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CMR
ARTICLE-40: Examination of testing proposals [go to this ARTICLE]
... 1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous according to Directive 67/548/EEC above 100 tonnes per year with uses resulting in widespread and
diffuse exposure. ...
ARTICLE-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... 1.0.2. The human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribution
and elimination) of the substance and the following groups of effects, (1) acute effects (acute toxicity, irritation and corrosivity),
(2) sensitisation, (3) repeated dose toxicity and (4) CMR effects (carcinogenity, mutagenicity and toxicity for reproduction). Based on all the available information, other effects
shall be considered when necessary. ...
... 1.3.1. The appropriate classification and labelling developed in accordance with the criteria in Directive 67/548/EEC
shall be presented and justified. Where applicable Specific Concentration limits, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC, shall
be presented and, if they are not included in Annex I to Directive 67/548/EEC, justified. The assessment should always include
a statement as to whether the substance fulfils or does not fulfil the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2. ...
ARTICLE-II: GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS [go to this ARTICLE]
... - CMR effects (carcinogenity, mutagenicity and toxicity for reproduction). ...
... For substances subject to registration, summaries of the information derived from the application of Annexes VII to XI of this Regulation shall be given. The information shall also include the result of the comparison of the available data
with the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2, following paragraph 1.3.1 of Annex I of this Regulation. ...
ARTICLE-XV: DOSSIERS [go to this ARTICLE]
... 2. Dossier for the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern according to Article 59 ...
... The proposal shall include the identity of substance(s) concerned and whether it is proposed to be identified as a CMR according to Article 57(a), (b) or (c), a PBT according to Article 57(d), a vPvB according to Article 57(e), or a substance of equivalent concern according to Article 57(f). ...