…Two proposals for harmonised classification and labelling

Under EC Regulation No. 1272/2008 on Classification, Labelling and Packaging, there is a legal obligation for suppliers to evaluate the hazards of chemicals (substances and mixtures) to be placed on the market, and to classify and label them appropriately. An option also exists for Member State Competent Authorities or industry to ask for the classification and labelling of a substance to be harmonised across Europe, whereupon the European Chemicals Agency organises a public consultation period of 45 days. Under this scheme, proposals have been recently submitted by the Dutch and German authorities to standardise the classification and labelling of imazalil and tebuconazole.

European Chemicals Agency.
Proposal for harmonised classification and labelling. Imazalil. May 2012.
Proposal for harmonised classification and labelling. Tebuconazole. Based on Regulation (EC) No. 1272/2008 (CLP Regulation), Annex VI, Part 2. August 2012.




…Consultations on 54 potential Substances of Very High Concern (SVHCs)

Member State competent authorities and the European Chemicals Agency may prepare Annex XV dossiers for SVHCs, as defined in Article 57 of the REACH regulation. SVHCs include substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or of an equivalent level of concern. The latest Annex XV dossiers have been released by the Austrian, Dutch, German, Slovakian, Swedish and UK authorities, and by ECHA, and cover 54 potential SVHCs, including three respiratory sensitisers (diazene-1,2-dicarboxamide, cyclohexane-1,2-dicarboxylic anhydride and hexahydromethylphthalic anhydride).

Annex XV dossiers. Proposals for the identification of a substance as a Category 1A or 1B CMR, PBT, vPvB or a substance of an equivalent level of concern. Proposals available for comment until 18 October 2012.



…Other items of interest

Draft revised guidance for Annex V – exemptions from the obligation to register concerning recommendations for oils, fats and waxes obtained from genetically modified (GM) plants sent to Competent Authorities for REACH and CLP (CARACAL) via fast-track procedure.



Draft revised Guidance on the Application of the CLP Criteria – Part 3 Health Hazards relating to specific concentration limits (SCLs) sent to CARACAL.



ECHA, in collaboration with the Organisation for Economic Co-operation and Devlopment, invites industry to a workshop introducing version 3.0 of the OECD QSAR Toolbox in November.



ECHA urges 574 registrants of intermediates to improve the quality of their dossiers.



ECHA strengthens its compliance check strategy.



Two testing proposals involving vertebrate animals: request for information from third parties (by 19 October 2012).



The above items were taken from the October 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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