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

In these Regulations —

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

• F1...

• F2...

• “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 M1;

• “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 M2;

• “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 M3;

• F3“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 M4;

• “Regulation 10/2011” means Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food M5;

• F4“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 —

  1. (a)

     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 M6 by section 7(1) of that Act), the Common Council of the City of London; and

  2. (b)

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

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

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.

Any reference in these Regulations to an F7... instrument defined in regulation 2(1) is a reference to that ... instrument as amended from time to time.

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).

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).

Any person who contravenes paragraph (1) or (2) or Article 11(4) or (5) (F1... authorisation) or 17(2) (traceability) is guilty of an offence.

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

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

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.

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 M1.

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

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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).

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.

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.

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.

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 %.

No person may place on the market a ceramic article that does not comply with the requirements of regulation 10(1) as read with regulation 10(2).

At the marketing stages up to and including the retail stage, ceramic articles which are not yet in contact with foodstuffs must be accompanied by a written declaration in accordance with Article 16 of Regulation 1935/2004. That declaration is to be issued by the manufacturer or by a seller in Great Britain and must contain the information laid down in Schedule 4.

Appropriate documentation to demonstrate that the ceramic articles comply with the migration limits for lead and cadmium set out in regulation 10 must be made available by the manufacturer or the importer to the competent authorities on request. That documentation must contain the results of the analysis carried out, the test conditions and the name and the address of the laboratory that performed the testing.

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

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

In this Part —

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.

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URCF and CRCF may be manufactured using only the substances or groups of substances listed in F1Schedule 5 (list of substances authorised in the manufacture of regenerated cellulose film) and subject to the restrictions set out in F2that Schedule but, by way of derogation, substances other than those listed in Schedule 5 may be used when these substances are employed either as —

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

PRCF may be manufactured, prior to coating, using only substances or groups of substances listed in the first part of F3Schedule 5 and subject to the restrictions set out in that part.

The coating to be applied to PRCF may be manufactured using only substances or groups of substances F4authorised under Regulation 10/2011 and subject to the restrictions in F5the authorisations concerned.

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.

Printed surfaces of regenerated cellulose film must not come into contact with foodstuffs.

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.

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

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 F6paragraphs (5) or (7).

Subject to the transitional arrangements set out in Article F122(5) and Article 23 M1, 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 F2Schedule 1 is guilty of an offence.

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In this Part —

Subject to Article 6(1),(2) and (4) (transitional provisions) M2, 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 —

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Any person who contravenes F3paragraph (2) is guilty of an offence.

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

No person may —

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

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).

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;

For the purposes of determining vinyl chloride released by materials and articles to foodstuffs, the detection limit is 0.01 mg/kg;

Vinyl chloride released by materials and articles to foodstuffs is in principle determined in the foodstuffs. When the determination in certain foodstuffs is shown to be impossible for technical reasons, competent authorities may permit determination by simulants for these particular foodstuffs.

Any person who contravenes F2regulation 10A(1), 12(8) or 18(2) is guilty of an offence.

Any person who fails to comply with a compliance notice served on them under regulation 19A is guilty of an offence.

Any person who intentionally obstructs a person acting in the execution of Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 282/2008, Regulation 450/2009, Regulation 10/2011, Regulation 2018/213 or these Regulations is guilty of an offence.

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

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

A person guilty of an offence is liable—

Nothing in paragraph (3) or (4) is to be construed as requiring a person to answer any question or give any information if to do so might incriminate that person.

If an authorised officer has reasonable grounds for believing that any person has not complied with, is not complying with, or is not likely to comply with a provision specified in regulation 19B (which provisions concern declarations of compliance with legislative requirements or supporting documentation), the officer may serve a compliance notice on that person.

A compliance notice must state—

An authorised officer may serve a notice on a person withdrawing, varying or suspending a compliance notice.

paragraphs (2) and (3) of regulation 10A;

paragraph (6) of regulation 12;

Article 16 of Regulation 1935/2004;

Article 5 of Regulation 1895/2005;

Articles 10(3) and 12 of Regulation 282/2008;

Articles 12 and 13 of Regulation 450/2009;

the second sentence of Article 8, Article 15 as read with Annex 4 and Article 16 of Regulation 10/2011;

Article 4 of Regulation 2018/213.

Any person served with a compliance notice may appeal against that notice to a magistrates’ court.

The procedure on appeal to a magistrates’ court is by way of complaint for an order, and the Magistrates’ Courts Act 1980 applies to the proceedings.

The period within which an appeal may be brought is one month from the date on which the compliance notice was served on the person wishing to appeal and the making of a complaint for an order is deemed for the purposes of this paragraph to be the bringing of the appeal.

A compliance notice is not suspended pending an appeal unless—

The court may—

Each food authority in its area is to execute and enforce Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 282/2008, Regulation 450/2009, Regulation 10/2011, Regulation 2018/213 and these Regulations.

Each port health authority in its district is to execute and enforce Regulation 1935/2004, Regulation 1895/2005, Regulation 450/2009, Regulation 10/2011, Regulation 2018/213 and these Regulations.

