EFSA Opinion about titanium dioxide (E171)
Questions and answers regarding E171
What is EFSA?
The European Food Safety Authority (EFSA) is the single European body set up to establish the safety of food. It carries out risk assessments using the latest scientific evidence and methodology. Its opinions are the basis for legislation to limit risks to consumers from food. Legislation to protect consumers’ health is set by the European Commission and the Member States of the European Union taking account of EFSA’s opinions.
What is titanium dioxide (E171)?
Titanium dioxide (E171) is an approved food additive that is used in food as a colour to provide whiteness and opacity.
How do I know if it is in food?
All additives used in a food or drink are required by law to be listed by either name or E‑number on the product’s ingredients list on the food label along with the functional class (what it does in the food, e.g., preservative, colour) associated with the additive in the particular foodstuff. Therefore, if titanium dioxide is present in a food, the ingredients list on the food label will say “colour: titanium dioxide” or “colour: E171”.
What food can it be used in?
Titanium dioxide (E171) is a widely used food additive that has been considered safe for over 50 years. It is permitted to be used in 48 different categories of food. According to EFSA, the main food categories contributing to dietary exposure of E171 are fine bakery wares, soups, broths and sauces (for infants, toddlers and adolescents); and soups, broths, sauces, salads and savoury based sandwich spreads (for children, adults and the elderly). Processed nuts are also a main contributing food category for adults and the elderly. It is also used in confectionary, chewing gum, food supplements and cake icing. As there is no maximum numerical levels set out in the legislation, food businesses must use it in accordance with good manufacturing practice (GMP) and only use the amount needed to achieve its intended purpose and no more. This is called the ‘Quantum Satis’ principle.
What are the safety rules on the use of additives in food?
As additives are deliberately added to food to perform a certain technological function/effect (e.g., to colour, to sweeten, to preserve, etc.), they must be safe for use and be listed in the EU positive list for food additives as set out in Regulation (EC) 1333/2008. In order for these additives to be listed in the EU list, they must go through an extensive safety risk assessment performed by EFSA. The usage levels for the specific food additive in the various food categories proposed are also considered in the EFSA risk assessment. As part of its safety evaluations of food additives, EFSA seeks to establish where possible, an Acceptable Daily Intake (ADI) for each substance. The ADI is the amount of a substance that people can consume on a daily basis during their whole life without any appreciable health risk. ADIs are usually expressed in mg per kg of body weight per day (mg/kg bw/day).
What has EFSA said about titanium dioxide (E171)?
In its opinion published on 6th May 2021, EFSA concluded that based on the overall evidence available, titanium dioxide (E171) can no longer be considered as safe when used as a food additive. EFSA looked at over 11,000 scientific publications and the results of a special toxicity study recommended by EFSA and commissioned by industry. Although the evidence for general toxic effects was not conclusive, on the basis of the new data and strengthened methods EFSA’s scientists could not rule out a concern for genotoxicity (damage to DNA which is the genetic material of cells) and consequently they could not establish a safe level for daily intake of titanium dioxide (E171) as a food additive.
What's happening now?
The European Commission convened a special meeting of Member State’s food additives experts on 18 May 2021, to consider the necessary measures needed to protect consumers’ health. At this meeting, the European Commission and the Member States agreed to remove all uses of titanium dioxide (E 171) as a food additive in food. A draft regulation to ban the use of the additive was subsequently endorsed unanimously by the Member States in September 2021 at the Standing Committee on Plants, Animals, Food and Feed.
On the 14 January 2022, a regulation withdrawing the authorisation to use titanium dioxide as a food additive in food products was adopted, i.e., Commission Regulation (EU) 2022/63.
This regulation withdrawing the use of titanium dioxide is effective in each EU Member State, and in Northern Ireland. Some third countries, such as the United Kingdom (excluding Northern Ireland), continue to permit the use of titanium dioxide.
When did this Regulation enter into force?
Commission Regulation (EU) 2022/63 entered into force on the twentieth day following that of its publication in the Official Journal of the European Union, i.e., 7 February 2022.
In order to mitigate the potential impact on food business operators, a six-month transitional period had been included in the Regulation to allow food business operators time to phase out the use of this additive and to reformulate their products using suitable alternatives. This period ended on the 7 August 2022.
Until 7 August 2022, foods produced in accordance with the rules applicable before 7 February 2022 could continue to be placed on the market. After that date, they could remain on the market until their date of minimum durability or ‘use by’ date.
FSAI encourages food businesses to source suitable alternatives to titanium dioxide (E171) and start the process of reformulation.
Why wasn't titanium dioxide (E171) banned right away?
EFSA has not identified any acute effect linked to the ingestion of titanium dioxide (E171), which would warrant an immediate ban. EFSA does not conclude that titanium dioxide (E171) is genotoxic, but it has not been able to establish a maximum acceptable daily intake (ADI) for this food additive, in particular due to uncertainties with respect to genotoxicity. EFSA thus concluded that the safety of the product cannot be confirmed.
Is food containing titanium dioxide (E171) safe to eat?
The scientific data around the safety of titanium dioxide (E171) is uncertain. However, EFSA has concluded that it has sufficient concern that titanium dioxide (E171) should no longer be used in food as a food additive. Because titanium dioxide (E171) is used in food throughout the EU, a European wide approach is needed to consider the next steps to protect consumers health. The FSAI joined other Member States at a meeting with the European Commission on the 18th May 2022 where these steps were discussed. Some people may have personal concerns and they can identify foods containing titanium dioxide (E171) by looking at the ingredients list on the food label which will say “colour: titanium dioxide” or “colour: E171” if the additive is in the food. This will enable consumers to make an informed purchasing decision.