…Eight SVHCs added to ECHA’s authorisation list

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:

  • acids generated from chromium trioxide and their oligomers
  • ammonium dichromate
  • chromium trioxide
  • potassium chromate
  • potassium dichromate
  • odium chromate
  • odium dichromate
  • trichloroethylene

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.


See http://echa.europa.eu/view-article/-/journal_content/title/authorisation-list-updated
for ECHA news item.


…Proposed restriction of lead and its compounds in consumer articles

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.



…Proposals for the harmonised classificationand labelling of two compounds

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:

  • bifenazate
  • Direct Blue FC 57087
  • triflusulfuron-methyl

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.


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.


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.



…Draft Swedish proposal for nanomaterial regulation under REACH

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.



…Other items of interest

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.



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.


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).

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