# Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance), Division II.6.4.1.2

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

Factors to be taken into account when considering the need for such data include:
(a)the structure of the substance and its similarity to substances with known toxicological effects;
(b)the class of the substance and known toxicological properties of other substances in the class;
(c)the mode of action of the substance;
(d)any effects seen in the standard toxicity studies that warrant further investigation (e.g. immunotoxicity, neurotoxicity or endocrine dysfunction);
(e)the existence of published literature highlighting relevant findings, including literature relating to effects seen in humans exposed to the substance.

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Source: https://www.legislation.gov.uk/eur/2018/782/annex/I/division/II/division/II.6/division/II.6.4/division/II.6.4.1/division/II.6.4.1.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.4/division-II.6.4.1/division-II.6.4.1.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.