# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 2.9.2

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

For compounds with a molar (decadic) absorption coefficient (ε) > 10 (1 × mol–1 × cm–1) at a wavelength λ ≥ 290 nm, direct phototransformation in purified (e.g. distilled) water at 20 to 25 °C, of purified active substance usually radio labelled using artificial light under sterile conditions, if necessary using a solubiliser, must be determined and reported. Sensitisers such as acetone must not be used as a cosolvent or solubiliser. The light source must simulate sunlight and be equipped with filters to exclude radiation at wavelengths λ < 290 nm. The identity of breakdown products formed which at any time during the study are present in quantities ≥ 10 % of the active substance added, a mass balance to account for at least 90 % of the applied radioactivity, as well as photochemical halflife must be reported.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/2/division/2.9/division/2.9.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-2/division-2.9/division-2.9.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.