The Notification of New Substances Regulations 1993

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be mentioned.

In addition to the information and tests referred to in regulation 4(1), laid down in Part A, the following polymer-specific information is required:

Without prejudice to regulation 16, further tests may be required additionally in certain cases, eg:

• Light-stability if the polymer is not specifically light stabilized

• Long-term extractivity (leachate test); depending on the results of this test, appropriate tests on the leachate may be requested on a case by case basis.

In addition to the information and tests referred to in regulation 6(1), laid down in Part B, the following polymer-specific information is required:

In addition to the information and tests referred to in regulation 6(2), laid down in Part C, the following polymer-specific information is required:

Under certain conditions the base-set test package for polymers can be reduced.

CRITERIA FOR POLYMERS FOR WHICH A REDUCED TEST PACKAGE IS ACCEPTABLE

Substances with a high number-average molecular weight, a low content of low molecular weight species and low solubility/extractivity will be rded as being non-bioavailable.Consequently the following criteria shall be used to determine the polymers for which a reduced test package is acceptable:

• (a) for non-readily degradable polymers placed on the Community market in quantities of ≥ 1 t/a (or total quantities of ≥ 5 t), the following criteria define those polymers for which a reduced test package is acceptable:

• (I) High number-average molecular weight (Mn).The competent authority shall decide whether or not a polymer satisfies this criterion;

• (II) Extractivity in water (3.6.1) < 10 mg/l excluding any contribution from additives and impurities;

• (III) Less than 1% with MW < 1000; the percentage refers only to molecules (components) directly derived from and including monomer(s), excluding other components e.g. additives or impurities.

If all the above criteria are fulfilled, the polymer is regarded as a polymer for which a reduced test package is acceptable.

• (b) in the case of non-readily degradable polymers placed on the Community market in quantities < 1 t/a (or total quantities of < 5 t), it is sufficient that criteria I and II above are fulfilled.

If it is not possible to prove the criteria with the assigned tests, the notifier has to demonstrate compliance witha the criteria by other means. Under certain circumstances toxicological and ecotoxicological tests may be required.

SCHEDULE 3 — (This Schedule sets out the provisions of Annex VIII to the Directive)

Tests under this Part shall be according to methods recognized and recommended by the competent international bodies where such recommendations exist.

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be indicated.

LEVEL 1

Physico-chemical studies

Further studies on physico-chemical properties are dependent upon the results of the studies laid down in Annex VII. Such further studies could include for example the development of analytical methods which make it possible to observe and detect a substance or its transformation products and studies on thermal decomposition products.

Toxicological studies

Fertility studies (one species, one generation, male and female, most appropriate route of administration).

If there are equivocal findings in the first generation, study of a second generation is required.

Depending upon the dosing schedule it may be possible in this study to obtain an indication of teratogenicity. A positive indication should be examined in a formal teratology study.

• Teratology study (one species, most appropriate route of administration).

• This study is required if teratogenicity has not been examined in the fertility study.

• Sub-chronic and/or chronic toxicity study, including special studies (one species, male and female, most appropriate route of administration) shall be required if the results of the repeated-dose study in Annex VII or other relevant information demonstrate the need for further appropriate investigation.

• The effects which would indicate the need for such a study could include for example: serious or irreversible lesions; a very low or absence of a “no effect” level; a clear relationship in chemical structure between the substance being studied and other substances which have been proved dangerous.

• Additional mutagenesis studies and/or screening study(ies) for carcinogenesis as prescribed in the testing strategy described in Annex V.When both tests in the base set are negative, further tests shall be conducted according to the specific properties and the proposed use of the substance.

• When a test or both tests were positive in the base set, a supplementary should include the same or different end points in other in vivo test methods.

• Basic toxicokinetic information.

Ecotoxicity studies

• Prolonged toxicity study with Daphnia magna (21 days).

• Tests on higher plants.

• Tests on earthworms.

• Further toxicity studies with fish.

• Tests for species accumulation: one species, preferably fish.

