…Annex XV transitional reports

Under article 136 (3) of the REACH Regulation, EU Member States were required to submit transitional reports on the risk assessments and possible risk reduction options for certain existing substances, where the work was not finalised before 1 June 2008. These substances were prioritised under previous legislation (Regulation (EEC) No. 793/93), either due to their large production volumes or because of their potential persistent, bioaccumulative and toxic properties. Annex XV reports on nearly 30 of these substances (which provide information useful to companies planning to register the chemicals) have now been made available on ECHA’s website (via http://echa.europa.eu/chem_data/transit_measures/annex_xv_trans_reports_en.asp). {182768-92}

…Voluntary risk assessment reports on lead and copper compounds

Following an industry initiative, voluntary risk assessment reports on copper compounds (submitted by the European Copper Institute) and lead compounds (submitted by the Lead Development Association International) are available. To access these reports from ECHA visit http://echa.europa.eu/chem_data/transit_measures/vrar_en.asp (site last updated 13 July 2009). {182709-10}

…Hydrogenated oligomerisation products of tetradec-1-ene and alkene

ECHA has requested information on the reproductive toxicity of the hydrogenated oligomerisation products, including dimers and trimers, of tetradec-1-ene and alkene. This is to ensure that the best use is made of existing information and to avoid unnecessary animal testing. Holders of relevant data were invited in August 2009 to submit information via forms on the ECHA website (at http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp).

…Draft updated guidance document on requirements for substances in articles

When ECHA updates or develops new guidance, a consultation process takes place before the documents are finalised to hopefully ‘iron out’ any shortcomings. The consultation procedure consists of three steps involving discussions with a Partner Expert Group (PEG; composed of experts from stakeholders, interested parties, the European Commission and Member State competent authorities), 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 made available on the ECHA website (via http://guidance.echa.europa.eu/guidance4_en.htm). The latest document currently at the PEG stage (as announced on 23 July 2009) is an update of the guidance document on requirements for substances in articles. {178068}

…Number of SIEFs grows – must be the summer sun and showers

Although the number of SIEFs (Substance Information Exchange Fora) continues to grow, a News Alert from ECHA (ECHA/NA/09/12), dated 14 July 2009, stresses that more are expected to submit joint dossiers by the first registration deadline of 30 November 2010. ECHA is reminding companies of the urgency to get their SIEFs established, and to nominate the Lead Registrant, who will then become eligible for dedicated assistance from the Agency. As part of its ongoing SIEF awareness campaign, ECHA is preparing a special service for Lead Registrants, which will include a workshop to be held on 11 September 2009.

…IUCLID 5 upgrade

An upgrade (5.1.1) is available for the standalone and the distributed versions of IUCLID 5. This June 2009 upgrade can be downloaded free of charge from the “Get IUCLID 5” section of the IUCLID 5 website (via http://iuclid.echa.europa.eu/).

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

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