…Revised manuals to ensure compliance with the new version of REACH-IT

Since the new version of REACH-IT finally made it online (see news alert ECHA/10/12 dated 25 March 2010), ECHA has updated some of its manuals to accommodate the changes required to ensure “business rule failures” will not apply to dossiers submitted under the new version (2.0). The updated manuals can be accessed via on ECHA’s website.

…Read all about it – ECHA’s practical guides to preparing registration dossiers

With only seven months to go before the first registration deadline is with us, ECHA has produced a series of six publications to explain the level of detail needed to complete its registration dossiers and to help companies make the best use of integrated testing strategies. The six practical guides cover reporting of the following: in vitro data; robust study summaries; weight of evidence; data waiving; (Q)SARs; read-across and categories. The publications can be accessed via http://www.echa.europa.eu/publications_en.asp (then click on “Practical Guides”). Further information is given in news alert ECHA/NA/10/16 of 9 April 2010. {184827-32}

…Commission determined to speed up registration and authorisation

Following their undertaking given during Hearings in the European Parliament and a visit to ECHA, Vice President Tajani and Commissioner Potočnik have announced the actions they are taking to ensure the successful registration of high-volume chemicals by the 30 November 2010 deadline. Agreement was also reached on setting the criteria for the identification of substances that are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative; these criteria will be set out in the revised Annex XIII of REACH. The Commission has asked ECHA to identify additional priority substances of very high concern (SVHC) for inclusion in the “candidate list” (which currently contains 29 substances), bringing the total to 106 by 2012. More details are given in EU press release IP/10/360 of 25 March 2010.

…Acrylamide branded as SVHC

ECHA has announced in a press release (ECHA/PR/10/05) dated 30 March 2010 that acrylamide has been added to the “Candidate List” of substances of very high concern. A decision will be made later on whether this chemical will be subject to authorisation. The Member State Committee documents in support of inclusion of substances in the list are obtainable from ECHA (via http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp). {182932}

…Draft guidance document published

As part of the consultation process 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, followed by discussions involving ECHA Committees and/or the Forum, and a concluding consultation with the European Commission and Member State competent authorities. To ensure transparency, drafts at various stages of the procedure are placed on the ECHA website (for full details, visit http://guidance.echa.europa.eu/guidance4_en.htm). The latest document to enter this formal consultation process (in March 2010) is a draft Guidance on the compilation of safety data sheets. {184730}

…New guidances released

Having completed the consultation process through the various committee and consultation stages, an updated document has now been issued for the Guidance on information requirements and chemical safety assessment (Chapter R.12: Use descriptor system), as well as a new Guidance for Annex V exemptions from the obligation to register. Both documents are dated March 2010 and are available via http://guidance.echa.europa.eu/guidance_en.htm on the ECHA website. {179540; 181248}

…REACH-IT industry user manual

New titles added to the manual in March 2010 are Part 15 – Manage your Group of Manufacturers or Importers and Part 17 – Legal Entity Change, together with updated versions of Part 6 – Dossier submission and Part 8 – Invoicing. All the documents can be obtained by visiting http://echa.europa.eu/reachit/supp_docs_en.asp on the internet. {179752}

…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 submissions of relevant data to ensure that additional animal testing is only conducted as a last resort. Currently, information is required on sodium tripolyphosphate (90-day inhalation study in the rat) and 11-aminoundecanoic acid (developmental toxicity). For more information or to submit data (by 24 May 2010) visit the ECHA website (at http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp).

…Webinar presentations available online for registrants

The fourth to seventh in a series of interactive webinars for Lead Registrants can be accessed (via http://www.echa.europa.eu/news/webinars_en.asp) on the ECHA website. These latest presentations are on substance identity (mono-constituent substances, multi-constituent substances and UVCB substances i.e. those of unknown or variable composition, complex reaction products or substances of biological origin), the Technical Completeness Check (including how to use the TCC tool to check the completeness of a dossier before submitting it to ECHA) and Chemical Safety Assessment and Chemical Safety Report, parts 1 and 2.

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

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