EFSA prohibits titanium dioxide in food- should pharmaceuticals be next?

IF 4.8 3区医学 Q1 PHARMACOLOGY & PHARMACY

Toxicology Pub Date : 2025-02-17 DOI:10.1016/j.tox.2025.154089

Chandni Dand, Aanchal Bajaj, Sarika Wairkar

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引用次数: 0

Abstract

Titanium dioxide (TiO₂) is a natural, inorganic compound widely used across various industries due to its multiple properties. Recently, the European Food Safety Authority (EFSA) raised safety concerns regarding the use of TiO₂ in foods, specifically its potential for genotoxicity, accumulation in the body, and associated health risks when used as a food additive. As a result, its use in food has been banned in the food industry in the European Union (EU) since 2022. Furthermore, the safety of TiO₂ is currently being evaluated as a pharmaceutical excipient, and its use is likely to be banned in EU by 2025. The food industry is significantly impacted by the ban, and a subsequent pharmaceutical ban can lead to issues such as the lack of a single replacement for its multiple applications, product redevelopment/revalidation and regulatory submissions. Other regulatory authorities from other countries conducted independent reviews and concluded that there is insufficient evidence to justify a ban on TiO₂ in foods, thereby allowing its continued use. Various substitutes, both natural and synthetic, are being explored, however none can fully replicate all the properties provided by TiO₂ alone. In this review, we discuss the safety concerns associated with TiO₂, which have led to its ban on food products, as well as the challenges that may arise if a similar ban is imposed on its use in pharmaceuticals.

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来源期刊

Toxicology 医学-毒理学

CiteScore

7.80

自引率

4.40%

发文量

222

审稿时长

23 days

期刊介绍： Toxicology is an international, peer-reviewed journal that publishes only the highest quality original scientific research and critical reviews describing hypothesis-based investigations into mechanisms of toxicity associated with exposures to xenobiotic chemicals, particularly as it relates to human health. In this respect "mechanisms" is defined on both the macro (e.g. physiological, biological, kinetic, species, sex, etc.) and molecular (genomic, transcriptomic, metabolic, etc.) scale. Emphasis is placed on findings that identify novel hazards and that can be extrapolated to exposures and mechanisms that are relevant to estimating human risk. Toxicology also publishes brief communications, personal commentaries and opinion articles, as well as concise expert reviews on contemporary topics. All research and review articles published in Toxicology are subject to rigorous peer review. Authors are asked to contact the Editor-in-Chief prior to submitting review articles or commentaries for consideration for publication in Toxicology.