On 6 November 2019, the EU Commission published Commission Regulation, amending Annex VI to Regulation (EC) No 1223/2009. The updates refer to titanium dioxide (nano), which is listed in entry 27a of Annex VI and is currently allowed as a UV filter in cosmetic products. This ingredient is allowed in a concentration of up to 25% in ready for use preparations, except in applications which may lead to exposure of the end user’s lungs by inhalation. It is also subject to specific physico-chemical characteristics, which are listed in the entry.
In an opinion of 7 March 2017, which was corrected on June 2018, the Scientific Committee on Consumer Safety (SCCS) evaluated three forms of titanium dioxide (nano) and concluded that they are safe for use on healthy, intact skin. They assessed the safety of three forms – 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). However, the SCCS noted that this conclusion doesn’t apply to powders or aerosols.
Additionally, SCCS has raised concern regarding the possible ingestion of certain products, such as lipsticks. They concluded that the possible harmful effects should be taken into consideration in case of manganese dioxide-coated nano forms, which are used in application that may lead to oral ingestion. Since some face products, such as sunscreens, may also be applied on the lips, under reasonably foreseeable conditions of use, their use on the lips should also be restricted.
Based on the SCCS opinion, the following three evaluated combinations and their respective limits are allowed for use with titanium dioxide in its nano form as a UV-filter and are added to entry 27a:
- Silica at a maximum concentration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %,
- Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0.7 %,
- Alumina at a maximum concentration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %,
Considering possible health risk relating to ingestion of manganese dioxide, it has been concluded that coatings with manganese dioxide and alumina are not allowed to be used in lip products. In order to avoid application on the lips, face products, which contain titanium dioxide (nano) coated with alumina and manganese dioxide have to bear warning ‘Not to be used on the lips.’’.