…Guidance on nanomaterial Information Requirements and Chemical Safety Assessment

Draft appendices to chapters R.7a, R.7b and R.7c of ECHA’s guidance on Information Requirements and Chemical Safety Assessment provide endpoint specific guidance for registrants preparing REACH dossiers on nanomaterials. These appendices are relevant to physico-chemical and (eco)toxicological endpoints. A further three draft appendices to chapters R.8, R.10 and R.14 have also been released, and provide guidance relevant to nanomaterials on the characterisation of dose-response for human health and the environment, and occupational exposure estimation. All six draft appendices have been sent to ECHA’s Competent Authorities for REACH and CLP (CARACAL) for consultation.

ECHA (2012). Guidance on information requirements and Chemical Safety Assessment. Appendices R7-1, R7-2, R8-15, R10-2 and R14-4. Issued March and April 2012. Click on ‘Appendices for nanomaterials’ on the following page:



…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 Austrian and Norwegian authorities to standardise the classification and labelling of fenoxaprop-P-ethyl and 8:2 fluorotelomer alcohol.



…Other items of interest

Corrigendum to the Guidance on Substance Identification available in 22 EU languages.


ECHA has published a full revision of its Guidance on Data sharing (version 2.0).


Third draft revised Guidance on Registration sent to ECHA’s Competent Authorities for REACH and CLP (CARACAL).


Draft revised Guidance on the application of the CLP criteria sent to CARACAL.


ECHA to publish total tonnage band for registered substances.


ECHA call for a meeting of experts to discuss reproductive and repeated dose toxicity of cymoxanil.


ECHA had updated its Classification and Labelling Inventory (including bug fixes and recently received notifications).


ECHA to update REACH-IT and IUCLID 5.


Chesar 2.0 to be released in June.


Testing proposals involving vertebrate animals: request for information from third parties on two substances (deadline 1 June 2012).


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

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