Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Article 21 U.K. Waiving of data requirements

1. By way of derogation from Article 20, the applicant need not provide data required under that Article where any of the following applies:

(a) the data are not necessary owing to the exposure associated with the proposed uses;

(b) it is not scientifically necessary to supply the data; or

(c) it is not technically possible to generate the data.

2. The applicant may propose to adapt the data requirements of Article 20 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with reference to the specific rules in Annex IV.

F1 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Art. 21(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 82; 2020 c. 1, Sch. 5 para. 1(1)