Points 3.6.3 to 3.6.5 of Annex II of Regulation (EC) No 1107/2009 provide that active substances, safeners or synergists, classified on the basis of Regulation (EC) No 1272/2008 as carcinogen category 1A or 1B or toxic for reproduction category 1A or 1B, or having endocrine disrupting properties which may cause adverse effects on humans, cannot be approved "unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible".
In addition, point 3.8.2 of this same Annex stresses that active substances, safener or synergists, shall only be approved if they are not considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms "unless the exposure of non-target organisms to that active substance in a plant protection product under realistic proposed conditions of use is negligible".
Therefore, the purpose of this guideline is to provide practical guidance in regulatory decision-making regarding this key concept of "negligible exposure" applied to some cut-off active substances, both in the context of human and environmental exposures.