…Updated ECHA guidance on registration

This document (dated 9 November 2009) has been revised to clarify the information that needs to be submitted for updating dossiers of previously notified substances (NONS). It is available (at http://guidance.echa.europa.eu/docs/guidance_document/registration_en.pdf) from the ECHA (European Chemicals Agency) website. {169341}

…Draft guidance documents for consultation

As part of the consultation procedure when ECHA updates or develops new guidance documentation, discussions take place with a PEG (Partner Expert Group) composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities. The latest consultation documents to reach the PEG stage (as announced on 29 October and 4 November 2009) are the second draft of an updated guidance on requirements for substances in articles (along with comments made on the first draft), and a new guidance document on the preparation of dossiers for harmonised classification and labelling under Regulation (EC) No. 1272/2008. Visit http://guidance.echa.europa.eu/guidance4_en.htm to obtain copies. {178068; 183519}

…Chemical safety assessments made simple

A further publication (announced on 3 November 2009) in ECHA’s “Guidance in a nutshell” series is intended to assist industry in understanding the general provisions for conducting a chemical safety assessment under REACH. Standing at just over 20 pages, it is available from ECHA (via http://guidance.echa.europa.eu/docs/guidance_document/nutshell_guidance_csa_en.pdf). {177085}

…ECETOC advice on using human data for setting DNELs and DMELs

A key conclusion of an ECETOC/TNO workshop held in December 2007 was that, although the REACH guidance on information requirements and chemical safety assessments (Chapter R.8) recognised the value of human data, it included no specific advice on how these data should be used for setting DNELs and DMELs. As a consequence, a document was developed under the auspices of ECETOC and TNO that outlines how human data can be incorporated into DNEL/DMEL derivations. Although the report does not represent approved ECHA advice, the Agency has announced its intention of using the document to assist in the revision of official REACH guidance (probably in 2010).

[Working document for the Expert Review Panel on using human data in DNEL/DMEL (Derived No-Effect Level/ Derived Minimal-Effect Level) derivations. May 2008 – version 2. Available from the website of the European Centre for Ecotoxicology and Toxicology of Chemicals (via http://www.ecetoc.org/index.php?mact=Newsroom,cntnt01,details,0&cntnt01documentid=87&cntnt01dateformat=%25d-%25m-%25Y&cntnt01returnid=76).] {183486}

…Amended format for an Annex XV restriction report

A new combined format for an Annex XV restriction report replaces the existing formats provided in the “Guidance on Annex XV for restrictions” and the “Guidance on socio-economic analysis (SEA) – restrictions”. The amended format (dated 1 October 2009) can be downloaded by visiting http://guidance.echa.europa.eu/docs/authorities/AXV_restriction_format_01102009.doc on the ECHA website.

…ECHA introduces web zone on restrictions

On 5 November 2009 (presumably without any fireworks), ECHA launched a new section of its website ) devoted to existing restrictions and the procedure for new restrictions.

…First appeal against a dismissed registration

A summary of the first appeal against a rejected registration and its outcome was made available (on 4 November 2009) on the Appeals section of the ECHA website. Details can be found at http://echa.europa.eu/appeals_en.asp (click on “Appeal announcements” in the menu).

The above items were taken from the December 2009 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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