CTPA Annual Report 2013 - page 11

Scientific and Technical Issues
Annexes to the Cosmetics Regulation
The Annexes list thousands of ingredients which are approved
for specific uses, limited for use in certain concentrations
or banned from use in cosmetics. Ingredients are added
following a detailed scientific assessment of their human
safety. It was disappointing therefore that, when the
Annexes taken from the old Cosmetics Directive were added
to the new Cosmetics Regulation, very many technical errors
were inadvertently introduced. This caused many practical
difficulties for those who formulate cosmetic products.
The European Commission was keenly aware of the
cosmetic industry’s concerns about these errors and
agreed that no enforcement could take place when the
Regulation entered fully into force in July. Rather, the
Commission welcomed the work carried out by our industry
to detail all of the technical errors and has said it will correct
these errors in a single update in 2014.
In the meantime, a number of other technical adaptations
have been made to the Annexes of the Cosmetics Regulation
covering a number of hair dyes, hydrogen peroxide,
polidocanol and some preservatives and UV filters. The approval
of some twelve hair dyes was also extended so that they could
be used to colour eyelashes as well as hair.
Ingredient Safety
CTPA continues to monitor the work of the European
Commission’s Scientific Committee on Consumer Safety
(SCCS), reporting to members when new updates become
available and engaging with Cosmetics Europe in the
support of substances and ingredients important to industry.
In 2013, 24 final opinions, 8 preliminary opinions or drafts
open for comment, 19 open requests and 1 memorandum
were published by the SCCS.
An opinion was adopted by the SCCS following a request
by the European Commission to review the use of propyl
and butyl parabens, used as preservatives in cosmetic
products, and determine whether previous opinions on
these ingredients required updating. The SCCS confirmed
its previous conclusions but requested an improvement in
some of the data.
Following adoption of the opinion, the European Commission
launched a public consultation on its proposal to amend the
Cosmetics Regulation to reflect the recommendations of the
SCCS. The proposal is to reduce the permitted levels of
parabens in cosmetic products and prohibit the use of propyl
and butyl paraben in leave-on products intended to be used
in the nappy area for children under the age of three.
The public consultation ended in November.
Cosmetics Europe submitted comments with regard to the
labelling requirements of baby products, the implementation
dates and the error that has been made in converting the
level of 0.19% as ester quoted in the SCCS opinion to
0.14% when expressed as acid. We expect the draft measure
to amend the Annex of permitted preservatives to be
presented to the Standing Committee on Cosmetics,
composed of representatives from national governments
of EU countries, for discussion and voting in the first half
of 2014.
A proposal to ban certain isoparabens, whose use had not
been supported by our industry, was voted on by the
Standing Committee at the end of 2013. The World Trade
Organisation had been notified of the draft regulation and
the amendment to the legislation was due to be published
in the Official Journal during early 2014.
Methylisothiazolinone (MIT) was approved as a cosmetic
preservative in June 2005. It is currently authorised for
use at a maximum concentration of 0.01% (100 ppm).
Several EU countries have requested the safety of MIT to be
assessed following concerns over data suggesting that MIT
is a contact allergen in humans. In addition, the European
Society of Contact Dermatitis (ESCD) has written to the
Commission asking it to address the rapidly increasing
incidence of allergies caused by MIT. In response to these
data, the European Commission issued a mandate on MIT
to the SCCS requesting a safety assessment.
A Task Force was established by Cosmetics Europe and it
met members of the ESCD in October. The meeting was
hosted and moderated by the British Association of
Dermatologists (BAD). Industry and dermatologists presented
data at the meeting. It was acknowledged by both parties
that there is a wide range of uses of MIT and that current use
of MIT in cosmetics significantly contributes to the observed
increase in allergies to the substance. It was also agreed that
the safe use of MIT in leave-on skin products cannot be
substantiated with the current safety data.
Following on from the meeting, on 12 December Cosmetics
Europe issued an industry-wide recommendation to
discontinue the use of the preservative MIT in leave-on
skin cosmetics and personal care products.
The SCCS’s draft opinion on MIT was published on
18 December, open for public comment until
17 February 2014. In the draft opinion, the SCCS concluded
that current clinical data indicate that MIT at a concentration
of 100 ppm in cosmetic products is not safe for the consumer
and suggested restrictions. Industry will respond to the call
for public comment on the opinion.
CTPA Annual Report
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