The Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1995

Made: 15th February 1995

Laid before Parliament: 17th February 1995

Coming into force: 10th March 1995

The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly, in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred by sections 6(4), 16(2), 17(1), 26(1)(a) and (3), 31 and 48(1) of the Food Safety Act 1990[^f00001] and of all other powers enabling them in that behalf; the Minister of Agriculture, Fisheries and Food and the Secretary of State being Ministers designated[^f00002] for the purposes of section 2(2) of the European Communities Act 1972[^f00003] in relation to materials and articles in contact with food or drink or intended for such contact, acting jointly, in exercise of the powers conferred on them by the said section 2(2) and of all other powers enabling them in that behalf; and after consultation in accordance with section 48(4) of the Food Safety Act 1990 with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations (in so far as the Regulations are made in exercise of the powers conferred by the said Act of 1990), hereby make the following Regulations:—

Title, commencement, extent and interpretation

1

• (1) These Regulations may be cited as the Plastic Materials and Articles in Contact with Food (Amendment) Regulations 1995 and shall come into force on 10th March 1995.

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

• (3) In these Regulations “the principal Regulations” means the Plastic Materials and Articles in Contact with Food Regulations 1992[^f00004].

Amendment of the principal Regulations

2

The principal Regulations shall be amended as follows—

• (a) in paragraph (4)(b)(i) of regulation 5, for the words “of not less than 500 millilitres and not more than 10 litres” there shall be substituted the words “of less than 500 millilitres or more than 10 litres”;

• (b) in paragraph (6) of regulation 5, for the words “regulation 3 comprising” there shall be substituted the words “these Regulations, where it is alleged that the commission of the offence is due to”;

• (c) in paragraph (2) of regulation 6, for the word “refences” there shall be substituted the word “references”;

• (d) before and above regulation 12 there shall be inserted the following heading to that regulation “Use, sale and importation until 1st April 1995”;

• (e) after regulation 12 there shall be inserted the following regulation—

(13) Until 1st April 1996 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 D of Part I of Schedule 1— (a) may be used in the course of a business in connection with the storage, preparation, packaging, 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 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.

• (f) the Item number and letter, PM/REF No., CAS No., name and restriction (if any) for each monomer identified in Schedule 1 to these Regulations shall be inserted in Section A of Part 1 of Schedule 1 at the place corresponding to the number and letter specified for that monomer in the column headed `Item' in Schedule 1 to these Regulations;

• (g) for the entry in column 4 (Restrictions) of Section A of Part 1 of Schedule 1, opposite and corresponding to item 26, there shall be substituted the following entry “The specific migration of this substance shall not exceed 5mg/kg.”;

• (h) the contents of Schedule 2 to these Regulations shall be substituted for Section B of Part 1 of Schedule 1;

• (i) the contents of Schedule 3 to these Regulations shall be inserted after Section C of Part I of Schedule 1;

• (j) after paragraph 4(2) of Section A of Part 1 of Schedule 2 there shall be inserted the following sub-paragraphs—

(3) The verification of compliance with a migration limit using food 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) The verification of compliance with a migration limit using a simulant or simulants shall be carried out in accordance with the provisions of this Schedule using the simulant or simulants and the migration test conditions which are considered to be the most severe on the basis of experience.

• (k) in paragraph 1 of Part II of Schedule 2, in relation to Simulant D, after the words “sunflower oil.”, there shall be inserted the following sentence “If rectified olive oil, a mixture of synthetic triglycerides or sunflower oil is not appropriate, other food simulants and conditions of time and temperature may be used.”;

• (l) for paragraph 1 of Part III of Schedule 2 there shall be substituted the following—

(1) (1) Subject to paragraph (2) below, the migration testing of a plastic material or article which may come into contact with any food shall be carried out using one or more of the simulants specified in Part II of this Schedule. (2) Simulant A shall not be used in migration testing of a plastic material or article which may come into contact with any food other than where its use is specified in the Table to Part IV of this Schedule. (3) Subject to regulations 4(1) and 5(5), the migration testing of a plastic material or article which may come into contact only with a specific food or a specific group of foods shall be carried out— (a) where the specific food or specific group of foods is specified in the Table to this part of this Schedule, using the simulant or simulants specified in relation to that specific food or specific group of foods; or (b) where the specific food or specific group of foods is not specified in that Table, using the simulant or simulants which correspond most closely in extractive capacity to that food or group of foods. (4) A simulant is specified in relation to a specific food or a specific group of foods for the purposes of this paragraph 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. (5) 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.

