RAC concludes nine scientific opinions
The Committee for Risk Assessment (RAC) adopted eight opinions and agreed on one opinion which will be adopted following public consultation.
Helsinki, 12 March 2013 – The Committee for Risk Assessment has adopted six opinions for harmonised classification and labelling (CLH), two opinions at the Executive's Director request and one opinion on a restriction proposal.
Mandipropamid is used as a fungicide in agriculture.
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 acute aquatic toxicity with an M-factor of 1. However, RAC also agreed that the classification for long-term aquatic hazard as Aquatic Chronic 1 with an M-factor of 1 is warranted as this is a more severe classification than what was proposed by the dossier submitter.
Fenoxaprop-p-ethyl is used as a herbicide in agriculture.
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 fenoxaprop-p-ethyl as a substance, which may cause damage to the kidney through prolonged or repeated exposure, and as very toxic to aquatic life with acute and long lasting effects. RAC also agreed to classify fenoxaprop-p-ethyl as a substance which may cause an allergic skin reaction but concluded on Category 1 instead of Category 1B as was proposed by Austria.
Isoxaflutole is used as a herbicide in agriculture.
Isoxaflutole already has a harmonised classification in Annex VI to the CLP Regulation as a substance which is suspected of damaging the unborn child, and as very toxic to aquatic life with long lasting effects. RAC agreed with the proposal from the Netherlands to assign an M-factor of 10 to the acute aquatic classification and of 100 to the chronic aquatic classification.
Potassium sorbate is used as a biocide.
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 potassium sorbate as a substance which causes serious eye irritation but did not find classification for skin irritation warranted.
Tricalcium diphosphide is used as a rodenticide in agriculture.
Tricalcium diphosphide already has a harmonised classification in Annex VI to the CLP Regulation as a substance which, in contact with water, releases a toxic and flammable gas which may ignite spontaneously, as fatal if swallowed (minimum classification) and as very toxic to aquatic life (M-factor of 100). RAC agreed with the proposal from Germany to convert the minimum classification as fatal if swallowed into a regular harmonised classification and to classify it as toxic in contact with skin. RAC did not support the proposal from Germany to classify the substance as causing severe skin burns, but proposed to classify it as causing serious eye damage as well as irritating to the skin according to the Dangerous Substances Directive. Finally, RAC proposed to classify tricalcium diphosphide as fatal if inhaled and as a substance which liberates very toxic gas when in contact with acids.
8:2 Fluorotelomer alcohol (FTOH)
8:2 FTOH is mainly used for as a component in the coating of textiles, paper and carpets to achieve oil, stain and water repellent properties, and in cleaning agents. It can be residually present in raw materials.
The classification and labelling of this substance has so far not been harmonised at EU level.
RAC concluded that the data provided by Norway's proposal to classify 8:2 FTOH as a substance which may damage the unborn child is insufficient to conclude on a classification.
Diisononylphthalate and diisodecylphthalate in toys and childcare articles
The phthalates DINP and DIDP are restricted in toys and childcare articles, which can be placed in the mouth by children, in accordance with entry 52 of the Restriction List (Annex XVII). ECHA has evaluated the new scientific evidence in relation to the risks of DINP and DIDP when present in articles.
In April 2012, ECHA's Executive Director requested RAC for an opinion on the draft review report of ECHA "Evaluation of new scientific evidence concerning DINP and DIDP in relation to entry 52 of Annex XVII to Regulation (EC) No 1907/2006 (REACH)".
RAC concluded that a risk from mouthing of toys and childcare articles with DINP and DIDP could not be excluded if the existing restriction on these articles were lifted.
RAC did not identify further uses that would cause a risk to children or adults. ECHA will finalise the review report taking the opinion by RAC into consideration and the comments received during public consultation.
1,4-dichlorobenzene in air fresheners and toilet blocks
RAC adopted its opinion concluding that the ECHA proposal for a restriction on the placing on the market and use of air fresheners and toilet blocks containing 1,4-dichlorobenzene is justified. According to the RAC conclusion, a risk is identified for both domestic and professional users.
At the request of ECHA's Executive Director, RAC agreed a draft opinion on gallium arsenide which is used in the microelectronics industry.
In May 2010, RAC adopted an earlier opinion on gallium arsenide as a substance which may damage fertility (Repr. 1B) in agreement with a harmonised classification and labelling proposal from France.
RAC assessed additional information related to toxicity to reproduction submitted by industry and at its 24th meeting agreed that no change was warranted to the proposal to classify gallium arsenide as a substance which may damage fertility (Repr. 1B), as stated in its previous opinion from March 2010. In accordance with the mandate from the Executive Director of ECHA, the draft opinion will be subject to a public consultation before its final adoption.
The opinions will be available at the following link in the near future.
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.