The Notification of New Substances Regulations 1993

Reduced notification requirements for substances placed on the market in quantities of less than one tonne per year by a single manufacturer

6.—(1) Subject to the following paragraphs of this regulation and regulation 7, a person responsible for placing a new substance on the market in a total quantity of less than one tonne per year from a single manufacturer shall not place that substance on the market unless he has sent to the competent authority a notification including a summary of—

(a) a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may create for human health and the environment and containing all available relevant data for this purpose and including at least the information and results of the tests referred to in Part B of Schedule 2; and

(b) all the other information referred to in sub-paragraphs (b) to (f) of regulation 4.

(2) Subject to paragraph (4), where the quantities to be placed on the market are below 100 kg per year from a single manufacturer, the person responsible for placing the substance on the market may restrict the information in the technical dossier referred to in paragraph (1)(a) to that provided for in Part C of Schedule 2, he shall also provide all the other information referred to in paragraph (1)(b) and this information shall be notified to the competent authority in summary form.

(3) At the request of the competent authority, the person responsible for placing the substance on the market shall provide it with the full information referred to in paragraph (1) or (2), as appropriate, together with a detailed and full description of the studies conducted or bibliographic references to them.

(4) Subject to paragraph (5) and the conditions set out below, the following new substances shall be treated as having been notified under these Regulations—

(a) polymers except those containing in combined form 2 per cent or more of a new substance;

(b) subject to paragraph (6), substances placed on the market in quantities of less than 10 kg per year per manufacturer;

(c) substances placed on the market in quantities of less than 100 kg per year per manufacturer and intended solely for the purposes of scientific research and development on condition that the person placing the substance on the market maintains a record of the identity of the substance, labelling data and a list of customers in member States;

(d) substances placed on the market for the purposes of process-orientated research and development with a limited number of registered customers in quantities that are limited to those purposes, subject to the following conditions—

(i) the substance is duly notified within one year of its first having been placed on the market unless on reasoned grounds provided by the person responsible for placing the substance on the market the competent authority approves an extension for up to a further year,

(ii) the person responsible for placing the substance on the market has notified to the competent authority the following information about the substance, namely, identity, labelling data, a justification for the quantity placed on the market,

(iii) the person responsible for placing the substance on the market has provided a list of the customers,

(iv) the person responsible for placing the substance on the market has provided an assurance that the substance or a preparation in which it is incorporated will only be handled by the customer’s staff in controlled conditions and will not be made available to the general public at any time, and

(v) the person responsible for placing the substance on the market satisfies any condition imposed by the competent authority, which shall be limited to requiring the information provided for in paragraph (1).

(5) In the case of any substance to which paragraph (4) applies and which on the basis of the information available might reasonably be expected to be very toxic, toxic, carcinogenic, toxic for reproduction or mutagenic, the person responsible for placing the substance on the market shall forthwith notify to the competent authority any appropriate information relating to paragraphs 2.3, 2.4 and 2.5 of Part A of Schedule 2, and, where available, any acute toxicity data.

(6) In the case of a substance to which paragraph (4)(b) applies, which on the basis of the information available might reasonably be expected to be dangerous for the environment and which is intended to be used outside physical containment, the person responsible for placing the substance on the market shall forthwith notify to the competent authority any appropriate information relating to paragraph 2.3 of Part C of Schedule 2.

(7) Substances to which paragraphs (1), (2) and (4) apply shall be packaged and labelled in accordance with the requirements of the Chemicals (Hazard Information and Packaging) Regulations 1993 insofar as the notifier may reasonably be expected to be aware of their dangerous properties, and if it is not reasonably practicable to label the substances completely on the basis of tests carried out in accordance with Schedule 2, Part A, in addition to the label deriving from such tests, the label shall carry the warning “Caution-substance not yet fully tested”.

(8) In the case of a notifier who has submitted a reduced notification dossier in conformity with paragraph (2), he shall before the quantity of the substance reaches 100 kg per year from a single manufacturer or a total quantity of 500 kg per manufacturer, provide the competent authority with the information necessary to complete the dossier to the level of Part B Schedule 2.

(9) In the case of a notifier who has submitted a reduced notification dossier in conformity with paragraph (1), he shall before the quantity of the substance reaches 1 tonne per year from a single manufacturer or a total quantity of 5 tonnes per manufacturer, submit to the competent authority a full notification in conformity with regulation 4.