• (m) in paragraph 1 of Part IV of Schedule 2 for the words “paragraph 2” there shall be substituted the words “paragraphs 2 and 2A”;

• (n) in paragraph 1(a) of Part IV of Schedule 2 after the words “most closely to” there shall be inserted the words “but which are not less than”;

• (o) for sub-paragraphs (b) and (c) of paragraph 1 of Part IV of Schedule 2 there shall be substituted the following sub-paragraphs—

(b) subject to sub-paragraph (d) below, where the intended use of a plastic material or article covers two or more combinations of time and temperature specified in column 1 of the Table to this Part of this Schedule, capability of migration shall be determined by subjecting that plastic material or article successively to each applicable test condition specified in column 2 using the same aliquot of simulant. (c) subejct to sub-paragraph (d) below, where a plastic material or article is intended to be used under any conditions of time— (i) if that plastic material or article may be used at any temperature not exceeding 70°C and such use is indicated by appropriate labelling or instructions, the 10 day test at 40°C shall be carried out; (ii) if that plastic material or article may be used at a temperature exceeding 70°C and no labelling or instructions indicate the temperature expected in actual use, simulant D shall be used for 2 hours at 175°C and simulants B and C shall be used either— (aa) at reflux temperature; or (bb) for two hours at 100°C; (iii) if that plastic material or article may be used at a temperature exceeding 70°C and labelling or instructions indicate conditions expected in actual use, times and temperatures shall be selected from the Table to this Part of this Schedule;

• (p) after sub-paragraph (c) of paragraph 1 of Part IV of Schedule 2 there shall be inserted the following sub-paragraph—

(d) where a plastic material or article is intended to be used for periods of less than 15 minutes at temperatures of not less than 70°C and not more than 100°C and this is indicated by labelling or instructions, the 2 hour test at 70°C and the 10 day test at 40°C shall be carried out separately using a different sample of the plastic material or article for each test.

• (q) after paragraph 2 of Part IV of Schedule 2 there shall be inserted the following paragraph—

(2A) Migration testing of plastic materials and articles intended for use in a microwave oven shall be carried out using a conventional oven selecting appropriate time and temperature conditions from the Table to this Part of this Schedule.

• (r) the Table in Schedule 4 to these Regulations shall be substituted for the Table in Part IV of Schedule 2.

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

3

At the end of Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990[^f00005] (provisions to which those Regulations do not apply) there shall be added in the left hand column the title to the principal Regulations and against it in the right hand column their reference.

SCHEDULE 1

SCHEDULE 2

“SECTION B — Monomers authorised up to the end of 1996

SCHEDULE 3

“SECTION D — Monomers authorised until 1st April 1996

SCHEDULE 4

Signed

Angela Browning — Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food — 6th February 1995

Signed by the authority of the Secretary of State for Health

Cumberlege — Parliamentary Under-Secretary of State, — Department of Health — 7th February 1995

Hector Monro — Parliamentary Under-Secretary of State, Scottish Office — 7th February 1995

Signed by authority of the Secretary of State for Wales

Rod Richards — Parliamentary Under-Secretary of State, Welsh Office — 15th February 1995

Explanatory note

(This note is not part of the Regulations)

These Regulations amend the Plastic Materials and Articles in Contact with Food Regulations 1992 (S.I. 1992/3145) (“the principal Regulations”) and implement Commission Directive 93/8/EEC (OJ No. L90, 14.4.93, p.22), amending Council Directive 82/711/EEC (OJ No. L297, 23.10.82, p.26) laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, and Commission Directive 93/9/EEC (OJ No. L90, 14.4.93, p.26), amending Commission Directive 90/128/EEC (OJ No. L75, 21.3.90, p.19, to be read with corrigendum in OJ No. L349, 13.12.90, p.26) relating to plastic materials and articles intended to come into contact with foodstuffs.

• The Regulations— provide that the capacity of an article specified in regulation 5(4)(b)(i) of the principal Regulations is less than 500 millilitres or more than 10 litres (regulation 2(a)); correct a drafting error in regulation 5(6) of the principal Regulations (regulation 2(b)); correct an error and an omission in the principal Regulations (regulation 2(c) and (d) respectively); permit the use, sale or importation of plastic materials and articles manufactured using one or more of the monomers in Section D as inserted in Part I of Schedule 1 to the principal Regulations by these Regulations, until 1 April 1996 (regulation 2(e) and (i)); add specified monomers to those listed in Section A of Part I to Schedule 1 of the principal Regulations (monomers authorised without time limit) (regulation 2(f)); amend the restriction at item 26 (11- Aminoundecanoic acid) in Section A of Part I of Schedule 1 to the principal Regulations (regulation 2(g)); substitute for Section B of Part I of Schedule 1 to the principal Regulations (monomers authorised to the end of 1996) an amended list with fewer authorised monomers (regulation 2(h)); add two further requirements to paragraph 4 of Section A of Part I of Schedule 2 to the principal Regulations specifying the conditions under which verification of compliance with migration limits is to be carried out using food and simulants respectively (regulation 2(j)); amend provisions relating to simulants to be used, and their use, in migration testing (regulation 2(k) and (l)); amend provisions relating to time and temperature test conditions (regulation 2(m) to (r)); amend the Food Safety (Sampling and Qualifications) Regulations 1990 (S.I. 1990/2463) so that those Regulations do not apply to any sample taken under the provisions of the principal Regulations (regulation 3).

• A copy of the Compliance Cost Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament and further copies can be obtained from the Chemical Safety of Food Division of the Ministry of Agriculture, Fisheries and Food, Ergon House, 17 Smith Square, London SW1P 3JR.

Footnotes

[^f00001]: 1990 c. 16; “the Ministers” is defined in section 4(1) of the Act.

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

[^f00003]: 1972 c. 68.

[^f00004]: S.I. 1992/3145.

[^f00005]: S.I. 1990/2463; amended by S.I. 1991/2843.