The Plastic Materials and Articles in Contact with Food Regulations 1992

PART II — SUPPLEMENTARY

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.

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

SCHEDULE 2

PART I — PROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS

A. General provisions

1

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.

2

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=m.a2a1.q×.1000$ 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; a₁ is the surface area in square decimetres of the sample in contact with the food or simulant during the migration test; a₂ 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.$

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 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.

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.

• (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.

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 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 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.

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 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 (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 (M₂ and M₃, 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 M₃ − M₂ 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 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.

PART II — SIMULANTS TO BE USED IN MIGRATION TESTS

PART III — SPECIFICATION OF SIMULANTS TO BE USED

PART IV — TEST CONDITIONS (TIMES AND TEMPERATURES)

Signed

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

Explanatory note

(This note is not part of the Regulations)

These Regulations implement Commission Directive (EEC) 90/128 (OJ No. L349, 13.12.90, p.26) as amended by Commission Directive (EEC) 92/39 (OJ No. L168, 23.6.92, p.21) relating to plastic materials and articles intended to come into contact with foodstuffs, as read with Council Directives (EEC) 82/711 and 85/572 (OJ Nos. L297, 23.10.82, p.26 and L372, 30.12.85, p.14 respectively) which between them lay down the basic rules necessary, and the list of simulants to be used, for testing migration of certain constituents of plastic materials and articles intended to come into contact with foodstuffs. The Regulations prescribe limits both in relation to content of the materials and articles in question and migration of constituents into food, and the tests by which migration is to be established. The materials and articles to which these Regulations relate are also subject to the Materials and Articles in Contact with Food Regulations 1987.

Plastic materials and articles manufactured before the coming into force of these Regulations containing certain constituents which by these Regulations can no longer be used in manufacture may be used for the purposes of storage etc and may be sold for such purposes until 1st April 1995 (regulation 12).

Footnotes

[^f00001]: 1990 c. 16.

[^f00002]: S.I. 1976/2141.

[^f00003]: 1972 c. 68.

[^f00004]: S.I. 1987/1523, amended by S.I. 1990/2487, 1991/1476.

[^f00005]: OJ No. L349, 13.12.90, p.26.

[^f00006]: OJ No. L168, 23.6.92, p.21.