The Plastic Materials and Articles in Contact with Food Regulations 1992

• Citation: S.I. 1992/3145
• Sections: 32

Section 1 Title, commencement and extent

(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.

Section 2 Interpretation

(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 ;

“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 as amended ;

“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.

Section 3 Restriction on sale etc. , and importation of plastic materials and articles

(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.

Section 4 Transfer of constituents

(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.

Section 5 Monomers

(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.

Section 6 Method of testing capability of transferring constituents

(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.

Section 7 Labelling

(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.

Section 8 Enforcement

(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.

Section 9 Offences

(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.

Section 10 Presumption as to food with which a plastic material or article is to come into contact

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.

Section 11 Application of other provisions

(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.

Section 12 Application of other provisions

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).

Section 1

In regulation 5 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, and

(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.

Section 1

The items identified in Part I of this Schedule—

(a) shall be taken to include—

(i) substances undergoing polymerisation (which shall be taken to include polyconden sation, polyaddition or any other similar process) to manufacture macromolecules,

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

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

(2)

(a) 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.

(b) If 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.

Section 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.

Section 1 A. General provisions

When the results of the migration tests specified in this Schedule 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 1

Subject to the provisions of this Schedule, the simulants which may be used in migration testing are as follows—

Simulant A: distilled water or water of equivalent quality;

Simulant B 3% acetic acid (w/v) in aqueous solution;

Simulant C 15% ethanol (v/v) in aqueous solution;

Simulant D: Rectified olive oil, save that if for technical reasons connected with the method of analysis it is necessary to use a different simulant, rectified olive oil shall be replaced by a mixture of synthetic triglycerides or by sunflower oil.

Section 1

(1) Subject to the provisions of this Part of this Schedule, capability of migration into food shall be treated for the purposes of these Regulations as being determined by carrying out the migration test described in this Schedule—

(a) in any case where a simultant is specified in the Table to this Schedule, either on the simulant or on the food; and

(b) in any case where the food is not specified in that table, either on the simulant which corresponds most closely in extractive capacity to the food or on the food.

(2) A simulant is specified in relation to a food for the purposes of this paragraph where ‘X’ is placed in the column headed by that simulant opposite the food 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.

(3) Where more than one simulant is to be used in relation to a migration test, a new sample of the plastic material or article shall be used for each such test.

Section 1

Subject to paragraph 2 below—

(a) the migration tests shall be carried out, selecting from the times and temperatures specified in the Table to this Part of this Schedule those which correspond most closely to the normal or foreseeable conditions of contact for the plastic material or article being studied;

(b) if a plastic material or article is intended to be used successively at short intervals in several of the conditions of contact referred to in column 1 of the table, migration will be determined by subjecting that plastic material or article successively to each correspond ing test condition specified in column 2, using the same simulant;

(c) where the plastic material or article may in actual use be employed under any conditions of contact time or temperature, the 10-day tests at 40°C and the two-hour tests at 70°C shall be carried out to test migration, except that, where simulant D is used (rectified olive oil or any of its substitutes), only the 10-day test at 40°C shall be carried out.

Section 2 A. General provisions

Where any migration test specified in this Schedule 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:

M is the migration in mg/kg;

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

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

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

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

Section 2

The particulars of simulant D referred to in paragraph 1 above are as hereinafter described:

(a) the characteristics of rectified olive oil shall be as follows—

(b) the composition of the synthetic triglycerides mixture shall be as follows—

(i) fatty acid distribution

No of C—atoms in fatty acid

(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 (cell of 1 cm, reference: water at 35°C)

characteristics of sunflower oil shall be as follows—

Section 2

Where, in the Table to this Part of this Schedule, “X” is followed by an oblique stroke and a figure, the result of any migration test on the simulant shall be divided by the number indicated.

Section 2

If it is found that carrying out the tests required by paragraph 1 above under the conditions specified in the table causes physical or other changes in the plastic material or article, the migration tests shall be carried out under conditions more appropriate to the specific case.

Section 3 A. General provisions

(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 impracti-cable, 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 3

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.

