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

• Citation: S.I. 2006/1401
• Sections: 80

Section 1 Title, application and commencement

These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (England) Regulations 2006, apply in relation to England only and come into force on 30th June 2006.

Section 2 Interpretation

(1) In these Regulations —

“ the Act ” means the Food Safety Act 1990;

“authorised officer” means any person, whether or not an officer of the enforcement authority, who is authorised by it in writing to act in matters arising under these Regulations;

“BADGE” has the meaning given in Article 1(1)(a) of Regulation 1895/2005 ;

“ BFDGE ” has the meaning given in Article 1(1)(b) of Regulation 1895/2005;

“business” is to be construed in accordance with section 1(3) of the Act;

“capable” means capable as established under regulation 11;

“ Directive 82/711 ” means Council Directive 82/711/ EEC 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 ;

“ 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 ;

“ 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 ;

“ 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 ;

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

“ 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 ;

“the 2005 Regulations ” means the Materials and Articles in Contact with Food (England) Regulations 2005 ;

“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 , Commission Directive 95/45/EC laying down purity criteria concerning colours for use in foodstuffs and Commission Directive 96/77/EC laying down specific purity criteria for food additives other than colours or sweeteners ;

“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 ;

“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.

Section 3 Restriction on the use, sale or import of plastic materials and articles

(1) No person may —

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

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

(c) import from anywhere other than an EEA State for the purpose of handling of food,

a plastic material or article which fails to meet the required standard.

(2) For the purposes of this regulation a plastic material or article fails to meet the required standard if —

(a) it has been manufactured with a prohibited monomer as described in regulation 4(2) or a prohibited additive as described in regulation 5(2); or

(b) it does not meet the required standards set out in regulation 6, 7, 8, 9 or 10.

Section 4 Restriction on the use of monomers in the manufacture of plastic materials and articles

(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.

Section 5 Restriction on the use of additives in the manufacture of plastic materials and articles

(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.

Section 6 Required standard for non-migration of constituents of monomers

(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.

Section 7 Required standard for non-migration of constituents of additives

(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.

Section 8 Required standard for products obtained by bacterial fermentation

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.

Section 9 Required standards relating to overall migration limits

(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.

Section 10 Required standard for non-migration of primary aromatic amines

(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).

Section 11 Method of testing the capability of plastic materials or articles to transfer constituents, and methods of analysis

(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.

Section 12 Labelling

(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 ; 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.

Section 13 Provisions relating to the use of certain epoxy derivatives (BADGE, BFDGE and NOGE)

(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).

Section 14 Enforcement

Each food authority in its area and each port health authority in its district shall execute and enforce —

(a) the provisions of Regulation 1895/2005 mentioned in regulation 13, and

(b) these Regulations.

Section 15 Offences and Penalties

(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.

Section 16 General defences

(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.

Section 17 Transitional defences and savings

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.

Section 18 Procedure where a sample is to be analysed

(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.

Section 19 Secondary analysis by the Government Chemist

(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.

Section 20 Applications for inclusion of an additive in the Community list of authorised additives

(1) This regulation applies where a person wishes to make an application for the inclusion of an eligible additive in the Community list referred to in Article 4 of the Directive.

(2) The application mentioned in paragraph (1), including supporting data, must be made to EFSA before 1st January 2007.

(3) If during examination of the data referred to in paragraph (2), EFSA calls for supplementary information, the eligible additive may, if otherwise permitted to be used under English law, continue to be so used until EFSA has issued an opinion, provided the supplementary opinion is submitted within the time limits specified by EFSA.

(4) For the purposes of this regulation, an eligible additive is one whose use is permitted in one or more Member States before 1st January 2007.

Section 21 Application of provisions of the Act

The following provisions of the Act shall apply for the purposes of these Regulations as they apply for the purposes of the Act —

(a) section 3 (presumption that food is intended for human consumption);

(b) section 30(8) (relating to documentary evidence);

(c) section 36 (offences by bodies corporate);

(d) section 36A (offences by Scottish partnerships);

(e) section 44 (protection of officers acting in good faith).

Section 22 Amendment of the Food Safety (Sampling and Qualifications) Regulations 1990

In the Food Safety (Sampling and Qualifications) Regulations 1990 , 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.

Section 23 Amendments to the Materials and Articles in Contact with Food (England) Regulations 2005

(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 .

(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”.

Section 24 Revocations

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 ;

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

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

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

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

(g) regulation 15 of the 2005 Regulations.

