…ECHA guidance documents in the making

As part of the consultation process when ECHA updates or develops new guidance documents, discussions take place with a PEG (a Partner Expert Group composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities), with ECHA Committees and/or the Forum, and finally with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure can be obtained from ECHA (via http://guidance.echa.europa.eu/guidance4_en.htm). The latest document to be lodged (as announced on 11 November 2009) with a PEG under this consultation process is a draft guidance on information requirements and chemical safety assessment (chapter R.16 – Environmental Exposure Estimation). Meanwhile, two documents (as announced on 12 November 2009) have reached the giddy heights of the ECHA Committee/Forum stage of the review process: a draft guidance on Annex V (exemptions from the need to register) of REACH and a revised draft update of the guidance on information requirements and chemical safety assessment (chapter R.12 – Use Descriptor System). {179540; 181248; 181252}

…Calls for information to avoid unnecessary animal testing

ECHA publishes all proposals involving tests in vertebrate animals for the end-points specified in Annexes IX and X under REACH, and invites the submission of relevant data to ensure that animal testing is only conducted as a last resort. Currently, information is required (appropriately enough by 24 December 2009) on “polysulfo (5-hydroxy-1-naphthalen-2-yl-[4-[4-(2-sulfatoethyl-sulfonyl)-phenyl]diazenyl]-1H-pyrazole-3-carboxylic acid), alkali metal salt” for which the applicant is proposing an in vivo study on its genotoxicity. Also requested (by 11 January 2010) is information on 4-((triethoxysilyl)methyl) morpholine, for which studies on developmental and reproductive toxicity and subchronic toxicity are proposed. More information can be found at http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp on the ECHA website.

…REACH-IT takes a Christmas break

From 14 December 2009 until the New Year (3 January), REACH-IT will not be available for dossier submissions. This will allow ECHA to install a new version of the software in order to cope with the large number of registrations expected in 2010. Further information is given in an ECHA news alert dated 20 November 2009 (ECHA/NA/09/30).

…ECHA provides more answers to questions on CLP and REACH

“Frequently asked questions about CLP” is a new publication (dated 4 November 2009) that gives answers to potential queries about the classification, labelling and packaging of substances. It can be downloaded from http://echa.europa.eu/doc/CLP/clp_faq_1_0_20091104.pdf courtesy of ECHA. {183704}

Also available from ECHA (by visiting http://echa.europa.eu/doc/reach/reach_faq.pdf) is Version 3.0 (dated 19 November 2009) of “Frequently asked questions about REACH”. {177761}

…Webinar on preparing and submitting a registration dossier

The first in a series of interactive webinars for Lead Registrants can be accessed (via http://www.echa.europa.eu/news/webinars_en.asp) from ECHA. Presentations given at this virtual REACH-fest cover exporting information as a IUCLID 5 registration dossier and submission via REACH-IT, dossier processing at ECHA and receiving a registration number.

The above items were taken from the January 2010 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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