# Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance), Division 5.8.2: Supplementary studies on the active substance

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

Supplementary studies shall be carried out where they are necessary to further clarify observed effects taking into account the results of the available toxicological and metabolism studies and the most important exposure routes. Such studies may include:
(a)studies on absorption, distribution, excretion and metabolism, in a second species;
(b)studies on the immunotoxicological potential;
(c)a targeted single dose study to derive appropriate acute reference values (ARfD, aAOEL);
(d)studies on other routes of administration;
(e)studies on the carcinogenic potential;
(f)studies on mixture effects.
Studies required shall be designed on an individual basis, in the light of the particular parameters to be investigated and the objectives to be achieved.

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Source: https://www.legislation.gov.uk/eur/2013/283/annex/section/5/division/5.8/division/5.8.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.8/division-5.8.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.