Division 4 Candidate for substitution

An active substance shall be approved as a candidate for substitution pursuant to Article 24 where any of the following conditions are met:

• its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories,

• it meets two of the criteria to be considered as a PBT substance,

• 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),

• it contains a significant proportion of non-active isomers,

• 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 3.6.3,

• 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 3.6.4,

• if, on the basis of the assessment of F1nationally or internationally agreed test guidelines or other available data and information F2... , 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 3.6.5.