# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division: Aim of the test

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

The long-term studies conducted and reported, taken together with other relevant data and information on the active substance, must be sufficient to permit the identification of effects, following repeated exposure to the active substance, and in particular must be sufficient to:
identify adverse effects resulting from exposure to the active substance,
identify target organs, where relevant,
establish the dose-response relationship,
identify changes in toxic signs and manifestations observed, and
establish the Noael.
Similarly, the carcinogenicity studies taken together with other relevant data and information on the active substance, must be sufficient to permit the hazards for humans, following repeated exposure to the active substance, to be assessed, and in particular must be sufficient:
to identify carcinogenic effects resulting from exposure to the active substance,
to establish the species and organ specificity of tumours induced,
to establish the dose-response relationship, and
for non-genotoxic carcinogens, to identify the maximum dose eliciting no adverse effect (threshold dose).

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/5.5/division/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.5/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.