…Updated guidance released…

Having completed the process through the various committee and consultation stages, updated documents have now been issued for “Guidance on the preparation of dossiers for harmonised classification and labelling”, “Guidance on waste and recovered substances”, and “Guidance on information requirements and chemical safety assessment” Chapter R.14 (occupational exposure estimation), Chapter R.16 (environmental exposure estimation), and Exposure scenario format in Part D (exposure scenario building) and Part F (chemical safety report). The documents, which are dated May 2010, can be obtained via http://guidance.echa.europa.eu/guidance_en.htm from the ECHA website. {181234; 181236; 181250; 181252; 183519; 184130}

…and a freeze on the publication of further revised guidance documents

In a news alert (ECHA/NA/10/31) which is dated 2 June 2010, ECHA has announced that it has placed a six-month moratorium on the publication of ten updated guidance documents until 30 November 2010 (the first REACH registration deadline). This is apparently because industry associations need to devote more time to their members in preparing for the registration deadline (and therefore have less time for involvement in the guidance consultation process). However, ECHA stresses that companies may need to update their registrations following the publication of the revised documents. It also reminds companies of the clarifications that are already in place in the legal text and existing guidance on containment of isolated and transported intermediates, the scope of the exposure assessment, and exposure assessment for the waste life stage.

…Practical guides available

The latest publications in the Practical guide series are on “How to do a registration as a member of a joint submission”, “How to notify substances in the classification and labelling inventory” and “How to avoid unnecessary animal testing”. All the documents are dated May/June 2010 and are accessible (via http://echa.europa.eu/publications_en.asp) on the ECHA website. {185282-3; 185305}

…Notification to the classification and labelling inventory

ECHA is reminding companies that intend to place substances on the market that, from 1 December 2010, they must provide notification within one month and suggests, as a first step, that Practical guide 7 should be read (“How to notify substances in the classification and labelling inventory” – see above). Access http://echa.europa.eu/clp/inventory_notification_en.asp for further information.

…When is an intermediate not an intermediate under REACH?

Industry’s definition of an intermediate apparently differs from that of ECHA and the European Commission. To clarify the meaning of an intermediate under REACH, and to explain when a chemical substance can be registered solely as an intermediate and when a standard registration is required, ECHA has published a 12-page booklet (dated May 2010). This is available at http://guidance.echa.europa.eu/docs/guidance_document/clarificationintermediates_201005_en.pdf on the internet. {169340}

…Updated version of REACH-IT now released

The new version now includes features such as the ‘parallel joint submission’ that allows members of a joint submission to submit their dossiers as soon as the lead dossier has been accepted for processing (i.e. when it has passed the business rules). Also, a new online functionality allows companies to prepare their Classification and Labelling notifications directly in REACH-IT. More information is given in news alert ECHA/NA/10/29, which is dated 31 May 2010.

…Webinars for SIEF members

As a part of its SIEF (Substance Information Exchange Forum) awareness campaign, ECHA has prepared four webinar presentations for member registrants. The four presentations explain in detail how a member registrant who is part of a joint submission can prepare a registration dossier in IUCLID 5.2 and submit it via REACH-IT. The presentations are accessible via http://echa.europa.eu/news/webinars_en.asp on the ECHA website.

…Share and share alike

Data sharing is one of the core principles of REACH, helping to increase the efficiency of the registration system, reduce costs and avoid unnecessary animal testing. However, for companies failing to reach agreement on sharing data, ECHA has now issued dedicated webpages to provide assistance in the event of a dispute. Further information is provided in a news alert (ECHA/NA/10/24) which is dated 18 May 2010, or in the disputes section on the ECHA website (at .

…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 2,3-epoxypropyl neodecanoate (studies on 90-day sub-chronic toxicity, developmental toxicity and two-generation reproductive toxicity). For more information or to submit data (by 12 July 2010) visit http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp on the ECHA website.

…Forum publishes the results of its first industry inspections

The Forum for Exchange of Information on Enforcement has published the results of its first REACH-EN-FORCE project, which involved nearly 1600 inspections (878 manufacturers, 666 importers, 83 only representatives and 858 downstream users) in 23 Member States in addition to Norway and Iceland. Non-compliance with their obligations under REACH was found in 24% of the inspected companies. Forum members agreed to extend the inspection activities until Spring 2011 to assess compliance with the first registration deadline of 30 November 2010. Further information and a link to the project report are given in a press release (ECHA/PR/010/10) which is dated 1 June 2010.

…ECHA’s fourth stakeholders’ day

Over 350 people from around the world participated in this event, which was held on 19 May 2010. The programme was divided into three sessions: tips and tools for registration and classification and labelling notification, feedback from registration and evaluation, and dissemination. The presentations given at the event can be downloaded from the ECHA website (by accessing http://echa.europa.eu/news/events/4th_stakeholders_day_en.asp).

…RAC opinions on harmonised classification for four chemicals

As announced in a news alert (ECHA/NA/10/28) of 28 January 2010, ECHA’s Risk Assessment Committee (RAC) has agreed the proposals from two Member States (France and Germany) for the harmonised classification and labelling of four chemicals. The substances under scrutiny were tetrahydrofuran, for classification as a carcinogen; gallium arsenide for classification for reproductive toxicity and carcinogenicity (RAC recommended a more severe classification for carcinogenicity than that initially proposed, based on data available for other arsenic compounds); and synthetic and natural cryolites for de-classification for acute oral toxicity (RAC, however, considered the data insufficient to support the additional classification of cryolites for eye irritation and reproductive toxicity). RAC’s deliberations on these substances are available (via http://echa.europa.eu/about/organisation/committees/rac/committee_opinions_en.asp) on the ECHA website. {185365-7}

…Amendment to the REACH Regulation

Annexes II and VI of the REACH Regulation, (EC) No. 1907/2006, have been amended as regards the requirements for the compilation of safety data sheets to bring them in line with the criteria given in Regulation (EC) No. 1272/2008 on the classification and labelling of chemical substances.

[Commission Regulation (EU) No. 453/2010 of 20 May 2010 amending 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 2010, L133, 1 (visit http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2010:133:SOM:EN:HTML).] {185333}

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

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