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RAC adopts seventeen scientific opinions

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CORRIGENDA 14 December 2012

The Committee for Risk Assessment (RAC) has adopted fifteen opinions for harmonised classification and labelling (CLH), one opinion at the Executive Director's request concerning the safety of a plant protection product (Article 77(3)) and an opinion on the restriction proposal of Chromium VI in leather compounds.  

Helsinki, 07 December 2012 - The fifteen CLH opinions are on the following substances:

Formaldehyde

Formaldehyde is a building-block for many chemical compounds, especially polymers.

It already had a harmonised classification in Annex VI to the CLP Regulation as: acutely toxic if swallowed, inhaled and in contact with the skin; as skin corrosive; as a skin sensitiser; and as suspected of causing cancer. RAC agreed to the proposal from France to classify formaldehyde as also suspected of causing genetic effects (Muta. 2). RAC however disagreed with the proposal to classify it as known to have carcinogenic potential to humans (Carc. 1A), proposing a lower category but still protective category, namely as a substance which is presumed to have carcinogenic potential for humans (Carc. 1B).

3-Iodo-2-propynylbutylcarbamate (IPBC)

IPBC is used as a preservative in cans and films, for wood fibre, leather, rubber, polymerised materials and in masonry and metalworking fluids.

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

RAC agreed with the proposal from Denmark to classify IPBC as: acutely toxic through the oral and inhalation route; sensitising to skin; as well as seriously damaging to the eye. RAC also agreed that the substance should be classified for acute and chronic toxicity for the aquatic environment. RAC did not support classifying IPBC as causing respiratory irritation after single exposure but proposed to classify IPBC as causing damage to the larynx through prolonged or repeated exposure.  

Styrene

Styrene is used as a monomer in the production of a wide range of polymers including rubber.

Styrene already has a harmonised classification as flammable in liquid and vapour form; harmful if inhaled; and causing skin irritation and serious eye irritation.

RAC agreed to classify styrene as causing damage to the hearing organs through prolonged or repeated exposure via inhalation and as a substance suspected of damaging the unborn child (Repr. 2). For both effects the RAC opinion deviated from the proposal from Denmark who had orginally proposed to classify styrene as causing damage to the nervous system through prolonged or repeated exposure via inhalation and as a substance which may damage the unborn child.

Methyl-2,5-dichlorobenzoate

Methyl-2,5-dichlorobenzoate is used as a plant growth regulator and as a fungicide.

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

RAC agreed with the proposal from Germany to classify this substance as: harmful if swallowed; and as toxic to aquatic life with long lasting effects. In addition to that, RAC agreed to add a classification for narcotic effects after single exposure.

Tetrahydrofurfuryl alcohol (THFA)

THFA is widely used as an intermediate for industrial raw materials, as a solvent and plasticiser.

THFA already has a harmonised classification as an eye irritant causing serious eye irritation.

RAC agreed with the proposal from France to classify THFA irritating to the eyes and also as a substance which may damage fertility and the unborn child (Repr. 1B) .

Cycloxydim

Cycloxydim is used as a herbicide against perennial grasses.

The classification and labelling of this substance has so far not been harmonised within the EU.

RAC agreed with the proposal from Austria to classify Cycloxydim as flammable according to the Dangerous Substances Directive. Furthermore RAC agreed that Cycloxydim should be classified as a reproductive toxicant which is suspected of damaging the unborn child (Repr. 2) rather than the more severe classification proposed by Austria.

(1-methylethylidene)di-4,1-phenylene tetraphenyl diphosphate (Fyrolflex)

Fyrolflex is used as a flame retardant additive in thermoplastic resins for the production of components used in electrical and electronic goods.

Fyrolflex has a harmonised classification as hazardous to the aquatic environment - may cause long lasting harmful effects to aquatic life.

RAC agreed with the proposal from industry submitted by the United Kingdom to remove this current harmonised classification as hazardous to the aquatic environment. Fyrolflex would therefore no longer have a harmonised classification at EU level.

Tetrakis (2,6-dimethylphenyl)-m-phenylene biphosphate (PX-200)

PX-200 is used as a fire-preventing agent in electronic apparatus.

