# The Notification of New Substances Regulations 1993, Regulation 12: Substances manufactured outside the Communities


(1) Subject to paragraph (2), where for a substance manufactured outside the Communities—
(a) more than one notification exists for the same substance manufactured by the same manufacturer (whether to one or more competent authorities of member States); and
(b) the cumulative annual tonnage or the cumulative total tonnage determined by the European Commission and the competent authorities of the member States, on the basis of information notified underArticles 7(1), 8(1) and 14 of the Directive, exceeds for the first time any of the limits specified in regulation 5, each notifier established in Great Britain shall carry out the additional testing required under paragraph (1) of regulation 5 and shall provide the competent authority with the results of those tests in accordance with paragraph (2) of that regulation.
(2) Where the manufacturer has appointed a sole representative, the obligation to comply with paragraph (1) shall not apply to previous notifiers other than the sole representative, and only to the sole representative if he is established in Great Britain.
(3) Where in accordance with paragraph (1), the obligation to carry out further testing falls upon one or more notifiers established in Great Britain, the competent authority shall inform each such notifier of the identities of other notifiers within the Communities and draw attention to the collective responsibilities of notifiers under Article 11 of the Directive.

---
Source: https://www.legislation.gov.uk/uksi/1993/3050/regulation/12 (the official version)
Page: https://openlegislation.uk/notification-of-new-substances-regulations-1993/regulation-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.