…Just when you think it’s all over – ECHA issues updated REACH guidance documents

Updates have been published for Chapters R.5, R.8 and R.18 of the Guidance on Information Requirements and Chemical Safety Assessment, together with an update of the Guidance on Intermediates. In view of these changes, ECHA has invited companies to consider whether their registration dossiers need to be revised. The updated documents, which are all dated December 2010, can be accessed in the Guidance section (via http://guidance.echa.europa.eu/) on the ECHA website. {169340; 181241; 181244; 181254}

…Proposals for harmonised classification and labelling

Under EC Regulation No. 1272/2008 on Classification, Labelling and Packaging, 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, proposals have been recently submitted by the Norwegian authorities to standardise the classification of ammonium pentadecafluorooctanoate, perfluorooctanoic acid and its salts, and para-tert-butylphenol. To view the relevant background scientific reports, obtain further information, or comment on these proposals (by 21 February 2011), is the place to visit. {186946-8}

…ECHA recommends that eight SVHCs be subject to authorisation

Following the agreement of the Member State Committee (reported in Toxicology and Regulatory News 2011, 50(1), 3), a recommendation was made to the European Commission (in December 2010) that eight substances of very high concern (SVHCs) should not in future be used without authorisation. These substances are: diisobutyl phthalate, diarsenic trioxide, diarsenic pentaoxide, lead chromate, lead sulfochromate yellow (C.I. Pigment Yellow 34), lead chromate molybdate sulphate red (C.I. Pigment Red 104), tris(2-chloroethyl) phosphate and 2,4‑dinitrotoluene. All of the substances are classified as carcinogenic and/or toxic to reproduction. For further information, visit http://echa.europa.eu/news/pr/201012/pr_10_27_second_recommendation_20101220_en.asp on the ECHA website.

…Amendment to regulation on test methods applicable to REACH

Two new in vitro test methods for eye irritation have been included in an amendment to Regulation (EC) No. 440/2008 on REACH testing methodology.

[Commission Regulation (EU) No. 1152/2010 of 8 December 2010 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union 2010, L324, 13. The amendment regulation is obtainable at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:324:0013:0038:EN:PDF on the EUR-Lex website.] {177087}

…Other REACH items of interest

A new addition has been made to the Data Submission Manual in the form of Part 17 (How to derive a public name of a substance for use under the REACH Regulation), together with updates to Part 15 (How to determine what will be published on the ECHA website from the registration dossier) and Part 16 (Confidentiality Claims) (http://echa.europa.eu/help/help_docs_en.asp?view=dissemination).

Guidance on the communication of information on the risks and safe use of chemicals (http://guidance.echa.europa.eu/docs/guidance_document/risk_communications_en.pdf).

Information that companies will need to know for the Classification and Labelling of substances after 3 January 2011 notification deadline (http://echa.europa.eu/clp/info_clp_companies_en.asp).

Testing proposals involving vertebrate animals: request for information from third parties (http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp).

ECHA recommends companies to consult the current draft Guidance on Substances in Articles (http://echa.europa.eu/news/na/201012/na_10_82_substances_in_articles_20101222_en.asp).

The above items were taken from the February 2011 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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