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RAC delivers sixteen CLH opinions

ECHA/NA/14/12

Among the new CLH opinions there are: eight anticoagulant rodenticides, bisphenol A  and  biocidal products used in pharmaceutics, agriculture and households including boric acid and disodiumoctaborate tetrahydrate.

Helsinki, 21 March 2014 – At its 28th meeting from 11 to 14 March, the Committee for Risk Assessment (RAC) adopted the following opinions for harmonised classification and labelling (CLH):

 

Anticoagulant rodenticides

Anticoagulants are biocidal active substances that act by preventing blood clotting through an antivitamin K mechanism. They are mainly used for pest control of rats, mice and other rodents in domestic, agricultural, commercial and industrial sites. They are used as multiple-dose (warfarin and coumatetralyl) or single-dose (difenacoum, difethialone, brodifacoum, flocoumafen, chlorophacinone and bromadiolone) rodenticides. Warfarin is also a human pharmaceutical used to prevent thrombosis.

The eight CLH dossiers were submitted by eight Member States. Historically, these dossiers were originally evaluated but not agreed by the Technical Committee for Classification and Labelling.

 

Warfarin (ISO); 4-hydroxy-3-(3-oxo-1-phenylbutyl)-2H-chromen-2-one

Warfarin already has a harmonised classification in Annex VI to the CLP Regulation as a substance known to be a known human reproductive toxicant, as causing damage to organs after prolonged or repeated exposure and as harmful to aquatic life with long-lasting effects (Aquatic Chronic 3).

RAC agreed to the proposal by Ireland to classify the substance as fatal for all routes of exposure (Acute Tox. 1; H300, H310, H330). RAC also specified blood as the target organ for specific target organ toxicity after prolonged or repeated exposure. In addition, specific concentration limits were set for reproductive toxicity and for specific target organ toxicity after prolonged or repeated exposure, namely 0.003% for Repr. 1A, 0.5% for STOT RE 1 and 0.05% for STOT RE 2.

RAC agreed to the proposal by Ireland to upgrade the aquatic chronic classification, and as such, to classify the substance as toxic to aquatic life with long-lasting effects (Aquatic Chronic 2; H411).

 

Brodifacoum (ISO); 4-hydroxy-3-(3-(4'-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin

Brodifacoum already has a harmonised classification in Annex VI to the CLP Regulation as fatal if swallowed and if in contact with skin (minimum classification for the oral route), as causing damage to organs after prolonged or repeated exposure and as very toxic to aquatic life with long-lasting effects (Aquatic Acute 1 and Aquatic Chronic 1).

RAC agreed to the proposal by Italy to classify the substance as fatal for all routes of exposure (Acute Tox. 1; H300, H310, H330) and as causing damage to organs after prolonged or repeated exposure (STOT RE 1) for all routes with blood as the target organ. RAC disagreed with the proposal to classify the substance as Repr. 1B presumed of damaging fertility (H360D) but proposed classification as Repr. 1A known of damaging fertility (H360D).

RAC also did not agree to the proposal by Italy to classify the substance as a skin sensitiser. Beyond agreeing on classifications, RAC set specific concentration limits for reproductive toxicity and for specific target organ toxicity after prolonged or repeated exposure, namely 0.003% for Repr. 1A, 0.02% for STOT RE 1 and 0.002% for STOT RE 2.

RAC agreed to the proposal by Italy to add an M-factor of 10 to both the acute and the chronic aquatic classification.

 

Coumatetralyl (ISO); 4-hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl)coumarin

Coumatetralyl already has a harmonised classification in Annex VI to the CLP Regulation as fatal if swallowed and in contact with skin (minimum classification for the oral route), as causing damage to organs after prolonged or repeated exposure and as harmful to aquatic life with long-lasting effects (Aquatic Chronic 3).

RAC agreed to the proposal by Denmark to classify the substance as fatal if swallowed (Acute Tox. 2; H300) and as causing damage to organs after prolonged or repeated exposure (STOT RE 1) for all routes with blood as the target organ. RAC also agreed to classify coumatetralyl as fatal if inhaled (Acute Tox 2; H330) and to downgrade the classification for acute dermal toxicity to toxic in contact with skin (Acute Tox. 3; H311). RAC disagreed with the proposal to classify the substance as Repr. 1A known of damaging fertility (H360D) but proposed classification as Repr. 1B presumed of damaging fertility (H360D). In addition, specific concentration limits were set for reproductive toxicity and for specific target organ toxicity after prolonged or repeated exposure, namely 0.003% for Repr. 1B, 1.0% for STOT RE 1 and 0.1% for STOT RE 2.

Finally, RAC agreed to the proposal by Denmark to upgrade the aquatic chronic classification, and as such, to classify the substance as very toxic to aquatic life with long-lasting effects (Aquatic Chronic 1; H410) with an M-factor of 10.

 

Difenacoum (ISO); 3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin

Difenacoum already has a harmonised classification in Annex VI to the CLP Regulation as fatal if swallowed (minimum classification), as causing damage to organs after prolonged or repeated exposure and as very toxic to aquatic life with long-lasting effects (Aquatic Acute 1 and Aquatic Chronic 1).

