…RAC assesses the use of boric acid and borates by amateur photographers

Under the REACH Regulation (entries 28-30 of Annex XVII) there is a general ban on supplying the general public with substances that are classified as carcinogenic, mutagenic or toxic to reproduction. Asked to consider a derogation for the supply of boric acid and borates for photographic applications, ECHA’s Committee for Risk Assessment has assessed the available toxicity and exposure data, and published its evaluation. The final decision rests with the European Commission.

[Committee for Risk Assessment. Opinion on new scientific evidence on the use of boric acid and borates in photographic applications by consumers. ECHA/RAC/A77-O-0000001273-82-05/F. The opinion (adopted on 29 April 2010) and background documents are available from ECHA (via http://echa.europa.eu/about/organisation/committees/rac/opinions_echa_ed_rac_en.asp).] {185051}

…Chemical safety assessment and reporting tool (Chesar) now available

Chesar (apparently pronounced “Kayzar”) is an IT tool developed by ECHA to help companies prepare their Chemical Safety Assessments (CSA) and Chemical Safety Reports (CSR) and works as a plug-in of the stand-alone version of IUCLID 5.2. Chesar 1.0 will produce the full CSA more efficiently and help to structure the information for the exposure scenarios, although it will not generate a full CSR or the exposure scenarios for the extended safety data sheets. The first upgrade enabling full CSR generation is planned for July 2010. For further information see news alert ECHA/NA/10/21 of 12 May 2010, or visit http://chesar.echa.europa.eu/ (the Chesar section of the ECHA website).

…Dissemination of information on registered substances and mixtures

In view of Article 119 of the REACH Regulation that requires ECHA to allow free online access to certain information it holds on chemicals, the Agency has released a manual that provides details of the intended process for data dissemination. The manual is aimed at industry, and in particular at managers and technical experts within companies who are responsible for ensuring that comprehensive information is entered in registration dossiers. A series of technical annexes is provided to accompany the main manual. In addition, a specific IUCLID 5 plug-in is being developed (expected to be released in June 2010) to enable registrants to verify, when preparing the registration dossier in IUCLID 5, which information would be disseminated on the ECHA website. The manual is expected to be frequently updated, due to technical progress with IUCLID and the Dissemination portal, so it would be wise to check the website regularly for the most recent version of the document.

[REACH-IT Data Submission Manual Part 15 – Dissemination: How to determine what will be published on the ECHA website from the registration dossier. Dated April 2010. The manual and accompanying Annexes can be obtained from ECHA’s dissemination portal to information on registered substances via http://echa.europa.eu/help/help_docs_en.asp?view=dissemination while a search facility can be accessed at http://apps.echa.europa.eu/registered/registered-sub.aspx to find information on registered substances.] {185162}

…Preparing a IUCLID 5 Classification and Labelling (C&L) notification dossier

To help companies identify which of the numerous IUCLID 5 fields are of major importance for ensuring successful submission of a C&L notification, ECHA has recently published a new user manual (which assumes IUCLID is already installed and a user account is available).

[Data Submission Manual Part 12 – How to prepare and submit a classification and labelling notification using IUCLID. Dated March 2010, the document is available from the ECHA website (at http://echa.europa.eu/doc/reachit/data_submission_manual_12_c&l.pdf).] {185163}

…Submitting a dossier through REACH-IT – updated manual

REACH-IT Data Submission Manual Part 4 has been revised to incorporate essential elements of Part 8 of the manual. It explains the initial checks that are made by REACH-IT to determine whether the dossier can be accepted and outlines how and why these checks are carried out. It is also intended to give guidance on how to prepare the substance dataset and the dossier header in order to pass the business rule verification.

[REACH-IT Data Submission Manual Part 4 – How to pass business rule verification (“Enforce rules”). Please note the title has changed (somewhat confusingly) from “How to complete the IUCLID dossier header”. The document, which is dated 15 April 2010, can be accessed on the ECHA website (at http://echa.europa.eu/doc/reachit/how_pass_business_verification.pdf).] {177495}

…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 involving 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 placed on the ECHA website (for full details, visit http://guidance.echa.europa.eu/guidance4_en.htm). The latest documents to enter this formal consultation process (in April 2010) are a draft Guidance for intermediates and a Guidance on information requirements and chemical safety assessment (Chapter R.5: Adaptation of information requirements). {169340; 181241}

…New guidance released

Having completed the consultation process through the various committee and consultation stages, an updated document has now been issued for the Guidance on information requirements and chemical safety assessment (Chapter R.15: Consumer exposure estimation). The document, which is dated 29 April 2010, is obtainable via http://guidance.echa.europa.eu/guidance_en.htm on the ECHA website. {181251}

…Calls for information to avoid unnecessary animal testing

ECHA publishes all proposals involving tests in vertebrate animals for the end-points specified in Annexes IX and X under REACH, and invites submissions of relevant data to ensure that additional animal testing is only conducted as a last resort. Currently, information is required on 2‑hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl ethanaminium chlorides, esters with C16-18 and C18 unsaturated fatty acids (two-generation reproductive toxicity) and 12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine (repeated-dose inhalation study). For more information or to submit data (by 10 or 18 June 2010) visit the ECHA website (at http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp).

…Changing legal entity made easier

As announced in a recent news alert (ECHA/NA/10/17), dated 16 April 2010, changes in legal personality and ‘Only Representatives’ can now be reported to ECHA in the new version of REACH-IT. ECHA has also reversed its policy on asset sales, allowing registrations to be transferred provided the company supplies evidence of transfer. Further details can be found in a new publication, “Practical Guide 8, how to report changes in legal entities”, which is available at http://echa.europa.eu/doc/publications/practical_guides/pg_legal_entity_change_no8.pdf on the ECHA website.

…Time for a tough talk with SIEF members

To ensure that Lead Dossiers are submitted in time, the Directors’ Contact Group has recommended that Lead Registrants tell all their SIEF (Substance Information Exchange Forum) members the date of intended submission of the Lead Dossier, and to announce a cut-off-date (suggested at two months before the submission date) after which a dormant member’s dossier will be frozen. Further details are given in a news alert ECHA/NA/10/19 of 16 April 2010 (additional background information on SIEFs can be found at .

…Webinar presentations available online for registrants

The eighth to tenth 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 are on classification and labelling, business rules, and data sharing and dissemination.

…Proposal for harmonised Classification, Labelling and Packaging (CLP) of chloroform

Under CLP Regulation (EC) No. 1272/2008, there is a legal obligation for suppliers to evaluate the hazards of chemicals (substances and mixtures) to be placed on the market, and to classify and label them appropriately. An option also exists for Member State competent authorities or industry to ask for the classification and labelling of a substance to be harmonised across Europe, whereupon ECHA organises a public consultation period of 45 days. Under this scheme, a proposal has been recently submitted by the French authorities to standardise the classification of chloroform.

For further information, or to comment on this proposal (by 14 June 2010), visit the ECHA website (at . {185080}

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

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