# 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 13.4: Toxicity and other safety testing (including safety evaluation of products and devices for human medicine and dentistry and veterinary medicine)

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

13.4.1. This covers studies carried out on any product or substance to determine its potential to cause any dangerous or undesirable effects in humans or animals as a result of its intended or abnormal use, manufacture or as a potential or actual contaminant in the environment.
13.4.2. Where studies involve both mother and offspring, the mother shall be reported if she has been subject to a procedure above the threshold of minimum pain, suffering, distress and lasting harm. Offspring shall be reported if they are an integral part of the procedure such as in the case of end-points for reproduction.

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Source: https://www.legislation.gov.uk/eudn/2020/569/annex/III/part/B/division/B/division/13/division/13.4 (the official version)
Page: https://openlegislation.uk/eu-decision-2020-569/annex-III/part-B/division-B/division-13/division-13.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.