…Information requirements for repeated dose toxicity and reproductive toxicity

To prevent unnecessary animal tests, ECHA published a fact sheet (ECHA-09-FS-05-EN, dated 15 September 2009) that explains the possible options if short-term repeated dose toxicity and/or reproductive and developmental toxicity tests are not available at the time of registration. This is intended to help companies decide on the data that needs to be included in their dossiers (for substances manufactured or imported at quantities greater than, or equal to, 100 tonnes/year) in order to pass ECHA’s technical completeness check.

…Registration of notified substances

A revised version (dated 1 October 2009) of Data Submission Manual 5: how to complete a technical dossier for registrations and PPORD notifications (Release 2.1) has been published on the ECHA website (at http://echa.europa.eu/doc/reachit/compl_tech_dossier_manual.pdf). New sections are provided to include additional information on when to update a registration that is based on a previous notification, how to claim a registration number for a substance previously notified under the dangerous substances Directive 67/548/EEC, and how to update confidentiality claims. Guidance is also provided on the minimum data requirements for IUCLID 5. {177496}

Aimed at resolving any queries resulting from the revised manual, an update of “Questions and answers for the registrants of previously notified substances” has been made available at http://echa.europa.eu/doc/reachit/prev_not_sub_registrants_qa.pdf on ECHA’s website. {179289}

…Guiding the way for lead registrants

A press release (ECHA/PR/09/14, dated 15 September 2009) provides links to the presentations and ‘webstreaming’ of the workshop for lead registrants held in Brussels on 11 September 2009. Companies can also find information on a series of interactive ‘webinars’ (about one per month between now and early summer 2010). Run by ECHA experts, these will cover: general principles of dossier preparation and submission; information requirements – part I (e.g. robust study summaries, waiving information requirements and justification); information requirements – part II (e.g. QSARs, read-across, categories and in vitro data); substance identity; technical completeness check (TCC tool); chemical safety report (CSR) and chemical safety assessment (CSA) – part I (e.g. CSA tool and human health end-points); CSR and CSA – part II (e.g. CSA tool and environmental end-points); business rules and classification and labelling notifications.

…Time is ticking for downstream users to contact their suppliers about chemical uses

A further press release (ECHA/NA/09/19, dated 12 October 2009) reminds downstream users to inform their suppliers about substance uses if they want these to be included in the chemical safety assessment of the registrant. Less than two months remain before the 30 November 2009 deadline, which applies to substances required to be registered before 1 December 2010. The press release also provides links to background documents and further information.

…List of registered substances published

A list of 156 substances, based on the complete registration dossiers submitted by companies to ECHA before 24 September 2009, is now available to view on the ECHA website (via http://echa.europa.eu/chem_data/registered_substances_en.asp). ECHA notes that not all substances for which a registration had been submitted at this stage could be included.

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

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