…ECHA’s multi-annual work programme for 2014-2018

ECHA’s five-year strategic plan, now open for public consultation, is structured around the Agency’s four long-term goals:

  • improving the quality of information on chemicals
  • making best use of that information for risk management and control
  • addressing scientific challenges
  • efficient and effective working on old, as well as new, tasks coming from the Biocidal Products and Prior Informed Consent Regulations

Comments are welcomed by 15 July 2013.
European Chemicals Agency. Multi-annual work programme 2014-2018. Draft for public consultation (MB/06/2013).




…Six new substances of very high concern (SVHCs) added to Candidate List for authorisation

An ECHA Press Release (ECHA/PR/13/26) announced the addition of the following six SVHCs to ECHA’s Candidate List for authorisation, bringing the total number of listed substances up to 144:

  • ammonium pentadecafluorooctanoate (APFO)
  • cadmium
  • cadmium oxide
  • dipentyl phthalate (DPP)
  • 4-nonylphenol, branched and linear, ethoxylated
  • pentadecafluorooctanoic acid (PFOA)

These new additions are classified as carcinogenic, mutagenic and/or toxic to reproduction (CMR), as persistent, bioaccumulative and toxic (PBT), and/or of an “equivalent level of concern”. 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’s Committee for Risk Assessment (RAC) adopts fourteen opinions

As announced in a June 2013 news alert (ECHA/NA/13/22), RAC has considered proposals (from the Austrian, Dutch, French, German and Swedish authorities) for the harmonised classification and labelling of thirteen chemicals. The following classifications were recommended (some in addition to existing harmonised classifications):

  • branched and linear 1,2-benzenedicarboxylic acid, dihexyl ester [dihexyl phthalate] as a substance which may damage fertility and the unborn child
  • carvone as a skin sensitiser
  • decanoic acid as a skin and eye irritant, and as harmful to aquatic life with long-lasting effects
  • dimethenamid-P as a skin sensitiser, harmful if swallowed, and very toxic to aquatic life with long-lasting effects (with acute and chronic M-factors of 10)
  • etridiazole as a skin sensitiser, with the removal of the existing classifications as toxic if inhaled and harmful if in contact with the skin. Acute and chronic M-factors of 1 were assigned to the existing classification as very toxic to aquatic life with long-lasting effects
  • flonicamid as harmful if swallowed
  • imazalil as toxic if swallowed, harmful if inhaled, seriously damaging to the eye, and a substance suspected of causing cancer. It was also agreed that the acute aquatic classification should be removed, while an M-factor of 10 should be included in the existing chronic classification as very toxic to aquatic life with long lasting effects
  • metosulam as a substance suspected of causing cancer, a substance which may damage organs through prolonged or repeated exposure, and as very toxic to aquatic life with long-lasting effects (with acute and chronic M-factors of 1000 and 100, respectively)
  • nitric acid as fatal if inhaled. Supplemental labelling as corrosive to the respiratory tract was also supported. The severity of the existing classification as an oxidising liquid should be increased
  • nonanoic acid as a skin and eye irritant (replacing existing classification as causing severe skin burns and eye damage) and as harmful to aquatic life with long-lasting effects
  • octanoic acid as causing severe skin burns and eye damage, and as harmful to aquatic life with long-lasting effects
  • tebuconazole as very toxic to aquatic life with long-lasting effects (upgrading its existing aquatic toxicity classification, and with acute and chronic M-factors of 1 and 10, respectively)
  • tembotrione as a skin sensitiser, a substance which may cause damage to organs through prolonged or repeated exposure, a substance suspected of damaging fertility or the unborn child, and as very toxic to aquatic life with long-lasting effects (with acute and chronic M-factors of 100 and 10, respectively)

RAC also adopted an opinion on two phenolic benzotriazoles at the request of ECHA’s Executive Director. It concluded that 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) and 2-(2H-benzotriazol-2-yl)-4,6-di-tert-pentylphenol (UV-328) should be classified for specific target organ toxicity (to the liver, and liver and kidney, respectively) following prolonged or repeated exposure.



…RAC opinion on the reproductive toxicity of gallium arsenide

At the request of ECHA’s Executive Director, RAC has drafted an opinion on the reproductive toxicity of gallium arsenide, evaluating new data made available since its previously adopted (2010) opinion. Based on “clear evidence of testicular toxicity in two or more species”, the new draft assessment supports the originally proposed classification of gallium arsenide as a presumed human reproductive toxicant (category 1B).

European Chemicals Agency (2013). Committee for Risk Assessment (RAC). Opinion on gallium arsenide in relation to toxicity to reproduction. May 29, 2013 revised draft.


…Harmonised classification and labelling proposals for tributyltin compounds and PHMB

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 French and German authorities to standardise the classification and labelling of tributyltin compounds and polyhexamethylene biguanide hydrochloride (PHMB).

European Chemicals Agency. CLH reports.
Proposals for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2.
Tributyltin compounds, with the exception of those specified elsewhere in this Annex. Version number: 2.0. April 2013.


Polyhexamethylene biguanide or poly(hexamethylene) biguanide hydrochloride or PHMB. Version number: 2. May 2013.


…Other items of interest

Harmonised classifications according to the Dangerous Substances Directive (DSD) are now available in ECHA’s classification and labelling (C&L) Inventory.



Industry registers 2923 more chemicals under REACH.



1,4-benzenediamine, N,N’-mixed phenyl and tolyl derivatives proposed for inclusion in ECHA’s community rolling action plan (CoRAP) for immediate evaluation due to possible persistent, bioaccumulative and toxic (PBT) potential.



ECHA’s Committee for Socio-Economic Analysis (SEAC) supports ECHA’s proposal to restrict 1,4‑dichlorobenzene in air fresheners and toilet blocks.



RAC and SEAC agree on the main principle for the length of the review period for applications for authorisation.


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

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