# Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, Division 4: Candidate for substitution

Extent: E+W+S+N.I.

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 nationally or internationally agreed test guidelines or other available data and information ... , 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.

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Source: https://www.legislation.gov.uk/eur/2009/1107/annex/II/division/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2009-1107/annex-II/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.