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RAC concludes on nine scientific opinions for CLH

ECHA/NA/13/43

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

Helsinki, 10 December 2013 - At its last meeting from 2 to 5  December 2013, the RAC adopted the following opinions for harmonised classification and labelling (CLH).

Sulfoxaflor

Sulfoxaflor is a new insecticide, acting as an agonist to insect nicotinic acetylcholine receptors.

The classification and labelling of sulfoxaflor has so far not been harmonised at EU level.

RAC agreed to the proposal by Ireland to classify sulfoxaflor as harmful if swallowed (Acute Tox. 4) and as very toxic to aquatic life with long lasting effects (Aquatic Acute 1 and Aquatic Chronic 1, M=1 in both cases). Based on mechanistic data, the Committee agreed with the dossier submitter not to classify this substance for carcinogenicity or reproductive toxicity.

Phenol, dodecyl-, branched (TPP)

Phenol, dodecyl-, branched (TPP) is a complex mixture of branched alkyl-substituted phenols. It is widely used in the chemicals industry for the synthesis of polymers.

The classification and labelling of the substance has so far not been harmonised at EU level.

Two dossier submitters, the chemical companies SI Group and Chevron, separately proposed the harmonised classification and labelling of the substance. While SI Group proposed to classify the substance as suspected of damaging fertility (Repr. 2, H361f), Chevron proposed to classify it as Repr. 1B, H360F, which is a more severe classification.

RAC agreed with the latter dossier submitter and concluded on classification as a substance which may damage fertility (Repr. 1B, H360F). Information on other hazard classes can be found in the link below.

Lead (metallic)

Lead is a heavy metal with a large variety of uses, both for industrial purposes and in consumer products.

The classification and labelling of lead has so far not been harmonised at EU level.

RAC agreed to the proposal by Sweden to classify lead as a substance which may damage fertility and the unborn child (Repr. 1A; H360FD) and to set a specific concentration limit of 0.03% for developmental effects. In addition, RAC agreed that classification for lactation effects (Lact.,H362) was warranted.

The harmonised classification and labelling will cover all forms of lead.

Tributyltin compounds

Tributyltin compounds are used as intermediates in the production of other organotin materials.

Tributyltin compounds are currently classified as toxic if swallowed and harmful in contact with skin, as causing damage to organs through prolonged or repeated exposure, as an eye and skin irritant and as very toxic to aquatic life with long lasting effects (Aquatic Acute 1 and Aquatic Chronic 1) in Annex VI to the CLP Regulation.

RAC agreed to the proposal by Germany to classify tributyltin compounds as substances which may damage fertility or the unborn child (Repr. 1B, H360FD).

Trisulfuron methyl, bifenazate, fenpyroximate and lenacil are all plant protection products, respectively, a herbicide on sugar and fodder beets, an acaricide used in crops and ornamentals, another acaricide on grapes, apples, pears and beans and finally a general agricultural herbicide. The classification and labelling of these substances has so far not been harmonised at EU level. The Committee recommended classifying these substances as summarised below:

Trisulfuron methyl: RAC agreed to the proposal by France to classify triflusulfuron methyl as a substance which is suspected of causing cancer (Carc. 2, H351) and which is very toxic to aquatic life with long lasting effects (Aquatic Acute 1 and Aquatic Chronic 1) with an M-factor of 100 for aquatic acute toxicity and an M-factor of 10 for aquatic chronic toxicity.

Bifenazate: RAC agreed to the proposal by the Netherlands to classify the substance as a skin sensitiser (Skin Sens. 1) without specifying a sub-category, as a substance which may cause damage to organs through prolonged or repeated exposure (STOT RE 2) and as very toxic to aquatic life with long lasting effects (Aquatic Acute 1 and Aquatic Chronic 1, M=1 in both cases).

Fenpyroximate: RAC agreed to the proposal by Germany to classify the substance as toxic if swallowed (Acute Tox. 3), as fatal if inhaled (Acute Tox. 2) and as a skin sensitiser (Skin Sens. 1B). RAC also agreed to classify fenpyroximate as very toxic to aquatic life with long lasting effects (Aquatic Acute 1 and Aquatic Chronic 1), with an M-factor of 100 for aquatic acute toxicity and an M-factor of 1 000 for aquatic chronic toxicity.

Lenacil: RAC agreed to the proposal by Belgium to classify lenacil as very toxic to aquatic life with long lasting effects (Aquatic Acute 1 and Aquatic Chronic 1, M=10 in both cases).

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