…Proposal for the restriction of methanol considered by ECHA

An Annex XV report submitted by the Polish authorities proposes a restriction on placing methanol on the market (for supply to the general public) as a constituent of windscreen washer fluids, or as an additive to denatured alcohol (methylated spirits), in concentrations of 3% (by weight) or more.

European Chemicals Agency. Annex XV restriction report. Proposal for a restriction. Methanol. Version 1. 16 January 2015. http://echa.europa.eu/documents/10162/78b0f856-3751-434b-b6bc-6d33cd630c85


…RAC deliberations on the restriction of ammonium salts and bisphenol A (BPA)

RAC has adopted its opinion supporting a restriction of the use of inorganic ammonium salts in cellulose insulation materials. The aim is to reduce the risks of eye and respiratory irritation posed by the release of ammonia. Meanwhile, discussions continue on a French proposal to restrict BPA in thermal paper (used in receipts), to address risks to the health of exposed consumers and pregnant workers.

European Chemicals Agency. RAC continued its deliberations on bisphenol-A and agreed on a further restriction proposal […]. 18 March 2015. http://echa.europa.eu/documents/10162/21774240/Annex_RAC_32a_b.pdf Opinion on an Annex XV dossier proposing restrictions on inorganic ammonium salts. ECHA/RAC/RES-O-0000005359-66-02/D. 3 March 2015. http://echa.europa.eu/documents/10162/001796db-70f5-44dc-bc1f-0fc052f2d6e3


…Trichloroethylene authorisation subject to RAC opinions

Eleven draft opinions on the authorisation of certain uses of trichloroethylene have been agreed upon.

European Chemicals Agency. RAC […] evaluated 12 applications for authorisation, agreeing on 11 of 17 draft opinions for individual uses […]. 18 March 2015. http://echa.europa.eu/documents/10162/21774240/Annex_RAC_32a_b.pdf


…Dose-response relationships and health guidance values for SVHCs

RAC has agreed on carcinogenicity dose-response relationships for two substances of very high concern (SVHCs): 2,2′-dichloro-4,4′-methylenedianiline (MOCA) and technical 4,4’-methylenedianiline (MDA). A further dose-response relationship for ethylene dichloride, and a derived-no-effect level (DNEL) for diglyme are to be subject to future RAC consultation.

European Chemicals Agency. RAC continued its deliberations on [carcinogenicity dose-response relationship for SVHCs]. 18 March 2015. http://echa.europa.eu/documents/10162/21774240/Annex_RAC_32a_b.pdf


…Adoption of the Community Rolling Action Plan (CoRAP) for 2015-2017

ECHA’s CoRAP for substance evaluation in 2015-2017 includes 134 substances, of which 48 are specified for evaluation this year. Registrants should also prepare for requests from ECHA to provide further information on the substances evaluated under CoRAP in 2014.

European Chemicals Agency (2015). Evaluation kicks off for 48 substances in 2015. ECHA/PR/15/05. http://echa.europa.eu/view-article/-/journal_content/title/evaluation-kicks-off-for-48-substances-in-2015

Registrants should get ready to comment on substance evaluation draft decisions. ECHA/NA/15/08. http://echa.europa.eu/view-article/-/journal_content/title/registrants-should-get-ready-to-comment-on-substance-evaluation-draft-decisions


…Other items of interest

ECHA has published its first annual report on its roadmap for the identification of substances of very high concern (SVHC) and the implementation of REACH risk management measures. http://echa.europa.eu/view-article/-/journal_content/title/echa-focuses-on-substances-that-matter-most


ECHA calls for comments on a proposed guideline on the upcoming amendment of restriction provisions on lead and its compounds in consumer articles, and on the preparation of an Annex XV restriction dossier on polyfluorinated silanes in aerosol spray cans. http://echa.europa.eu/addressing-chemicals-of-concern/restriction/calls-for-comments-and-evidence


ECHA’s Committee for Socio-Economic Analysis (SEAC) has concluded on restriction proposals on ammonium salts, chrysotile asbestos and cadmium compounds and examined twelve applications for the authorisation of trichloroethylene. http://echa.europa.eu/view-article/-/journal_content/title/the-committee-for-socio-economic-analysis-concludes-on-three-restriction-proposals-and-examines-12-applications-for-authorisation-of-trichloroethylene


ECHA’s Forum for the Exchange of Information on Enforcement has decided on a second pilot project to ensure relevant substances are not on the market without an authorisation, and to check whether authorisation holders comply with the conditions of the granted authorisation. http://echa.europa.eu/view-article/-/journal_content/title/forum-starts-a-pilot-project-on-authorised-substances


A draft update to the guidance on information requirements and chemical safety assessment (IR&CSA) – Chapter R.7a (section R.7.6 related to reproductive toxicity) has been sent for consultation by ECHA’s Committee for Risk Assessment (RAC) and Member State Committee (MSC), essentially to replace the requirement for a two-generation reproduction study with the requirement for an extended one-generation reproduction toxicity study (EOGRTS).http://echa.europa.eu/documents/10162/13643/draft_ir_csa_r7a_r76_reprotox_en.pdf
ECHA encourages registrants, especially those with pending testing proposals, to familiarise themselves with the amended information requirement for reproductive toxicity. http://echa.europa.eu/view-article/-/journal_content/title/are-you-affected-by-changes-to-reproductive-toxicity-tests-


ECHA has clarified how to report substances used in hydraulic fracturing. http://echa.europa.eu/view-article/-/journal_content/title/echa-clarifies-how-to-report-substances-used-in-hydraulic-fracturing



The above items were taken from the May 2015 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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