Section 3

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

Test conditions to be chosen, according to conditions of contact in actual use (times (t) and temperatures (T))

For plastic materials in contact with foodstuffs for which a preservation temperature of less than 20°C is specified on the labelling or by law, the test conditions will be 10 days at 20°C.

Use only simulant D at these temperatures, in addition to simulants A, B and C as appropriate, at 100°C or at reflux temperature.

or reflux temperature.

Section 4 A. General provisions

(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.

(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.

Section 4

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.

Table

If it can be demonstrated under regulation 10 or proved by means of an appropriate test that there is to be no fatty contact with the plastic material or article, simulant D shall not be used.

Simulant B shall not be used where the pH is more than 4.5.

Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than 5% vol.:

Waters, ciders, fruit or vegetable juices of normal strength or concentrated, musts, fruit nectars, lemonades and mineral waters, syrups, bitters, infusions, coffee, tea

Alcoholic beverages of an alcoholic strength equal to or exceeding 5% vol.:

Beverages shown under heading 01.01 but with an alcoholic strength equal to or exceeding 5% vol.:

Wines, spirits and liqueurs

(A) With fatty substances on the surface

(B) Other

(A) With fatty substances on the surface

(B) Other

Confectionery products:

In solid form:

(I) With fatty substances on the surface

(II) Other

(B) In paste form:

(I) With fatty substances on the surface

(II) Moist

(A) In solid form

(B) Honey and the like

(C) Molasses and sugar syrups

(A) Dried or dehydrated fruit, whole or in the form of flour or powder

(B) Fruit in the form of chunks, purée or paste

(C) Fruit preserves (jams and similar products–whole fruit or chunks or in the form of flour or powder, preserved in a liquid medium):

(I) In an aqueous medium

(II) In an oily medium

(III) in an alcoholic medium (≥5% vol.)

(A) Shelled, dried

(B) Shelled and roasted

(C) In paste or cream form

(A) Dried or dehydrated vegetables whole or in the form of flour or powder

(B) Vegetables, cut, in the form of purées

(C) Preserved vegetables:

(I) In an aqueous medium

(II) In an oily medium

(III) In an alcoholic medium (≥5% vol.)

(A) Fresh, chilled, salted, smoked

(B) In the form of paste

(A) Fresh, chilled, salted, smoked

(B) In the form of paste, creams

(A) In an aqueous medium

(B) In an oily medium

(A) Powdered or dried

(B) Other

(A) Liquid

(B) Powdered or frozen

(A) Whole

(B) Partly dried

(C) Skimmed or partly skimmed

(D) Dried

(A) Whole, with rind

(B) Processed cheeses

(C) All others

(A) In liquid or viscous form

(B) Powdered or dried

(A) Fried potatoes, fritters and the like

(B) Of animal origin

Preparations for soups, broths in liquid, solid or powder form (extracts, concentrates), homogenized composite food preparations, prepared dishes:

Powdered or dried:

(I) With fatty substances on the surface

(II) Other

(B) Liquid or paste:

(I) With fatty substances on the surface

(II) Other

(A) In paste form

(B) Dried

(A) Without fatty substances on the surface

(B) Mayonnaise, sauces derived from mayonnaise, salad creams and other oil in water emulsions

(C) Sauce containing oil and water forming two distinct layers

(A) With fatty substances on the surface

(B) Other

(A) With fatty substances on the surface

(B) Other

(A) Cocoa powder

(B) Cocoa paste

Aromatic herbs and other herbs:

Camomile, mallow, mint, tea, lime blossom and others

Spices and seasonings in the natural state:

Cinnamons, cloves, powdered mustard, pepper, vanilla, saffron and other

Section 5 A. 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 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 B. Special provisions relating to overall migration

(1) Subject to the following sub-paragraphs of this paragraph, 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 regulation 3 comprising excess of an overall migration limit, it shall be a defence for the person charged to prove that—

(a) if an aqueous simulant specified in this Schedule 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 B. 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 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 procedures for an offence under regulation 3 comprising excess of an overall migration limit as determined under sub-paragraph (1) above, 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 B. 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) 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 simultant 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 this Schedule.