Harmonised classification and labelling proposals for fluopyram and glutaraldehyde

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 Finnish and German authorities to standardise the classification and labelling of fluopyram and glutaraldehyde

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

N-{2-[3-chloro-5-(trifluoromethyl)pyridin-2-yl]ethyl}-2-(trifluoromethyl)benzamide (ISO name Fluopyram). Version 2.0. September 2013.


Glutaraldehyde. Version 2.0. 12 September 2013.



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

As announced in a September 2013 news alert (ECHA/NA/13/31), RAC has considered proposals (from industry and the Austrian, Dutch and German authorities) to harmonise the classification and labelling of six chemicals. The following classifications were recommended (some in addition to existing harmonised classifications):

  • Dodemorph as a substance suspected of damaging the unborn child, as a skin sensitiser, as causing severe skin burns and eye damage, as potentially damaging to the liver following prolonged or repeated exposure, and as very toxic to aquatic life with long-lasting effects. An M-factor of 1 was also assigned for acute and chronic effects to the aquatic environment. The substance should also be labelled as corrosive to the respiratory tract.
  • Dodemorph acetate, newly classified as for dodemorph.
  • 1,2-Epoxybutane, to be no longer classified as harmful to aquatic life with long-lasting effects.
  • Imidazole as a substance suspected of damaging the unborn child, as harmful if swallowed, and as causing severe skin burns and eye damage.
  • Pyridaben as toxic if inhaled and if swallowed. An M-factor of 1000 was also assigned for acute and chronic effects to the aquatic environment.
  • Spirotetramat as an eye irritant, a respiratory irritant, a high-potency skin sensitiser, a substance suspected of damaging fertility and the unborn child, and as very toxic to aquatic life with long-lasting effects and an M-factor of 1 for acute and chronic effects.

European Chemicals Agency. ECHA/NA/13/31.



Proposed restriction of N-methylpyrrolidone, nonylphenol and nonylphenol ethoxylates

A report submitted to ECHA by the Dutch authorities reviews the human health effects of
N-methylpyrrolidone (NMP), and proposes that this compound should only be manufactured if occupational exposure does not exceed an 8-hour time-weighted average limit of 5 mg/m3, while peak exposures should not exceed 10 mg/m3. In addition, NMP should only be manufactured and used if occupational dermal exposure is avoided through the use of protective clothing and gloves. The critical toxicological endpoints were repeated dose and developmental toxicity.

Another restriction report, submitted by the Swedish authorities, concerns nonylphenol (NP) and nonylphenol ethoxylates (NPEs). It proposes that textile clothing, fabric accessories, and interior textile articles that can be washed in water should not be placed on the market if they contain NP or NPEs (alone or in combination) at concentrations of at least 100 mg/kg textile. Concern for NP and NPEs in the aquatic compartment is based on their combined toxicity to aquatic organisms and potential endocrine-disrupting effects.

ECHA is accepting comments on both reports until 18 March 2014.

European Chemicals Agency. Annex XV restriction reports.

N-methylpyrrolidone (NMP). Proposal for a restriction. Version number 2. 9 August 2013.


Nonylphenol and nonylphenolethoxylates in textiles. Proposal for a restriction. Version number 3. 29 July 2013.



Other items of interest

Updated Navigator tool to help industry identify obligations under REACH.



Draft revised guidance for downstream users sent to Competent Authorities for REACH and CLP (CARACAL).



Draft revised guidance on the compilation of safety data sheets sent to CARACAL.



Draft updated guidance for the preparation of Annex XV dossiers sent to ECHA’s Member State Committee (MSC).



Testing proposals involving vertebrate animals: request for information from third parties on five compounds (deadlines 4 November 2013, 18 November 2013).



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

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