Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)

Article 62U.K.Data sharing

1.In order to avoid animal testing, testing on vertebrates for the purposes of this Regulation shall be undertaken only as a last resort. Testing on vertebrates shall not be repeated for the purposes of this Regulation.

2.Any person intending to perform tests or studies (‘the prospective applicant’)

(a)shall, in the case of data involving tests on vertebrates; and

(b)may, in the case of data not involving tests on vertebrates,

submit a written request to the Agency to determine whether such tests or studies have already been submitted to the Agency or to a competent authority in connection with a previous application under this Regulation or Directive 98/8/EC. The Agency shall verify whether such tests or studies have already been submitted.

Where such tests or studies have already been submitted to the Agency or to a competent authority in connection with a previous application, under this Regulation or Directive 98/8/EC, the Agency shall, without delay, communicate the name and contact details of the data submitter and data owner to the prospective applicant.

The data submitter shall, where relevant, facilitate contacts between the prospective applicant and the data owner.

Where the data acquired under those tests or studies are still protected under Article 60, the prospective applicant:

(a)shall, in the case of data involving tests on vertebrates; and

(b)may, in the case of data not involving tests on vertebrates,

request from the data owner all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications under this Regulation.