The Plastic Materials and Articles in Contact with Food (England) Regulations 2006

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"Directive 82/711" means Council Directive 82/711/EEC[4] laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as last amended by Commission Directive 97/48/EC[5];

"Directive 85/572" means Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs[6];

"Directive 88/388" means Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production[7];

"Directive 89/107" means Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised in foodstuffs intended for human consumption[8];

"the Directive" means Commission Directive 2002/72/EC[9] relating to plastic materials and articles intended to come into contact with foodstuffs, as last amended by Commission Directive 2004/19/EC[10];

"EEA State" means a Member State (other than the United Kingdom), Norway, Iceland and Liechtenstein;

"EFSA" means the European Food Safety Authority;

"enforcement authority" means an authority having responsibility under regulation 14 for executing and enforcing these Regulations;

"food" is to be construed in accordance with section 16(5) of the Act;

"good technical quality" means good technical quality as regards the purity criteria;

"handling of food" means use in connection with the storage, preparation, packaging, sale or serving of food;

"import" means import in the course of a business;

"material or article" means a material or article falling within the definition of materials and articles in Article 1(2) of Regulation 1895/2005;

"monomer" means any substance that is included for the purposes of the Directive among monomers and other starting substances;

"NOGE" has the meaning given in Article 1(1)(c) of Regulation 1895/2005;

"the 1998 Regulations" means the Plastic Materials and Articles in Contact with Food Regulations 1998[11];

"the 2005 Regulations" means the Materials and Articles in Contact with Food (England) Regulations 2005[12];

"plastic material or article" means anything which for the purposes of the Directive is included among those plastic materials and articles and parts thereof to which the Directive applies;

"the Purity Directives" means Commission Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs[13], Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs[14] and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners[15];

"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[16];

"sell" includes offer or expose for sale or have in possession for sale, and "sale" shall be construed accordingly;

    (2) For the purposes of these Regulations the supply otherwise than on sale, in the course of a business, of any material or article is deemed to be a sale.

    (3) Any other expression used in these Regulations and in the Directive, Directive 82/711, Directive 85/572 or Regulation 1895/2005 bears the same meaning in these Regulations as it bears in that Directive or Regulation.

Restriction on the use of monomers in the manufacture of plastic materials and articles
     4. —(1) Subject to paragraphs (3), (4) and (5), no person may use any prohibited monomer in the manufacture of any plastic material or article.

    (2) A prohibited monomer is any monomer which is not —

(a) of good technical quality;

(b) identified by PM/REF No, CAS No (if any) and name in columns 1, 2 and 3 respectively of the relevant section of Part 1 of Schedule 1; and

(c) used in accordance with any restrictions and specifications for that monomer set out or referred to in column 4 of that section.

    (3) Paragraph (1) does not apply to the use of a monomer in the manufacture of any —

(a) surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, including but not limited to varnishes, lacquers and paints;

(b) epoxy resins;

(c) adhesives and adhesion promoters; or

(d) printing inks.

    (4) Paragraph (1) shall not be taken to prohibit the manufacture of any plastic material or article with any substance if the substance in question is a mixture which falls within paragraph 3(c) (relating to mixtures of authorised substances) of Annex II to the Directive and is of good technical quality.

    (5) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with paragraph (1) because it was manufactured with any monomer (whether or not of good technical quality) other than one mentioned in paragraph (2)(b) it shall be a defence for the person accused to prove that —

(a) each monomer is present in the finished plastic material as an impurity, a reaction intermediate or a decomposition product which falls within paragraph 3(a) of Annex II to the Directive, or

(b) each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof which falls within paragraph 3(b) of that Annex,

and is of good technical quality.

    (6) Part 2 of Schedule 1 has effect to supplement this regulation and Part 1 of that Schedule.

Restriction on the use of additives in the manufacture of plastic materials and articles
     5. —(1) Subject to paragraph (3) no person may use in the manufacture of any plastic material or article any prohibited additive.

