CTPA Annual Report 2012 - page 9

CTPA Annual Report
Nanomaterials and the measures needed to comply with the
new Cosmetics Regulation continue to be the topics of much
discussion within companies and between industry and the
European Commission. While the safety of nanomaterials
in cosmetic products is already covered by the Cosmetics
Directive, the new Regulation does require extra action to
be taken to further demonstrate this.
One key aspect is the definition of a nanomaterial and
its interpretation. However, there is a problem as the
nanomaterial definition contained in the Cosmetics Regulation
is different from the overarching definition of a nanomaterial
contained in a Recommendation published in 2011 by
the European Commission’s Directorate-General for the
Environment. Discussions continue between various
stakeholders on how to update the nanomaterial definition
for cosmetics and provide guidance on characterisation
methods, that is, how to measure the dimensions of
such small materials.
However, the Commission will not be issuing formal
technical guidance before July 2013. Cosmetics companies
and national authorities will have to manage a
non-harmonised interpretation and will have to fulfil their
obligations without routine measurement tools being
available. Cosmetics Europe has issued a nano guidance
package for use in the meantime.
Another, and important, new requirement for nanomaterials
is the need to notify them. This is over and above the normal
product notification but will be done using the electronic
CPNP. The Commission liaised with the cosmetics industry
to ensure that the portal will be intuitive to use. The CTPA
took part in the Commission’s ‘train the trainers’ day towards
the end of the year. CTPA is therefore able to offer specific
advice to companies if they require help in notifying products
after the nano-notification portal goes live in January 2013.
The Cosmetics Regulation has annexes listing substances
whose use in cosmetics is restricted. Additionally, colours,
preservatives and UV filters must be listed in their respective
Annexes before they may be used. All of the restrictions and
conditions of use are specified, including whether or not the
nanomaterial form of the substance is approved.
However, no ingredient annex entry currently has a specific
nano listing. To use any of the listed ingredients in their
nanomaterial form after 11 July 2013, new safety dossiers
must be created and submitted for review by the European
Commission’s expert Scientific Committee on Consumer
Safety, the SCCS. Although only a few colours and UV filters
are involved, Cosmetics Europe has set up consortia
to defend those ingredients and dossiers have been
submitted. Once approved, the relevant entries in the
Annexes will be changed to include the nanomaterial
form of those substances. The SCCS and the European
Commission are aware of the tight deadline.
The notification requirements for nanomaterials do
not apply to substances listed in the Annexes to the
Cosmetics Regulation.
Animal Testing
The final deadline for the complete phasing out of the
placing on the EU market of cosmetic products that have
been tested on animals is 11 March 2013. The Cosmetics
Regulation requires the European Commission to study any
technical difficulties in complying with the ban, in particular
the development of alternative methods for repeated dose
toxicity, reproductive toxicity and toxicokinetics. If the
European Commission concludes that alternative testing
methods that do not use animals will not be developed,
it must report to the European Parliament and the
European Council and put forward a legislative proposal
before that deadline.
Through Cosmetics Europe, the cosmetics industry has
submitted the information requested by the European
Commission as it carries out its study. No decision had
been taken by the end of 2012 on what legislative
proposals the Commission might bring forward.
Making Cosmetics
In March, CTPA made the unusual step of taking a stand
at a new exhibition called Making Cosmetics.
Other exhibitors included representatives from contract
manufacturing, packaging, laboratory, test and analytical
equipment companies. Alongside the exhibition there was
an extensive programme of seminars, workshops and
demonstrations. Making Cosmetics proved to be a
successful way of highlighting the new Cosmetics
Regulation to attendees but also it was good to speak
with so many budding cosmetics companies – and it was
important to be able to highlight the legislation to them!
The decision to exhibit again at Making Cosmetics in 2013
was supported by the Board. As well as taking a stand,
CTPA will be involved in the programme of lectures providing
a presentation to start-up companies on the basics of
cosmetics legislation – an ‘all you need to know’ check list.
CTPA will also present on the new Cosmetics Regulation.
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