 9 E+W Enforcement

Offences and penalties E+W

19.—(1) Any person who contravenes the provisions of regulation 10(3) F35 ..., 12(8) or 18(2) is guilty of 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[F36 , Regulation 2018/213] or these Regulations is guilty of an offence.

(3) Any person who, without reasonable excuse, fails to provide any assistance or information that person may reasonably require for the performance of their functions under the Regulations mentioned in paragraph (2) F37 ... is guilty of 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, is guilty of an offence.

[F38 (5) A person guilty of an offence is liable—

(a) in the case of an offence created by paragraph (1) or (4) or by regulation 4(3), 5, 7(1), 14(1), [F39 16(4) or 17B] —

(i) on conviction on indictment to a fine or to a term of imprisonment not exceeding two years or both, or

(ii) on summary conviction to a fine; and

(b) in the case of an offence created by paragraph (2) or (3), on summary conviction to a fine not exceeding level 4 on the standard scale.]

(6) Nothing in paragraph (2) or (3) is to be construed as requiring any person to answer any question or give any information if to do so might incriminate them.

Textual Amendments

F35 Words in reg. 19(1) omitted (14.9.2017) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 10(a)

F36 Words in reg. 19(2) inserted (6.9.2018) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2018 (S.I. 2018/913), regs. 1(3), 6(a)

F37 Words in reg. 19(3) omitted (14.9.2017) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 10(b)

F38 Reg. 19(5) substituted (14.9.2017) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 10(c)

F39 Words in reg. 19(5)(a) substituted (6.9.2018) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2018 (S.I. 2018/913), regs. 1(3), 6(b)

Execution and enforcement E+W

20.—(1) Each food authority in its area and each port health authority in its district must execute and enforce—

(a) Regulation 1935/2004, Regulation 1895/2005, Regulation 450/2009 and Regulation 10/2011; and

(b) except in relation to the provisions referred to in paragraph (3), these Regulations.

[F40 (2) The Food Standards Agency may also execute and enforce the provisions of—

(a) Articles 16(1) and 17(2) of Regulation 1935/2004;

(b) Article 13 of Regulation 450/2009; and

(c) Article 16(1) of Regulation 10/2011.]

(3) Each food authority in its area must execute and enforce the provisions of Regulation 2023/2006 specified in regulation 5 and these Regulations.

Textual Amendments

F40 Reg. 20(2) substituted (14.9.2017) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 11

Offences by corporate bodies or Scottish partnerships E+W

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 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 partner 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 E+W

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 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 E+W

23.—(1) 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.

(2) Paragraph (1) does not apply to an offence under regulation F41 ...19(2) or (3).

Textual Amendments

F41 Words in reg. 23(2) omitted (14.9.2017) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 12

General defences E+W

24.—(1) In any proceedings for an offence under these Regulations it is, subject to paragraph (5), a defence to prove that the person accused (“the accused”) took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by the accused or by a person under the control of the accused.

(2) Without prejudice to the generality of paragraph (1), a person accused of an offence under regulation 4(3), 7(1), 14(1), 16(4) [F42 , 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 is to 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 is not without leave of the court to 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.

Textual Amendments

F42 Word in reg. 24(2) inserted (6.9.2018) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2018 (S.I. 2018/913), regs. 1(3), 7

Procedure where a sample is to be analysed E+W

25.—(1) An authorised officer who has procured a sample under section 29 of the Act and who considers it should be analysed must divide the sample into three parts.

(2) If the sample consists of sealed containers and opening them would, in the opinion of the authorised officer, impede a proper analysis, the authorised officer must divide the sample into parts by putting the containers into three lots, and each lot must be treated as being a part.

(3) The authorised officer must—

(a) if necessary place each part in a suitable container and seal it;

(b) mark each part or container;

(c) as soon as is reasonably practicable, give one part to the owner and notify the owner in writing that the sample will be analysed;

(d) submit one part for analysis in accordance with section 30 of the Act; and

(e) retain one part for future submission under regulation 26.

Secondary analysis by the Government Chemist E+W

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,

paragraphs (2) to (7) apply.

(2) The authorised officer—

(a) may of the officer's own volition; or

(b) must—

(i) if requested by the prosecutor (if a person other than the authorised officer),

(ii) if the court so orders, or

(iii) (subject to paragraph (6)) if requested by the accused,

send the retained part of the sample to the Government Chemist for analysis.