• Supplementary degradation study(ies), if sufficient degradation has not been proved by the studies laid down in Annex VII.

• Further studies on absorption/desorption dependent upon the results of the investigations laid down in Annex VII.

LEVEL 2

Toxicological studies

The test programme shall cover the following aspects unless there are strong reasons to the contrary, supported by evidence, that it should not be followed:

• Chronic toxicity study.

• Carcinogenicity study.

• Fertility study (e. g. three-generation study): only if an effect on fertility has been established at level 1.

• Developmental toxicity study on perinatal and postnatal effects.

• Teratology study (species not employed in the respective level 1).

• Additional toxicokinetic studies which cover biotransformation, pharmokinetics.

• Additional tests to investigate organ or system toxicity.

Ecotoxicological studies

• Additional tests for accumulation, degradation, mobility and absorption/desorption.

• Further toxicity studies with fish.

• Toxicity studies with birds.

• Additional toxicity studies with other organisms.

SCHEDULE 4 — FEES FOR NOTIFICATIONS ETC.

Signed

Signed by order of the Secretary of State.

Michael Forsyth — Minister of State, — 15th December 1993

John Gummer — Secretary of State, — 15th December 1993

Explanatory note

(This note is not part of the Regulations)

These Regulations implement—

• (a) as respects Great Britain the provisions of Council Directive 92/32/EEC (OJ No. L154, 5.6.92, p.1) (“the Directive”) amending for the 7th time Council Directive 67/548/EEC (OJ No.196, 16.8.67, p. 1, (OJ/SE1967, p. 234)) relating to the classification, packaging and labelling of dangerous substances insofar as those provisions relate to the placing on the market of new substances together with Commission Directive 93/105/EEC setting out Annex VIID of the Directive (relating to polymers); and

• (b) as respects the United Kingdom, the provisions of the Directive relating to the importation of new substances into the United Kingdom.

The Regulations supersede the Notification of New Substances Regulations 1982 which they revoke.

Part I Interpretation and general Regulations 1 to 3 Regulation 2 defines the expressions used in the Regulations, in particular “new substance” means a substance which does not appear in the European Inventory of Existing Commercial Chemical Substances (“EINECS”) and the competent authority for Great Britain is the Secretary of State for the Environment and the Health and Safety Executive acting jointly. With certain specified exceptions the Regulations are applied by regulation 3 to new substances which are placed on the market either alone or in preparations.

Part II Notifications Regulations 4 to 15 By regulation 4, a person responsible for placing a new substance on the market in a quantity of one tonne or more per year is required to send a notification to the competent authority which shall include the particulars about the substance specified in Part A of Schedule 2. Further testing is required when the quantity of the substance placed on the market reaches 10 tonnes per manufacturer per annum or a total of 50 tonnes per manufacturer (regulation 5). By Regulation 6, reduced notification requirements for new substances placed on the market in quantities of less than one tonne per year are imposed and, with certain specified exceptions, new substances are deemed to have been notified if placed on the market in quantities of less than 10 kg per year. Special notification requirements relate to new substances which are polymers as defined in regulation 2(1) (regulation 7). By Regulation 8, new substances which have been duly notified may be placed on the market no sooner than 60 days after the notification was received by the competent authority, or in cases where the substance is subject to reduced notification requirementsunder regulation 6, no sooner than 30 days after the receipt of the notification. Where further tests are required to evaluate the risks created by the substance, the competent authority may require the notifier to carry out those tests (regulation 8). By Regulation 10 the notifier of a new substance already notified by him is required to inform the competent authority of any changes to the particulars previously notified and of changes in the quantity of the substance placed on the market. In the case of a substance that had previously been notified at least 10 years previously only limited information is required to be provided (regulation 11). By Regulation 12, in the case of substances manufactured outside the Communities for which more than one notification has been made the duty to notify additional information under regulation 5 is imposed on each notifier established in Great Britain unless the manufacturer has appointed a sole representative when that duty is only imposed on that sole representative if established in Great Britain. By Regulation 13, where a substance has already been notified under the Directive, the competent authority may agree that a subsequent notifier may make use of the particulars previously notified with the consent of the previous notifier. For the purpose of avoiding the duplication of animal testing, a prospective notifier of a new substance is required to enquire from the competent authority whether the substance which he intends to notify has already been notified to the competent authority of any member State. If this is the case the prospective notifier is required to try to reach agreement with the previous notifier to share information with a view to reducing the amount of animal testing. By Regulation 14, the notifier is required to ensure that any tests carried out for the purpose of these Regulations conform to the principles of good laboratory practice. By Regulation 15, notifications and reports submitted to the competent authority for Great Britain are required to be in English.

