# 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Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 5.3: Specific toxicity, pathogenicity and infectiveness studies

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

In certain cases, it can be necessary to carry out supplementary studies to further clarify the adverse human effects.
In particular, if results from earlier studies indicate that the micro-organism may cause long-term health effects, studies on chronic toxicity, pathogenicity and infectiveness, carcinogenicity and reproductive toxicity must be carried out. Furthermore, where a toxin is produced, kinetic studies must be performed.
Studies required must be designed on an individual basis, in the light of the particular parameters to be investigated and the objectives to be achieved. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/5/division/3/division/5.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-5/division-3/division-5.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.