# Commission Implementing Decision (EU) 2020/569 of 16 April 2020 establishing a common format and information content for the submission of the information to be reported by Member States pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes and repealing Commission Implementing Decision 2012/707/EU (notified under document C(2020) 2179) (Text with EEA relevance), Division 12.7

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

‘Non-regulatory Toxicology and Ecotoxicology’ refers to discovery toxicology and investigations to prepare for the regulatory submission and method development. This category does not include studies required for regulatory submissions (preliminary studies, MTD (Maximum Tolerated Dose)). Dose-range-finding (DRF) studies, when carried out with a view to satisfying legislative requirements, are also excluded and covered in ‘Regulatory use and routine production’ under ‘Other efficacy and tolerance testing’.

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Source: https://www.legislation.gov.uk/eudn/2020/569/annex/III/part/B/division/B/division/11/division/12.7 (the official version)
Page: https://openlegislation.uk/eu-decision-2020-569/annex-III/part-B/division-B/division-11/division-12.7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.