ECHA helps with homework…

Under the Temporary Submission Procedures for registrations and PPORD (product and process oriented research and development) notifications, few companies have received top marks for their technical dossiers due to missing or incomplete information. To avoid this in any future submissions, ECHA has issued a manual to help identify “which of the numerous IUCLID 5 fields are of uppermost importance in relation to technical completeness check”.

[European Chemicals Agency. Data Submission Manual 5. How to complete a technical dossier for registrations and PPORD notifications (Release 1, 27 June 2008). Available at on the internet.] {177496}

A further manual explains how to submit a valid dossier to ECHA and how to complete the dossier header so that the submission will be accepted for processing. This is a temporary measure as, once REACH-IT is up and running, it will not be possible to submit a dossier without fulfilling these various requirements.

[European Chemicals Agency. Data Submission Manual 4. How to submit a valid dossier to ECHA and complete the dossier header (Release 1, 25 June 2008). Available at on the internet.] {177495}

…answers questions on REACH-IT…

A new page on the ECHA website (added on 4 July 2008) gives responses to 13 technical questions and 14 administrative questions that are frequently asked in relation to REACH-IT (see {177519}

…and consults on substances of very high concern

Competent Authorities of the Member States and ECHA may prepare Annex XV dossiers for substances of very high concern as defined in Article 57 of the REACH regulation (Regulation (EC) No. 1907/2006). These include substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or substances for which there is scientific evidence of probable cause of serious effects in humans or on the environment (e.g. endocrine disruptors). In a website entry dated 4 July 2008, comments are invited (by 14 August 2008) on the first of these dossiers, which cover the following compounds: benzyl butyl, dibutyl and di(2-ethylhexyl) phthalates; diarsenic trioxide and pentaoxide, lead hydrogen arsenate and triethyl arsenate; anthracene; bis(tributyltin) oxide; cobalt chloride; cyclododecane and hexabromocyclododecane; musk xylene; 4,4′‑diaminodiphenylmethane; short chain chlorinated paraffins (alkanes, C10-13, chloro); and sodium dichromate dihydrate. The documents and “commenting forms” are available (via . {177497}

The above items were taken from the August 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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