Section 1

In regulation 4 and Part 1 of this Schedule—

(a) the PM/REF number. of any substance is its EEC packaging material reference number;

(b) the CAS number of any substance is its CAS (Chemical Abstracts Service) Registry Number;

(c) the name of any substance is its chemical name, and to the extent that there is any inconsistency between the CAS number and the name, the name shall take precedence over the CAS number; and

(d) references to specific migration are to be taken to mean specific migration as measured in accordance with Schedules 5 and 6.

Section 2

If a substance appearing in Part 1 of this Schedule as an individual compound also falls within a generic term which appears therein, any restriction applying to that substance shall be that indicated for the individual compound and the entry applying to the generic term shall be treated as varied to such extent as is necessary.

Section 3

(1) The items identified in Part 1 of this Schedule shall be taken to include—

(a) substances undergoing polymerisation (including polycondensation, polyaddition or any other similar process) to manufacture macromolecules;

(b) natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers required to synthesise them are not so identified; and

(c) substances used to modify existing natural or synthetic macromolecular substances.

(2) If a substance identified in Part 1 of this Schedule is an acid, a phenol or an alcohol and has salts (including double salts) of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc) then any such salts shall be treated as included in the specification of that substance.

(3) If, as indicated in paragraph 2 of Annex II to the Directive, a substance is identified in Part 1 of this Schedule as an “… acid, salt” and has salts of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance.

Section 4

Where an entry in column 4 of Part 1 of this Schedule (restrictions and specifications) includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in that Part —

(1) Warning: there is a risk that the specific migration limit could be exceeded in fatty food simulants.

(2) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.

(3) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.

(4) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.

(5) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.

(14) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(21) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260, 18670, 54880 and 59280.

(22) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13620, 36840, 40320 and 87040.

(23) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13720 and 40580.

(24) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 16650 and 51570.

(25) QM(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the substances having PM/REF/Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.

(27) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.

(28) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.

(29) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.

(32) Compliance testing when there is a fat contact should be performed using isooctane as substitute of simulant D (unstable).

(33) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.

Section 1

In regulations 5 and 7 and Parts 1 and 2 of this Schedule—

(a) the PM/REF No of any additive is its EEC packaging material reference number,

(b) the CAS No. of any additive is its CAS (Chemical Abstracts Service) Registry Number; and

(c) the name of any additive is its chemical name, and to the extent that there is any inconsistency between the CAS No. and the name, the name shall take precedence over the CAS No.

Section 2

If a substance identified in Parts 1 or 2 is an acid, a phenol or an alcohol and has salts (including double salts) of one or more of the following names (that is to say salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then any such salts shall be treated as included in the specification of that substance.

Section 3

If, as indicated in paragraph 2 of Annex III to the Directive, a substance is identified in Parts 1 or 2 as an “… acid, salt” and has salts of one or more of the following names (that is to say, salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then the free acid corresponding to that substance is not treated as included in the specification of that substance.

Section 4

Where an entry in column 4 of Part 1 or Part 2 includes a bracketed number, that entry shall be subject to a note relating to that number as follows, the following bracketed numbers corresponding with those appearing in those Parts —

(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.

(2) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 10060 and 23920.

(3) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 15760, 16990, 47680, 53650 and 89440.

(4) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 19540, 19960 and 64800.

(5) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 14200, 14230 and 41840.

(6) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration of the substances having PM/REF Nos. 66560 and 66580.

(7) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.

(8) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 38000, 42400, 64320, 67896, 73040, 85760, 85840, 85920 and 95725.

(9) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.

(10) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels (expressed as iodine) of the substances having PM/REF Nos. 45200, 64320, 81680 and 86800.

(11) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 36720, 36800, 36840 and 92000.

(12) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 39090 and 39120.

(13) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 44960, 68078, 82020 and 89170.

(14) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(15) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 49600, 67520 and 83599.

(16) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.

(17) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PR/REF Nos. 67600, 67680 and 67760.

(18) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 60400, 60480 and 61440.

(19) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 66400 and 66480.

(20) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 93120 and 93280.

(21) SML(T) in this cases means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 17260, 18670, 54880 and 59280.

(22) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13620, 36840, 40320 and 87040.

(23) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF/Nos. 13720 and 40580.

(24) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the substances having PM/REF Nos. 16650 and 51570.

(26) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.

(27) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 10599/90A, 10599/91, 10599/92A and 10599/93.

(28) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 13480 and 39680.

