ECHA adopted the proposed CLH for 11 ais

Date:07-01-2013

The ECHA’s Committee for Risk Assessment (RAC) adopted opinions for harmonised classification and labelling (CLH) of 8 agrochemicals and 3 non-crop pesticides.They are: the herbicides, metosulam, dimethenamid-P and tembotrione; the fungicides, etridiazole, imazalil and tebuconazole; the insecticide, flonicamid; the plant growth regulator (PGR), carvone; and the non-crop insecticides/repellents, octanoic acid, nonanoic acid and decanoic acid.

The herbicide metosulam has so far no harmonised classification and labelling at EU level.

RAC agreed with the proposal from France to classify metosulam as a substance which is suspected of causing cancer (Carc. 2) and which may cause damage to organs through prolonged or repeated exposure (STOT RE 2). RAC also agreed with the proposal to classify the substance as very toxic to aquatic life with long lasting effects, assigning an M-factor of 1 000 to acute aquatic and an M-factor of 100 to chronic aquatic effects (Aquatic Acute 1 and Aquatic Chronic 1).

Dimethenamid-P is composed of two enantiomers; the S-enantiomer is used as a herbicide in plant protection products.

The classification and labelling of dimethenamid-P has so far not been harmonised at EU level.RAC agreed to the proposal by Germany to classify the substance as a skin sensitiser (Skin Sens. 1), 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), together with an M-factor of 10 for both acute and chronic aquatic toxicity.


Tembotrione is used as an herbicide against grasses and broad leaved weeds.

The classification and labelling of this substance has so far not been harmonised at EU level.RAC agreed with the proposal from Austria to classify tembotrione as a substance which may cause an allergic skin reaction (Skin Sens. 1) as well as damage to organs through prolonged or repeated exposure (STOT RE 2). In addition, RAC proposed to classify the substance as suspected of damaging fertility or the unborn child (Repr. 2). RAC also agreed to classify the substance as very toxic to aquatic life with long lasting effects (Aquatic Chronic 1 and Aquatic Acute 1). While RAC supported the proposal to assign an M-factor of 10 to chronic hazards, it increased the proposed M-factor for the acute hazard from 10 to 100.

Fungicide etridiazole already has some harmonised classifications.

RAC agreed with the proposal from the Netherlands to classify etridiazole as a substance which may cause an allergic skin reaction but did not consider a further sub-categorisation warranted (Skin Sens. 1). RAC also confirmed the current harmonised classification as harmful if swallowed (Acute Tox. 4) and agreed to remove the classifications as toxic if inhaled and as harmful if in contact with skin from Annex VI as proposed by the Netherlands. RAC did not consider the evidence sufficient to classify the substance for respiratory irritation. The Committee re-confirmed the harmonised classification of etridiazole as a substance which is suspected of causing cancer (Carc. 2). Finally, RAC agreed with the dossier submitter to assign an M-factor of 1 to both the acute and the chronic aquatic (Aquatic Acute 1 and Aquatic Chronic 1) classification in Annex VI.


Imazalil is a fungicide intended for post-harvest use on fruits.

The substance already has some harmonized classifications.RAC agreed to the proposal by Germany to classify the substance as toxic if swallowed (Acute Tox. 3), to delete the acute aquatic classification and to include an M-factor of 10 for the chronic aquatic classification. RAC also agreed with Germany to add a classification as suspected of causing cancer (Carc. 2). Further to the proposal by Germany, RAC confirmed that the substance should be classified as harmful if inhaled (Acute Tox. 4) and as seriously damaging to the eye (Eye Dam. 1).


Tebuconazole is a fungicide for foliar and seed treatment applications on a wide range of different crops.

The substance already has some harmonised classification . RAC agreed to the proposal by the Netherlands to upgrade the aquatic classification, i.e. to classify the substance as very toxic to aquatic life with long lasting effects ( Aquatic Acute 1 and Aquatic Chronic 1) with an acute M-factor of 1 and a chronic M-factor of 10 and to confirm the classification as harmful if swallowed (Acute Tox. 4).


Flonicamid is an insecticide used on e.g. potatoes, wheat and apples.

The classification and labelling of this substance has so far not been harmonised at EU level. RAC agreed with the proposal from France to classify flonicamid as a substance which is harmful if swallowed (Acute Tox. 4). RAC also agreed with the dossier submitter proposal not to classify flonicamid for environmental endpoints.  As the conclusion on the discussion on carcinogenicity properties, the RAC decided to not classify this substance as suspected of causing cancer, finding the supporting data insufficiently strong.


Carvone is found naturally in many essential oils. It is composed of two enantiomers, which are used in agriculture as plant growth regulators and as pesticide active substances. Carvone is also used as a flavouring agent in food and in personal care products.

The classification and labelling of carvone has so far not been harmonised at EU level. RAC agreed to the proposal by the Netherlands to classify the substance as a skin sensitiser (Skin Sens. 1). The Committee agreed not to classify the substance for skin irritation.


Octanoic acid is a linear, unbranched fatty acid, used as an active substance in biocidal and pesticidal products.

The classification and labelling of octanoic acid has so far not been harmonised at EU level.RAC agreed with the proposal by Austria to classify octanoic acid as a substance which cases severe skin burns and eye damage (Skin Corr. 1C), but decided not to assign specific concentration limits as the available data was insufficient to do so.As for environmental hazards, RAC agreed to the proposal by Austria to classify the substance as harmful to aquatic life with long lasting effects (Aquatic Chronic 3).


Nonanoic acid is a linear, unbranched fatty acid, used as an active substance in biocidal and pesticidal products.

Nonanoic acid already has a harmonised classification as a substance which cases severe skin burns and eye damage in Annex VI to the CLP Regulation.RAC agreed to change the classification for irritation/corrosion and classify nonanoic acid for skin and eye irritation. While the agreed classification in relation to skin is the same as proposed by Austria (Skin Irrit. 2), the classification in relation to eyes is less severe (Eye Irrit. 2) than the classification for serious eye damage which had originally been proposed by the dossier submitter (Eye Dam. 1).As for environmental hazards, RAC agreed to the proposal by Austria to classify the substance as harmful to aquatic life with long lasting effects (Aquatic Chronic 3).

Decanoic acid is a linear, unbranched fatty acid, used as an active substance in biocidal and pesticidal products.

The classification and labelling of decanoic acid has so far not been harmonised at EU level. RAC agreed to classify decanoic acid for skin and eye irritation. While the agreed classification in relation to skin is the same as proposed by Austria (Skin Irrit. 2), the classification in relation to eyes is less severe (Eye Irrit. 2) than the classification for serious eye damage which had originally been proposed by the dossier submitter (Eye Dam. 1).As for environmental hazards, RAC agreed to the proposal by Austria to classify the substance as harmful to aquatic life with long lasting effects (Aquatic Chronic 3).