Title, commencement and extent

1.-(1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food Regulations 1998 and shall come into force on 1st July 1998.

(2) These Regulations apply in Great Britain.

Interpretation

2.-(1) In these Regulations, unless the context otherwise requires-

"the Act" means the Food Safety Act 1990;

"additive" means a substance, other than one which directly influences the formation of polymers, which is-

"business" has the same meaning as it has in the Act;

"capable" means capable as established under regulation 6;

"Council 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(4), as amended by Commission Directives 93/8/EEC(5) and 97/48/EC(6);

"the Directive" means Commission Directive (EEC) No. 90/128 relating to plastics materials and articles intended to come into contact with foodstuffs(7) (as corrected) and as amended by Commission Directives 92/39/EEC, 93/9/EEC, 95/3/EC and 96/11/EC(8);

"EEA Agreement" means the Agreement on the European Economic Area(9) signed at Oporto on 2nd May 1992 as adjusted by the Protocol(10) signed at Brussels on 17th March 1993;

"EEA State" means a State (other than the United Kingdom) which is a contracting party to the EEA Agreement;

"food" has the same meaning as it has in section 16(5) of the Act;

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

"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;

"the 1987 Regulations" means the Materials and Articles in Contact with Food Regulations 1987(11);

"the 1992 Regulations" means the Plastic Materials and Articles in Contact with Food Regulations 1992(12);

"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; and

"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 expression, other than one defined in paragraph (1) of this regulation, used both in these Regulations and in the Directive, Council Directive 82/711 or 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(13) has, in so far as the context admits, the same meaning as it bears in the Directive in which it appears.

(4) 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 the use, sale or importation of plastic materials and articles

3.-(1) A plastic material or article which fails to meet the requisite standards shall not be-

(a)used by any person in the course of a business in connection with the storage, preparation, packaging, sale or serving of food for human consumption;

(b)sold by any person for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption; or

(c)imported by any person from any place other than an EEA State for the purpose of its being used in connection with the storage, preparation, packaging, sale or serving of food for human consumption.

(2) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article which fails to meet the requisite standards was used, sold or imported 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 to a country, other than an EEA State, which has legislation analogous to these Regulations and that the plastic material or article complies with such legislation.

(3) In any proceedings for an offence under these Regulations where it is alleged that a plastic material or article which fails to meet the requisite standards was used, sold or imported it shall be a defence for the person charged to prove that the plastic material or article was manufactured-

(a)before 1st July 1998; and

(b)in accordance with regulation 5 of the 1992 Regulations as that regulation applied when the plastic material or article was manufactured.

(4) For the purposes of this regulation a plastic material or article fails to meet the requisite standards-

(a)if-

(i)it has been manufactured with a prohibited monomer as described in regulation 4(1) or a prohibited additive as described in regulation 5(1) or does not comply with regulation 4(5) or 7; and

(ii)no defence indicated in regulation 4(7), 5(2) or 7(5) would be available in proceedings for an offence under these Regulations relating to that manufacture or want of compliance; or

(b)if it has been manufactured outside Great Britain and sub-paragraph (a) above would have applied to it had it been manufactured in Great Britain.

Restriction on manufacture with monomers

4.-(1) Subject to the following paragraphs of this regulation, no plastic material or article shall be manufactured by any person with any prohibited monomer, that is to say any monomer other than a monomer which is-

(a)of good technical quality;

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

(c)used in accordance with the restrictions (if any) specified in the corresponding entry in column 4 of the relevant section of that Part of that Schedule.

(2) For the purposes of this regulation the relevant section of Part I of Schedule 1 is-

(a)in the case of a plastic material or article manufactured before 1st January 1999, Section A, B or C;

(b)in the case of a plastic material or article manufactured after 31st December 1998 and before 1st January 2002, Section A or B; and

(c)in the case of a plastic material or article manufactured after 31st December 2001, Section A.

(3) Paragraph (1) of this regulation 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)silicones;

(c)epoxy resins;

(d)products obtained by means of bacterial fermentation;

(e)adhesives and adhesion promoters; or

(f)printing inks.

(4) Paragraph (1) of this regulation shall not be taken to prohibit the manufacture of any plastic material or article with any substance if the substance is a mixture which falls within paragraph 3(c) of Annex II to the Directive and does not contravene paragraph 4 of that Annex.

