…Public consultation on proposed inclusion of new substances in the Authorisation List

ECHA has recommended that the following ten Substances of Very High Concern should, in future, not be used without authorisation:

  • formaldehyde, oligomeric reaction products with aniline (technical MDA)
  • arsenic acid
  • dichromium tris(chromate)
  • strontium chromate
  • potassium hydroxyoctaoxodizincatedichromate
  • pentazinc chromate octahydroxide
  • bis(2-methoxyethyl) ether (diglyme)
  • N,N-dimethylacetamide (DMAC)
  • 1,2-dichloroethane (EDC)
  • 2,2′-dichloro-4,4′-methylenedianiline (MOCA)

Each of these compounds has been classified as either carcinogenic, mutagenic or reprotoxic (CMR). The ultimate decision as to whether these chemicals will be included in Annex XIV of the REACH regulation lies with the European Commission.



…ECHA’s Committee for Risk Assessment (RAC) adopts opinions on five chemicals

As announced in a June 2012 news alert (ECHA/NA/12/30), RAC has considered proposals from industry and from the Austrian, German, Norwegian and UK authorities to harmonise the classification and labelling of five chemicals.

RAC agreed with the following proposals:

  • para-tert-butylphenol, as seriously damaging to the eye, irritating to the skin and toxic to reproduction
  • acrolein, as acutely toxic through the oral, dermal and inhalation routes, and corrosive to the skin. RAC was also of the opinion that a classification as toxic to the aquatic environment following acute or chronic exposure was required for this chemical
  • fluazinam, as acutely toxic through the inhalation route, sensitising to the skin, toxic to reproduction, seriously damaging to the eye, and toxic to the aquatic environment following acute or chronic exposure
  • dioctyltin bis(2-ethylhexyl mercaptoacetate), as toxic to reproduction (with RAC recommending a more severe category)
  • ethylbenzene, as toxic through repeated exposure and as toxic upon aspiration

RAC did not agree with a proposal from Austria recommending the classification of fluazinam as irritating to the skin and respiratory tract.



…Six proposals for harmonised classification and labelling

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, French and German authorities to standardise the classification and labelling of:

  • flonicamid
  • tricalcium diphosphide
  • nitric acid
  • octanoic acid
  • nonanoic acid
  • decanoic acid



…Public consultation on reproductive toxicity of epoxiconazole

Following industry’s provision of a number of new study reports, ECHA has launched a 30-day public consultation on the reproductive toxicity of this fungicide active ingredient. The newly available studies are detailed in an information report, to help RAC adopt an opinion on the harmonised classification and labelling of this chemical.

European Chemicals Agency. Additional information report for a substance under harmonised classification and labelling process. Epoxiconazole. 15 June 2012.



…Other items of interest

RAC has adopted an opinion on a proposal from the UK to harmonise the classification and labelling of Thixatrol® MAX.


Public consultation launched on draft opinion from ECHA’s Committee for Socio-economic Analysis (SEAC) on restricting four phthalates.


Practical guide on exposure scenarios published for downstream users.


Additional information to be published from registration dossiers.


ECHA to identify parties concerned during public consultations on CLH proposals


Joint campaign with European trade unions on the REACH 2013 registration deadline.


New version of REACH-IT is now online.


Dissemination, fee calculation, query tool and technical completeness check plug-ins now available for IUCLID 5.4.


70 testing proposals involving vertebrate animals: request for information from third parties (by 9 or 30 August 2012).



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

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