PX-200 already has a harmonised classification as hazardous to the aquatic environment - may cause long lasting harmful effects to aquatic life, and as skin sensitiser.

RAC agreed to the proposal from the United Kingdom to remove the current harmonised classification as hazardous to the aquatic environment.

Fenpyrazamine

Fenpyrazamine is used as a fungicide.

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 Fenpyrazamine as toxic to aquatic life with long lasting effects.

Etofenprox

Etofenprox is used as an active substance in biocidal products and as an insecticide.

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 the substance for effects on or via lactation and as very toxic to aquatic life with long lasting effects. RAC also agreed to assign the aquatic classifications already at low concentrations of the substance (M (acute) = 100 and M (chronic) = 1000). RAC did not agree to the proposal from Austria to classify the substance as toxic to the liver and kidneys after repeated exposure.

Muscalure (cis-Tricos-9-ene)

Muscalure is used as an active substance (insect attractant) in biocidal products.

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 this substance for skin sensitisation.

Dimethyltin dichloride (DMTC)

DMTC is used as a heat stabilizer in PVC plastics.

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 DMTC as: a reproductive toxicant which is suspected of damaging the unborn child (Repr. 2); as harmful if swallowed and in contact with skin; as fatal if inhaled; as corrosive to skin and eyes; and as causing damage to the nervous and immune systems after repeated exposure.  Additionally, RAC concluded that DMTC should be labelled as corrosive to the respiratory tract.

Dimethyltin bis(2-ethylhexylmercaptoacetate) (DMT EHMA)

DMT EHMA is used as a heat stabiliser in PVC plastics.

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 DMT EHMA as a reproductive toxicant which is suspected of damaging the unborn child (Repr. 2); as harmful if swallowed; as skin sensitising; and as causing damage to the nervous and immune systems after repeated exposure.

Benzoic acid

Benzoic acid is used as an active substance in biocidal products and in particular as bactericide, viricide and fungicide for the disinfection of materials.

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

RAC agreed with the proposal from Germany to classify benzoic acid as skin irritant and as seriously damaging the eye. RAC also agreed to classify benzoic acid as causing damage to lungs after repeated exposure via inhalation. However, RAC agreed on a higher category for the latter effect than Germany who originally proposed to classify benzoic acid as a substance which may cause damage to lungs through prolonged or repeated exposure.

Ethephon

Ethephon is an active substance in plant protection products and is used as a plant growth regulator.

Ethephon already has a harmonised classification as: acutely toxic through inhalation and through the dermal route; as causing severe skin burns and eye damage; and as potentially harmful to aquatic life with long lasting effects.

RAC agreed with the proposal from the Netherlands to classify Ethephon as acutely toxic through the oral route.  In addition, RAC concluded that Ethephon should be classified as harmful to aquatic life with long lasting effects and labelled as corrosive to the respiratory tract.

At the request of ECHA's Executive Director - Epoxiconazole

Epoxiconazole is used as a fungicide in agriculture.

It already had a harmonised classification in Annex VI to the CLP Regulation as: a substance suspected of causing cancer (Carc. 2); suspected of damaging fertility and the unborn child (Repr.2); and as toxic to aquatic life with long lasting effects. The dossier submitter Sweden proposed a more severe classification for reproductive toxicity (Repr. 1B) and RAC agreed, adopting this opinion originally in March 2010.

At the request of the ECHA Executive Director, RAC assessed the additional information submitted in two stages by industry and at its 23rd.meeting confirmed its previous opinions from March 2010 and March 2011 proposing to classify epoxiconazole as a presumed human reproductive toxicant, which may damage fertility or the unborn child (Repr. 1B).

Restriction proposal on Chromium VI in leather compounds

RAC adopted its opinion concluding that there is currently a risk from chromium (VI) in leather articles and the Danish restriction proposal for Chromium VI in leather compounds is justified. Following the comments received during the earlier public consultation and the advice from the Forum for Exchange of Information on Enforcement, the wording of the restriction was amended to enhance its enforceability and to better cover all leather articles of concern.

Further information

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

 

Background Information

The role of RAC in EU regulatory processes

RAC 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 is available on the ECHA website at the link below: