ELZBIETA BIENKOWSKA
Ms Michele Rivasi MEP
European Parliament
Bat. ASP - 06£204
60, rue Wiertz
B-1047 Brussels
Brussels, 03 SEP 2015
WerCaasyzeuiseoS
Dear Ms Rivasi.
Thank you for your letter of 22 July 2015 conceming nanomaterials in cosmetics
Since the entry into force of Regulation EC (No) 1223/2009 on cosmetics products the
Commission has been attaching great importance to the proper application of its various
provisions pertaining to nanomaterials.
As mentioned in your letter, Titanium Dioxide in its nano form is not authorised in cosmeties
according to Regulation (EC) No 1223/2009 (‘Cosmetics Regulation). However, the
authorisation of Titanium Dioxide lawfully dates back to the old Cosmetics Directive where
there were no specific provisions covering nanomaterials. Both nano and non-nano forms
were covered. in line with the scientific opinion of the Scientific Committee on Cosmetic
Products and Non-Food Products intended for Consumers (SCCNFP, replaced by the
Scientific Committee on Consumer Safety (SCCS)).
It is with the new Cosmeties Regulation, which became applicable on 11 July 2013, tha
ter allowed for use in its nano form, the
in
order to have a colorant, a preservative or a U
nano form has to be specifically authorised. This is why, in the meantime, the SCCS re-
essed the safety of Titanium Dioxide (nano), Based_on the conclusion:
lanium Dioxide (nano) is considered safe for use as a UV-filter according to the
specilications included in the SCCS opinion. SCS
Against this background, the Commission has prepared a draft proposal to authorise the use of
Titanium Dioxide (nano) as a UV-filter according to the SCCS specifications. The
Commission proposal also contains the conclusion of the SCCS regarding the exclusion of
Titanium Dioxide (nano) in applications that may lead to exposure of the end user's lungs by
inhalation. 7
RUE DE LA LO! 200 - &-1049 BRUSSELS - TEL: (-32-2)295.40.80,This draft proposal has already been discussed with national authorities and stakeholders on
several occasions. Afier a vote by the Standing Committee on Cosmetics Products, which
expected to take place before the end of this year, followed by a three-month scrutiny period
from both the European Parliament and the Council, the text could be finally adopted by the
Commission early 2016.
In the meantime, as agreed at the Standing Committee on Cosmetic Products, Member States
may withdraw cosmetic products containing this nanomaterial, if they are not in conformity
opinion,
ications indicated in the SC‘
with the speci
Regarding the use of synthetic amorphous silica (SAS) in cosmetics, the SCCS received a
large number of comments from various stakeholders folowing the adoption of its opinion in
March 2015, The SCS is currently-assessing them and is expected to decide in the early
autumn whether some of them could be taken into account in an updated opinion on SAS. On
the basis of the SCCS conclusions the Commission will reflect on appropriate risk
management measures to ensure a safe use of SAS in cosmetic products.
The Commission started the preparation of the catalogue of nanomaterials in due time before
the deadline la
evel of inaccurate information from operators. who notified cosmetics containing
nanomaterials. For instance, many nanomaterials substances, which are very unlikely to be
nanomaterials (e.g. aqua), have been notified.
id down in the Cosmetics
Regulation. However, we have received a significant
A
asked the economi
nnot publish a catalogue containing incorrect information, it
¢ operators who had submitted information on nanomaterials to verify their
on has requested the Member States to carry out
market surveillance actions and contact operators for verifications by October 2015. The
incorrectly
{and to improve the compliance of those that have been legitimately notified. Once
accurate and complete information is received, the Commission intends to publish the
catalogue.
the Commission clearly
notifications. In addition, the Commi:
purpose of this exercise is to considerably reduce the number of nanomaterials
not
The same answer has been sent to Mr Bas Eickhout, MEP.
Yours sincerely.
we ee
“fa Bienkowska