Titanium dioxide (TiO2) is one of the most important and effective sunscreens for protecting skin and has been safely used for decades. Unlike other compounds used in sunscreens, which may absorb only a part of the UV radiation, TiO2 is extremely efficient at protecting against all aspects of UV light that can affect skin by absorbing and scattering both UVA and UVB rays.
TiO2 is a mineral sunscreen that forms a protective layer on the top of the skin to reflect UV rays, whereas other chemical filters are absorbed into the skin.
The European Commission’s Scientific Committee on Consumer Safety (SCCS) carried out a number of assessments on the safety and concluded that TiO2 in sunscreens can be considered to pose no risk of adverse effects in humans.
The main assessments were carried out by the SCCS in 2013 and 2014 and concluded that TiO2 up to 25%, the maximum assessed, was safe for healthy, intact or sunburnt skin. The SCCS also concluded that particles remain on the outer layer of our skin and are not absorbed into the skin or subdermal tissues when applied as a cream. The SCCS excluded spray applications from their conclusions as they had insufficient information. The safety of TiO2 in sunscreens was confirmed again in further review and opinions by the SCCS in 2018 and 2020.
The TDMA has submitted extensive new safety information and plans to carry out the same tests for other types of TiO2 used in cosmetics to reassure its safety. This follows the recent reaffirmation of the safety of TiO2 as a food additive by the World Health Organisation (WHO) and other comprehensive evaluations published by the US, UK, Canada, Australia, New Zealand and Japan which, following the publication of the EFSA opinion in 2021, did not raise any health concerns around the safety of TiO2 in foods.
The SCCS has stated in the past that consumers could rest assured that ingredients in sunscreens in Europe are subject to the most stringent safety assessment in the world.
Based on the SCCS Opinions, TiO2 is authorized as UV-filter under entries 27 and 27a (nano form) of Annex VI to Regulation (EC) No. 1223/2009 on cosmetics which includes some provisions on its use.
The safety of TiO2 in sunscreen has also been confirmed by the Danish Environmental Protection Agency (Miljøstyrelsen) which tested the use of TiO2 in sunscreens, finding its use to be harmless. TiO2 is widely authorised globally for use in sunscreens.
Mineral filters such as TiO2 are the only type that are generally recognised as safe and effective (GRASE) by the United States Food and Drug Administration (FDA), while some organic filters have been banned due to their detrimental effects on coral reefs or for health related concerns.
