SCCS/1661/23: Scientific Opinion on Titanium Dioxide in Orally Used Cosmetics

The Scientific Committee on Consumer Safety (SCCS) has published scientific advice on titanium dioxide (TiO2). The SCCS cannot exclude a genotoxicity potential for nearly all TiO2 grades used in orally applied cosmetics. The opinion SCCS/1661/23 was adopted on 13 May 2024 and published on 23 May 2024.

What the SCCS assessed

The starting point was a request from the European Commission. The occasion was the EFSA opinion of 2021 on genotoxicity concerns regarding the food additive E171 (titanium dioxide as a food colorant). The Commission wanted to know whether this had implications for the use of titanium dioxide in cosmetics.

The SCCS considered a wide range of TiO2 materials: 44 pigmentary grades and 40 nano grades used in cosmetic products. The pigmentary grades differ from the food additive E171 in, among other things, crystal form, particle size and coating. An exception is formed by 13 uncoated pigmentary grades that can be considered equivalent to E171. This concerns the substances with the CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/215-280-1 and 1317-80-2/215-282-2.

The key finding: genotoxicity cannot be excluded

After reviewing all information, including the data evaluated by EFSA (2021), the SCCS concludes that the available evidence is insufficient to exclude a genotoxicity potential for nearly all TiO2 grades used in orally applied cosmetics.

There are two exceptions. For the nano grades RM09 and RM11, the submitted genotoxicity data raise no concerns. However, the SCCS emphasizes that for these two grades further information on possible uptake and cellular effects in the oral mucosa is needed before they can be considered safe for oral care products.

For the remaining grades, both pigmentary and nano, the SCCS requests more experimental data. These studies must be conducted according to valid protocols and appropriate test guidelines in order to exclude the genotoxicity potential.

Why the SCCS view differs from EFSA

The SCCS notes that its approach to risk assessment differs slightly from that of EFSA. Cosmetics are not intended for ingestion. Oral uptake can only occur unintentionally and accidentally. The orally ingested amounts of cosmetic ingredients are therefore far lower than for titanium dioxide as a food additive, which is ingested through the consumption of food.

For the SCCS, other questions therefore take priority: possible absorption and retention, translocation, and harmful effects of nanoparticles in the oral mucosa. The Committee points out that cells of the oral mucosa can take up nanoparticles, including TiO2 nanoparticles. The particles can penetrate the mucus layer and be taken up by epithelial cells.

Another point concerns frequency of use. Products such as toothpaste are used daily and sometimes several times a day. The SCCS considers further investigations necessary to exclude a risk from long-term, repeated exposure of the oral mucosa.

What applies to dermal and inhalation applications

For dermally applied cosmetics, i.e., applied to the skin, the conclusions of the earlier SCCS opinions (SCCS/1516/13, SCCS/1580/16) remain unchanged. This applies to the TiO2 grades and coatings assessed there. For other grades and coatings not covered by the Cosmetics Regulation (EC) No 1223/2009 or by entry 27a in Annex VI, new data on dermal absorption will be required.

The nano form of TiO2 is already restricted under entry 27a of Annex VI of the Cosmetics Regulation. It must not be used in applications that may lead to exposure of the end user's lungs through inhalation. The conclusions of the earlier opinions on inhalation exposure (SCCS/1583/17, SCCS/1617/20) also remain unchanged.

Since the SCCS could not exclude the genotoxicity hazard potential for almost all grades, it cannot recommend safe limit values for applications with oral or inhalation exposure. Only the values already stated in the earlier opinions (SCCS/1516/13, SCCS/1580/16, SCCS/1617/20) apply.

Specifications and open questions

Due to the possible removal of the E171 purity specification from food law, the Commission asked for a review of the specifications for cosmetic applications. The SCCS recommends that applicants develop a proposal for specifications of the various TiO2 grades that may lead to oral or inhalation exposure. The SCCS offers to support the Commission in reviewing such a proposal.

For pigmentary TiO2 grades, the SCCS points out a further aspect: some contain a significant proportion of particles in the nano range, in some cases over 50 percent (based on particle number, median constituent particle size). This should also be included in the safety assessment.

What manufacturers should take into account now

Important: A scientific opinion of the SCCS is not yet a change in the legal situation. It forms the scientific basis on which the Commission can decide on possible adjustments to the annexes of the Cosmetics Regulation. The opinion does not specify any deadlines or concrete legal consequences in this regard.

Manufacturers of orally used cosmetics, such as toothpaste or lip products, and of products with inhalation potential should check which TiO2 grades they use and whether these are pigmentary or nano. The nanoparticle content of pigmentary grades is also relevant. Anyone wishing to update the safety assessment (CPSR under Annex I) for affected formulations can submit the formulation to us for review. The full opinion is available from the European Commission: Scientific Advice on Titanium dioxide (SCCS/1661/23). An overview of all SCCS opinions is available on the SCCS Opinions page.