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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)

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Article 21Waiving 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.

3.In order to ensure the harmonised application of paragraph 1(a) of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying criteria for defining when the exposure associated with the proposed uses would justify adapting the data requirements of Article 20.

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