(5) Subject to paragraph (6) of this regulation, where column 4 of the relevant section 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)the number of milligrams expressed therein released per kilogram of food in the case of any plastic material or article other than one specified in sub-paragraph (b) below; and

(b)one sixth of the number of milligrams expressed therein 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 which can be filled, with a capacity of less than 500 millilitres or 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.

(6) A plastic material or article manufactured from any monomer in respect of which column 4 of the relevant section 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 (5) of this regulation if the only food which that plastic material or article may come into contact with is food to which regulation 7(3) applies.

(7) 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) of this regulation because it was manufactured with any monomer (whether or not of good technical quality) other than one identified in the relevant section 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 which falls within paragraph 3(a) of Annex II to the Directive,

(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, or

(c)each such monomer falls within either sub-paragraph (a) or sub-paragraph (b) above,

and does not contravene paragraph 4 of that Annex.

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

Restriction on manufacture with additives

5.-(1) Subject to the following paragraphs of this regulation, no person shall use in the manufacture of plastic materials or articles any prohibited additive, that is to say an additive identified by PM/REF No., CAS No. (if any) and name respectively in columns 1, 2 and 3 of Part I of Schedule 2 which is not of good technical quality.

(2) 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 I of Schedule 2 which is not of good technical quality, it shall be a defence for the person charged 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.

(3) Part II of Schedule 2 shall have effect to supplement this regulation and Part I of Schedule 2.

Method of testing capability of transferring constituents

6.-(1) For the purposes of these Regulations, a plastic material or article 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 Schedules 3 and 4;

(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 Schedules 3 and 4, references 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.

(3) In paragraph (1)(a) above analytical tolerances, as referred to in paragraph 8 of Schedule 3, shall be treated as included among verification methods.

Transfer of constituents

7.-(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.

(2) For the purposes of this regulation 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 food to which paragraph (3) below applies.

(3) This paragraph applies to food which is specified in the Table to Part IV of Schedule 4 where there is no "X" placed anywhere in the group of columns headed "Simulants to be used" opposite that food.

(4) 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.

(5) In any proceedings for an offence under these Regulations an element of which is that a plastic material or article does not comply with this regulation the defences in paragraph 6(2) and 7(2) of Schedule 3 shall be available as specified therein.

Labelling

8.-(1) Subject to paragraph (2) of this regulation, at marketing stages other than the retail stage a person who is in possession of any plastic material or article which is intended to come into contact with food shall ensure that that plastic material or article is accompanied by a written declaration attesting that it complies with the legislation applicable to it.

(2) Paragraph (1) of this regulation shall not apply to a person in possession of any plastic material or article which by its nature is clearly intended to come into contact with food.

Enforcement

9.-(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

10.-(1) Any person who contravenes or fails to comply with regulation 3, 4(1), 5(1) or 8 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.

(3) Nothing in paragraph (2)(b) of this regulation shall be construed as requiring any person to answer any question or give any information if to do so might incriminate him.

(4) Any person who, in purported compliance with any such requirement as is mentioned in paragraph (2)(b) of this regulation-

(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.

(5) 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.

(6) For the purposes of paragraph (5) of this regulation "body corporate" shall in Scotland include a partnership.

(7) 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.

(8) In any proceedings for an offence under these Regulations it shall, subject to paragraph (12) 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.

(9) Without prejudice to the generality of paragraph (8) of this regulation, 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 (10) or (11) of this regulation.

(10) 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.

(11) 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.

(12) If in any case the defence provided by paragraph (8) of this regulation 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.

(13) 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.

(14) No prosecution for an offence under these Regulations shall be begun after the expiry of-

(a)three years from the commission of the offence; or

(b)one year from its discovery by the prosecutor,

whichever is the earlier.

Presumption as to food with which a plastic material or article is to come into contact

11. 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

12.-(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 to avoid restricting the scope of paragraph (1)(a), (b), (e) and (f) above.

Amendment of existing Regulations

13. In the Food Safety (Sampling and Qualifications) Regulations 1990(14) in Schedule 1 (provisions to which those Regulations do not apply) for the title and reference of the 1992 Regulations there shall be substituted the title and reference of these Regulations.

Revocation of existing Regulations

14. The 1992 Regulations, the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1995(15), the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1996(16) and the Plastic Materials and Articles in Contact with Food (Amendment) (No. 2) Regulations 1996(17) are hereby revoked.