RAC agreed to the proposal by Finland to classify the substance as fatal for all routes of exposure (Acute Tox. 1; H300, H310, H330) and as causing damage to organs after prolonged or repeated exposure (STOT RE 1) for all routes with blood as the target organ. RAC disagreed with the proposal to classify the substance as Repr. 1A known of damaging fertility (H360D) but proposed classification as Repr. 1B presumed of damaging fertility (H360D). In addition, specific concentration limits were set for reproductive toxicity and for specific target organ toxicity after prolonged or repeated exposure, namely 0.003% for Repr. 1B, 0.02% for STOT RE 1 and 0.002% for STOT RE 2.

RAC agreed to the proposal by Finland to add an M-factor of 10 to both the acute and the chronic aquatic classification.

 

Difethialone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one

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

RAC agreed to the proposal by Norway to classify the substance as fatal for all routes of exposure (Acute Tox. 1; H300, H310, H330) and as causing damage to organs after prolonged or repeated exposure (STOT RE 1) for all routes with blood as the target organ. RAC disagreed with the proposal to classify the substance as Repr. 1A known of damaging fertility (H360D) but proposed classification as Repr. 1B presumed of damaging fertility (H360D). In addition, specific concentration limits were set for reproductive toxicity and for specific target organ toxicity after prolonged or repeated exposure, namely 0.003% for Repr. 1B, 0.02% for STOT RE 1 and 0.002% for STOT RE 2.

RAC agreed to the proposal by Norway to add an M-factor of 100 to both the acute and the chronic aquatic classification.

 

Flocoumafen (ISO); Reaction mass of cis-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin and trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin

Flocoumafen already has a harmonised classification in Annex VI to the CLP Regulation as fatal if swallowed, if inhaled and in contact with skin (minimum classifications for the oral and inhalation route), as causing damage to organs after prolonged or repeated exposure for all routes with blood as the target organ and as very toxic to aquatic life with long-lasting effects (Aquatic Acute 1 and Aquatic Chronic 1).

RAC agreed to the proposal by the Netherlands to classify the substance as fatal for all routes of exposure (Acute Tox. 1; H300, H310, H330) and as causing damage to organs after prolonged or repeated exposure (STOT RE 1) for all routes with blood as the target organ. RAC disagreed with the proposal to classify the substance as Repr. 2 suspected of damaging fertility (H361d) but proposed classification as Repr. 1B presumed of damaging fertility (H360D). In addition, specific concentration limits were set for reproductive toxicity and for specific target organ toxicity after prolonged or repeated exposure, namely 0.003% for Repr. 1B, 0.05% for STOT RE 1 and 0.005% for STOT RE 2.

RAC agreed to the proposal by the Netherlands to add an M-factor of 10 to both the acute and the chronic aquatic classification.

 

Chlorophacinone (ISO); 2-[(4-chlorophenyl)(phenyl)acetyl]-1H-indene-1,3(2H)-dione

Chlorophacinone already has a harmonised classification in Annex VI to the CLP Regulation as fatal if swallowed, in contact with skin and toxic if inhaled (minimum classifications for the oral and the inhalation route) as causing damage to organs after prolonged or repeated exposure for all routes with blood as the target organ and as very toxic to aquatic life with long-lasting effects (Aquatic Acute 1 and Aquatic Chronic 1).

RAC agreed to the proposal by Spain to classify the substance as fatal for inhalation and dermal routes of exposure (Acute Tox. 1; H330, H310) but disagreed with the proposal to classify the substance as Acute Tox. 2 (H300) for the oral route and proposed classification as Acute Tox. 1 (H300). RAC also agreed to the proposal by Spain to classify the substance as causing damage to organs after prolonged or repeated exposure (STOT RE 1) for all routes with blood as the target organ. RAC disagreed with the proposal to classify the substance as Repr. 1A known of damaging fertility (H360D) but proposed classification as Repr. 1B presumed of damaging fertility (H360D). In addition, specific concentration limits were set for reproductive toxicity and for specific target organ toxicity after prolonged or repeated exposure, namely 0.003% for Repr. 1B, 0.1% for STOT RE 1 and 0.01% for STOT RE 2.

RAC agreed to the proposal by Spain to add an M-factor of 1 to both the acute and the chronic aquatic classification.

 

Bromadiolone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-chromen-2-one

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

RAC agreed to the proposal by Sweden to classify the substance as fatal if swallowed, in contact with skin and if inhaled (Acute Tox. 1; H300, H310, H330) and as causing damage to organs after prolonged or repeated exposure (STOT RE 1; H372 – blood) for all routes with  blood as the target organ. RAC disagreed with the proposal to classify the substance as Repr. 1A known of damaging fertility (H360D) but proposed classification as Repr. 1B presumed of damaging fertility (H360D). In addition, specific concentration limits were set for toxicity to reproduction and for specific target organ toxicity after prolonged or repeated exposure (STOT RE 1), namely 0.003% for Repr. 1B, 0.005% for STOT RE 1 and 0.0005% for STOT RE 2.

