Statutory Instrument 1992 No. 3145

The Plastic Materials and Articles in Contact with Food Regulations 1992

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© Crown Copyright 1992

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1992 No. 3145

FOOD

The Plastic Materials and Articles in Contact with Food Regulations 1992

The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly, in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred by sections 4(1), 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990^[1], and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designated^[2] for the purposes of section 2(2) of the European Communities Act 1972^[3] in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) and of all other powers enabling them in that behalf; and after consultation in accordance with section 48(4) of the Food Safety Act 1990 with such organisations as appear to them to be representative of interests substantially affected by the Regulations (in so far as the Regulations are made in exercise of the powers conferred by the said Act of 1990), hereby make the following Regulations:—

Title, commencement and extent
    1.—(1)  These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Regulations 1992 and shall come into force on 1st January 1993.

    (2)  These Regulations shall not extend to Northern Ireland.

Interpretation
    2.—(1)  In these Regulations, unless the context otherwise requires—
"the Act" means the Food Safety Act 1990;
"the 1987 Regulations" means the Materials and Articles in Contact with Food Regulations 1987^[4];
"business" has the same meaning as it has in the Act;
"capable" means capable as established under regulation 6;
"the Directive" means Commission Directive (EEC) No. 90/128 relating to plastics materials and articles intended to come into contact with foodstuffs^[5] as amended^[6];
"food" has the same meaning as it has in the Act;
"human consumption" has the same meaning as it has in the Act;
"import" means import in the course of a business;
"monomer" means anything which is included for the purposes of the Directive among monomers and other starting substances;
"person charged" includes, in Scotland, the accused;
"plastic material or article" means anything which for the purposes of the Directive is included among those plastics materials and articles and parts thereof to which the Directive applies;
"preparation" has the same meaning as it has in the Act;
"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 of any plastic material or article, otherwise than on sale, in the course of a business shall be deemed to be a sale of the plastic material or article.

    (3)  Any reference in these Regulations to a numbered regulation or Schedule shall unless the context otherwise requires be construed as a reference to the regulation or Schedule bearing that number in these Regulations.

Restriction on sale etc., and importation of plastic materials and articles
    3.—(1)  No person shall use any plastic material or article which does not comply with these Regulations in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption.

    (2)  No person shall sell any plastic material or article which does not comply with these Regulations for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption.

    (3)  No person shall import from any place other than a member State of the European Economic Community any plastic material or article which does not comply with these Regulations for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption.

    (4)  In any proceedings for an offence under this regulation it shall be a defence for the person charged to prove that the plastic material or article in respect of which the offence is alleged to have been committed was intended for export and complied with the importing country's domestic legislation relevant to the alleged offence.

Transfer of constituents
    4.—(1)  No plastic material or article shall be capable of transferring its constituents to food with which it may come into contact in quantities exceeding the appropriate limit provided that a plastic material or article shall not be considered capable of transferring its constituents to food with which it may come into contact, in quantities exceeding the appropriate limit, if the only food which that plastic material or article may come into contact with is a food or foods specified in the Table to Part III of Schedule 2 in relation to which no simulant is specified.

    (2)  For the purposes of this regulation and regulation 5(5) no simulant is specified in relation to a food specified in the Table to Part III of Schedule 2 where there is no "X' placed in the column headed "Simulants to be used' opposite that food.

    (3)  For the purposes of this regulation the appropriate limit is—
 (a) an overall migration limit of 60 milligrams of constituents released per kilogram of food in the case of any plastic material or article comprising—
 (i) an article which is a container or is comparable to a container or which can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres;
 (ii) an article which can be filled and for which it is impracticable to estimate the surface area in contact with food;
 (iii) a cap, gasket, stopper or similar device for sealing, and
 (b) in the case of any other plastic material or article, an overall migration limit of 10 milligrams per square decimetre of the surface area of the plastic material or article.

Monomers
    5.—(1)  Subject to the following paragraphs of this regulation, no plastic material or article shall be manufactured with any monomer other than a monomer which is of good technical quality and is identified by PM/REF No. (if any), CAS No. (if any) and name respectively in columns 1, 2, 3 of the relevant fraction of Part I of Schedule 1 and used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 thereof, and for the purposes of this regulation the relevant fraction of Part I comprises—
 (a) in the case of a plastic material or article manufactured before 1st January 1997, Sections A and B of Part I, and
 (b) in the case of a plastic material or article manufactured after 31st December 1996, Section A of Part I.

    (2)  Paragraph (1) of this regulation does not apply to plastic materials or articles comprising—
 (a) surface coatings obtained from resinous or polymerized products in liquid, powder or dispersion form, including, but not limited to, varnishes, lacquers and paints;
 (b) silicones;
 (c) epoxy resins;
 (d) products obtained by means of bacterial fermentation;
 (e) adhesives and adhesion promoters;
 (f) printing inks.

