…Happy bunnies as EU introduces replacement in vitro test methods for skin irritation

Regulation (EC) No. 440/2008, which describes the test methods pursuant to REACH, has been amended to include, among other changes, a new in vitro test method for skin irritation using reconstructed human epidermis models.

[Commission Regulation (EC) No. 761/2009 of 23 July 2009 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 2009, L220, 1. The document is available from the EUR-Lex website (at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:220:0001:0094:EN:PDF).] {177087}

…ECHA consults on substances of very high concern

Member State competent authorities and the European Chemicals Agency may prepare Annex XV dossiers for substances of very high concern as defined in Article 57 of the REACH regulation. These include substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB). The latest batch of dossiers, all dated July or August 2009, cover the following compounds: acrylamide; high temperature coal tar pitch; 2,4-dinitrotoluene; diisobutyl phthalate; refractory ceramic fibres of zirconia aluminosilicate or of aluminosilicate; tris(2-chloroethyl) phosphate; lead chromate and the related pigments C.I. Pigments Red 104 and Yellow 34; and various anthracene oils. These reports (plus ‘commenting forms’ for submission by 15 October 2009) are available via http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp from the ECHA website. {182931-9}

…Don’t be backward at coming forward; ECHA’s plea to Lead Registrants

A News Alert from ECHA (ECHA/NA/09/14) dated 31 August 2009, reminds Lead Registrants that they cannot benefit from the dedicated special service being offered to help with their SIEF (Substance Information Exchange Forum) activities if they do not identify themselves and register with ECHA. The Agency is aware that some nominated individuals have concerns about the legal implications of such action and would like to assure them that, from ECHA’s point of view, such a notification does not have legal implications beyond those already stemming from the REACH Regulation.

The above items were taken from the October 2009 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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