…ECHA proudly announces the arrival of IUCLID 5.2

In a News Alert (ECHA/NA/10/03) dated 4 February 2010, the European Chemicals Agency announced the launch on 15 February of IUCLID 5.2, which enables registrants to record classification and labelling details and facilitates the automation of dossier processing by REACH-IT. In addition, sections 3.5 and 3.6 on use description have been adapted, as explained in the updated guidance on information requirements and chemical safety assessment. Registrants have until March 2010 to submit their dossiers using previous versions of IUCLID, although data stored in the IUCLID 5.0 or 5.1 formats can be automatically transferred into the new format during installation of IUCLID 5.2. A refinement of REACH-IT (to include a number of new features) is expected to be available in March 2010, and an update to the technical Completeness Check Tool (to reflect the changes within IUCLID) is also in progress.

…Draft guidance documents published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 by 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 documents lodged with the PEG (December 2009-February 2010) are new draft guidances on risk communication and on waste and recovered substances, and draft updates on information requirements and chemical safety assessment (Chapters R.8 – Characterisation of dose (concentration)-response for human health characterisation (DNEL/DMEL derivations), R.14 – Occupational exposure estimation, and R.15 – Consumer exposure estimation). Now at the ECHA Committee/Forum stage of the review process (in January/February 2010) are draft updates on (other aspects of) information requirements and chemical safety assessment (Chapter R.16 – Environmental exposure estimation) and on requirements for substances in articles, plus draft guidance on the preparation of dossiers for harmonised classification and labelling (CLH) under Regulation (EC) No. 1272/2008. Nearing conclusion are the consultations on a further draft update covering information requirements and chemical safety assessment (Chapter R.12 – Use descriptor system) and on the draft guidance relating to Annex V exemptions (where REACH registration is deemed inappropriate or unnecessary); these documents were received (on 21 December 2009 and 3 February 2010) for final scrutiny by the EC/Member State competent authorities. {177086; 179540; 181244 ; 181248; 181250-2; 183519; 184130-1}

…Annex IV review

Chemicals included in Annex IV of the REACH regulation are exempted from registration requirements because there is sufficient information for them to be “considered to cause minimum risk because of their intrinsic properties”. A recently published paper summarises the toxicological criteria for demonstrating minimum risk, and also describes the findings of the review that resulted in the Commission’s 2008 amendment to Annex IV. The investigators conclude that “although developed in the frame of REACH registration”, the risk criteria “could be more widely used in the sound management of chemicals” (Blainey M. et al., Regulatory Toxicology and Pharmacology 2010, 56, 111; http://dx.doi.org/10.1016/j.yrtph.2009.09.016). {184196}

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

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