Table 2 Requirements over time for submitting new data on active substances to national authorities

Company’s action if new studies indicate new effects

Member States shall prescribe that the holder of an authorization or those to whom an extension of the field of application has been granted in accordance with Article 9 (1) must immediately notify the competent authority of all new information on the potentially dangerous effects of any plant protection product, or of residues of an active substance on human or animal health or on groundwater, or their potentially dangerous effects on the environment. Member States shall ensure that the parties concerned immediately notify this information to the other Member States and to the Commission, which shall refer the information to the committee referred to in Article 19. (Article 7)

The holder of an authorisation for a plant protection product shall immediately notify the Member States that granted an authorisation of any new information concerning that plant protection product, the active substance, its metabolites, a safener, synergist or co-formulant contained in the plant protection product, which suggests that the plant protection product no longer complies with the criteria set out in Articles 29 and 4 respectively [i.e. the approval criteria for plant protection products and active substances]. (Article 56 paragraph 1)