What the Make America Healthy Again report is missing
Background
Titanium dioxide (commonly referred to as E171) can be used as a colourant in foods to brighten food products and to add texture. There is a growing consensus that the use of E171 in food is safe and this has been confirmed by a growing number of global regulators. The recent Make America Healthy Again (MAHA) report, which includes a reference to the safety of E171, does not include an accurate reflection of the current state of the science on the safety of E171 used in food.
The TDMA will keep engaging with relevant stakeholders to ensure that ongoing and future reviews of the safety of TiO2 are conducted using all available data and best practices.
Global regulatory consensus on E171
The World Health Organization (WHO) confirmed the safety of TiO2. This opinion follows a growing scientific consensus over the safety of TiO2 published by the Japanese Ministry of Health, Labour and Welfare (MHLW) and Japanese National Institute of Health Sciences (NIHS), as well as the United States Food and Drug Administration (FDA) in early 2023.
Other authorities, such as Health Canada, the national health policy department of the Canadian government, the Food Standards Australia New Zealand (FSANZ), and the United Kingdom’s Food Standard Agency (FSA) have also confirmed that TiO2 is safe for consumers as a food additive.
These reaffirmations by leading authorities of E171’s safety in food, follows concerns raised by the EU’s European Food Safety Authority (EFSA) in 2021. While EFSA had previously reviewed the safety of E171 in 2016, 2018, and 2019 – each time confirming its safety – it later concluded in May 2021 that E171 could no longer be considered safe due to concerns for genotoxicity that could not be ruled out.
This shift in position occurred despite the absence of conclusive evidence showing harmful effects from the intake of E171. This marked a departure from EFSA’s earlier position, which stated that “the use of TiO2 as a food additive does not raise a genotoxic concern.”
Following the publication of the EFSA 2021 Opinion, the European Commission restricted the use of E171 in food based on the precautionary principle. This principle in Europe allows regulators to ban a substance even where no actual hazard or risk to consumers has been confirmed. However, most global regulators do not follow this approach when making safety assessments focussing on identifiable risks to the consumer. As a result an increasing number of global regulators have disagreed with EFSA and the European Commission.
For instance, the Brazilian Health Regulatory Agency (ANVISA) in concluding that E171 was safe for continued use, stated that EFSA’s conclusion was a “precautionary principle-related approach based on identified uncertainties and not based on a concrete risk”.
What the MAHA report is missing
The MAHA report refers to TiO2 as a food additive that “may cause cellular and DNA damage” and cites only two scientific references in support of this statement: the EFSA 2021 Opinion and a paper published by Rolo et al (2022) titled 'Adverse Outcome Pathways Associated with the Ingestion of Titanium Dioxide Nanoparticles - A Systematic Review'.
The MAHA report however does not reference the growing consensus amongst global regulators that E171 is safe for use in food, nor the new scientific evidence published following the EFSA Opinion further confirming that E171 can be used safely in foods.
The paper by Rolo et al (2022) is not directly applicable to use of E171 in food as the report relies heavily on studies involving TiO2 nanoparticles which are not used in food. The review does not account for physicochemical variability, manufacturing conditions or particle aggregation status relevant to food-grade TiO2.
Moreover, the studies cited by Rolo et al (2022) were not subjected to a formal reliability scoring framework. The authors themselves acknowledge significant limitations in the cited studies, including frequent gaps in data related to crystalline structure, dispersion, and surface characteristics – factors that are critical for assessing relevance and reliability.
The proposed AOP framework detailed in the Rolo et al (2022) publication also fails to provide any plausible scientific rationale linking key events to adverse outcomes. The lines connecting key events are seemingly based on correlation rather than causation and mechanistic rationale linking events to outcomes is absent. The linking of chromosome damage to induction of pre-neoplastic lesions without any plausible mechanism or data is purely subjective and non scientific.
New Scientific Evidence confirms the safety of E171
There is also a growing body of new scientific evidence further confirming the safety of E171. An independent study published by the Chinese National Centre for Food Safety Risk Assessment [1], China’s food safety body, shows that E171 does not show any adverse effects on human health.
In 2023 the Ministry of Health, Labour and Welfare of Japan (MHLW) also published a report confirming the safety of E171 as a food additive. The conclusions of the report were based on three key points:
- The results from an independent 90-day study carried out by the Japanese National Institute of Health Sciences (NIHS) also show extremely low absorption and no adverse effects from the oral ingestion of TiO2. This was undertaken to address the concerns raised by the European Food Safety Authority (EFSA) in their opinion from 6 May 2021.
- A literature review revealed that since 2021 no new studies had been identified that would raise concerns for TiO2.
- The Consistency with the opinions of global regulatory consensus on the safety of E171
[1] Liang C et al. (2024). Genotoxicity evaluation of food additive titanium dioxide using a battery of standard in vivo tests. Regulatory Toxicology and Pharmacology 148: 105586.
doi: 10.1016/j.yrtph.2024.105586.