    (3)  Paragraph (1) of this regulation shall not be taken to prohibit the presence in any plastic material or article of any substance if the substance is a mixture of monomers of good technical quality identified in the relevant fraction of Part I of Schedule 1.

    (4)  Subject to the proviso in paragraph (5) of this regulation, where column 4 of the relevant fraction of Part I of Schedule 1 expresses a migration limit of mg/kg in relation to any monomer, no plastic material or article manufactured from that monomer shall be capable of transferring constituents of that monomer to food with which that 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) in the case of any plastic material or article other than one specified in subparagraph (b) below, the number of milligrams expressed therein released per kilogram of food, and
 (b) if the plastic material or article comprises—
 (i) an article which is a container or is comparable to a container or which can be filled, with a capacity of not less than 500 millilitres and not more than 10 litres, or
 (ii) sheet, film or other material which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of that material and the quantity of food in contact with that surface area,
one sixth of the number of milligrams expressed therein per square decimetre of surface area of the plastic material or article.

    (5)  A plastic material or article manufactured from any monomer in respect of which column 4 of the relevant fraction of Part I of Schedule 1 expresses a migration limit of mg/kg shall not be considered capable of transferring constituents of that monomer to food with which that plastic material or article may come into contact in quantities exceeding the appropriate limit in paragraph (4) of this regulation if the only food which that plastic material or article may come into contact with is a food or foods specified in the Table to Part III of Schedule 2 in relation to which no simulant is specified.

    (6)  In any proceedings for an offence under regulation 3 comprising the manufacture of a plastic material or article with any monomer (whether or not of good technical quality) other than those identified in the relevant fraction of Part I of Schedule 1, it shall be a defence for the person charged to prove that—
 (a) each such monomer is present in the finished plastic material as an impurity, a reaction intermediate or a decomposition product,
 (b) each such monomer is an oligomer or a natural or synthetic macromolecular substance or a mixture thereof and every monomer required to synthesise it is of good technical quality and identified in the relevant fraction of Part I of Schedule 1, or
 (c) each such monomer falls within either sub-paragraph (a) or sub-paragraph (b) above.

    (7)  Part II of Schedule 1 shall have effect to supplement this regulation and Part I of Schedule 1.

Method of testing capability of transferring constituents
    6.—(1)  Plastic material, for the purposes of these Regulations, shall be treated as being capable of transferring constituents to food with which it may come into contact to the extent that it is established for those purposes—
 (a) in any case other than one to which sub-paragraph (b) below relates, by the verification methods specified in Schedule 2, and
 (b) in any case where the extent to which vinyl chloride, as identified in Section A of Part I of Schedule 1, is capable of such transfer falls to be established, by the method referred to in regulation 14(2) of the 1987 Regulations.

    (2)  In Schedule 2 refences to migration or release of a substance shall 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.

Labelling
    7.—(1)  Subject to paragraph (2) below, any plastic material or article which is intended to be placed in contact with food and is at a marketing stage other than the retail stage shall be accompanied by a written declaration attesting that it complies with the legislation applicable to it.

    (2)  Paragraph (1) above shall not apply to any plastic material or article which by its nature is clearly intended to come into contact with food.

Enforcement
    8.—(1)  Each authority which is the enforcement authority for the 1987 Regulations shall enforce and execute in its area the provisions of these Regulations.

    (2)  Nothing in this regulation shall be taken as authorising in Scotland an enforcement authority to institute proceedings for an offence against these Regulations.

Offences
    9.—(1)  If any person contravenes or fails to comply with any of the provisions of these Regulations he shall be guilty of an offence.

    (2)  Any person who—
 (a) intentionally obstructs any person acting in the execution of these Regulations, or
 (b) without reasonable cause, fails to give to any person acting in the execution of these Regulations any assistance or information which that person may reasonably require of him for the performance of his functions under these Regulations,
shall be guilty of an offence, but nothing in sub-paragraph (b) above shall be construed as requiring any person to answer any question or give any information if to do so might incriminate him.

    (3)  Any person who, in purported compliance with any such requirement as is mentioned in paragraph (2)(b) above—
 (a) furnishes information which he knows to be false or misleading in a material particular, or
 (b) recklessly furnishes information which is false or misleading in a material particular,
shall be guilty of an offence.

    (4)  Where an offence under these Regulations which has been committed by a body corporate is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of—
 (a) any director, manager, secretary or other similar officer of the body corporate, and in Scotland, any partner of a partnership, or
 (b) any person who was purporting to act in any such capacity,
he as well as the body corporate shall be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

    (5)  For the purposes of these Regulations "body corporate" shall in Scotland include a partnership.