    (2) A prohibited additive is —

(a) any additive identified by PM/REF No, CAS No (if any) and name in columns 1, 2 and 3 respectively of Part 1 or Part 2 of Schedule 2 which —


(i) is not of good technical quality, or

(ii) is not used in accordance with any restrictions and specifications for that additive set out in the corresponding entry in column 4 of Part 1 or Part 2 of that Schedule; or



(b) any food additive authorised by Directive 89/107 or any flavouring authorised by Directive 88/388 that migrates into food —



(i) in a quantity that has a technological function in the final food product, or

(ii) where the food is of a type for which the use of any such food additive or flavouring is so authorised, in quantities exceeding the limits provided for in Directive 89/107 or Directive 88/388 as appropriate, or in Schedule 2, whichever is the lower.

    (3) In any proceedings for an offence under these Regulations where it is alleged that the commission of the offence is due to the manufacture of a plastic material or article with any additive identified in Part 1 or Part 2 of Schedule 2 which is not of good technical quality, it shall be a defence for the person accused to prove that each such additive is present in the finished plastic material or article as an impurity, a reaction intermediate or a decomposition product.

    (4) Part 3 of Schedule 2 has effect to supplement this regulation and Parts 1 and 2 of that Schedule.

Required standard for non-migration of constituents of monomers
     6. —(1) Subject to paragraph (2), where a migration limit expressed in mg/kg is indicated in column 4 of the relevant section of Part 1 of Schedule 1 in relation to any monomer, a plastic material or article manufactured from that monomer meets the required standard under this regulation if it is not capable of transferring constituents of that monomer to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is —

(a) the number of milligrams expressed in column 4 released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b); and

(b) one sixth of the number of milligrams expressed in column 4 per square decimetre of surface area of the plastic material or article if the plastic material or article comprises —


(i) an article which is a container or is comparable to a container or can be filled, having a capacity of less than 500 millilitres or more than 10 litres, or

(ii) sheet, film or other plastic material or article which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the material or article in question and the quantity of food in contact with that surface area.

    (2) A plastic material or article manufactured from any monomer for which a migration limit in mg/kg is expressed in column 4 of the relevant section of Part 1 of Schedule 1 is not deemed to be capable of transferring constituents of that monomer to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (1) if the only food with which that plastic material or article may come into contact is food to which regulation 9(3) applies.

Required standard for non-migration of constituents of additives
     7. —(1) Subject to paragraph (2), where a migration limit expressed in mg/kg is indicated in column 4 of Part 1 or 2 of Schedule 2 in relation to any additive, a plastic material or article manufactured containing that additive meets the required standard under this regulation if it is not capable of transferring constituents of that additive to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit, and for the purposes of this paragraph the appropriate limit is —

(a) the number of milligrams indicated in column 4 released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b); and

(b) one sixth of the number of milligrams expressed in column 4 per square decimetre of surface area of the plastic material or article if the plastic material or article comprises —


(i) an article which is a container or is comparable to a container or can be filled, having a capacity of less than 500 millilitres or more than 10 litres, or

(ii) sheet, film or other plastic material or article which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of the material or article in question and the quantity of food in contact with that surface area.

    (2) A plastic material or article manufactured containing an additive for which a migration limit in mg/kg is expressed in column 4 of Part 1 or Part 2 of Schedule 2 is not deemed to be capable of transferring constituents of that additive to food with which the plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (1) if the only food with which that plastic material or article may come into contact is food to which regulation 9(3) applies.

Required standard for products obtained by bacterial fermentation
     8. A product obtained by bacterial fermentation meets the required standard under this regulation if it is —

(a) of good technical quality;

(b) identified by PM/REF No, CAS No and name in columns 1, 2 and 3 respectively of Schedule 3: and

(c) in compliance with the restrictions and specifications set out in column 4 of that Schedule.

Required standards relating to overall migration limits
     9. —(1) Subject to paragraph (3), a plastic material or article meets the required standard under this regulation if it is not capable of transferring its constituents to food with which it may come into contact in quantities exceeding the appropriate limit specified in paragraph (2).

