SCCS sparks debate on titanium dioxide safety in oral care products

12 Dec 2023 --- Concerns about the use of titanium dioxide (TiO2) emerge once again, this time pertaining to oral care products. According to the EU Scientific Committee on Consumer Safety (SCCS), TiO2 in its various ranges requires further assessment of its genotoxicity potential.

While acknowledging specific nano grades (RM09 and RM11) show no genotoxicity concerns, the SCCS highlights the lack of sufficient evidence for most TiO2 grades.

This preliminary opinion is open for clarifications and comments until February 6, 2024.

Evaluating genotoxicity in oral cosmetic products
The SCCS, in response to concerns raised by the European Food Safety Authority (EFSA), scrutinizes the safety of TiO2 in various cosmetic products, particularly in items like toothpaste and mouthwash.

“TiO2 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 regarding crystalline forms, particle sizes, coatings, etc., except 13 uncoated pigmentary grades that can be considered equivalent to E171,” details the SCCS.

Diverging from EFSA’s approach, SCCS emphasizes that cosmetic products are not intended for oral ingestion, and any unintended ingestion is minimal. The committee underscores the importance of assessing the potential absorption, retention, translocation and adverse effects of nanoparticles in the buccal mucosa (inner cheek lining) for safety evaluation.

Unchanged conclusions
The SCCS affirms that previous opinions on dermal exposure to TiO2 in cosmetic products remain unchanged. The SCCS highlights the lack of sufficient evidence for most TiO2 grades.

However, it suggests new data on dermal absorption for types of TiO2 grades not covered by current regulations. The nanoform of TiO2 is already restricted, and previous conclusions on inhalation exposure also stand.

“SCCS is of the opinion that the use of pigmentary TiO2 up to a maximum concentration of 25% in a typical hair styling aerosol spray product is not safe for either general consumers or hairdressers,” warned the committee in 2020.

“The safety assessment has shown that using pigmentary TiO2 in loose powder up to a maximum concentration of 25% in a typical face makeup application is safe for the general consumer. Without more information, it may not be clear whether these conclusions would apply to the use of pigmentary TiO2 materials in other similar types of cosmetic applications on the market.”

However, these assessments do not concern oral care products.

Safety recommendations
In response to concerns about genotoxicity, the SCCS refrains from recommending safe concentration limits for TiO2 in cosmetic products that may lead to oral or inhalation exposure.

The committee calls for applicants to propose specifications for TiO2 grades, considering potential exposure routes and commits to assisting the EU Commission in reviewing the proposal.

Highlighting potential risks associated with long-term oral exposure to TiO2 nanoparticles, especially in daily-use products like toothpaste, the SCCS recommends further investigations.

Safety assessments should consider the nano-size scale in pigmentary TiO2 grades used in cosmetics.

The SCCS’s preliminary opinion on TiO2 in cosmetic products emphasizes the need for a nuanced approach to risk assessment, considering the unique nature of cosmetic applications.

The controversy concerns the complex evaluation of TiO2 genotoxicity in cosmetic products, differing approaches between regulatory bodies, and the need for more data and standardized safety measures. The ongoing dialogue between regulatory bodies, industry stakeholders, and scientific committees will shape the safety framework for TiO2 in personal care and cosmetic formulations.

In previous developments, the French government appealed the EU General Court’s judgment of annulling the classification of TiO2 as a suspected carcinogen when inhaled or consumed in powder forms.

The General Court annulled the TiO2 classification of European Commission Regulation on November 23 last year.

By Venya Patel

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