Harmonised classification and labelling proposals for five chemicals

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 Czech, Dutch, French and Polish authorities to standardise the classification and labelling of:

  • bisphenol A
  • chlorobenzene
  • flumioxazin
  • methyloxirane
  • 1-methyl-2-pyrrolidone

European Chemicals Agency. CLH reports.

Proposals for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2.

Bisphenol A. Version 2. 17 July 2013.


Chlorobenzene. Version 2. 30 July 2013.


Flumioxazin (ISO); N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide. Version 5. 2 August 2013.


Methyloxirane (propylene oxide). Version 2. August 2013.


1-Methyl-2-pyrrolidone. Version 2. August 2013.


Consultations on seven potential Substances of Very High Concern (SVHCs)

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 Austrian, Dutch, German and Swedish authorities, and cover the following potential SVHCs:

  • cadmium sulphide
  • CI Direct Black 38
  • CI Direct Red 28
  • dihexyl phthalate
  • imidazolidine-2-thione
  • lead di(acetate)
  • trixylyl phosphate

European Chemicals Agency. 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 17 October 2013.


RAC opinion on the reproductive toxicity of gallium arsenide

RAC has revised and adopted its draft opinion on the reproductive toxicity of gallium arsenide, which considers new data made available since its previously adopted (2010) opinion. Based on “clear evidence of testicular toxicity in two species”, the new draft assessment supports the originally proposed classification of gallium arsenide as a presumed human reproductive toxicant (category 1B).

European Chemicals Agency. Committee for Risk Assessment (RAC). Opinion on gallium arsenide in relation to toxicity to reproduction. ECHA/RAC/A77-O-0000001412-86-11/F. Adopted 23 July 2013.


ECHA finalises its report on di-isodecyl phthalate (DIDP) and di-isononyl phthalate (DINP)

In ECHA’s final review report, the current legislation preventing the use of these phthalates in toys and childcare articles which can be placed in the mouth was considered to be sufficiently protective of childhood exposure. For adults, it was “not likely” that exposure to DIDP or DINP from the use of sex toys would result in a liver toxicity risk, but it was noted that there were substantial uncertainties regarding exposure levels duration and migration rates. No further risk management measures were considered necessary to be needed to reduce exposure levels for adults or children.

European Chemicals Agency. Evaluation of new scientific evidence concerning DINP and DIDP in relation to entry 52 of Annex XVII to REACH Regulation (EC) No 1907/2006. Final review report. ECHA-13-R-07-EN. August 2013.


Other items of interest

IUCLID version 5.5.1 now available.


Registration numbers granted to 9030 dossiers submitted to ECHA by 31 May 2013, corresponding to 2998 more substances registered under REACH.


Draft revised guidance on the application of the CLP Criteria (Part 3: health hazards) sent to CARACAL.


Testing proposals involving vertebrate animals: request for information from third parties on three compounds (deadlines 18 October 2013 and; 24 October 2013).


The above items were taken from the October 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).


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