RAC adopts seven scientific opinions by S119sl3

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									~dREACH Update
~tRAC adopts seven scientific opinions
~w2011-09-21
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.

RAC opinions on harmonised classification and labelling
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).

The full RAC opinions will be available shortly at:
http://echa.europa.eu/about/organisation/committees/rac/committee_opi
nions_en.asp
ECHA, 20 September 2011
<a href="http://echa.europa.eu">http://echa.europa.eu</a>


~dREACH Update
~tECHA consults on proposed phthalate cocktail ban
~w2011-09-21
The European Chemicals Agency (ECHA) is consulting on a Danish
proposal to ban a combination of four phthalates from some goods. The
proposal for a restriction under article 17 of REACH would apply to
DEHP, BBP, DBP and DIBP. Denmark wants to ensure that the combined
concentration of these endocrine-disrupting substances does not
exceed 0.1% in goods intended for indoor use or likely to come into
direct contact with skin or mucous membranes. The proposal says
around 184,000 tonnes of the phthalates were used in the production
of articles in the EU in 2009. Denmark is concerned about their joint
concentrations because endocrine disruptors can act in combination.
The European Commission is still considering how to assess this type
of risk. Under existing law, manufacturers wanting to use three of
the phthalates – DEHP, DBP and BBP – from 2015 will have to apply for
authorisations. The fourth one, DIBP, is recommended for addition to
REACH's annex 14 authorisation list. But the authorisation process
does not cover imported products. The consultation will run for six
months but the chemicals agency would like responses earlier to help
its risk assessment (RAC) and socio-economic assessment (SEAC)
committees which will start discussing the proposal in January.
ENDS Europe Daily, 20 September 2011
<a
href="http://www.endseuropedaily.com">http://www.endseuropedaily.com<
/a>


~dREACH Update
~tSEAC adopts three scientific opinions on lead, mercury and
phenylmercuries
~w2011-09-21
The Committee for Socio-economic Analysis (SEAC) has adopted opinions
on three restriction proposals during its 12th meeting, held from 13-
15 September 2011 in Helsinki.

SEAC opinion on lead
Following the submission by France of a restriction proposal aimed at
reducing children's exposure to lead, the Committee for Risk
Assessment (RAC) adopted its opinion supporting France's proposal in
principle but with significant modifications in March 2011. At the
same time, SEAC agreed on its draft opinion, which concluded that the
benefits for human health of the restriction of lead in jewellery
outweigh the costs of the restriction. SEAC proposed the restriction
to be based only on the content of lead in jewellery articles as it
is easier to measure in practice.
Derogations for crystals and precious and semi-precious stones were
proposed, as well as for jewellery more than 50 years old. The draft
opinion of SEAC was submitted for public consultation for 60 days.
Following the comments received, SEAC included additional derogations
for vitreous enamels and non-accessible parts of watches in its
opinion. The final opinion has now been adopted.

Opinions on restrictions intended to reduce the emissions of mercury
Mercury and most of its compounds are highly toxic to humans, animals
and ecosystems. High doses can be fatal for humans, but even
relatively low doses can seriously affect the nervous system and have
been linked with possible harmful effects on the cardiovascular,
immune and reproductive systems. Once released, mercury persists in
the environment, where it circulates between air, water, sediments,
soil and biota in various forms. In the presence of bacteria, mercury
can change into methylmercury, its most toxic form, which
biomagnifies especially in the aquatic food chain, making populations
and wildlife with a high intake of fish and seafood particularly
vulnerable. Methylmercury readily passes through both the placenta
and the blood-brain barrier, so exposure to women of child-bearing
age, pregnant women and children, is of greatest concern. The
restrictions proposed by ECHA on behalf of the European Commission
and by Norway, are measures to further reduce mercury emissions and
protect against exposure.

SEAC opinion on mercury in measuring devices
At the request of the European Commission, ECHA has reviewed the
availability of safer alternatives to measuring devices containing
mercury and, as a result, prepared a restriction report proposing to
restrict mercury in several measuring devices that are used in
industrial and professional settings (thermometers,
sphygmomanometers, barometers, manometers, metering devices for the
determination of softening point, pycnometers and strain gauges). RAC
adopted its opinion in support of ECHA's proposal with some
modifications in June 2011. At the same time, SEAC agreed on its
draft opinion, which concluded that suitable alternatives to the
measuring devices are available and that the restriction (with some
minor derogations) is considered to be proportionate to the risks.
The draft opinion of SEAC was submitted for public consultation for
60 days. No comments were received that lead to changes to the final
opinion, which has now been adopted. For clarification, one minor
change was introduced to the proposed restriction.

SEAC opinion on Phenylmercury compounds
Norway prepared a restriction report proposing a ban on the
manufacture, placing on the market and use of five phenylmercury
compounds, as well as a ban on placing articles containing these
substances on the market. Phenylmercury compounds are mainly used in
the production of polyurethane coatings, adhesives, sealants and
elastomers. RAC adopted its opinion in support of Norway's proposal
with some modifications in June 2011. At the same time, SEAC agreed
on its draft opinion, which also supported the proposal and concluded
that a restriction on the five phenylmercury compounds was
proportionate. The draft opinion of SEAC was submitted for public
consultation for 60 days. No comments were received that lead to
changes to the final opinion, which has now been adopted.

Further Information is available at:
http://echa.europa.eu/reach/restriction/restrictions_under_considerat
ion_en.asp
ECHA, 20 September 2011
<a href="http://echa.europa.eu">http://echa.europa.eu</a>

								
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