(29) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 22775 and 69920.

(30) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 86480, 86960 and 87120.

(31) Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.

(32) Compliance testing when there is a fat contact should be performed using isooctane as substitute of simulant D (unstable).

(33) QMA(T) in this case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances having PM/REF Nos. 14800 and 45600.

(34) SML(T) in this case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances having PM/REF Nos. 55200, 55280 and 55360.

Section 5

In the case of the substances listed in Part 2, the specific migration limits specified in column 4 of that Part (restrictions and specifications) shall have effect with effect from 1st July 2006 where the verification of compliance is carried out in simulant D or in test media of substitute tests as prescribed in Council Directive 82/711/EEC and Council Directive 85/572/EEC .

Section 1 General Provisions

When the results of the migration tests specified in this Schedule and, where appropriate Schedule 6, are analytically determined, the specific gravity of any simulants used shall be assumed to be 1, so that milligrams of any substance released per litre of simulant will correspond numerically to milligrams of that substance released per kilogram of that simulant.

Section 2 General Provisions

Where any migration test specified in this Schedule and, where appropriate, Schedule 6 is carried out on any sample taken from any plastic material or article and the quantities of food or simulant placed in contact with the sample differ from those employed in the actual conditions under which the plastic material or article is used or is to be used, the results obtained should be corrected by applying the formula M = (( m.a 2 /a 1 .q).1000) where —

(a) M is the migration in mg/kg:

(b) m is the mass in the mg of substance released by the sample as determined by the migration test;

(c) a 1 is the surface area in square decimetres of the sample in contact with the food or simulant during the migration test;

(d) a 2 is the surface area in square decimetres of the plastic material or article in actual conditions of use; and

(e) q is the quantity in grams of food in contact with the plastic material or article in actual conditions of use.

Section 3 General Provisions

(1) Subject to sub-paragraph (2), any testing of migration from any plastic material or article shall be carried out on that plastic material or article.

(2) In any case where determination in accordance with sub-paragraph (1) above is impracticable, such testing shall be carried out, using either specimens taken from that plastic material or article, or where appropriate, specimens representative of that plastic material or article.

(3) Any sample used for such testing shall be placed in contact with the simulant or food, as the case may be, in a manner representing the contact conditions in actual use, and for this purpose the testing shall be carried out in such a way that only those parts of the sample intended to come into contact with food in actual use will be in contact with the simulant or food.

(4) Any migration testing of caps, gaskets, stoppers or similar devices for sealing shall be carried out on these articles by applying them to the containers for which they are intended in a manner which corresponds to the conditions of closing in normal or foreseeable use.

Section 4 General Provisions

(1) Any sample of plastic material or article shall be placed in contact with the appropriate simulant or the food for a period and at a temperature which are chosen by reference to the contact conditions in actual use in accordance with the provisions of this Schedule and, where appropriate, Schedule 6.

(2) At the end of the period referred to in sub-paragraph (1), analytical determination of the total quantity of substances (overall migration), each specific quantity of a substance (specific migration) or, as the case may be, both that total and that specific quantity released by the sample shall be carried out on the simulant or food, as the case may be.

(3) Verification that migration into food complies with a migration limit specified in regulation 9, Schedule 1 or Schedule 2 shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use in accordance with the provisions of this Schedule.

(4) Verification that migration into food simulants complies with a migration limit specified in regulation 9, Schedule 1 or Schedule 2 shall be carried out in accordance with the provisions of this Schedule and using conventional migration tests, the basic rules for which are set out in Schedule 6.

Section 5 General Provisions

Where a plastic material or article is intended to come into repeated contact with food, any migration test shall (subject to paragraph 7 below) be carried out three times on a single sample in accordance with the conditions laid down in this Schedule and, where appropriate, Schedule 6 using separate samples of the simulant or, as the case may be food, on each occasion, and the level of the migration found in the third test shall be treated as the level relevant to that test.

Section 6 Special provisions relating to overall migration

(1) Subject to sub-paragraph (2), any method of analytical determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.

(2) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article does not comply with regulation 9 it shall be a defence for the person charged to prove that—

(a) if an aqueous simulant specified in Schedule 6 had been used, and the analytical determination of the total quantity of substances released by a sample of the plastic material or article tested had been carried out by evaporation of the simulant and weighing of the residue; or

(b) if rectified olive oil or any of its substitutes had been used as a simulant and—

(i) a sample of the plastic material or article had been weighed before and after contact with the simulant;

(ii) the simulant absorbed by the sample had been extracted and determined quantitatively;

(iii) the quantity of simulant so found had been subtracted from the weight of the sample measured after contact with the simulant; and

(iv) the difference between the initial and corrected final weights had been determined to represent the overall migration of the sample examined,

there would have been no such excess so determined.

