ECHA Risk Assessment Committee Adopts Seven Scientific Opinions

The following information comes from the ECHA web site:



The Committee for Risk Assessment (RAC) has adopted opinions on seven proposals for harmonised classification and labelling across Europe during its 17th meeting, held from 13-16 September 2011 in Helsinki.


Polyhexamethylene biguanide hydrochloride (PHMB)

RAC agreed with the proposal from France to classify PHMB as acutely toxic by the oral and inhalation route, damaging to the eye, as a skin sensitiser, as toxic to the respiratory tract after repeated exposure, suspected carcinogen and hazardous to the aquatic environment. The classification of this substance is not currently harmonised at EU level. PHMB is used as biocidal product (disinfectant).

Di-n-hexyl phthalate (DnHP)

RAC agreed with the proposal from France to classify DnHP for reproductive toxicity due to the potential for effects on unborn babies as well as on male fertility. The classification of this substance is not currently harmonised at EU level. DnHP is used in the manufacture of plastics.

Fenamiphos

RAC agreed with the proposal from the Netherlands to classify Fenamiphos as acutely toxic by the inhalation route and as an eye irritant. Fenamiphos already has a harmonised classification as acutely toxic by the oral and dermal route and as hazardous to the aquatic environment. RAC agreed with the proposal to replace the minimum classification for acute toxicity (indicate by an asterix) with the definite classification based on data. Further, RAC proposed an M-factor of 100 for chronic aquatic toxicity. Fenamiphos is used as a plant protection product.

Trichloromethylstannane (MMTC)

RAC agreed with the proposal from France to classify MMTC as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMTC as mutagenic. The classification of this substance is not currently harmonised at EU level. MMTC is used as an industrial intermediate in the production of other organotin chemicals.

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MMT (EHMA))

RAC agreed with the proposal from France to classify MMT(EHMA) as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMT(EHMA) as mutagenic. The classification of this substance is not currently harmonised at EU level. MMT(EHMA) is used as a heat stabiliser in PVC.

Benzenamine, 2-chloro-6-nitro-3-phenoxy- (Aclonifen)

RAC agreed with the proposal from Germany to classify Aclonifen as a suspected carcinogen, as a skin sensitiser and as hazardous to the aquatic environment. Aclonifen already has a harmonised classification as hazardous to the aquatic environment. Aclonifen is used as a plant protection product (herbicide).

Perestane

RAC agreed with the proposal from the UK to classify Perestane as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and as toxic to the eye after single exposure and to remove the classification for mutagenicity. Perestane already has a harmonised classification as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and mutagenic. Perestane is used as a biocide (surface disinfectant).

More information can be found on the ECHA web site.

ECHA Committee Adopts First Proposals to Restrict Chemical Substances Under REACH

A key committee responsible for determining chemicals that should be restricted under REACH has issued its first two opinions.  The Committee for Risk Assessment (RAC) decided on March 8-11, 2011 that dimethylfumarate (DMFu) should be restricted in articles and lead and lead compounds should be restricted in jewelry.  Both of these chemical substances will now be severely restricted from being used.

The RAC found that:

There is a serious risk to consumers from the use of articles treated with DMFu and that the suggested restriction on the production and placing on the market of articles containing DMFu is appropriate in order to reduce the risk to consumers.

There will now be a temporary ban of the inclusion of DMFu in articles placed on the market in the EU until March 15, 2102, after which a decision will need to be made on whether to make the ban permanent.  DMFu had been used as an anti-mold agent, but there had been "several reports in many Member States of severe skin reactions (dermatitis) in consumers exposed to DMFu in articles, such as leather sofas and shoes." 

The RAC also found that:

Lead contained in jewellery may significantly contribute to the exposure of children to lead by them putting it in their mouths, and that a restriction is therefore appropriate...[A]fter assessing the dossier and the information submitted during the public consultation...basing the restriction on the content of lead in articles unless it could be demonstrated that lead is not released should a child put a piece of jewellery in his or her mouth. 

The main concern is the increased exposure to children, whose behavior often includes sucking or even swallowing small jewelry, and the well-known severe adverse effects to development of the central nervous system in children.

Along with the RAC determinations were parallel determinations on these two substances by the Committee for Socio-economic Analysis (SEAC).  More information on both can be found on the ECHA web site.  The opinions will also be available soon following the links.