The Notification of New Substances Regulations 1993

Requirements for further testing for substances notified under regulation 4

5.—(1) Any notifier of a substance already notified under regulation 4 shall inform the competent authority—

(a) when the quantity of the substance placed on the market reaches 10 tonnes per year from a single manufacturer or when the total quantity of substance reaches 50 tonnes per manufacturer; the competent authority may then require some or all of the additional tests or studies or both laid down in Schedule 3 at level 1, to be carried out within the time limit that the competent authority shall determine;

(b) when the quantity of the substance placed on the market reaches 100 tonnes per year from a single manufacturer or when the total quantity of the substance reaches 500 tonnes per manufacturer; the competent authority shall then require the additional tests or studies or both laid down in Schedule 3 at level 1, to be carried out within the time limit that the competent authority shall determine, unless the notifier can give good reason why a given test or study is not appropriate or an alternative test or study would be preferable;

(c) when the quantity of the substance placed on the market reaches 1000 tonnes per year from a single manufacturer or when the total quantity of the substance reaches 5000 tonnes per manufacturer; the competent authority shall then draw up a programme of tests or studies or both according to Schedule 3, level 2 to be carried out by the notifier within the time limit determined by the competent authority.

(2) Where additional testing has been carried out, either in accordance with paragraph (1) or voluntarily, the notifier shall forthwith provide the competent authority with the results of those tests together with a certificate in writing from the person who carried out the tests stating that those tests were carried out in accordance with the principles of good laboratory practice referred to in regulation 14(1).