Regulation 4

SCHEDULE 1

PART IAuthorised Monomers

SECTION AMonomers authorised without time limit

SECTION BMonomers authorised up to the end of 2001

SECTION CMonomers authorised up to the end of 1998

PART IISupplementary

1. In regulation 4 and Part I of this Schedule-

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

(b)the CAS No. 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 No. and the name, the name shall take precedence over the CAS No., and

(d)references to specific migration are to be taken to mean specific migration as measured in accordance with Schedules 3 and 4.

2. If a substance appearing in Part I of this Schedule as an individual compound also falls within a generic term which appears therein, the restriction (if any) 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 (if any) as is necessary therefor.

3.-(1) The items identified in Part I of this Schedule shall be taken to include-

(a)substances undergoing polymerisation (which shall be taken to include 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 synthesize them are not so identified, and

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

(2) If a substance identified in Part I 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 (including double salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then any such salts (including double 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 I 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.

Regulation 5

SCHEDULE 2

PART IAdditives

PART IISUPPLEMENTARY

1. In regulation 5 and Part I 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.

2. If a substance identified in Part I 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 (including double salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium or zinc), then any such salts (including double salts) shall be treated as included in the specification of that substance.

3. If, as indicated in paragraph 2 of Annex III to the Directive, a substance is identified in Part I 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.

Regulations 6 and 7

SCHEDULE 3PROVISIONS APPLICABLE WHEN TESTING COMPLIANCE WITH THE MIGRATION LIMITS

A. General provisions

1. When the results of the migration tests specified in this Schedule and, where appropriate, Schedule 4 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.

2. Where any migration test specified in this Schedule and, where appropriate, Schedule 4 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 following formula:

3.-(1) Subject to sub-paragraph (2) below, 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.

4.-(1) Any sample of a 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 4.

(2) At the end of the period referred to in sub-paragraph (1) above, 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 7 or Schedule 1 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 7 or Schedule 1 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 4.

5. 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 4 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.

B. Special provisions relating to overall migration

6.-(1) Subject to sub-paragraph (2) below, 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 7 it shall be a defence for the person charged to prove that-

(a)if an aqueous simulant specified in Schedule 4 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.

7.-(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 above, 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) below, 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 7 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 (M₁),

(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 (M₁ and M₂ respectively), and

(d)the plastic material or article had been deemed to comply with the overall migration limit relevant to it provided that either M₁ or M₂-M₃ did not exceed that overall migration limit,

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

8.-(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) below 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)6 mg/kg or, as the case may be, 1 milligram per square decimetre in migration tests using other simulants referred to in Schedule 4.

Regulations 6 and 7

SCHEDULE 4OVERALL AND SPECIFIC MIGRATION TESTING USING FOOD SIMULANTS

PART IBasic Rules

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

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

3. Subject to paragraph 4 of this Part of this Schedule, alternative tests as specified in Part VII of this Schedule may be used instead of the migration test with fatty food simulants specified in Part III of this Schedule but the results of such alternative tests may not be used to determine compliance with a migration limit unless the conditions specified in Part VII of this Schedule are fulfilled.

4. In migration testing it is permissible to-

(a)reduce the number of tests to be carried out to that or those which, in the specific case under examination, is or are generally recognised to be the most severe on the basis of scientific evidence;

(b)omit the migration, the substitute or the alternative tests where there is conclusive proof that the migration limits cannot be exceeded in any foreseeable conditions of use of the material or article.

PART IIFood Simulants to be used in Migration Testing

1. Subject to Parts III, IV, V, VI and VII of this Schedule, the simulants to be used in migration testing are specified in the Table to this paragraph (referred to in this Part of this Schedule as "the Table").

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.

3. The characteristics of rectified olive oil referred to in the Table are as hereinafter described-

• Iodine value (Wijs) = 80 to 88

• Refractive index at 25°C = 1.4665 to 1.4679

• Acidity (expressed as % of oleic acid) = 0.5% maximum

• Peroxide number (expressed as oxygen milliequivalents per kg of oil) = 10 maximum

4. The fatty food simulants referred to in the Table are-

(a)corn oil with standardised specifications;

(b)sunflower oil the characteristics of which are-

• Iodine value (Wijs) = 120 to 145

• Refractive index at 20°C = 1.474 to 1.476

• Saponification number = 188 to 193

• Relative density at 20°C = 0.918 to 0.925

• Unsaponifiable matter = 0.5% to 1.5%; and

(c)a synthetic mixture of triglycerides the composition of which is as follows-

(i)fatty acid distribution

(ii)purity

(iii)typical absorption spectrum (thickness of layer: d = 1 cm; Reference: water at 35°C)

• At least 10% light transmittance at 310 nm

5. Where a fatty food simulant specified in paragraph 4 of this Part of this Schedule is used in migration testing and the result of that test shows that a plastic material or article does not comply with any migration limit specified in regulation 7 or Schedule 1 verification that the plastic material or article does not comply with the specified migration limit shall be carried out by testing that material or article using olive oil if such testing is technically feasible and if such testing is not technically feasible the plastic material or article shall be deemed not to comply with the specified migration limit.

