anx_IV__cpt_1__cpt_3__cpt_1__text_4

An exposure assessment shall be performed, covering primary and secondary exposure under realistic worst case for all intended uses of the biocidal product that contains the active substance for which approval is applied, or of the biocidal product for which the authorisation is sought. If a new exposure scenario is introduced at a later stage, during the product authorisation process, additional data shall be submitted to assess whether the justification for data adaptation still applies. The reasons why the outcome of the exposure assessment justifies waiving of data requirements shall be clearly and transparently explained.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.