Section 7 Special provisions relating to overall migration

(1) Where a plastic material or article is intended to come into repeated contact with food and it is technically impossible to carry out the test described in paragraph 5, the test shall be so modified as to enable the level of migration occurring during the third such test to be determined and, subject to sub-paragraph (2), such a determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.

(2) In any proceedings for an offence under these Regulations where it is alleged, following determination under sub-paragraph (1) above, that a plastic material or article does not comply with regulation 9 it shall be a defence for the person charged to prove that, if—

(a) three identical samples of the plastic material or article had been procured;

(b) one of them had been subjected to the appropriate test according with paragraph 4 above and the overall migration determined (M 1 );

(c) the second and third samples had been subjected to the same conditions of temperature but the period of contact had been two and three times that specified and overall migration had been determined in each case (M 2 and M 3 respectively); and

(d) the plastic material or article had been deemed to comply with the overall migration limit relevant to it provided that either M 1 or M 3 – M 2 did not exceed that overall migration limit,

the plastic material or article would not have been deemed to exceed that limit.

Section 8 Special provisions relating to overall migration

(1) Any plastic material or article which exceeds its overall migration limit by an amount not exceeding the analytical tolerance specified in sub-paragraph (2) shall be deemed for the purposes of these Regulations not to exceed its overall migration limit.

(2) The following analytical tolerances shall be applied for limits of overall migration—

(a) 20 mg/kg or, as the case may be, 3 milligrams per square decimetre in migration tests using as a simulant rectified olive oil or substitutes;

(b) 12mg/kg or, as the case may be, 2 milligrams per square decimetre in migration tests using other simulants referred to in Schedule 6.

Section 1

Subject to paragraphs 2, 3 and 4 of this Part, migration tests for the determination of specific and overall migration shall be carried out using the food simulants specified in Parts 2, 3 and, where appropriate 4, and under conventional migration test conditions as specified in Part 5.

Section 1

Subject to Parts 3, 4, 5 and 7, the simulants to be used in migration testing are specified in the Table to this paragraph (referred to in this Part as “the Table”).

1

Abbreviation

2

Food Simulant

Section 1 Testing, reduction factors and definition of food types

The testing of plastic materials and articles shall be carried out under the test conditions specified in Part 5 using a simulant or simulants selected in accordance with this Part and taking a new test specimen of the plastic material or article for each simulant used.

Section 1

For the purposes of this Schedule a simulant is specified in relation to a specific food or a specific group of foods where “X” is placed in the column headed by that simulant opposite that specific food or specific group of foods in the Table to this Part, and the Table shall be read in conjunction with the notes to it and with paragraphs 2 to 5.

Section 1 General criteria

Subject to paragraphs 2, 4, 6 and 7 below and to paragraph 4.4 of Chapter II of the Annex to Directive 82/711, when carrying out migration tests the time and temperature used shall be the time and temperature selected from column 2 of the Table to this Part which correspond to the worst foreseeable conditions of contact specified in column 1 of that Table for the plastic material or article being tested and to any labelling information on maximum temperature for use.

Section 1

Subject to paragraphs 2, 4 and 5, all the test media specified in the Table to this Part shall be used in the substitute fat test for overall or specific migration under the test conditions corresponding to the test conditions for simulant D.

Section 1

Subject to paragraph 2 of this Part the conditions which must be fulfilled to allow the result of either test specified in paragraph 3 to be used as an alternative to the result of a migration test carried out under Part 3 are that—

(a) the result obtained in a “comparison test” shows that the values are equal to or greater than those obtained in the test with simulant D; and

(b) the migration occurring in either test specified in paragraph 3 does not, after application of the appropriate reduction factor, exceed the appropriate migration limit.

Section 2

Subject to paragraphs 3 and 4 of this Part, substitute tests which use test media under the conventional substitute test conditions as specified in Part 6 shall be carried out if the migration test using the fatty food simulants specified in Part 3 is not feasible for technical reasons connected with the method of analysis.

Section 2

For the purposes of this Schedule a reference to an abbreviation in column 1 of the Table shall mean a reference to the simulant in column 1 of that Table opposite that abbreviation.