The European Commission is banning titanium dioxide (E171) as a food additive in the EU, starting with a six-month phasing out period as of February 7, , until August 7, , after which a full ban applies. Following the publication of Commission Regulation (EU) /63 in the EU&#;s Official Journal (OJ) on January 18, , Annex II and III to Regulation (EC) No / on food additives will be amended accordingly. The Regulation also includes a commitment to review the necessity to maintain or delete titanium dioxide (E171) from the EU list of food additives for exclusive use as a color in medicinal products. On November 30, , the Commission had already published Commission Implementing Regulation (EU) / in the OJ, denying the authorization of titanium dioxide (E171) as a feed additive for all animal species.
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Why was titanium dioxide used in food products and why has it now been banned
Titanium dioxide is the naturally occurring oxide of titanium, primarily used as a colourant in a wide range of different applications. It has been used for decades to impart white colour to many foods, from baked goods and sandwich spreads to soups, broths, sauces, salad dressing and food supplements.
Examining the safety of all food and consumer products is something that the EU does, and even repeats if new evidence has come to light, therefore the safety of titanium dioxide, when used as a food additive (E171), has been examined regularly.
In March , the Commission asked the European Food Safety Authority (EFSA) to update its Opinion on titanium dioxide (E 171). While in , the EFSA did not indicate any safety concerns, however, it identified some data gaps and uncertainties especially regarding the particle size. This parameter may have an influence on the toxicological properties of E 171.
While the new EFSA Opinion, published on 6 May , does not conclude that E171 is a definite risk to health, it does not rule out that possibility either. In particular, EFSA does not rule out genotoxicity concerns, meaning that there is a possibility that the use of titanium dioxide as food additive might cause DNA or chromosomal damage. In the EU, the fact that the safety of a food additive cannot be confirmed is sufficient to warrant a ban.
Is titanium dioxide also being banned in non-food products?
The new EFSA opinion assessed titanium dioxide when used as a food additive in foods.
Titanium dioxide will still be authorised for use in medicinal products until other safe alternatives are found. This is to avoid causing shortages of medicinal products that could negatively impact public health or animal health and welfare. This approach is supported by the European Medicines Agency (EMA) analysis on the use of titanium dioxide in medicines published on 8 October . The Commission, together with EMA, will re-evaluate the situation in the future.
The pharmaceutical industry is invited to accelerate the research and development of alternatives in both new and already authorised products, and to submit the necessary changes to the terms of the marketing authorisations concerned.
Titanium dioxide as a common chemical is also widely used in other products such as paints, paper, plastics, printing inks or cosmetic products and the potential relevance of the new EFSA Opinion is considered for other sectors.
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How is the safety of food additives assessed?
EFSA scientifically assesses the safety of the food additives. New food additives are evaluated based on a dossier with relevant data, which is usually provided by an applicant (normally the producer or a potential user of the food additive).
Food additives are under continuous observation and the Commission may request a new safety assessment whenever it is needed, based on new scientific information available.
In the safety assessment EFSA determines the level below which the intake of the substance is considered safe, the so-called Acceptable Daily Intake value (ADI) and other safety-relevant factors. When needed, the Commission, based on the EFSA&#;s assessment, proposes to amend the legislation to ensure the safe use of food additives.
Why are food additives even used?
Food additives are added to foods for a technological purpose such as antioxidants and sweeteners and many processed foods as we know them today would not exist without food additives.
EU legislation is very strict and food additives may only be used if several conditions are met: these include a reasonable technological need, the use does not mislead the consumer and that there are advantages and benefits for the consumer, like preserving the food&#;s nutritional quality.
Additives can help extend products&#; shelf-life, which cuts down food waste, and plays a crucial role in aiding the manufacture, processing, preparation, treatment, packing, transport or storage of food.
To help consumers make better choices and to provide complete transparency, the EU requires that additives to be labelled according the rules set out in Regulation (EU) No /.
But we know that not everyone takes time to read the fine print. And they don&#;t have to &#; they can trust that the food products sold in the EU meet the highest safety requirements.
For more information on the recent ban of Titanium Dioxide in food products, please visit: Re-evaluation (europa.eu). For all other information of food additives, please visit: Additives (europa.eu)
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