CTPA Annual Report 2012 - page 12

Review of the Year
Ingredient Issues
The Scientific Committee on Consumer Safety (SCCS) issued
over 30 opinions in 2012, many becoming final opinions
following a public consultation. The SCCS continued its
work on assessing hair dyes for eventual positive listing in
the Annexes to the Cosmetics Regulation. Other subjects
addressed were various preservatives and also an in-depth
review of nitrosamines.
One opinion was that addressing the potential for fragrance
ingredients to cause allergy. A follow-up to a 1999 opinion
was issued by the SCCS as a preliminary opinion in
December 2011 and was subject to a public consultation.
The final opinion was adopted in June 2012 with some
amendments. However the SCCS continued to defend its
conclusions that additional labelling and/or limits should be
applied to specific allergens and that HICC (hydroxyisohexyl
3-cyclohexene carboxaldehyde, Lyral), chloroatranol and
atranol are not considered safe when used in cosmetic
products. The opinion contains lists of substances that
are ranked as likely, possible and established fragrance
allergens of special concern.
Cosmetics Europe is working with the International Fragrance
Association (IFRA) to discuss the opinion with the European
Commission and what risk management measures may result.
Discussions continued on the proposed entry for propyl- and
butyl-parabens in Annex V of the Cosmetics Regulation,
the positive list for preservatives, and the anticipated ban
of the branched-chain parabens. The European Commission
mandated the SCCS to look again at propyl- and
butyl-parabens to address questions raised by Denmark on the
exposure from sunscreens for children under three years old.
The Commission is addressing the proposed ban of the
iso-parabens separately and a public consultation closed at
the end of November. There is still no definite date when
the final ban will be implemented but we anticipate that an
Adaptation to Technical Progress (ATP), amending the
Cosmetics Regulation, will be issued in 2013.
Cyclic Siloxanes (D4 & D5) Risk Management Measures
Cyclic siloxanes are incredibly useful and important cosmetic
ingredients with a unique range of attributes. They are used
in a wide range of products, are volatile but not flammable
and have a low heat of evaporation which means they don’t
feel cold on the skin. They act as solvents and give a smooth,
silky feel to skin products. For many years, the cyclic siloxanes
known as D4 and D5 have been the subject of a long series
of reviews for both human and environmental safety.
A potential environmental problem has been identified
where D4 and D5 are discharged to rivers or the sea from
their use in cosmetic products. Regulatory action in this
type of case is undertaken under the auspices of the
REACH Regulation (Registration, Evaluation, Authorisation
and Restriction of Chemicals). The cosmetics industry has
been waiting for the UK REACH Competent Authority to
announce its intentions with regard to proposed
environmental risk management measures.
CTPA has been informed that the UK will ‘undertake further
work with a view to submitting targeted Annex XV
Restriction dossiers to the European Chemicals Agency (ECHA)
for D4 and D5’. The UK’s Risk Management Opinion analysis
papers, which were prepared as part of the decision-making
process, have been shared with CTPA, members of the
Cosmetics Europe Task Force D4/D5 and the European
Chemical Industry Council (Cefic/CES).
The HSE states in its reports for both D4 and D5:
“The exact nature and scope of the restriction will
depend on the detailed analysis that will be performed
as the Annex XV dossier is developed, but we anticipate
that it would most likely relate to concentration limits
for personal care and cleaning/household care products
(and possibly sub-categories thereof), and possibly
waste water emission limits at non-IPPC sites.”
The UK REACH Competent Authority has engaged consultants
to carry out a socio-economic assessment of the effects of
measures to control the use of D4 and D5. It has invited
the cosmetics industry to continue its dialogue with it on
the use of these materials. Cosmetics Europe’s Task Force
has engaged its own consultants to gather data to feed
into the UK review. The outcome should be known by
the summer of 2013 at which point it will be submitted to
the ECHA.
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