# 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 3.6.3

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

An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist in relation to the relevant constituent territory and other available data and information, including a review of the scientific literature ... , it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, 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, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18A of Regulation (EC) No 396/2005 in relation to the relevant constituent territory.

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Source: https://www.legislation.gov.uk/eur/2009/1107/annex/II/division/3/division/3.6/division/3.6.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2009-1107/annex-II/division-3/division-3.6/division-3.6.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.