20221110 Position Paper on the Implementing Regulation on the Identification of Unacceptable Co-form
23 November 2022
The implementing act foresees that it will be the task of the Member States to identify potential unacceptable co-formulants “on the basis of the information submitted in an application dossier” and to submit these 'candidates' to the Commission. [...] These endpoints are meant to enable a risk assessment for human health as well as the environment, that enables to ensure the absence of harm to human health and the absence of unacceptable harm to the environment, in compliance with the prescriptions of the pesticide regulation. [...] Nowhere is it written that it is the responsibility of Member States to assess the risk posed by co-formulants and that they should be the trigger of the setting of co- formulants in the negative list. [...] Non-respect of EU case law In the Blaise ruling (case C616-17), the General Court of the EU ruled very clearly that it is the obligation of Member States to carry out long-term toxicity assessment of the formulations7. [...] 7 §116: It is therefore the task of the competent authorities, when examining an application for the authorisation of a plant protection product, to verify that the material submitted by the applicant, and primarily the tests, analyses and studies of the product, is sufficient to exclude, in the light of current scientific and technical knowledge, the risk that that product exhibits such carcinoge.