Division 3.8.1

An active substance, safener or synergist shall only be approved if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in F1Article 29(6)(a) in relation to the relevant constituent territory under realistic proposed conditions of use of a plant protection product containing the active substance, safener or synergist. The assessment must take into account the severity of effects, the uncertainty of the data, and the number of organism groups which the active substance, safener or synergist is expected to affect adversely by the intended use.