…Thirteen substances identified as SVHC for REACH

ECHA (the European Chemicals Agency) has announced in a press release (ECHA/PR/12/16), dated 18 June 2012, that thirteen more substances, all of which are carcinogenic, mutagenic or toxic to reproduction (CMR), have been added to the “Candidate List” of substances of very high concern. These include:

  • triglycidyl isocyanurate
  • β-triglycidyl isocyanurate
  • lead (II) bis(methanesulfonate)
  • formamide
  • diboron trioxide
  • 1,2-dimethoxyethane (EGDME)
  • triglyme (TEGDME)
  • Michler’s ketone
  • Michler’s base

While the following where added when containing at least 0.1% Michler’s base or Michler’s ketone:

  • C.I. Basic Violet 3
  • C.I. Solvent Blue 4
  • C.I. Basic Blue 26
  • 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol

A decision will be made later as to whether these chemicals will be subject to authorisation. ECHA reminds companies that they may have legal obligations resulting from these additions to the list.



…ECHA proposes restriction on 1,4-dichlorobenzene

A press release (ECHA/PR/12/17) announced the publication of an Annex XV restriction report, submitted by ECHA, which reviews the health effects of 1,4-dichlorobenzene. A restriction on the placing on the market and use of 1,4-dichlorobenzene-based air fresheners and toilet blocks is proposed. This report is open for comment until 19 December 2012 but ECHA encourages interested parties to submit their opinions by 1 September 2012.

European Chemicals Agency. Annex XV report. Proposal for a restriction on 1,4-dichlorobenzene. 19 April 2012.



…RAC adopts opinion on four phthalates

ECHA’s Committee for Risk Assessment has adopted its opinion that the proposed restriction of four phthalates (DEHP, DBP, BBP and DIBP) in consumer articles is not justified. As described in a June 2012 press release (ECHA/PR/12/15), RAC concluded that available data do not indicate that there is currently a risk from combined exposure to these four phthalates.



…Illustrative Chemical Safety Report (CSR) from ECHA

ECHA’s illustrative CSR demonstrates the assessment of a hypothetical organic compound, exemplifying how to describe uses, assess hazards, estimate exposure and build exposure scenarios for chemicals to be registered under REACH, in a format consistent with REACH Annex I.

European Chemicals Agency (2012). Chemical Safety Report. An illustrative example. ECHA-12-G-03-EN.


…Other items of interest

IUCLD version 5.4 now available.


Chesar 2.0 released and strongly recommended.


Live demonstration of Chesar 2.0.


Late pre-registration of substances to be registered in 2013 closing soon.


Further updated guidance on information requirements and chemical safety assessment for nanomaterials.


Guidance for monomers and polymers now available in 22 EU languages.


Draft revised Guidance on the Application of the CLP criteria sent to ECHA’s Committee for Risk Assessment and Forum for Exchange of Information on Enforcement.


Member State Committee agrees on identification of five SVHCs and finalises 41 dossier evaluations.


ECHA publishes information on substances notified under Directive 67/548/EEC.


ECHA provides an online form for downstream user report submission.


Testing proposals involving vertebrate animals: request for information from third parties on three substances (deadline 19 July 2012; 2 August 2012).



The above items were taken from the July 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).


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