Article 6 / Data requirements for an application
An application for approval of an active substance shall contain at least the following elements:
a dossier for the active substance satisfying the requirements set out in Annex II;
a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and
if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.
Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies:
the data are not necessary owing to the exposure associated with the proposed uses;
it is not scientifically necessary to supply the data; or
it is not technically possible to generate the data.
However, sufficient data shall be provided in order to make it possible to determine whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1), if required by the evaluating competent authority under Article 8(2).