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As announced in an ECHA news item dated 19 April 2013 (ECHA/NI/13/03), Annex XIV of REACH has been amended to include the following eight substances:
These compounds, which are all classified as carcinogenic, mutagenic or reprotoxic (CMR), will be subject to authorisation for use after 21 April 2016 (trichloroethylene) or 21 September 2017 (the listed chromium compounds).
Commission Regulation (EU) No 348/2013 of 17 April 2013 amending Annex XIV to Regulation (EC) No 1907/2006 of the EuropeanParliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union 2013, L108, 1-5.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:108:0001:0005:EN:PDF
See http://echa.europa.eu/view-article/-/journal_content/title/authorisation-list-updated
for ECHA news item.
A press release (ECHA/PR/13/15) announced the publication of an Annex XV report, submitted by the Swedish authorities, which reviews the health effects of lead and lead compounds. The report proposes that lead levels in consumer articles should be restricted to 0.05% (by weight) for items which can be placed in the mouth by children. The critical endpoint was considered to be non-threshold neurotoxicity and neurodevelopmental effects, particularly in children. The report is open for comment until December 2013, but ECHA invites interested parties to submit their opinions by 1 June 2013.
European Chemicals Agency. Annex XV report. Proposal for a restriction. Lead and its compounds in articles intended for consumer use. Version number: 1. 21 December 2012.
http://echa.europa.eu/documents/10162/80f7edca-b6c1-4433-8734-854594530db2
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 submitted by the Dutch, French and German authorities to standardise the classification and labelling of the following substances:
European Chemicals Agency. CLH reports.
Proposal for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP regulation), Annex VI, Part 2. Bifenazate. Version number: 2.2. January 2013.
http://echa.europa.eu/documents/10162/59681748-ed1a-4420-835e-67b071304ba5
Proposal for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2. Lithium sodium 3-amino-10-{4-(10-amino-6,13-dichloro-4,11-disulfonatobenzo[5,6][1,4]oxazino[2,3-b] henoxazine-3-ylamino)-6-[methyl(2-sulfonato-ethyl)amino]-1,3,5-triazin-2-ylamino}-6,13-dichlorobenzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate (Direct Blue FC 57087). Version number: 1. January 2013.
http://echa.europa.eu/documents/10162/b458eefc-b0ef-406c-9381-d77ea63f4bc5
Proposal for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2. Triflusulfuron-methyl. Version number: 2. 2 November 2011.
http://echa.europa.eu/documents/10162/3d2da54b-13e4-4f85-ab71-1afafd70f84a
A draft proposal from the Swedish Chemicals Agency (Kemi) aims to supplement the existing REACH regulation to better account for nanomaterials.
Swedish Chemicals Agency. April 2013.
http://www.kemi.se/Documents/Forfattningar/Reach/Draft-proposal-regulation-nanomaterials.pdf
Follow the REACH 2013 registration progress online on the new REACH 2013 webpage.
Extended opening hours for REACH-IT in May, giving registrants more time to submit relevant dossiers.
http://echa.europa.eu/view-article/-/journal_content/title/reach-it-opening-hours
New Biocidal Products Committee starts working for safe biocidal products.
IUCLID (v.5.5) now ready for Biocidal Products Regulation.
New content available on Chesar’s support page.
Chesar 2.2 can now import assessment files created with Stoffenmanager 5.0® as “external exposure estimation tool” based assessment.
Draft revised guidance for downstream users (version 2.0) sent to Partner Expert Group (PEG).
Draft updated guidance on the compilation of safety data sheets (version 1.2) sent to PEG.
http://echa.europa.eu/documents/10162/13643/draft_guidance_sds_to_peg_201304_en.pdf
The above items were taken from the May 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).
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), very persistent and very bioaccumulative (vPvB), or of an equivalent level of concern. The latest Annex XV dossiers have been released by the German, Polish and Swedish authorities, and cover the following potential SVHCs:
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 on concern. Proposals available for comment until 18 April 2013.
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 recently been submitted by the Danish, Dutch, Finnish, French, Irish, Italian, Norwegian, Spanish and Swedish authorities to standardise the classification and labelling of the following substances:
CLH reports. Proposals for harmonised classification and labelling based on the CLP Regulation (EC) No 1272/2008, Annex VI, Part 2. Reports dated October 2011 to February 2013. Available for comment until 19 April 2013.
As announced in a March 2013 news alert (ECHA/NA/13/11), RAC has considered proposals (from the Austrian, Dutch, German and Norwegian authorities) for the harmonised classification and labelling of six chemicals. The following were considered:
RAC has also adopted two opinions at the request of ECHA’s Executive Director, concluding the following:
Lastly, RAC concluded that a restriction proposal on the use and placing on the market of air fresheners and toilet blocks containing 1,4-dichlorobenzene is justified.
http://echa.europa.eu/view-article/-/journal_content/title/rac-concludes-nine-scientific-opinions
As announced in a recent press release (ECHA/PR/13/14), ECHA has released its first annual update of CoRAP, listing chemicals to be evaluated by Member States between 2013 and 2015. A total of 115 substances are included, with 53 from the first CoRAP, adopted in 2012.
Reductions to the administrative charge of small and medium-sized enterprise (SME) size verification.
REACH fee regulation updated: lower amounts for SMEs.
ECHA offers support to registrants in exceptional cases.
First substance evaluation results – further information needed on 32 substances.
Opinion on bisphenol A diphosphate available from ECHA’s Committee for Risk Assessment (RAC).
http://echa.europa.eu/documents/10162/c84af302-bee8-4480-85eb-690229c1e158
ECHA to conduct a preliminary study and hold a webinar on the use of five cobalt salts (cobalt sulphate, cobalt dichloride, cobalt dinitrate, cobalt carbonate and cobalt diacetate).
ECHA’s Committee for Socio-economic Analysis (SEAC) has concluded on scientific opinions for two restriction proposals.
Public consultation on SEAC's draft opinion on a restriction proposal for 1,4-dichlorobenzene in air fresheners and toilet blocks.
SEAC agrees on how they will examine economic feasibility.
REACH evaluation report 2012 shows quality information required for REACH compliance.
EU General Court confirms ECHA’s approach in identifying PBTs and vPvBs as substances of very high concern.
Draft revised Guidance on the Application of the CLP Criteria – Part 2: Physical hazards and Part 3: Health hazards (2nd and 4th ATP) sent for a second Partner Expert Group (PEG) consultation.
http://echa.europa.eu/documents/10162/13562/clp_3rd_atp_chapter_2_phys_chem_en.pdf
http://echa.europa.eu/documents/10162/13562/draft_guidance_peg_clp_hh_rev4_v2_201303_en.pdf
Chesar 2.2 supports generation of exposure scenarios for communication.
Survey launched to prepare the next phases of IUCLID 6 development.
IUCLID manual for nanomaterials updated.
The above items were taken from the April 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).
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