RAC also agreed to the proposal by Sweden to classify bromadiolone as very toxic to aquatic life with long-lasting effects (Aquatic Acute 1 and Aquatic Chronic 1, M=1 in both cases).

 

Bisphenol A

Bisphenol A is a monomer mainly used in the production of polycarbonate plastics and epoxy resins. Bisphenol A already has a harmonised classification in Annex VI to the CLP Regulation as a substance suspected of damaging fertility, as causing respiratory irritation, eye damage and allergic skin reactions.

RAC agreed to the proposal by France to assign a higher, more severe category for reproductive toxicity, namely to classify Bisphenol A as a substance which is presumed of damaging fertility (Repr. 1B; H360F).

 

Boric acid

Boric acid is used in industrial, professional and consumer products. It is approved as an active substance in biocidal products. It currently has a harmonised classification in Annex VI to the CLP Regulation as a substance which may damage fertility and the unborn child, with a specific concentration limit of 5.5% (w/w).

RAC concluded that the harmonised classification in Annex VI based on effects on fertility and development should be retained. RAC did not agree with the proposal by Poland to downgrade the classification to a lower category and relate it to developmental effects only (Repr. 2 - H361d). The current specific concentration limit for boric acid was not modified by RAC as it was not proposed by the dossier submitter.

 

Disodiumoctaborate tetrahydrate

Disodiumoctaborate tetrahydrate is approved as an active substance to be used in biocidal products. The substance does not currently have a harmonised entry in Annex VI to the CLP Regulation.

RAC agreed with the dossier submitter (the Netherlands) to assign a harmonised classification as a substance which may damage fertility and the unborn child (Repr. 1B; H360FD). As the substance is a medium potency reproductive toxicant, the generic concentration limit of 0.3% (w/w) is applicable. The Committee also concluded that classification into other hazard classes was not warranted.

 

Disodiumoctaborate anhydrate

Disodiumoctaborate anhydrate is a chemical intermediate used for the production of disodiumoctaborate tetrahydrate. The substance does not currently have a harmonised entry in Annex VI to the CLP Regulation.

RAC agreed with the dossier submitter (the Netherlands) to assign a harmonised classification as a substance which may damage fertility and the unborn child (Repr. 1B; H360FD). As the substance is a medium potency reproductive toxicant, the generic concentration limit of 0.3% (w/w) is applicable.

 

Lithium sodium 3-amino-10-{4- (10-amino-6,13-dichloro-4,11- disulfonatobenzo[5,6][1,4]oxazino[2,3- b]phenoxazine-3-ylamino)-6- [methyl(2-sulfonato- ethyl)amino]-1,3,5-triazin-2- ylamino}-6,13-dichlorobenzo[5,6][1,4]oxazino[2,3- b]phenoxazine-4,11-disulfonate (Direct Blue FC 57087)

Direct blue FC 57087 is used as a textile dye for cellulosic fabrics. The substance currently has an Annex VI entry as harmful if swallowed, in contact with skin and if inhaled (minimum classifications) and as a substance which may cause damage to organs. The classifications were due to a methanol content greater than 3%.

RAC agreed with the dossier submitter (France) to remove the current harmonised classifications and thus the whole entry from Annex VI as the content of methanol in Direct Blue FC 57087 has been minimised to a mean value below 0.5%.

 

Hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde (HICC)

Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) is a synthetic fragrance known under the trade name Lyral® in Europe and the United States. It is commonly used in the manufacture of various consumer products, such as household cleaners, air fresheners, detergents and personal care products.

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

RAC agreed to the proposal by Sweden to classify HICC as a skin sensitiser (Skin Sens. 1A), but did not see it warranted to assign the proposed specific concentration limit of 0.01% in view of the data provided.

 

Polyhexamethylene biguanide hydrochloride (PHMB)

PHMB is used as a disinfectant. Based on an opinion adopted by RAC in 2011, an entry was introduced into Annex VI to the CLP Regulation through Commission Regulation (EU) No 944/2013 (fifth ATP to the CLP Regulation), harmonising a number of classifications of the substance.

After the adoption of the RAC opinion in 2011, France submitted a new CLH dossier proposing additional harmonised classification as fatal if inhaled (Acute Tox. 2; H330) for PHMB, because new data had been made available. RAC agreed on the proposed classification.

 

Chlorobenzene

Chlorobenzene is used as an intermediate and solvent in various industrial processes as well as in analytical laboratories.

It currently has a harmonised classification in Annex VI to the CLP Regulation as flammable liquid and vapour, as harmful if inhaled (minimum classification) and as a substance which is toxic to aquatic life with long-lasting effects (Aquatic Chronic 2).

RAC agreed to the proposal of the dossier submitter (Poland) to classify chlorobenzene as causing skin irritation (Skin. Irrit. 2; H315) and as harmful if inhaled (Acute Tox.4; H332), thus transforming the minimum classification into a regular harmonised classification based on data.

Further information

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

Opinions

RAC proposes to strengthen the classification of bisphenol A

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.

Further information about RAC