(3) The Government Chemist must analyse the part sent under paragraph (2) and send to the authorised officer a certificate specifying the results of the analysis.

(4) Any certificate of the results of analysis transmitted by the Government Chemist must be signed by or on behalf of the Government Chemist, but the analysis may be carried out by any person under the direction of the person who signs the certificate.

(5) The authorised officer must immediately on receipt supply the prosecutor (if a person other than the authorised officer) and the accused with a copy of the Government Chemist's certificate of analysis.

(6) Where a request is made under paragraph (2)(b)(iii) the authorised officer may give notice in writing to the accused requesting payment of a fee specified in the notice to defray some or all of the Government Chemist's charges for performing the functions under paragraph (3), and in the absence of agreement by the accused to pay the fee specified in the notice the authorised officer may refuse to comply with the request.

(7) In this regulation “the accused” (“y cyhuddedig”) includes a person against whom an authorised officer is intending to commence proceedings.

Application of various provisions of the Act E+W

[F43 27.— (1) Section 10(1) and (2) of the Act (improvement notices) applies for the purposes of these Regulations with the modification (in the case of section 10(1)) set out in Part 1 of Schedule 2 for the purposes of—

(a) enabling an improvement notice to be served on a person requiring that person to comply with any of the following provisions—

(i) regulations [F44 10A(1), 10A(3)] and 12(6);

(ii) Article 16 of Regulation 1935/2004;

(iii) Article 5 of Regulation 1895/2005;

(iv) Articles 12 and 13 of Regulation 450/2009; F45 ...

(v) the second sentence of Article 8, Article 15 as read with Annex IV, and Article 16 of Regulation 10/2011; and

[F46 (vi) Article 4 of Regulation 2018/213; and]

(b) making the failure to comply with a notice referred to in sub-paragraph (a) an offence.

(2) The provisions of the Act specified in column 1 of the table in Part 2 of Schedule 2 apply, with the modifications (if any) specified in column 2 of that table.

(3) Paragraphs (1) and (2) are without prejudice to the application of the Act to these Regulations for purposes other than those specified in paragraph (1).]

Textual Amendments

F43 Reg. 27 substituted (14.9.2017) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2017 (S.I. 2017/832), regs. 1(3), 13

F44 Words in reg. 27(1)(a)(i) substituted (31.12.2020) by S.I. 2019/425, reg. 3(6A) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments and Saving Provision) (Wales) (EU Exit) Regulations 2020 (S.I. 2020/1581), regs. 1(2), 2(3)(c))

F45 Word in reg. 27(1)(a)(iv) omitted (6.9.2018) by virtue of The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2018 (S.I. 2018/913), regs. 1(3), 8(a)

F46 Reg. 27(1)(a)(vi) inserted (6.9.2018) by The Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2018 (S.I. 2018/913), regs. 1(3), 8(b)

PART 10 E+W General and supplementary

Consequential amendment to the Food Safety (Sampling and Qualifications) Regulations 1990 E+W

F47 28.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F47 Reg. 28 omitted (26.7.2018) by virtue of The Food and Feed (Miscellaneous Amendments and Revocations) (Wales) Regulations 2018 (S.I. 2018/806), regs. 1(3), 22(5)

Amendment to the Food Labelling Regulations 1996 E+W

F48 29.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F48 Reg. 29 omitted (26.7.2018) by virtue of The Food and Feed (Miscellaneous Amendments and Revocations) (Wales) Regulations 2018 (S.I. 2018/806), regs. 1(3), 22(5)

Revocations E+W

30.  The following Regulations are revoked—

(a) The Ceramic Articles in Contact with Food (Wales) Regulations 2006 M7 ;

(b) The Plastic Materials and Articles in Contact with Food (Wales) Regulations 2009 M8 ;

(c) The Materials and Articles in Contact with Food (Wales) Regulations 2010 M9 ;

(d) The Plastic Materials and Articles in Contact with Food (Wales) (Amendment) Regulations 2011 M10 .

Marginal Citations

M7 S.I. 2006/1704 (W.166), amended by S.I. 2011/1043.

M8 S.I. 2009/481 (W.49), amended by S.I. 2010/2288 (W.200).

M9 S.I. 2010/2288 (W.200).

M10 S.I. 2011/233 (W.45).

Lesley Griffiths

Minister for Health and Social Services, one of the Welsh Ministers