The Notification of New Substances Regulations 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.