News

RAC concludes on scientific opinions for CLH

ECHA/NA/14/40

The Committee for Risk Assessment (RAC) adopted five opinions for harmonised classification and labelling (CLH).

Helsinki, 17 September 2014 – The RAC opinions, all agreed by consensus, are as follows:

Methanol

Methanol is used in a variety of industrial applications, in waste water treatment, and as a fuel.

Other uses include the production of formaldehyde, acetic acid, chloromethanes, methyl methacrylate, methylamines, dimethyl terephthalate, and as a solvent or antifreeze in paint strippers, aerosol spray paints, wall paints, carburettor cleaners, and car windshield washer fluids.

The substance currently has a harmonised classification in Annex VI to the CLP Regulation as a flammable liquid, as a substance causing specific target organ toxicity after single exposure and as toxic if swallowed, inhaled or in contact with skin.

The dossier submitter, Italy, proposed to classify methanol as a substance which may damage the unborn child (Repr. 1B; H360D). RAC disagreed with the proposal to classify methanol for developmental toxicity, instead concluding that classification for this hazard class is not warranted, based on the available data.

Chloralose (INN)

Chloralose is used as a rodenticide in ready-to-use bait form, at a concentration of ca. 4 % w/w. Chloralose is placed on the market as a mixture of α- and β-isomers. The β-isomer is considered as a non-active component.

The substance currently has a harmonised classification in Annex VI to the CLP Regulation as harmful if swallowed or inhaled.

The dossier submitter, Portugal, proposed to classify chloralose in addition to the existing classification in Annex VI to the CLP Regulation as a substance causing specific target organ toxicity after single exposure, causing drowsiness and dizziness, and as very toxic to aquatic life with long lasting effects, assigning an M-factor of 10 both to the acute and chronic aquatic classifications (Aquatic Acute 1 and Aquatic Chronic 1; H410).

RAC agreed with the proposal of the dossier submitter, but due to lack of data did not provide a recommendation on whether or not to confirm the existing classification as harmful if inhaled. In addition RAC agreed to classify chloralose as toxic if swallowed (Acute Tox. 3, H301).

N,N dimethylacetamide (DMAC)

N,N dimethylacetamide (DMAC), an aprotic solvent is mainly used as a combined solvent and reaction catalyst in the production of agrochemicals, pharmaceuticals and fine chemicals.

The substance currently has a harmonised classification in Annex VI to the CLP Regulation as harmful if inhaled and in contact with skin and as a substance which may damage the unborn child (presumed human reproductive toxicant) with a specific concentration limit (SCL) of 5%.

RAC agreed to the proposal by the Netherlands to remove the SCL relating to the classification as presumed reproductive toxicant (Repr. 1B; H360) so that the generic concentration limit (GCL) of 0.3% applies.

Iodomethane

Iodomethane is used in the EU as an industrial and pharmaceutical methylating agent and as an intermediate in pharmaceutical and pesticide manufacture. It is also imported into the EU and stored for despatching outside of the EU for the same uses.

The substance currently has a harmonised classification in Annex VI to the CLP Regulation as suspected of causing cancer, toxic if swallowed or inhaled, harmful in contact with skin, a substance which may cause respiratory irritation and which causes skin irritation.

The dossier submitter, the United Kingdom, proposed to remove the classification as suspected of causing cancer.

RAC agreed to retain the classification of iodomethane as suspected of causing cancer (Carc. 2; H351).

Heptadecafluorononanoic acid and its sodium and ammonium salts (PFNA)

PFNA is primarily used as a processing aid for fluoropolymer manufacture, most notably for polyvinylidene fluoride. PFNA is also used as a lubricating oil additive, surfactant for fire extinguishers, cleaning agent, textile antifouling finishing agent, polishing surfactant, and in liquid crystal display panels.

The substance has currently no entry in Annex VI to CLP.

RAC agreed to classify PFNA as harmful if swallowed and if inhaled, as causing serious eye damage, as a substance which is suspected of causing cancer (Carc. 2; H351) and harm to breast-fed children (Lact.; H362). RAC also agreed to classify the substance as causing damage to liver through prolonged or repeated exposure, but added thymus and spleen to the list of affected target organs. As to reproductive toxicity, RAC shared the view of the dossier submitter to classify PFNA as a substance which may damage the unborn child (Repr. 1B; H360D). In addition, RAC agreed to classify PFNA as Repr. 2 for fertility effects. Therefore an overall reproductive toxicity classification as Repr. 1B (H360Df) was concluded.

Further information

The opinions will be available at the following link in the near future:

Opinions

Background Information

The role of RAC in EU regulatory processes

The Committee is responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions and proposals for harmonised classification and labelling. RAC also prepares opinions on specific questions relating to risks of chemicals to human health or the environment and on any other aspects concerning the safety of substances at the Executive Director's request. The final decision for proposals for harmonised classification and labelling, for proposals for restrictions as well as on applications for authorisation will be taken by the European Commission through a committee procedure.

Further information about RAC