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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