Regulation 4 Full notifications
Subject to regulations 6 and 7, a person shall not place a new substance on the market in a total quantity of one tonne or more per year unless he has sent to the competent authority a notification including—
a technical dossier supplying the information necessary for evaluating the foreseeable risk, 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 A of Schedule 2 together with a detailed and full description of the studies conducted or bibliographic references to them;
a certificate in writing from the body which carried out the tests for the purpose of the technical dossier stating that those tests were carried out in accordance with the principles of good laboratory practice referred to in regulation 14(1);
a declaration concerning the unfavourable effects of the substance in terms of the various foreseeable uses of the substance;
if the substance is a dangerous substance, proposals for the purposes of the Chemicals (Hazard Information and Packaging) Regulations 1993 for—
the classification and labelling of the substance for supply, and
the safety data sheet referred to in regulation 6 of those Regulations;
in the case of a substance manufactured outside the Communities, where appropriate, a statement by the manufacturer that the notifier has been appointed, for the purpose of submitting a notification of the substance in question, as his sole representative and that he has informed all the importers of the same substance manufactured by him of the name of the sole representative; and
if so desired, a statement that the notifier requests, on reasoned grounds, that the notification be exempted from the provisions of regulation 13 (avoidance of animal testing) for a period which shall not exceed one year from the date of the notification.