On 6 November 2019, Annex VI and Annex V of the EU Cosmetics Regulation 1223/2009/EC were amended. Annex VI lists the UV filters and Annex V the preservatives allowed in cosmetic products made available on the European market.
More specifically, entry 27a in Annex VI on titanium dioxide nano form was amended following the SCCS opinion from 7 March 2017, corrected on 22 June 2018, which concludes that:
- Titanium dioxide (nano) coated with either silica and cetyl phosphate (up to 16 % and 6 %, respectively), alumina and manganese dioxide (up to 7 % and 0,7 %, respectively), or alumina and triethoxycaprylylsilane (up to 3 % and 9 %, respectively), is safe when intended to be used in cosmetic products to be placed on healthy, intact or sunburnt skin;
- Moreover, face products containing titanium dioxide (nano) with alumina and manganese dioxide coatings, must bear clear precautions for use on avoiding having these products used on the lips due to the ingestion possibility and the harmful effects implied by their ingestion.
Entry 60 of Annex V was amended to refer to HEPB – Hydroxyethoxyphenyl Butanone (CAS # 569646-79-3). Based on the SCCS opinion from March 2019, which amended a previous opinion from April 2017,
- HEPB can still be considered safe – now even regarding eye irritation – in an aggregate exposure scenario when used as a preservative in rinse off, oral care and leave-on cosmetics at a maximum concentration of 0.7% in the finished cosmetic product;
The Annexes of the EU Cosmetics Regulation cover essential information to successfully develop a compliant cosmetic product to be placed on the European market. These Annexes are constantly and continuously revised and updated following input from the market, technical and scientific progress, as such it is very important to remain updated at all times.
December 10th, 2019
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