…Deluge as ECHA goes operational

Staff at the European Chemicals Agency can expect to be a bit busy – ECHA received almost 5000 pre-registration files in the first week that it was fully operational. The European Commission has informed ECHA that there may be some chemicals that were lawfully on the market before 1 June 2008 but that do not qualify for phase-in status (and therefore do not benefit from the extended registration deadlines). ECHA has been approached, in particular, by importers of certain cosmetic products containing such substances, and has now made it clear in a recent press release that companies manufacturing or importing these substances should “contact ECHA by making a company sign-up, followed by an inquiry” (see http://echa.europa.eu/reachit_en.asp for instructions).

[European Chemicals Agency. Press release: ECHA/PR/08/12. 9 June 2008. Data submission to ECHA active – almost 5000 files received. Available at http://echa.europa.eu/doc/press/PR_08_12_Received_Submissions_Inquiry20080609.pdf on the internet.] {177088}

…Keeping up-to-date on data submission

At present REACH-IT only supports the creation of company accounts, on-line entry and pre-registration of single substances. There are temporary submission procedures for PPORD notifications (product and process oriented research and development), enquiries and registration, details of which are given on the ECHA website (via http://echa.europa.eu/reachit_en.asp – updated 6 June 2008).

More detailed information on data submission is provided in the documents “Data submission manual 1: How to prepare and submit a PPORD Notification”, dated 28 May 2008 (available at http://echa.europa.eu/doc/reachit/how_to_prep_sub_ppord_en_20080529.pdf) and “Data submission manual 3: How to complete the submission form”, dated 31 May 2008 (available at http://echa.europa.eu/doc/reachit/data_submission_manual_20080531.pdf). {177081-2}

Four presentations prepared for training purposes on the different functionalities of REACH-IT are available (via http://echa.europa.eu/reachit/portal_en.asp – updated 16 June 2008). {177089}

…Your questions answered on pre-registration

A document (dated 30 May 2008) providing answers to commonly asked questions covering general (and IT-related) issues when considering pre-registration of substances is available from the European Chemicals Agency (at http://echa.europa.eu/doc/pre-registration/pre-reg-QA_en.pdf). {177083}

…Guidance documents

Sit back and enjoy a good read with the 28 files that make up the new “Guidance on information requirements and chemical safety assessment”. The package of documents (all dated May 2008) describes what is required with respect to substance properties, exposure, use and chemical safety assessment. Issued by the European Chemicals Agency, the Guidance is available at on the ECHA website. {177085}

Another new document, “Guidance on requirements for substances in articles”, aims to assist companies in deciding whether they are manufacturers or importers of substances (on their own or in preparations) or producers/importers of articles. This document, which is dated May 2008, is available at from ECHA. {177086}

Updated (May 2008) documents on “Guidance for monomers and polymers” and “Guidance on registration”, which usefully list the changes in the appendices, can be downloaded from the ECHA website (via . {169341-2}

Finally, the “Navigator” (which helps industry to determine its obligations under REACH and find the appropriate guidance on how to fulfil these obligations) has been updated due to the publication of “Guidance on requirements for substances in articles” and “Guidance for Downstream Users”. Navigator sessions conducted before 26 May 2008 can no longer be retrieved. Information on the Navigator is available at from ECHA. {177084}

…Regulation on the test methods applicable to REACH

For those looking for suitable reading material during the long summer break(?), over 700 pages are available on the test methods that are required to generate information on the physicochemical properties, toxicity and ecotoxicity of substances and preparations.

[Commission Regulation (EC) No. 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union 2008, L142, 1. (Corrigendum to title issued 3 June 2008, ibid. 2008, L143, 55.) Available via http://eur-lex.europa.eu/JOIndex.do?ihmlang=en on the internet.] {177087}

The above items are taken from the July 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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