…Exemptions under Annexes IV and V of the REACH Regulation

The European Commission has prepared a draft proposal for amending Annexes IV and V, and its adoption by the European Parliament is expected in September or October 2008. The European Chemicals Agency (ECHA) is advising companies who are in doubt as to whether they may be affected by these changes to pre-register their chemicals (which entails no obligation to consequently register), rather than miss the 1 December 2008 deadline. The draft regulation (D000689/02) is available from ECHA (via http://echa.europa.eu/reach/legislation_en.asp). {177999}

…Bulk pre-registration substances

Companies may now pre-register up to 500 substances listed in EINECS (European INventory of Existing Commercial chemical Substances) in a single file using a pre-prepared XML format and selecting the bulk upload page in REACH-IT for submission. For substances not listed in EINECS, the REACH-IT online system must be used. Further information is available on the ECHA website (via http://echa.europa.eu/reachit/pre-registration-it_en.asp). ECHA has also published a manual to aid in the preparation and submission of multiple pre-registrations. [European Chemicals Agency. Data Submission Manual 6. Submission of bulk pre-registrations (Release 1). 22 July 2008. Available at http://echa.europa.eu/doc/reachit/bulk_submission_manual_20080722.pdf on the internet.] {177998}

…Data submission form

Apparently as the result of feedback from industry, ECHA has revised the submission form for registration, PPORD (product and process orientated research and development) and inquiry dossiers, allowing companies to nominate alternative contact addresses. The new submission form is available at http://echa.europa.eu/doc/reachit/submission_form.doc (Release 3; 29 July 2008). Ongoing dossier submissions using the previous form are not affected by this change. An amended manual has been issued to help with completion of the new submission form. [European Chemicals Agency. Data Submission Manual 3. How to complete the submission form (Release 3; 28 July 2008). Available at http://echa.europa.eu/doc/reachit/data_submission_manual.pdf on the internet.] {177082}

…Chemical safety report

The template for the chemical safety report (CSR) is now available on the ECHA website (via . To accompany the CSR, the relevant guidance document has been updated, together with the publication of an Appendix explaining the template. [European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Part F: Chemical Safety Report (Version 2; July 2008). Guidance on information requirements and chemical safety assessment. Appendix to Part F: CSR template with explanation. Both documents are available to download (via {177085}

…Guidance documents on Annex XIV substances and priority setting for evaluation

ECHA’s “Guidance on inclusion of substances in Annex XIV” (August 2008) has been prepared primarily to help the Agency and Member States Competent Authorities with the identification of substances having properties of very high concern and the inclusion of such substances in Annex XIV. It has been suggested that this document will also help companies understand the process involved in the identification of such substances (Guidance available via . {178247}

A second document “Guidance on priority setting for evaluation” (August 2008) is intended principally for use within ECHA, but may be of interest to others in gaining an understanding of the approaches used (accessible via . {178248}

…Guidance fact sheets

The following fact sheets are available giving brief (four-page) overviews of the guidance documents covering requirements for substances in articles; registration; data sharing; information requirements and chemical safety assessment (part A), and exposure scenario building (Part D). All are available on the ECHA website (via http://echa.europa.eu/reach/fact_sheet_en.asp). {178068-72}

…Reporting identified uses in IUCLID 5

A temporary user guide has been published on reporting identified uses for REACH in IUCLID that explains in detail how sections 3.5 and 3.6 of the existing IUCLID version 5.0 should be completed. The recommendations are in accordance with the “Guidance on information requirements and chemical safety assessment” (see Toxicology and Regulatory News 2008, 47(7), 110), and according to ECHA should facilitate a smooth transition of the data from the current IUCLID 5.0 to the next IUCLID release 5.1 that is expected to be issued early in 2009. [How to report identified uses for REACH in IUCLID 5.0. July 2008. Available at on the internet.] {178158}

…Software tool for checking PPORD completeness

To enable companies to check the completeness of their PPORD notifications before submission, ECHA has launched a software tool that is available to download (via . {178329}

…Payment of fees and charges

Frequently asked questions on payments and charges and technical issues (for example, forgotten passwords) in REACH-IT are available in new publications (updated August 2008) on the ECHA website (via http://echa.europa.eu/reachit/reachit_faq_en.asp) and on the EC Enterprise and Industry website (via . {178167; 178225}

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

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