…More substances branded as SVHC

ECHA has added 14 more substances (13 January 2010) to the “Candidate List” of substances of very high concern (ECHA/PR/10/01). Decisions on whether these substances will be subject to authorisation will be taken at a later date.

…Updated manual for REACH registrations and PPORD notifications

A revised version (Release 2.2, dated 15 December 2009) has been recently issued of Data Submission Manual 5: “How to complete a technical dossier for registrations and PPORD [Product and Process Orientated Research and Development] notifications”. The manual is available from ECHA (visit http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual.pdf). {177496}

…First agreement on the need for further animal tests under REACH

The first decision by the Member State Committee on a chemical based on read-across data has not been favourable, suggesting that it may be difficult in some instances to reduce animal testing requirements for registration. After scrutiny of a registrant’s proposal to use read-across from another substance, the Committee deemed that there was not enough justification for this, and that studies for repeated dose toxicity and reproductive toxicity were required. Details concerning the substance (and registrant) have not been made public. More information is given in a news alert (ECHA/NA/09/33) dated 7 December 2009, which reports that a final decision on testing requirements will be reached by ECHA.

…REACH Technical Completeness Check (TCC) plug-in

To enable companies to check whether their registration dossiers are complete before submission, ECHA released (in December 2009) an IUCLID plug-in that can be accessed on the IUCLID website (via http://iuclid.echa.europa.eu/). Since the plug-in can also be used to check the technical completeness of Product and Process Orientated Research and Development (PPORD) dossiers, companies are advised to use it for this purpose, rather than the previous software made available, as the TCC rules have been updated.

…Database on registered substances

On 18 December 2009, ECHA made available (under the REACH Regulation) information submitted by companies on the hazards and safe use of chemical substances that have already been registered, although the Agency pointed out that this data has not been verified. Some information is not disseminated because companies have claimed confidentiality. The database can be accessed via http://apps.echa.europa.eu/registered/registered-sub.aspx on the ECHA website.

…Compliance checks on unfinished NONS dossiers

Under previous legislation there was a requirement for the Notification Of New Substances (NONS), which were assessed by Member State competent authorities. Some of these assessments were not finalised before REACH came into force (revoking the preceding NONS Directive), and toxicity data may be missing from certain dossiers. As a consequence, ECHA is now undertaking a compliance check on unfinished NONS submissions. Further information is given in a news alert (ECHA/NA/09/37) dated 18 December 2009.

…Webinar presentations available online for registrants

The second and third 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 on information requirements cover robust study summaries, weight of evidence approach, use of in vitro data, QSARs, waiving information requirements, read-across and categories.

…Forum check on how formulators comply with REACH

The Forum for Exchange of Information on Enforcement has announced that its next joint REACH enforcement project will focus on formulators of mixtures who are the first level of downstream users in the supply chain. More details can be obtained in a news alert (ECHA/NA/09/34) issued on 14 December 2009.

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

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