PART IIISelection of Food Simulants

A. Testing, reduction factors and definition of food types

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

2.-(1) Where a test is carried out on a plastic material or article intended to come into contact with more than one food or group of foods and a reduction factor is specified for one or more of those foods or groups of foods which is not equivalent to the reduction factor specified for one or more of the other foods or groups of foods with which the plastic material or article is intended to come into contact-

(a)the reduction factor specified for each food or group of foods, as appropriate, shall be applied to the test result; and

(b)the plastic material or article shall be treated as being capable of transferring its constituents to food with which it may come into contact in excess of a migration limit specified in regulation 7 or Schedule 1 if, following application of the specified reduction factors, one or more of the results show that the material or article does not comply with that specified migration limit.

(2) For the purposes of this paragraph-

(a)a reduction factor is the figure which follows an "X" and oblique stroke in the group of columns headed "Simulants to be used" in the Table to Part IV of this Schedule;

(b)a reduction factor is specified for a food or group of foods where, in the Table to Part IV of this Schedule-

(i)the food or group of foods is described in the column headed "Description of food"; and

(ii)"X" is placed in a column headed by a specified simulant opposite that food or group of foods followed by an oblique stroke and a reduction factor; and

(c)a reduction factor shall be applied to a test result by dividing the result by that reduction factor.

3. Food types are defined in the Table to this paragraph (referred to in this Part of this Schedule as "Table 1").

B. Selection of simulants for testing materials and articles intended for contact with all food types

4. The simulants to be used in testing a plastic material or article which is intended for contact with all food types shall be those mentioned below which, at the test conditions specified in Part V of this Schedule, are considered to be the more severe:

• simulant B;

• simulant C; and

• simulant D.

C. Selection of simulants for testing materials and articles which are already in contact with a known food

5. The simulant or simulants to be used in testing a plastic material or article which is already in contact with a known food shall be-

(a)where the known food is a specific food or is within a specific group of foods described in column 2 of the Table to Part IV of this Schedule and, for the purposes of Part IV of this Schedule, a simulant is, or simulants are, specified in relation to that specific food or specific group of foods, the simulant or simulants so specified;

(b)where the known food is neither a specific food nor within a specific group of foods described in the Table to Part IV of this Schedule, the simulant or simulants in column 2 of Table 2 to this Part of this Schedule opposite the description of food in column 1 of that Table which corresponds most closely to the known food.

D. Selection of simulants for testing materials and articles which are accompanied by a specific indication

6. The simulant or simulants to be used in testing a plastic material or article which, pursuant to regulation 7 or 8, as appropriate, of the 1987 Regulations, is accompanied by a specific indication stating any type or types of food described in Table 1 with which it may or may not be used shall be the simulant or simulants in column 2 of Table 2 to this Part of this Schedule opposite the contact food in column 1 of that Table which corresponds most closely to the type or types of food with which it may be used, as identified by the indication which accompanies the plastic material or article.

7. The simulant or simulants to be used in testing a plastic material or article which, pursuant to regulation 7 or 8, as appropriate, of the 1987 Regulations, is accompanied by a specific indication, expressed in accordance with paragraph 8 of this Part of this Schedule, stating any food or group of foods described in the Table to Part IV of this Schedule with which it may or may not be used shall be-

(a)where the indication states that the plastic material or article may be used with a food or group of foods described in column 2 of the Table to Part IV, the food simulant or food simulants which, for the purposes of Part IV of this Schedule, is or are specified in relation to that food or group of foods;

(b)where the indication states that the plastic material or article should not be used with any food or group of foods described in column 2 of the Table to Part IV of this Schedule, a simulant other than the simulant or simulants which, for the purposes of Part IV of this Schedule, is or are specified in relation to that food or group of foods.