    (6)  Where the commission by any person of an offence under these Regulations is due to an act or default of some other person, that other person shall be guilty of the offence; and a person may be charged with and convicted of the offence by virtue of this paragraph whether or not proceedings are taken against the first mentioned person.

    (7)  In any proceedings for an offence under these Regulations it shall, subject to paragraph (11) below, be a defence for the person charged 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.

    (8)  Without prejudice to the generality of paragraph (7) above, a person charged with an offence under these Regulations who neither—
 (a) prepared the plastic material or article in respect of which the offence is alleged to have been committed, nor
 (b) imported it into Great Britain,
shall be taken to have established the defence provided by that paragraph if he satisfies the requirements of paragraph (9) or (10) below.

    (9)  A person satisfies the requirements of this paragraph if he proves—
 (a) that the commission of the offence was due to an act or default of another person who was not under his control, or to reliance on information supplied by such a person;
 (b) that he carried out all such checks of the plastic material or article in question as were reasonable in all the circumstances, or that it was reasonable in all the circumstances for him to rely on checks carried out by the person who supplied the plastic material or article to him; and
 (c) that he did not know and had no reason to suspect at the time of the commission of the alleged offence that his act or omission would amount to an offence under these Regulations.

    (10)  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 an act or default of another person who was not under his control, or to 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 of the commission of the alleged offence that his act or omission would amount to an offence under these Regulations.

    (11)  If in any case the defence provided by paragraph (7) above involves the allegation that the commission of the offence was due to an act or default of another person, or to reliance on information supplied by another person, the person charged 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 a court in connection with the alleged offence, within one month of his first such appearance,
he has served on the prosecutor a notice in writing giving such information identifying or assisting in the identification of that other person as was then in his possession, and in this paragraph any reference to appearing before a court shall be construed as including a reference to being brought before a court.

    (12)  Any person guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or to both and on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or both.

Presumption as to food with which a plastic material or article is to come into contact
    10.    In establishing which descriptions of food a plastic material or article may come into contact with it shall be assumed for the purposes of these Regulations, until the contrary is proved, that, if particulars are shown in relation to that plastic material or article in accordance with the 1987 Regulations, those particulars are accurate and that, unless the particulars so indicate, there are no restrictions on the intended conditions of contact.

Application of other provisions
    11.—(1)  The following provisions of the 1987 Regulations shall apply in relation to plastic materials or articles as they apply to materials and articles for the purposes of those Regulations, as if those provisions formed part of these Regulations—
 (a) regulation 12 (powers of authorised officers);
 (b) regulation 13 (analysis, examination and testing);
 (c) regulation 16 (confidentiality);
 (d) regulation 17 (authorised officer acting in good faith);
 (e) regulation 20 (evidence of analysis); and
 (f) regulation 21 (analysis by Government chemist).

    (2)  Section 3(4) of the Act (relating to the presumption of intention for human consumption) shall apply for the purposes of these Regulations as it applies for the purposes of the Act.

    (3)  Sections 29 and 30 of the Act (which deal with procurement and analysis of samples) shall, in so far as they relate to plastic materials or articles, be modified to the extent necessary for the purposes of these Regulations.

    12.    Until 1st April 1995 a plastic material or article which has been manufactured using one or more of the monomers identified by PM/REF No. (if any), CAS No. (if any) and name respectively in columns 1, 2, 3 of Section C of Part I of Schedule 1—
 (a) may be used in the course of a business in connection with the storage, preparation, packing, sale or serving of food for human consumption,
 (b) may be sold for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption, or
 (c) may be imported for the purpose of its being used in connection with with the storage, preparation, packaging, sale or serving of food for human consumption,
provided that such monomer is of good technical quality and is used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 thereof and where column 4 expresses a migration limit of mg/kg in relation to any such monomer that monomer shall comply with the appropriate migration limit in regulation 5(4).

In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 10th December 1992.


John Selwyn Gummer

Minister of Agriculture, Fisheries and Food

Signed by the authority of the Secretary of State for Health

Tom Sackville

Parliamentary Under Secretary of State, Department of Health

8th December 1992

David Hunt

Secretary of State for Wales

10th December 1992

Hector Monro

Parliamentary Under Secretary of State, Scottish Office

9th December 1992

[1] 1990 c. 16. back

[2] S.I. 1976/2141. back

[3] 1972 c. 68. back

[4] S.I. 1987/1523, amended by S.I. 1990/2487, 1991/1476. back

[5] OJ No. L349, 13.12.90, p.26. back

[6] OJ No. L168, 23.6.92, p.21. back

Explanatory Note