 The Food Standards Agency may execute and enforce the provisions of—

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 —

that individual as well as the body corporate shall be deemed to be guilty of that offence and liable to be proceeded against and punished accordingly.

Where an offence under these Regulations which has been committed by a Scottish partnership is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of a partner, that partner as well as the partnership shall be deemed to be guilty of that offence and liable to be proceeded against and punished accordingly.

No prosecution for an offence under these Regulations shall be begun after the expiry of three years from the commission of the offence or one year from its discovery by the prosecutor, whichever is the earlier.

Paragraph (1) does not apply to an offence under F1regulation 19(3) or (4) .

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

Without prejudice to the generality of paragraph (1), a person accused of an offence under F1regulation 4(3), 7(1), 14(1), 15B, 16(4), 17B or 19(1) who did not import or prepare the material or article in respect of which the offence is alleged to have been committed shall be taken to have established the defence provided by paragraph (1) if the requirements of paragraphs (3) or (4) are satisfied.

The requirements of this paragraph are satisfied if it is proved that —

The requirements of this paragraph are satisfied if the offence is one of placing on the market and it is proved that —

If in any case the defence provided by this regulation involves the allegation that the commission of the offence was due to the act or default of another person, or to reliance on information supplied by another person, the accused shall not without leave of the court be entitled to rely on that defence unless —

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.

An authorised officer who has procured a sample under section 29 of the Act and who considers it should be analysed shall divide the sample into three parts.

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

The authorised officer shall —

Where a sample has been retained under regulation 25(3)(e) and —

paragraphs (2) to (7) apply.

The authorised officer —

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

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

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

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

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.

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

The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part of it is to be construed as a reference to these Regulations —

In the application of section 32 of the Act (powers of entry) for the purposes of these Regulations, the reference to the Act in subsection (1) is to be construed as including a reference to Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, F1Regulation 282/2008, Regulation 450/2009, Regulation 10/2011 or Regulation 2018/213 as appropriate.

The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act is to be construed as including a reference to Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, F2Regulation 282/2008, Regulation 450/2009, Regulation 10/2011 or Regulation 2018/213, as appropriate, and to these Regulations —

omit the title and reference of the Plastic Materials and Articles in Contact with Food (England) Regulations 2009 M2; and

for the title and reference of the Materials and Articles in Contact with Food (England) Regulations 2010 M3 substitute the title and reference of these Regulations.

The Food Labelling Regulations 1996 M1 are amended in accordance with paragraph (2).

In regulation 2(1) (interpretation), for the definition of “ingredient” substitute the following definition —

““ingredient” means —

1. (a)

   any substance, including any additive or food enzyme and any constituent of a compound ingredient, which is used in the preparation of a food and which is still present in the finished product, even if in altered form; or

2. (b)

   any released active substance within the meaning of Article 3(f) of Commission Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with food,

and a “compound ingredient” shall be composed of two or more such substances;.”.

Paragraphs (1) and (2) expire on 13th December 2014.

The Food Standards Agency must from time to time —

In carrying out the review the Food Standards Agency must, so far as is reasonable, have regard to F1the operation of the relevant F2assimilated instruments.

The report must in particular —

The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

Reports under this regulation are afterwards to be published at intervals not exceeding five years.

In this regulation “the F3relevant F4assimilated instruments” means F5... Regulation 1935/2004, Regulation 1895/2005, Regulation 2023/2006, Regulation 450/2009 and Regulation 10/2011.

The Ceramic Articles in Contact with Food (England) Regulations 2006 M1;

The Plastic Materials and Articles in Contact with Food (England) Regulations 2009;

The Materials and Articles in Contact with Food (England) Regulations 2010;

The Plastic Materials and Articles in Contact with Food (England) (Amendment) Regulations 2011 M2

Carry out the test at a temperature of 22 ± 2 °C for a duration of 24 ± 0,5 hours.

When the migration of lead is to be determined, cover the sample by an appropriate means of protection and expose it to the usual lighting conditions in a laboratory. When the migration of cadmium or of lead and cadmium is to be determined, cover the sample so as to ensure that the surface to be tested is kept in total darkness.

Samples which can be filled—

Fill the article with a 4 % (v/v) acetic acid solution to a level no more than1 mm from the overflow point; the distance is measured from the upper rimof the sample. Samples with a flat or slightly sloping rim should be filled so that the distance between the surface of the liquid and the overflow point is no more than 6 mm measured along the sloping rim.

Samples which cannot be filled—

The surface of the sample which is not intended to come into contact with foodstuffs is first covered with a suitable protective layer able to resist the action of the 4 % (v/v) acetic acid solution. The sample is then immersed in a recipient containing a known volume of acetic acid solution in such a way that the surface intended to come into contact with foodstuffs is completely covered by the test liquid.

4 % (v/v) acetic acid, in aqueous solution.

Add 40 ml of glacial acetic acid to water and make up to 1 000 ml.

