The Notification of New Substances Regulations 1993

PART III RIGHTS AND DUTIES OF THE COMPETENT AUTHORITY

Risk assessments

16.—(1) In the case of substances notified under regulation 4 or 6(1) or (2), the competent authority shall carry out an assessment of the real and potential risks created by the substance to human health and the environment in accordance with the general principles referred to inArticle 3(2) of the Directive and that assessment shall include recommendations—

(a) on the most appropriate method for testing the substance; and

(b) where appropriate, on measures which will enable the risks to human health and the environment in relation to the placing on the market of the substance to be lessened.

(2) The assessment made in accordance with paragraph (1) shall be reviewed in the light of any additional information becoming available to the competent authority, in particular any information provided in accordance with regulation 5, 6(8) or (9), 9 or 10.

Information to be sent by the competent authority to the European Commission

17.—(1) When the competent authority has received a notification under regulation 4 or 6(1), information on supplementary testing under regulation 5 or 6(8) or (9) or additional information under regulation 9 or 10, it shall forthwith send to the European Commission a copy of the dossier or information in pursuance of the regulation concerned or, in each case, a summary thereof.

(2) Where the competent authority has required further information from the notifier in accordance with regulation 5 or 9(1), the competent authority for Great Britain shall notify the European Commission of the tests chosen in pursuance of the regulation concerned, the reasons for the choice, the results and where appropriate, an assessment of those results.

(3) In the case of information received in pursuance of regulation 6(4), the competent authority shall send to the European Commission such elements of that information as would, in its opinion, be of common interest to the Commission and other competent authorities.

(4) The competent authority shall send to the European Commission a copy of any risk assessment made in pursuance of regulation 16 or a summary thereof as soon as it becomes available.

(5) The competent authority shall—

(a) give effect to any decision of the European Commission underArticle 18(2) of the Directive addressed to it;

(b) in a case where the competent authority has furnished a summary of the dossier or further information in accordance with the foregoing paragraphs of this regulation, allow the European Commission or another competent authority access to the full dossier and information; and

(c) have regard to suggestions made by other competent authorities for further testing or information made in accordance with Article 18(2) of the Directive.