    (2)

(a) In the case of any plastic material or article comprising —


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

(ii) an article which can be filled and for which it is impracticable to estimate the surface area in contact with food, or

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



the appropriate limit is an overall migration limit of 60 milligrams of constituents released per kilogram of food.

(b) In the case of any other plastic material or article, the appropriate limit is an overall migration limit of 10 milligrams per square decimetre of the surface area of the plastic material or article.

    (3) For the purposes of this regulation a plastic material or article is not deemed to fail to meet the required standard under paragraph (1) if the only food with which that material or article may come into contact is food —

(a) which is specified in the table to Part 4 of Schedule 6; and

(b) where there is no "X" placed anywhere in the group of columns headed "Simulants to be used" opposite that food.

    (4) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with this regulation, the defences available in paragraph 6(2) and 7(2) of Schedule 5 shall be available as specified in those paragraphs.

Required standard for non-migration of primary aromatic amines
     10. —(1) Subject to paragraph (3), a plastic material or article manufactured using isocyanates or colourants prepared by diazo-coupling meets the required standard under this regulation if it is not capable of transferring in a detectable quantity primary aromatic amines (expressed as aniline), not being primary aromatic amines listed in these Regulations, to food with which that plastic material or article may come into contact.

    (2) Schedule 4 has effect for the purpose of prescribing, for certain items listed in Part 1 of Schedule 1, Part 1 or 2 of Schedule 2, or Schedule 3, the specifications for those items that are referred to in column 4 of the Part or Schedule concerned.

    (3) In paragraph (1) a detectable quantity means a quantity which can be determined with an analytical method capable of achieving a detection limit of at least 0.02 milligrams per kilogram of food or food simulant (including analytical tolerance).

Method of testing the capability of plastic materials or articles to transfer constituents, and methods of analysis
     11. —(1) A plastic material or article shall be treated as capable of transferring constituents to food with which it may come into contact to the extent that such capability is established —

(a) in any case other than one to which sub-paragraph (b) applies, and subject to Article 8.4 of the Directive (which may be applied on compliance with the conditions stated therein), by the verification methods specified in Schedule 5 (including the analytical tolerances referred to in paragraph 8 of that Schedule) and Schedule 6;

(b) in any case where the extent to which vinyl chloride, as identified in Part 1 of Schedule 1, is capable of such transfer falls to be established, by the method referred to in regulation 7(2) of the 2005 Regulations.

    (2) In Schedules 5 and 6, references to migration or release of a substance are to be construed as references to the transfer of constituents to the simulant representing the food or, as the case may be, food with which it may come into contact.

    (3) The specific migration of a constituent from a plastic material or article shall where applicable be determined in the manner specified in the relevant sub-paragraph of paragraph 8 of Annex II to the Directive.

    (4) The quantity of a constituent in a plastic material or article shall where applicable be determined in the manner specified in the sub-paragraph of paragraph 8 of Annex II to the Directive relating to the term "QM(T)", "QMA" or "QMA(T)" as the case may be.

Labelling
     12. —(1) At marketing stages other than the retail stage a person who is in possession of any plastic material or article must ensure that the plastic material or article is accompanied by a written declaration which —

(a) accords with the requirements of Article 16(1) of Regulation (EC) No. 1935/2004 of the European Parliament and of the Council[17]; and

(b) provides, in respect of substances that are subject to a restriction on quantities migrating into food, information obtained from experimental data or theoretical calculation concerning —


(i) the levels of migration specific to those substances;

(ii) where appropriate, purity criteria in accordance with the purity Directives.

    (2) In establishing which descriptions of food a material or article may come into contact with, it is to be assumed until the contrary is proved that, for the purposes of these Regulations, if particulars are shown in relation to that material or article in accordance with paragraph (1)(a), those particulars are accurate and that unless the particulars so indicate, there are no restrictions on the intended conditions of contact.