Part III Rights and duties of the competent authority Regulations 16 and 17 By Regulation 16, in the case of notifications received, the competent authority is required to carry out and keep up to date an assessment of the risks to human health and the environment created by the substance. By Regulation 17, the competent authority is required to send information about notifications and reports received to the European Commission in relation to the substance concerned.

Part IV Disclosure of information Regulations 18 to 20 By Regulation 18, a notifier may ask that information that is commercially sensitive is kept confidential, but certain information specified in the regulation cannot be kept confidential. Regulation 19 sets out the way in which confidential information is to be treated and by regulation 20, in certain circumstances, a new substance which has been notified may appear in the European List of Notified Chemical Substances (“ELINCS”) in the form of its trade name.

Part V Miscellaneous and general Regulations 21 to 25 Regulation 21 makes provision for enforcement and provides for the Health and Safety Executive to be the enforcing authority for the Regulations. By Regulation 22 the importation or placing on the market of substances that have not been duly notified is prohibited. Regulation 23 provides for exemption from the requirements of the Regulations in certain circumstances, and regulation 24 specifies fees to be charged for specified purposes. Regulation 25 revokes the Notification of New Substances Regulations 1982 and provides for consequential modifications. This regulation also provides for transitional provisions. In addition Regulation 25 amends Regulation 18(3) of the Chemicals (Hazard Information and Packaging) Regulations 1993 to conform with the enabling power contained in section 2(2) of the European Communities Act 1972.

Footnotes

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

[^f00002]: 1972 c. 68.

[^f00003]: 1974 c. 37; sections 15(1) and 50(3), were amended by the Employment Act 1975 (c. 71), Schedule 15, paragraphs 6 and 16(3) respectively.

[^f00004]: S.I. 1993/1746.

[^f00005]: OJ No. L196, 16.8.67, p. 1 (OJ/SE 1967 p. 247).

[^f00006]: OJ No. L154, 5.6.92, p. 1.

[^f00007]: OJ No. C146A, 15.6.90, p. 1.

[^f00008]: OJ No. C130, 10.5.93, p. 1.

[^f00009]: S.I.1982/1496, amended by S.I.1984/1244, 1985/1333, 1986/890, and 1991/1914.

[^f00010]: 1968 c. 67.

[^f00011]: 1990 c. 16.

[^f00012]: S.I. 1991/2840.

[^f00013]: OJ No. L230, 19.8.91, p. 1.

[^f00014]: S.I. 1985/1333.

[^f00015]: OJ No. L75, 26.3.91, p. 32.

[^f00016]: OJ No. L377, 31.12.91, p. 20.

[^f00017]: S.I. 1989/2233.

[^f00018]: OJ No. L251, 29.8.92, p. 13.

[^f00019]: OJ No. L15, 17.1.87, p. 29.

[^f00020]: OJ No. L11, 12.1.90, p. 37.

[^f00021]: OJ No. L145, 11.6.88, p. 35.

[^f00022]: 1972 c. 68.

[^f00023]: S.I. 1989/1903.

[^f00024]: 1979 c. 2.

[^f00025]: S.I. 1982/1496.

[^f00026]: S.I. 1986/890.

[^f00027]: S.I. 1991/1914.