8. A specific indication referred to in paragraph 7 of this Part of this Schedule is expressed in accordance with this paragraph if it is expressed-

(a)at a marketing stage other than retail, by using the reference number in column 1 of the Table to Part IV of these Regulations or the decription of food in column 2 of that Table which, in either case, corresponds to the food;

(b)at the retail stage, by using an indication which refers to only a few foods or groups of foods described in the Table to Part IV of this Schedule.

PART IVSimulants to be used in relation to a specific food or a specific group of foods

1. For the purposes of this Part 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 of this Schedule, and the Table shall be read in conjunction with the notes thereto and the following paragraphs of this Part of this Schedule.

2. For the purposes of this Part of this Schedule-

(a)a reduction factor is the figure which follows an "X" and oblique stroke in the group of columns headed "Simulants to be used" in the Table to this Part of this Schedule;

(b)a reduction factor is specified in relation to a specific food or group of foods where, in the Table to this Part of this Schedule-

(i)the food or group of foods is described in the column headed "Description of food"; and

(ii)"X" is placed in a column headed by a specified simulant opposite that food or group of foods allowed by an oblique stroke and a reduction factor.

3. Where, in the Table to this Part of this Schedule, a reduction factor is specified relation to a specific food or a specific group of foods, that reduction factor shall be applied to the result of any migration test using the simulant specified in relation to that food or group of foods by dividing the result of the test by that reduction factor.

4. Where, in the Table to this Part of this Schedule, the letter "a" is shown in brackets after the "X", only one of the two simulants specified shall be used in the migration test, that is to say-

(a)if the pH value of the food is higher than 4.5, simulant A shall be used,

(b)if the pH value of the foodstuff is 4.5 or less, simulant B shall be used.

5. Where a food is listed in the Table to this Part of this Schedule under both a specific and a general heading, the simulant relating to the specific heading is the simulant which falls to be used for the migration test.

PART VMigration Test Conditions (Times and Temperatures)

A. General criteria

1. 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 of this Schedule 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.

2. Where the plastic material or article being tested is intended for a food contact application covered by a combination of two or more times and temperatures specified in column 2 of the Table to this Part of this Schedule the migration test shall be carried out by subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.

3. For the purposes of this Part of this Schedule the worst foreseeable conditions of contact are those which are recognised to be the most severe on the basis of scientific evidence.

B. Volatile migrants

4. When carrying out a test of the specific migration of volatile substances any test using a simulant shall be performed in a manner which recognises the loss of volatile migrants which may occur in the worst foreseeable conditions of use.

C. Special cases

5. When carrying out a migration test of a plastic material or article which is intended for use in a microwave oven, if the appropriate time and temperature is selected from the table to this Part of this Schedule, either a conventional oven or a microwave oven may be used.

6. Where the carrying out of a migration test under contact conditions specified in the Table to this Part of this Schedule causes any physical or other change in the test specimen which does not occur under the worst forseeable conditions of use of the plastic material or article being tested the migration test shall be carried out in the worst foreseeable conditions of use in which such physical or other change does not occur.

7. Where, in actual use, the plastic material or article being tested is intended to be used for periods of less than 15 minutes at any temperature of not less than 70°C and not more than 100°C and such use is indicated by appropriate labelling or instructions no test other than for 2 hours at 70°C shall be carried out on the plastic material or article unless the plastic material or article is also intended to be used for storage at room temperature in which case no test other than for 10 days test at 40°C shall be carried out.

8. The Table to this Part of this Schedule shall be read with the notes to it.

PART VISubstitute Fat Test for Overall and Specific Migration

1. Subject to paragraphs 2, 4 and 5 below, all the test media specified in the Table to this Part of this Schedule 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.

2. Test conditions other than those specified in the Table to this Part of this Schedule may be used in the substitute fat test if the assumptions underlying the test conditions specified in that Table and, where the plastic material or article being tested is a polymer, the existing experience of that type of polymer are taken into account.

3. For each test-

(a)a new test specimen shall be used;

(b)the rules prescribed for simulant D in Part III, IV and V of this Schedule shall be applied for each test medium;

(c)subject to paragraph 4 below, compliance with a migration limit shall be determined by selecting the highest value using all the test methods.

4. Where carrying out a migration test causes any physical or other change in the test specimen which does not occur under the worst foreseeable conditions of use of the plastic material or article the result of that test shall not be used to ascertain compliance with a migration limit.

5. Any test conditions in the Table to this Part of this Schedule which are generally recognised on the basis of scientific evidence as not being appropriate for the material or article to be tested shall not be used.

