2024-10-18 12:55:00
Expertise which contributed to its ban as a food additive
The food additive E171, used for its coloring and opacifying properties, contains titanium dioxide particles. From 2017 to 2022, ANSES carried out several assessments on the risks linked to its ingestion. Each of these expert opinions concluded that it was not possible to resolve the uncertainties about the safety of the additive E171. Some research results suggest that TiO2 could promote the development of cancer or be genotoxic, but the available data are not sufficiently robust to rule on the toxicity of the food additive. These uncertainties led to the suspension of its use in foodstuffs in France in January 2020 and its ban in the European Union in January 2022 following an assessment by the European Food Safety Authority (EFSA).
A proposal for classification as a carcinogen by inhalation
In 2015, ANSES submitted a request to the European Chemicals Agency (Echa) to classify TiO2 as suspected carcinogen by inhalation (category 1B) under the CLP Regulation (relating to the classification and packaging of dangerous substances and mixtures). According to ANSES, TiO2 is a proven carcinogen by inhalation for animals on the basis of several studies.
In 2017, the Echa Risk Assessment Committee concluded that TiO2 in all its forms should be classified as suspected carcinogen (category 2) for humans by inhalation. This decision was endorsed by the European Commission, which obliges manufacturers to inform workers of the risks incurred when handling products containing TiO2 by affixing appropriate labeling.
This classification was, however, contested by manufacturers and annulled by the court of the European Union. On February 8, 2024, the French government, in support of the European Commission, filed an appeal against the decision of the European court. ANSES provides scientific support for this procedure. The appeal procedure is suspensive of the court’s annulment decision: TiO2 is currently still classified as a Category 2 carcinogen by inhalation in Europe.
Furthermore, ANSES is responsible for assessing the dangers and risks of TiO2 for human health and the environment as part of the REACh regulation (Registration, evaluation and authorization of chemicals). Titanium dioxide was first included in the Community Continuing Action Plan in 2013. The purpose of this plan is to prioritize the substances to be subject to evaluation. Titanium dioxide was included due to concerns about its potential carcinogenic and mutagenic properties.
Limit values to protect the general population and workers
In order to respond to the management challenges of industrial installations and sites in France, ANSES was tasked with defining a chronic toxicological reference value (TRV) by inhalation for TiO2 in nanometric form. This is the first VTR developed for a nanomaterial in France. The Agency recommends a long-term inhalation TRV of 0.12 µg.m-3 for the P25 form of TiO2. This value aims to prevent lung inflammation. As a continuation of this work and to strengthen risk prevention in the workplace, ANSES recommends nanoparticle TiO2 an occupational exposure limit value (OEL) over 8 hours of 0.8 µg.m-3. It also recommends not exceeding the concentration of 4 µg.m-3 over a period of 15 minutes, in order to limit the importance and number of exposure peaks during a working day. Finally, the Agency recommends the development and validation of methods for monitoring the concentration of nanoparticulate TiO2 in workplaces.
Evaluating the safety of TiO2 in cosmetics
TiO2 is a cosmetic ingredient authorized as dye and UV filter. Following concerns from EFSA regarding its potential genotoxicity, the European Commission asked the Scientific Committee for Consumer Safety (CSSC) to reassess its safety. It concluded that it was not possible to exclude a potential genotoxic effect of most forms of TiO2 used in cosmetics. This assessment was the subject of a public consultation during which ANSES submitted comments. The Agency supports the conclusions of the CSSC on the need for additional data to conclude on the safety of the use of cosmetic products containing TiO2.
In response to the CSSC’s evaluation, a group of industrialists shared with the Member States and the European Commission in May 2024 a froad map proposing an approach to provide additional data. This is based in particular on an approach of grouping the different forms of TiO2, called grades, according to their physicochemical characteristics. At the request of the Directorate General for Health (DGS) and the Directorate General for Competition, Consumption and Fraud Repression (DGCCRF), Anses analyzed this proposal. She identified methodological weaknesses and recommends in particular that other parameters than just the physico-chemical characteristics proposed by manufacturers be taken into account. The Agency also emphasizes the importance of demonstrating the representativeness of the grades chosen to be tested. The Agency’s conclusions, however, do not presume the assessment that the CSSC will be able to make.
Research funding
As part of the national Environment-Health-Work research program (PNR EST), ANSES funds projects aimed at acquiring knowledge on the health effects of TiO2. Results are being published to be shared with the scientific community.
Monitoring and evaluating nanomaterials
In its nanometric form, TiO2 is one of the four most produced and imported nanomaterials in France. ANSES manages the annual declaration register for nanomaterials R-nanowhich lists the different uses of substances in nanometric form. The Agency has carried out several works on nanomaterials, both on risk assessment and on the adoption of a definition common to all sectors of activity.
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