# 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.6.4.2.1.1

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

If relevant effects are seen in repeated dose or other toxicity studies (e.g. changes in lymphoid organ weights and/or histology and changes in cellularity of lymphoid tissues, bone marrow or peripheral leukocytes) additional functional testing may be required. The investigator shall justify the nature of any additional testing, taking account of the observations noted in other toxicity studies.

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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.6.4.2/division/II.6.4.2.1/division/II.6.4.2.1.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.4/division-II.6.4.2/division-II.6.4.2.1/division-II.6.4.2.1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.