6. The Table to this Part of this Schedule shall be read with the notes to it.

PART VIIAlternative Fat Tests for Overall and Specific Migration

1. Subject to paragraph 2 of this Part of this Schedule the conditions which must be fulfilled to allow the result of either test specified in paragraph 3 of this Part of this Schedule to be used as an alternative to the result of a migration test carried out under Part III of this Schedule 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 of this Part of this Schedule does not, after application of the appropriate reduction factor, exceed the appropriate migration limit.

2. The condition in sub-paragraph (a) of paragraph 1 of this Part of this Schedule does not have to be fulfilled if it can be shown on the basis of the result of scientific experiment that the values obtained in either of the tests specified in paragraph 3 of this Part of this Schedule are equal to or greater than those obtained in any of the migration tests specified in Part III of this Schedule.

3. The migration tests referred to in paragraphs 2 and 3 of this Part of this Schedule are-

(a)a test carried out using volatile media including isooctane, ethanol 95%, other volatile solvents or a mixture of solvents at such contact conditions as would result in values equal to or greater than those obtained in a test using simulant D;

(b)other tests using media having a very strong extraction power under very severe test conditions where, on the basis of scientific evidence, it is generally recognised that the results using these tests are equal to or higher than those obtained in a test using simulant D.

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which apply to Great Britain, come into force on 1st July 1998.

These Regulations implement-

(a)Council Directive (EEC) 82/711 (OJ No. L297, 23.10.82, p.26), as amended by Commission Directives 93/8/EEC (OJ No. L90, 14.4.93, p.22) and 97/48/EC (OJ No. L222, 12.8.97, p.10), laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs;

(b)Council Directive (EEC) 85/572 (OJ No. L372, 31.12.85, p.14) 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; and

(c)Commission Directive (EEC) 90/128 (OJ No. L75, 21.3.90, p.19, to be read with the corrigendum in OJ No. L349, 13.12.90, p.26), as amended by Commission Directives (EEC) 92/39 (OJ No. L168, 23.6.92, p.21), 93/9 (OJ No. L90, 14.4.93, p.26), 95/3/EEC (OJ No. L41, 23.2.95, p.44) and 96/11/EC (OJ No. L61, 12.3.96, p.26), relating to plastic materials and articles intended to come into contact with foodstuffs.

These Regulations-

(a)prohibit the use, sale or importation of plastic materials and articles which do not meet specified standards and provide a defence in relation to plastic materials and articles intended for export (regulation 3(1), (2) and (4));

(b)prohibit the manufacture of plastic materials and articles with any monomer other than one which meets specified requirements and provide a defence in relation to plastic materials and articles manufactured before 1st July 1998 and in accordance with regulation 5 of the Plastic Materials and Articles in Contact with Food Regulations 1992 (regulations 3(3) and 4);

(c)prohibit the use in the manufacture of plastic materials or articles of any specified additive which is not of good technical quality (regulation 5);

(d)provide the methods for testing the capability of plastic materials or articles of transferring constituents to food (regulation 6);

(e)stipulate the overall migration limit for plastic materials and articles (regulation 7);

(f)require, at marketing stages other than retail, persons in possession of any plastic material or article intended to come into contact with food to ensure such material or article is accompanied by a specified declaration (regulation 8);

(g)identify the enforcement authorities (regulation 9);

(h)provide offences and defences and specify penalties (regulation 10);

(i)provide that specified presumptions shall arise from particulars shown in relation to a plastic material or article in accordance with the Materials and Articles in Contact with Food Regulations 1987 ("the 1987 Regulations") (regulation 11);

(j)apply provisions of the 1987 Regulations and of the Food Safety Act 1990 (regulation 12); and

(k)amend and revoke other legislation (regulations 13 and 14).

The materials and articles to which these Regulations relate are also subject to the 1987 Regulations.

These Regulations are made under specified provisions of the Food Safety Act 1990 and-insofar as they cannot be made under those provisions-section 2(2) of the European Communities Act 1972. The provisions included under the 1972 Act are those which key into provisions of the 1987 Regulations (save where covered by section 48(1)(a) of the 1990 Act) and revocations of regulations made under section 2(2) of the 1972 Act.

A regulatory appraisal, which includes a compliance cost assessment, has been placed in the library of each House of Parliament and copies can be obtained from the Additives and Novel Foods Division of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.