Provisions relating to the use of certain epoxy derivatives (BADGE, BFDGE and NOGE)
     13. —(1) In this regulation —

(a) any reference to a numbered Article is a reference to that Article in Regulation1895/2005;

(b) paragraphs (2) to (5) are subject to Article 1(3) (exception relating to certain storage containers and pipelines);

(c) for the purpose of Article 6(4) the competent authority is the authority identified in regulation 14.

    (2) Subject to Article 6(1), (2) (transitional provisions) and (4) (labelling requirements), no person may —

(a) manufacture,

(b) use for the handling of food in the course of a business,

(c) sell for the purpose of the handling of food, or

(d) import for the purpose of the handling of food

any material or article in contravention of Article 3 or Article 4 (prohibitions relating to BFDGE and NOGE respectively).

    (3) No person may manufacture any material or article in such a way as to contravene the requirements of Article 2 (controls on the migration of BADGE from materials and articles).

    (4) Subject to Article 6(1), no person may —

(a) use for the handling of food in the course of a business,

(b) sell for the purpose of the handling of food, or

(c) import for the purpose of the handling of food

any material or article that has been manufactured in such a way as to contravene the requirements of Article 2.

    (5) Subject to Article 6(3) (transitional provisions relating to materials and articles brought into contact with food before 1st January 2007), no person shall contravene or fail to comply with the requirements of Article 5 (obligations regarding the provision of a written statement when marketing materials or articles containing BADGE or its derivatives).

    (6) No person shall without reasonable excuse fail to comply with a request made under Article 6(4) (requirement to disclose date of filling to competent authority).

Offences and Penalties
     15. —(1) Any person who —

(a) contravenes or fails to comply with regulation 3(1), 4(1), 5(1), 12(1) or 13(2) to (5);

(b) intentionally obstructs any person acting in the execution of Regulation 1895/2005 or these Regulations;

(c) contravenes regulation 13(6) or, without reasonable excuse, otherwise fails to give to any person acting in the execution of Regulation 1895/2005 or these Regulations any assistance or information which that person may reasonably require; or

(d) in purported compliance with any requirement mentioned in sub-paragraph (c), knowingly or recklessly supplies information that is false or misleading in any material particular,

is guilty of an offence.

    (2) Anyone convicted of an offence under these Regulations is liable —

(a) in the case of an offence under paragraph (1)(a) —


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

(ii) on summary conviction to a term of imprisonment not exceeding six months or to a fine not exceeding the statutory maximum or both;



(b) in the case of any other offence under these Regulations to a term of imprisonment not exceeding three months or to a fine not exceeding level five on the standard scale or both.

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

    (4) Where an offence under these Regulations which has been committed by a body corporate or 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) any director, manager, secretary or other similar officer of the body corporate or any partner of the Scottish partnership, or

(b) any person purporting to act in such a capacity,

he as well as the body corporate or, as the case may be, the Scottish partnership shall be deemed to be guilty of that offence and liable to be proceeded against and punished accordingly.

    (5) 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.

    (6) 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 shall also be 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.

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

    (2) Without prejudice to the generality of paragraph (1), a person accused of an offence under these Regulations who did not —

(a) prepare the plastic material or article or, as the case may be, the material or article in respect of which the offence is alleged to have been committed; nor

(b) import it into the United Kingdom,

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

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

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

(b) that either —


(i) he carried out all such checks of the plastic material or article or material or article in question as were reasonable in all the circumstances, or

(ii) it was reasonable in all the circumstances for him to rely on checks carried out by the person who supplied him with the plastic material or article or the material or article in question; and



(c) that he did not know and had no reason to suspect at the time the offence was committed that his 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 proves —

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

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

(c) that he did not know and could not reasonably have been expected to know at the time the offence was committed that his 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 shall 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 has previously appeared before the court in connection with the alleged offence, within one month of his first such appearance,

he 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 possession.

