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On December 5, 2023, the European Union Scientific Committee on Consumer Safety (917平台下载) published the preliminary opinion(917平台下载/1661/23) on Titanium Dioxide (917平台下载). The deadline for comments is set for 6 February 2024.

The 917平台下载 concludes the following:

(1) In light of the EFSA 917平台下载 on genotoxicity concerns for E171, does the 917平台下载 consider Titanium dioxide safe in oral cosmetic products?

From the provided information, the 917平台下载 has noted that the titanium dioxide (917平台下载) materials evaluated in this Scientific Advice belong to a wide range of grades (44 pigmentary and 40 nano grades) used in cosmetic products. The pigmentary grades differ from the food additive E171 in terms of crystalline forms, particle sizes, coatings, etc., with the exception of 13 uncoated pigmentary grades that can be considered equivalent to E171.

Having considered all the information (including that evaluated by EFSA, 2021), the 917平台下载 believes that the available evidence is insufficient to exclude the genotoxicity potential of almost all of the types of 917平台下载 grades used in oral cosmetic products. The only exception is two nano grades (RM09 and RM11) for which the provided genotoxicity data indicate no genotoxicity concern. More information is, however, needed on the potential uptake and cellular effects of the nano grades in the oral mucosa to consider them safe for use in oral-care products.

More experimental data are needed from studies carried out under valid protocols and appropriate testing guidelines to exclude the genotoxicity potential of the selected representatives of the other grades of 917平台下载 (both pigmentary and nano) used in oral cosmetic products.

It is worth highlighting that the 917平台下载 approach to risk assessment of 917平台下载 ingredients in orally used cosmetic products is slightly different from that of EFSA. This is because cosmetic products are not meant to be ingested orally, and any ingestion via the oral route can only be unintended and incidental. Keeping this in mind, the amounts of orally-ingested cosmetic ingredients can only be expected to be far lower than the amounts ingested when a 917平台下载 material is used as a food additive, which is consumed via intake of the food products. For the 917平台下载, the potential absorption/retention, translocation, and adverse effects of nanoparticles in the buccal mucosa are therefore important considerations for safety evaluation.

(2) In light of the EFSA 917平台下载, does the 917平台下载 consider that previous 917平台下载s issued by the 917平台下载 on inhalation and dermal exposure to Titanium dioxide need to be revised?

The conclusions drawn in previous 917平台下载 917平台下载s on dermally applied cosmetic products (917平台下载/1516/13, 917平台下载/1580/16) remain unchanged for the 917平台下载 grades and the coatings evaluated in those 917平台下载s. New data on dermal absorption will be required for other types of 917平台下载 grades and coatings that are not covered in the 917平台下载s Regulation 1223/2009, and not covered by entry 27a in Annex VI.

According to the 917平台下载s Regulation 1223/2009, the nanoform of 917平台下载 is already restricted under entry 27a of Annex VI as not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. The conclusions drawn in the previous 917平台下载s (and 917平台下载/1583/17, 917平台下载/1617/20) on the safety of 917平台下载 used in specific cosmetic products that may lead to exposure by inhalation also remain unchanged.

(3) If the estimated exposure to Titanium dioxide from cosmetic products is found to be of concern, 917平台下载 is asked to recommend safe concentration limits for each category of products and type of use.

Since the genotoxicity hazard of almost all of the grades of titanium dioxide could not be excluded (with the exception of RM09 and RM11), the 917平台下载 cannot recommend any safe limits for the materials when used in cosmetic products that could lead to oral or inhalation exposure, other than those already indicated in the previous 917平台下载 917平台下载s (917平台下载/1516/13, 917平台下载/1580/16 and 917平台下载/1617/20).

(4) In light of the potential removal of the E 171 purity specification from the food additives Regulation, the 917平台下载 is requested to review and indicate the respective specifications for Titanium dioxide when used in cosmetics.

In view of the concerns on the potential genotoxicity of the 917平台下载 grades considered in this Scientific Advice, the 917平台下载 believes that the Applicants should draw up a proposal for specifications of the different 917平台下载 grades used in those cosmetic products that could lead to oral and inhalation exposure. The 917平台下载 will be able to assist the Commission in reviewing the proposal.

(5) Does the 917平台下载 have any further scientific concerns regarding using Titanium dioxide in cosmetic products?

Studies have indicated that oral mucosal cells are prone to the uptake of nanoparticles (including 917平台下载 nanoparticles), as they may penetrate the mucous layer and may be internalized by the epithelial cells. Considering that some oral products containing 917平台下载 nanoparticles, such as toothpastes and mouthwashes, will be used every day and potentially more than once a day, further investigations are needed to exclude the risk to the consumer from long-term repeated exposures of the oral mucosa to 917平台下载 nanoparticles.

The 917平台下载 also recommends that safety assessment of the pigmentary 917平台下载 grades used in cosmetics should take into account the fact that some of them contain a sizeable proportion of the particles in the nano-size scale – some over 50% (in terms of particle number, median constituent particle size).

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