Cut-off criteria
Date: 23 April 2020
Annex II of REGULATION (EC) No 1107/2009 (points 3.6, 3.7 and 3.8) provides information about hazardous properties under which an active substance, safener or synergist (mentioned hereafter as “substance”) cannot be approved, the cut-off criteria.
These criteria are specified as a substance being:
- Carcinogenic (category 1A or 1B; Annex II, point 3.6.3)
- Mutagenic (category 1A or 1B; Annex II, point 3.6.2)
- Toxic for reproduction (category 1A or 1B; Annex II, point 3.6.4)
- Persistent, Bio-accumulative and toxic for the environment (PBT; detailed criteria listed in Annex II, point 3.7.2)
- A persistent organic pollutant (POP; detailed criteria listed in Annex II, point 3.7.1)
- Very persistent and very bio-accumulative (vPvB; detailed criteria listed in Annex II, point 3.7.3)
- Or endocrine disruptive (detailed criteria listed in Annex II, point 3.6.5 for impact on human health and 3.8.2 for ecotoxicology)
For the criteria of being mutagenic, PTB, POP and vPvB a strict exclusion of the substance on the basis of the hazard is foreseen and no approval can be granted.
For substances being carcinogenic, toxic for reproduction and/or endocrine disruptive an approval can be granted, under the premise that human exposure or exposure of non-target organisms is negligible under realistic proposed conditions of use (e.g. use in greenhouses or in storage rooms). Moreover, in case of a serious danger to plant health where no other possibility for control is available, such a substance may be approved for a limited period under certain conditions (separate article in our online academy).
Jasmin Philippi