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RAC concludes on scientific opinions for CLH

ECHA/NA/14/27

At its 29th meeting from 2 to 6 June, the Committee for Risk Assessment (RAC) adopted seven opinions for harmonised classification and labelling (CLH).

Helsinki, 11 June 2014 – The RAC opinions are as follows:

5-butyl-2-ethylamino-6-methylpyrimidin-4-yl dimethylsulphamate (Bupirimate (ISO))

Bupirimate (ISO) is used as a fungicide in agriculture and horticulture.

The substance currently has no harmonised classification in Annex VI to CLP.

RAC agreed to the proposal by the Netherlands to classify the substance as a suspected human carcinogen (Carc.2, H351), skin sensitiser (Skin Sens. 1B, H317), and very toxic to aquatic life with long lasting effects (Aquatic Chronic 1, H410) with an M-factor of 1.

1-methyl-2-pyrrolidone (NMP)

NMP has a range of industrial and professional applications, including coatings, cleaning agents, functional fluids and agrochemicals.

In relation to reproductive toxicity, the substance currently has a harmonised classification in Annex VI to the CLP Regulation 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 specific concentration limit (SCL) relating to the classification as presumed reproductive toxicant (Repr. 1B; H360) so that the generic concentration limit (GCL) of 0.3% applies.

Propylene oxide

Propylene oxide is a high-volume industrial intermediate. It is used for the production of polyether polyols, which are needed for the manufacture of polyurethane plastics among other uses.

The substance currently has a harmonised classification in Annex VI to the CLP Regulation as an extremely flammable liquid and vapour, presumed human carcinogen, harmful if swallowed, if inhaled and in contact with skin (minimum classifications), irritant to skin and eyes, causing respiratory irritation and as a substance which may cause genetic defects.

RAC agreed with the proposal by the Netherlands to confirm the classification as harmful if swallowed (Acute Tox. 4; H302) and to upgrade the classification to toxic in contact with skin and if inhaled (Acute Tox. 3; H311 and Acute Tox. 3; H331). In addition, RAC agreed to the proposal to remove the classification as skin irritant from Annex VI.

1,5-pentanedial (Glutaraldehyde)

Glutaraldehyde is a biocidal active substance used for disinfection purposes and in product and process preservation. It is also used as a fixative in laboratory tissue preparations.

The substance already has a harmonised classification in Annex VI to the CLP Regulation as toxic if swallowed and if inhaled (minimum classifications), as causing severe skin burns and eye damage, as a respiratory and skin sensitiser and as very toxic to aquatic life (Aquatic Acute 1; H400).

RAC agreed with the proposal by Finland to confirm the classification as toxic if swallowed (Acute Tox. 3; H301) but although the Committee agreed to classify the substance as fatal if inhaled, RAC proposed a lower category (Acute Tox. 2; H330) than that proposed by the dossier submitter (Acute Tox. 1; H330). In addition, RAC agreed to specify subcategory 1A for skin sensitisation, to add the classification for specific target organ toxicity after single exposure (STOT SE 3; H335), to add the classification as toxic to aquatic life with long lasting effects (Aquatic Chronic 2; H411) as well as the supplemental labelling as corrosive to the respiratory tract (EUH071). RAC also agreed to delete the specific concentration limits for corrosion and skin sensitisation. RAC did not agree to assign an M-factor of 10 to the acute aquatic classification, but proposed an M-factor of 1 instead.

Reaction mass of bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate and 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane (Tinuvin 123)

Tinuvin 123 has widespread use as a heat and light stabiliser, an oxidant and a radical scavenger in polymer applications.

Tinuvin 123 already has a harmonised classification in Annex VI to CLP as a substance which may cause long lasting harmful effects to aquatic life (Aquatic Chronic 4; H413).

RAC agreed with the proposal by Germany to remove the current classification as Aquatic Chronic 4 (H413) and thus the whole entry from Annex VI.

2-[7-fluoro-3-oxo-4-(prop-2-yn-1-yl)-3,4-dihydro-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione (Flumioxazin (ISO))

Flumioxazin is a herbicide used for the pre-emergence control of many annual broad-leaved weeds and some annual grasses.

Flumioxazin currently has a harmonised classification in Annex VI to the CLP Regulation as a substance which may damage the unborn child (presumed human reproductive toxicant) and as very toxic to aquatic life with long lasting effects (Aquatic Acute 1 and Chronic 1; H410), with an M-factor of 1 000 for the acute aquatic classification.

RAC agreed with the proposal of the Czech Republic to also assign an M-factor of 1 000 to the chronic aquatic classification. However, RAC did not agree to remove the reproductive toxicity classification from Annex VI, but concluded to retain the current classification for developmental effects, namely to classify as a substance which may damage the unborn child (Repr. 1B; H360D).

1,2-dichloropropane (PDC)

PDC is used as an intermediate in the production of perchloroethylene and other chlorinated chemicals.

PDC already has a harmonised classification in Annex VI to the CLP Regulation as a highly flammable liquid and vapour and as harmful if swallowed and if inhaled (minimum classifications).

RAC disagreed with the proposal by Dow Deutschland to classify the substance as a suspected human carcinogen (Carc. 2; H351), and proposed a more severe classification, namely as a presumed human carcinogen (Carc. 1B; H350).

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