Transitional defences and savings
     17. Not withstanding the revocations made in regulation 24, in relation to any plastic material or article —

(a) manufactured before the 1st July 1998, the defence in regulation 3(3) of the 1998 Regulations;

(b) manufactured or imported into the European Community before 1st January 2003, the defence in regulation 10(15) of the 1998 Regulations;

(c) put into free circulation in the European Community before 30th November 2002, the defence in regulation 10(16) of the 1998 Regulations;

(d) manufactured or imported into the European Community before 1st March 2004, the defence in regulation 10(21)(a) of the 1998 Regulations;

(e) manufactured or imported into the European Community before 1st March 2003, the defence in regulation 10(21)(b) of the 1998 Regulations;

(f) containing azodicarbonamide and brought into contact with food before 2nd August 2005, the defence in regulation 10(23) of the 1998 Regulations; or

(g) manufactured or imported into the European Community before 1st March 2006, the defence in regulation 10(25) of the 1998 Regulations,

shall apply in relation to offences under these Regulations in like manner as it applied to offences under the equivalent provisions in those Regulations.

Procedure where a sample is to be analysed
     18. —(1) 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.

    (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 shall divide the sample into parts by putting the containers into three lots, and each lot shall be treated as being a part.

    (3) The authorised officer shall —

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

(b) mark each part or container;

(c) as soon as reasonably practicable, give one part to the owner and notify him 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 19.

Secondary analysis by the Government Chemist
     19. —(1) Where a sample has been retained under regulation 18 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 above,

paragraphs (2) to (7) apply.

    (2) The authorised officer —

(a) may of his own volition;

(b) shall if requested by the prosecutor (if a person other than the authorised officer);

(c) shall if the court so orders; or

(d) shall (subject to paragraph (6)) if requested by the defendant,

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

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

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

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

    (6) Where a request is made under paragraph (2)(d) the authorised officer may give notice in writing to the defendant 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 defendant to pay the fee specified in the notice the authorised officer may refuse to comply with the request.

    (7) In this regulation "defendant" includes a prospective defendant.

Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990
     22. In the Food Safety (Sampling and Qualifications) Regulations 1990[18], in Schedule 1 (provisions to which those Regulations do not apply) for the title and reference of the 1998 Regulations substitute the title and reference of these Regulations.

Amendments to the Materials and Articles in Contact with Food (England) Regulations 2005
     23. —(1) The 2005 Regulations are amended in accordance with paragraphs (2) to (6).

    (2) In regulation 2(1) —

(a) omit the definition of "the 1998 Regulations";

(b) after the definition of "sell" add the following definition —

" ”the 2006 Regulations” means the Plastic Materials and Articles in Contact with Food (England) Regulations 2006[19]."

    (3) In regulation 8(4), for the expression "Schedules 1, 2 or 2A to the 1998 Regulations" substitute "Schedules 1, 2 or 3 to the 2006 Regulations".

    (4) In regulation 9(3) —

(a) for the expression "Part I of Schedule 1 to the 1998 Regulations" substitute "Part 1 of Schedule 1 to the 2006 Regulations"; and

(b) in sub-paragraph (b) for "Part II" substitute "Part 2".

    (5) In regulation 9(5), for the expression "Schedules 3 and 4 of the 1998 Regulations as read with regulation 6 of those Regulations" substitute "Schedules 5 and 6 of the 2006 Regulations as read with regulation 11 of those Regulations".

    (6) In regulation 10(2), for the expression "proceedings for an offence under regulation" substitute "proceedings for an offence of contravening regulation".

Revocations
     24. The following Regulations or parts thereof are revoked —

(a) the 1998 Regulations in so far as they apply in relation to England;

(b) the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000[20];

(c) the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2002[21];

(d) the Plastic Materials and Articles in Contact with Food (Amendment) (England) (No.2) Regulations 2002[22];

(e) the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2004[23];

(f) the Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005[24];

(g) regulation 15 of the 2005 Regulations.

Signed by authority of the Secretary of State for Health


Caroline Flint
Minister of State, Department of Health

23rd May 2006