All these items were written for inclusion in our monthly publication Toxicology and Regulatory News.
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Draft appendices to chapters R.7a, R.7b and R.7c of ECHA’s guidance on Information Requirements and Chemical Safety Assessment provide endpoint specific guidance for registrants preparing REACH dossiers on nanomaterials. These appendices are relevant to physico-chemical and (eco)toxicological endpoints. A further three draft appendices to chapters R.8, R.10 and R.14 have also been released, and provide guidance relevant to nanomaterials on the characterisation of dose-response for human health and the environment, and occupational exposure estimation. All six draft appendices have been sent to ECHA’s Competent Authorities for REACH and CLP (CARACAL) for consultation.
ECHA (2012). Guidance on information requirements and Chemical Safety Assessment. Appendices R7-1, R7-2, R8-15, R10-2 and R14-4. Issued March and April 2012. Click on ‘Appendices for nanomaterials’ on the following page:
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 the European Chemicals Agency organises a public consultation period of 45 days. Under this scheme, proposals have been recently submitted by the Austrian and Norwegian authorities to standardise the classification and labelling of fenoxaprop-P-ethyl and 8:2 fluorotelomer alcohol.
http://echa.europa.eu/harmonised-classification-and-labelling-consultation
Corrigendum to the Guidance on Substance Identification available in 22 EU languages.
http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach
ECHA has published a full revision of its Guidance on Data sharing (version 2.0).
http://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_en.pdf
Third draft revised Guidance on Registration sent to ECHA’s Competent Authorities for REACH and CLP (CARACAL).
http://echa.europa.eu/documents/10162/13629/registration_version2_draft_march_clean_en.pdf
Draft revised Guidance on the application of the CLP criteria sent to CARACAL.
ECHA to publish total tonnage band for registered substances.
http://echa.europa.eu/web/guest/view-article/-/journal_content/81cace06-43bf-4756-aa10-784f3561ea4c
ECHA call for a meeting of experts to discuss reproductive and repeated dose toxicity of cymoxanil.
http://echa.europa.eu/web/guest/view-article/-/journal_content/ea3d0425-63a8-48da-bf01-ef9ec94fab96
ECHA had updated its Classification and Labelling Inventory (including bug fixes and recently received notifications).
http://echa.europa.eu/web/guest/view-article/-/journal_content/872361ec-86d0-418d-84ed-775ac6c0d507
ECHA to update REACH-IT and IUCLID 5.
Chesar 2.0 to be released in June.
http://echa.europa.eu/web/guest/view-article/-/journal_content/5f409e9e-c0dc-4b04-8225-024fe5b6d521
Testing proposals involving vertebrate animals: request for information from third parties on two substances (deadline 1 June 2012).
http://echa.europa.eu/information-on-chemicals/testing-proposals/current
The above items were taken from the May 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).
As announced in a March 2012 news alert (ECHA/NA/12/06), ECHA’s Committee for Risk Assessment (RAC) has considered proposals from Austria, Germany and the UK to harmonise the classification and labelling of four chemicals.
RAC agreed with proposals on the following:
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 the European Chemicals Agency organises a public consultation period of 45 days. Under this scheme, proposals have been recently submitted by the Austrian and Dutch authorities to standardise the classification and labelling of the substances mandipropamid and etridiazole.
http://echa.europa.eu/harmonised-classification-and-labelling-consultation
As announced in a recent press release (ECHA/PR/12/07) an Annex XV restriction report has been produced by the Danish Competent Authority, reviewing the health effects of chromium (VI) compounds. A ban on the placing on the market of “articles of leather, coming into direct and prolonged or repetitive contact with the skin” containing “chromium (VI) in concentrations equal to or higher than 3 mg/kg” is proposed. This proposal will be open for comment until 16 September 2012, but ECHA encourages interested parties to submit their opinions by 1 June 2012.
European Chemicals Agency. Annex XV report. Proposal for a restriction on chromium (VI) compounds. 19 January 2012.
http://echa.europa.eu/documents/10162/4d88d444-4b8b-48ab-9c11-6e74819e047c
Member State competent authorities and the European Chemicals Agency may prepare Annex XV dossiers for SVHCs, as defined in Article 57 of the REACH regulation. SVHCs 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 Annex XV dossiers, released by the Belgian (with Poland), Dutch and German authorities, cover the following compounds:
ECHA, at the request of the European Commission, prepared Annex XV dossiers on Michler’s ketone and Michler’s base, and on the following colourings, when containing Michler’s ketone or base at levels of at least 0.1% by weight:
Annex XV dossiers. Proposals for the identification of a substance as a Category 1A or 1B CMR, PBT, vPvB or a substance of an equivalent level of concern. Proposals available for comment until 12 February 2012.
http://echa.europa.eu/web/guest/proposals-to-identify-substances-of-very-high-concern
A recent RIVM report discusses the risk management options available for skin and respiratory sensitizers, particularly under REACH, stating that existing legislation does not adequately control the risks associated with these chemicals. RIVM suggests that some sensitizers, particularly those classed as category 1A respiratory sensitizers under CLP (the EU Classification, Labelling and Packaging of substances and mixtures), qualify as SVHCs under article 57f of the REACH regulation, for possible inclusion in Annex XIV (substances subject to restrictions or authorisation). An “equivalent level of concern” to other substances routinely considered to be SVHCs is anticipated.
ter Burg W and Jongeneel WP (2012). Priority setting and risk management option under REACH for sensitizers. RIVM Letter Report 601030001/2012. Dutch National Institute for Public Health and the Environment.
http://www.rivm.nl/bibliotheek/rapporten/601030001.pdf
ECHA plans to update its guidance for registration of substances in nanoform.
http://echa.europa.eu/web/guest/view-article/-/journal_content/d2809a13-f2e7-4ce9-9815-c5c7f3f02009
ECHA publishes its 2011 progress report.
http://echa.europa.eu/documents/10162/13628/evaluation_report_en.pdf
Draft guidance for monomers and polymers sent to Competent Authorities for Reach and CLP (CARACAL) via fast-track procedure.
http://echa.europa.eu/documents/10162/13564/draft_update_guidance_polymers_feb_2012_en.pdf
Draft revision of the Guidance on Information Requirements and Chemical Safety Assessment - Endpoint Specific Guidance (Chapter R.7a/R.7.1 – physico-chemical properties) sent to Partner Expert Group.
http://echa.europa.eu/documents/10162/13564/r7a_peg_march_2012_clean_en.pdf
ECHA publishes information on consumer articles containing substances of very high concern (SVHCs).
First Community rolling action plan (CoRAP), containing 90 substances to be evaluated from 2012 to 2014, published.
http://echa.europa.eu/web/guest/view-article/-/journal_content/c26e0b90-8d88-4580-9954-842a934486a1
Testing proposals involving vertebrate animals: request for information from third parties on 22 substances (deadline 20 April 2012).
http://echa.europa.eu/information-on-chemicals/testing-proposals/current
The above items were taken from the April 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).
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