Stock solutions

Prepare stock solutions containing 1 000 mg/litre of lead and at least 500 mg/litre of cadmium respectively in a 4 % acetic acid solution, as referred to in paragraph (a).

The detection limit for lead and cadmium must be equal to or lower than— 0,1 mg/litre for lead; 0,01 mg/litre for cadmium.

The detection limit is defined as the concentration of the element in the 4 % acetic acid solution, as referred to in paragraph 3(a) which gives a signal equal to twice the background noise of the instrument.

The limit of quantification for lead and cadmium must be equal to or lower than— 0,2 mg/litre for lead; 0,02 mg/litre for cadmium.

Recovery. The recovery of lead and cadmium added to the 4 % acetic acid solution, as referred to in point 3(a), must lie within 80-120 % of the added amount.

Specificity. The instrumental method of analysis used must be free from matrix and spectral interferences.

Preparation of the sample

The sample must be clean and free from grease or other matter likely to affect the test.

Wash the sample in a solution containing a household liquid detergent at a temperature of approximately 40 °C. Rinse the sample first in tap water and then in distilled water or water of equivalent quality. Drain and dry so as to avoid any stain. The surface to be tested is not to be handled after it has been cleaned.

Determination of lead and/or cadmium

The sample thus prepared is tested under the conditions laid down in Schedule 2.

Before taking the test solution for determining lead and/or cadmium, homogenise the content of the sample by an appropriate method, which avoids any loss of solution or abrasion of the surface being tested.

Carry out a blank test on the reagent used for each series of determinations.

Carry out determinations for lead and/or cadmium under appropriate conditions.

the identity and address of the company which manufactures the finished ceramic article and of the importer who imports it into Great Britain;

the identity of the ceramic article;

the date of the declaration;

the confirmation that the ceramic article meets relevant requirements in these Regulations and Regulation 1935/2004.

The Regulations provide for the implementation of the following Directives and the enforcement of the following EU Regulations —

These Regulations revoke the Plastic Materials and Articles in contact with Food (England) Regulations 2009 (S.I. 2009/205). They also revoke and re-enact with certain amendments the provisions of the Ceramic Articles in Contact with Food (England) Regulations 2006 (S.I. 2006/1179) and the Materials and Articles in Contact with Food (England) Regulations 2010 (S.I. 2010/2225).

These Regulations provide that references to a specified EU instrument or specified parts of it are to be construed as references to the instrument or parts of it as they may be amended from time to time (regulation 2(3)).

These Regulations do not apply to materials or articles outside the scope of Regulation 1935/2004 (regulation 3). The materials identified in that Regulation as being outside its scope are materials and articles supplied as antiques, covering or coating materials forming part of the food and which may be consumed with it and fixed public or private water supply equipment.

Part 2 of these Regulations contains provisions which make it an offence to contravene certain requirements of Regulation 1935/2004 (regulation 4) and Regulation 2023/2006 (regulation 5). Regulation 1935/2004 is the principal framework Regulation on materials and articles in contact with food.

Part 2 also provides for designation of the competent authorities for the various purposes identified in Regulations 1935/2004 and 2023/2006 (regulation 6).

Part 3 provides for the enforcement of specified provisions of Regulation 450/2009 (regulation 7) and designates the competent authorities for the purposes of that Regulation (regulation 8).

Part 4 implements Directive 84/500, and the definition of a ceramic article is set out in regulation 9. It provides that no person may place on the market a ceramic article that does not meet the specifications set out in the Directive (regulation 10). This regulation additionally contains requirements relating to documentary proof of compliance which apply to new but not to second hand ceramic articles.

Part 5 of these Regulations, which implements Directive 2007/42, contains requirements relating to regenerated cellulose film and identifies the various types of such film to which the provisions apply (regulation 11). This Part, in regulation 12, contains conditions relating to the substances that may be used for the manufacture of regenerated cellulose film (paragraphs (1) to (4)), specifies that the printed surface of regenerated film must not come into contact with food (paragraph (5)) and specifies certain documentation and labelling requirements (paragraphs (6) and (7)).

Part 6 of these Regulations provides for the enforcement of Regulation 10/2011 and identifies those provisions of the EU Regulation which it constitutes an offence to contravene (regulation 14 and the Schedule). The competent authorities for the purposes of certain provisions of Regulation 10/2011 are designated in regulation 15.

Part 7 provides for the continuing enforcement of Regulation 1895/2005 which maintains a ban on the epoxy derivatives BFDGE and NOGE and restrictions on the use of BADGE (regulation 16). The competent authorities for the purpose of this EU Regulation are designated in regulation 17.

Part 8 maintains the controls on the use of vinyl chloride put in place by Directive 78/142 to the extent that those controls are not now effected by Regulation 10/2011 (regulation 18).

Part 9 contains enforcement and associated provisions that —

Part 10 contains general and supplementary provisions which —

A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Food Safety Group of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH and is annexed to the Explanatory Memorandum which is available alongside the instrument on www.legislation.gov.uk.