…Amendments to REACH and CLP Regulations

Amendments have been made to Annexes I and XIII of the REACH Regulation, (EC) No. 1907/2006. Changes to Annex I bring the requirements for the compilation of Chemical Safety Reports into line with the criteria given in Regulation (EC) No. 1272/2008 on CLP. Meanwhile, Annex XIII has been modified to ensure that when identifying persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances, all relevant information is considered by the registrant using a “weight of evidence” approach, and that a screening assessment is conducted initially in cases where only limited data are available in the dossier. [Commission Regulations (EU) No. 252/2011 and 253/2011, both of 15 March 2011, amending Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex I and Annex XIII, respectively. Official Journal of the European Union 2011, L69, 3; 7 (visit http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2011:069:SOM:EN:HTML).] {187338-9}

CLP Regulation (No. 1272/2008) has been revised to harmonise provisions with recent changes to the UN Globally Harmonised System of Classification and Labelling of Chemicals (GHS). Key alterations include new sub-categories for respiratory and skin sensitization, revision of the classification criteria for chronic toxicity to the aquatic environment and the creation of a new hazard class for substances and mixtures hazardous to the ozone layer. [Commission Regulation (EU) No. 286/2011 of 10 March 2011 amending, for the purposes of its adaption to technical and scientific progress, Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on Classification, Labelling and Packaging of substances and mixtures. Official Journal of the European Union 2011, L83, 1 (to access the Commission Regulation, click on http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:083:0001:0053:EN:PDF).] {187374}

…Harmonised classification and labelling

Under Regulation (EC) No. 1272/2008 on CLP, 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 the European Chemicals Agency organises a public consultation period of 45 days.

Harmonisation proposals have been submitted recently by industry and the German, United Kingdom and French authorities for trimagnesium diphosphide, perestane, N-ethyl-2-pyrrolidone, dioctyltin bis(2-ethylhexyl mercaptoacetate) and aluminium phosphide. Comments are invited by 9 May 2011; log onto for further details. {187375-9}

The public consultation period has now finished for harmonised classification and labelling proposals relating to trichloromethylstannane, 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate, sulcotrione, penconazole, nitrobenzene, ethylbenzene, di-n-hexyl phthalate and aclonifen. The proposals for each substance can still be obtained from the ECHA website by visiting http://echa.europa.eu/consultations/harmonised_cl/harmon_cl_prev_cons_en.asp (opinions of the Risk Assessment Committee will presumably be released in due course). {187380-7}

As announced in a news alert (ECHA/NA/11/10) of 14 March 2011, ECHA’s Risk Assessment Committee (RAC) has agreed with the proposals from two Member States (Germany and UK) for the harmonised classification and labelling of three chemicals. The substances under scrutiny were: 4-tert-butylbenzoic acid, for classification as acutely toxic (by the oral route), as toxic to the central nervous system, liver, kidney, reproductive organs, haemopoietic system and thymus after repeated exposure, and as potentially damaging to fertility; metazachlor, for classification as a skin sensitizer, suspected carcinogen and hazardous to the aquatic environment; and 2-ethoxyethanol, for the removal of the classification of this substance as harmful when in contact with the skin and modification of the current harmonised classification as harmful if inhaled, to toxic if inhaled. RAC’s opinions on these substances are available, together with supporting background documents, via http://echa.europa.eu/about/organisation/committees/rac/committee_opinions_en.asp on ECHA’s website. {187437-9}

Also as announced in ECHA News Alert ECHA/NA/11/10, RAC has reviewed some recent study plans in relation to classifying epoxiconazole as toxic to reproduction, and concluded that the proposed harmonised classification of the substance is unlikely to be modified by the results of the studies. The follow-up RAC opinion, which is dated March 2011, can be downloaded at http://echa.europa.eu/doc/about/organisation/rac/opinion/rac_opinion_epoxiconazole.pdf online. {181038}

…ECHA updates labelling and packaging guidance

To access ECHA’s new “Guidance on labelling and packaging in accordance with Regulation (EC) No. 1272/2008” visit http://guidance.echa.europa.eu/docs/guidance_document/clp_labelling_en.pdf on the ECHA website. Dated April 2011, the guidance is aimed at suppliers of chemical substances and mixtures, and clarifies labelling and packaging rules for substances and mixtures, as set out in the CLP Regulation. The document replaces the sections dealing with labelling and selection of precautionary statements that were presented in ECHA’s “Guidance on the Application of the CLP Criteria”, and a revised April 2011 version of this comprehensive guidance has also now been released (visit http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf). {182930}

…Other REACH items of interest

ECHA publishes new tools for preparation and submission of Authorisation Applications (http://echa.europa.eu/news/na/201104/na_11_16_authorisation_applications_20110405_en.asp).

New version of ECHA’s Chemical Safety Assessment and reporting tool Chesar (V1.1.3) available (http://echa.europa.eu/news/na/201104/na_11_17_chesar_update_20110406_en.asp).

Testing proposals involving vertebrate animals: request for information from third parties (15 March and 5 April 2011) (http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp?consultations_status=current).

Updated “Guidance on requirements for substances in articles”, dated April 2011 (http://guidance.echa.europa.eu/docs/guidance_document/articles_en.htm).

ECHA has revised its Guidance Consultation Procedure (http://echa.europa.eu/news/na/201104/na_11_15_consultation_procedure_20110405_en.asp).

A data submission manual (Part 22) on “How to prepare and submit an application for Authorisation using IUCLID 5”, dated April 2011, is available (http://echa.europa.eu/doc/reachit/dsm22/data_submission_manual_22_application_authorisation_iuclid5_en.pdf).

A test version of a multilingual terminology database provides the main REACH and CLP terms in 22 EU languages, including the CLP pictograms, and hazard and precautionary statements (http://echa.europa.eu/news/na/201104/na_11_14_reach_clp_term_in_22_languages_en.asp).

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

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