Skip to main content

Advertisement

Table 1 Criteria for the identification of active substances as candidates for substitution (CFS)

From: Comparative assessment of plant protection products: how many cases will regulatory authorities have to answer?

Number Legal text (Regulation (EC) No 1107/2009, Annex II, point 4)[[1]]a
1 Its ADI, ARfD, or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories
2 It meets two of the criteria to be considered as a PBT substance
3 There are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones)
4 It contains a significant proportion of non-active isomers
5 It is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, if the substance has not been excluded in accordance with the criteria laid down in point 3.6.3b
6 It is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B if the substance has not been excluded in accordance with the criteria laid down in point 3.6.4b
7 If, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, reviewed by the Authority, it is considered to have endocrine disrupting properties that may cause adverse effects in humans if the substance has not been excluded in accordance with the criteria laid down in point 3.6.5b,c
  1. aThe criteria apply independently, i.e. CFS meet one or more of them. bPoints 3.6.2 to 3.6.5 of Annex II of Regulation (EC) No 1107/2009 [[1]] define hazard-based criteria for substances that must not be approved, so-called cut-off criteria. cFor endocrine disrupters, currently the interim criteria laid down under point 3.6.5 of Annex II of Regulation (EC) No 1107/2009 [[1]] apply, i.e. substances classified as carcinogenic category 2 and toxic for reproduction category 2.