The Notification of New Substances (Amendment) Regulations 1991

Made: 21st August 1991

Laid before Parliament: 3rd September 1991

Coming into Force: 30th September 1991

The Secretary of State being the designated[^f00001] Minister for the purposes of section 2(2) of the European Communities Act 1972[^f00002] in relation to the notification and control of substances, in the exercise of the powers conferred on him by the said section 2 and section 15(1) and (2) of, and paragraph 15(1) of Schedule 3 to, the Health and Safety at Work etc. Act 1974[^f00003] (“the 1974 Act”) and of all other powers enabling him in that behalf and for the purpose of giving effect without modifications to proposals submitted to him by the Health and Safety Commission under section 11(2)(d) of the 1974 Act after the carrying out by the said Commission of consultations in accordance with section 50(3) of that Act, hereby makes the following Regulations:–

Citation, commencement and interpretation

1

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• (1) These Regulations may be cited as the Notification of New Substances (Amendment) Regulations 1991 and shall come into force on 30th September 1991.

• (2) In these Regulations, “the principal Regulations” means the Notification of New Substances Regulations 1982[^f00004].

Amendment to the principal Regulations

2

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• (1) The principal Regulations shall be amended in accordance with the following paragraphs of this regulation.

• (2) In regulation 2(1) of the principal Regulations, for the definition of “new substance” there shall be substituted the following definition–

• “new substance” means any substance except a substance which appears in the inventory referred to in Article 13.1 of the Directive;

• (3) In regulation 4 of the principal Regulations after paragraph (1), there shall be inserted the following paragraph–

(1A) The notification referred to in paragraph (1) shall be accompanied by a certificate in writing from the body which carried out the tests for the purposes of the technical dossier stating that those tests were carried out in conformity with the principles prescribed in regulation 11(1).

• (4) At the end of regulation 6 there shall be inserted the following paragraph–

(4) Any report made in pursuance of paragraph (1) shall be accompanied by a certificate in writing from the body that carried out the tests referred to in the report stating that those tests were carried out in conformity with the principles prescribed in regulation 11(1).

• (5) In paragraph (1) of regulation 11 of the principal Regulations for “good current laboratory practice” there shall be substituted “good laboratory practice referred to in Article 1 of Council Directive 87/18/EEC (OJ No. L15, 17.1.87, p. 29) on the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances.”.

• (6) For paragraph (2) of regulation 11 of the principal Regulations there shall be substituted the following paragraph–

(2) A person having control of a laboratory in which tests are carried out for the purposes of these Regulations shall ensure that those tests are carried out in accordance with the said principles of good laboratory practice and at the request of the manufacturer or importer who required the tests to be carried out shall provide him with a certificate in writing to that effect.

Signed

Signed by order of the Secretary of State

Eric Forth — Parliamentary Under Secretary of State, — Department of Employment — 20th August 1991

Tony Baldry — Parliamentary Under Secretary of State, — Department of the Environment — 21st August 1991

Explanatory note

(This note is not part of the Regulations)

1 These Regulations amend the Notification of New Substances Regulations 1982 (“the principal Regulations”) to implement, as respects Great Britain, Council Directive No. 87/18/EEC (OJ No. L15, 7.1.87, p. 15) on the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances, in so far as it relates to the tests required to be carried out under the principal Regulations and the verification of the application for those tests.

2 The Regulations also amend the definition of a “new substance” in regulation 2(1) of the principal Regulations following the publication of the inventory referred to in Article 13.1 of Council Directive 79/831/EEC (OJ No. L259, 15.10.79, p. 10) amending for the sixth time Council Directive 67/548/EEC (OJ No. L196, 16.8.67, p. 1) (OJ/SE 1967, p. 234)) on the classification packaging and labelling of dangerous substances and known as “the European Inventory of Existing Commercial Chemical Substances (EINECS)” as required by Article 1.4(a) of that Directive.

3 The Principles of Good Laboratory Practice is obtainable from The Organisation for Economic Co-operation and Development, Chemicals Division (Environment Directorate), 2, Rue Andre-Pascal, 75775 Paris, Cedex 16, and EINECS is available from Her Majesty’s Stationery Office, Agency Publications, 51 Nine Elms Lane, London SW8 5DR, ISBN 0 11 967896 9.

Footnotes

[^f00001]: S.I. 1981/1536.

[^f00002]: 1972 c. 68.

[^f00003]: 1974 c. 37; sections 15 and 50 were amended by the Employment Protection Act 1975 (c. 71), Schedule 15, paragraphs 6 and 16 respectively.

[^f00004]: S.I. 1982/1496, amended by S.I. 1986/890.