…Consultations on 10 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 German, Polish and Swedish authorities, and cover the following potential SVHCs:

  • ammonium pentadecafluorooctanoate (APFO)
  • 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)
  • 2-(2H-benzotriazol-2-yl)-4,6-di-tert-pentylphenol (UV-328)
  • 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)
  • 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)
  • cadmium
  • cadmium oxide
  • dipentyl phthalate (DPP)
  • 4-nonylphenol, branched and linear, ethoxylated
  • pentadecafluorooctanoic acid (PFOA)

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.



…Proposals for the harmonised classification and labelling of 11 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 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:

  • brodifacoum
  • bromadiolone
  • chlorophacinone
  • coumatetralyl
  • difenacoum
  • difethialone
  • flocoumafen
  • 475-glass special purpose fibres
  • E-glass special purpose fibres
  • phenol, dodecyl, branched
  • warfarin

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.



…ECHA’s Committee for Risk Assessment adopts opinions on nine chemicals

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:

  • Mandipropamid. RAC agreed on classification as acutely toxic to the aquatic environment (with an M-factor of 1), and also
    recommended classification as a long-term aquatic hazard (with an M-factor of 1).
  • Fenoxaprop-p-ethyl. RAC agreed on classification as a substance which may cause damage to the kidney through prolonged or repeated exposure, as very toxic to aquatic life with acute and long-lasting effects, and as a skin sensitiser (although RAC recommended classification as Category 1 instead of 1B).
  • Isoxaflutole (already classified as a substance suspected of damaging the unborn child, and as very toxic to aquatic life with long lasting effects). RAC agreed that M-factors of 10 and 100 should be added to existing acute and chronic aquatic toxicity classifications.
  • Potassium sorbate. RAC agreed on classification as causing serious eye irritation, but not on classification as a skin irritant.
  • Tricalcium diphosphide (already classified as a substance which, in contact with water, releases a toxic and flammable gas which may ignite spontaneously, as fatal if swallowed (minimum classification) and as very toxic to aquatic life (with an M-factor of 100)). RAC agreed that the existing minimum classification for acute oral toxicity should be changed to a regular harmonised classification, and that the substance should be classified as toxic in contact with skin. RAC also proposed classification as causing serious eye damage, as a skin irritant, as fatal if inhaled, and as a substance which liberates very toxic gas when in contact with acids, but disagreed with classification as a substance causing severe skin burns.
  • 8:2 Fluorotelomer alcohol (FTOH). Data were considered insufficient to conclude on whether 8:2 FTOH should be classified as a substance which may damage the unborn child.

RAC has also adopted two opinions at the request of ECHA’s Executive Director, concluding the following:

  • A risk from mouthing toys and childcare articles containing diisononylphthalate and diisodecylphthalate cannot be excluded if existing restrictions on these articles are lifted.
  • No change is warranted to the classification of gallium arsenide as a substance which may damage fertility.

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.



…ECHA updates its Community rolling action plan (CoRAP)

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.



…Other items of interest

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).



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.




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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