Food colours: titanium dioxide marks re-evaluation milestone

Over the past seven years, EFSA’s Panel on Additives and Nutrient An element or compound needed for normal growth, development and health maintenance. Essential nutrients cannot be made by the body and must, therefore, be consumed from food. Sources Added to Food (ANS) has re-assessed the safety of 41 food colours, taking into account all available scientific studies and data. Where possible, the Panel has established or updated an ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. for each substance.

Ruud Woutersen, Vice-Chair of the ANS Panel, said: “The completion of the food colour re-evaluations is an important milestone for EFSA, but our work does not stop here. There are still a considerable number of other food additives to be re-evaluated by 2020. And, of course, we are prepared to respond to any additional requests from the European Commission to review colours and other additives in the light of newly available scientific information.” (Full interview with Prof Woutersen)

Available toxicological data on titanium dioxide do not indicate adverse effects via oral ingestion. While the ANS Panel was unable to set an ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. for titanium dioxide because of data limitations, using the margin of safety The gap between the actual intake of a substance by a given population and the estimated daily dose over a lifetime that experts consider to be safe. approach, they concluded that dietary exposure For the purposes of risk assessment, measurement of the amount of a substance consumed by a person or animal in their diet that is intentionally added or unintentionally present (e.g. a nutrient, additive or pesticide). does not pose health concerns. The experts highlighted, however, the need for new research to fill data gaps on potential effects of titanium dioxide on the reproductive system.

What is titanium dioxide?

Titanium dioxide is a pigment commonly used to provide a cloudy effect and white background colour. Its main food uses are in confectionery, bakery and sauces but it is also found in cosmetics and has many industrial uses.

Following ingestion, most titanium dioxide passes through the body unchanged in the faeces but a small amount (maximum 0.1%) can be absorbed by the gut and distributed to various organs.

Food-grade titanium dioxide is not considered a nanomaterial Natural or manufactured material which contains miniscule single units typically measuring between 1 and 100 nanometers. A nanometer is one-billionth of a meter (a human hair is 80,000-100,000 nanometers wide). under the current European Commission Recommendation on the definition of nanomaterial but it may contain up to 3.2% nanoparticles (less than 100 nanometres in size) by weight. EFSA’s experts, therefore, evaluated studies with food-grade and non-food-grade (including nano-sized) titanium dioxide. A small number of studies with some non-food grade titanium dioxide suggest possible adverse effects on the reproductive system.

What is the margin of safety?

In the food additives area, when there are insufficient data for establishing an ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs., risk assessors calculate a margin of safety to determine whether current exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. might be of potential concern. Generally, a margin of safety of 100 or more is not considered to be a concern for public health.

In the most realistic scenario for food-grade titanium dioxide, the margin of safety for high-consuming children (the most exposed population Community of humans, animals or plants from the same species.) would be 150, but for most scenarios the margins were several times higher.

More data needed

Additional testing on food-grade titanium dioxide – an extended 90-day study or a multi-generation or extended one-generation reproductive toxicity The potential of a substance to cause harm to a living organism. study according to current OECD guidelines – would help to clarify possible reproductive effects and provide more comprehensive data for deriving an ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs..

EFSA’s experts recommend taking animal welfare into consideration when deciding on testing approaches for generating new toxicological data.

• Scientific Opinion on the re-evaluation of titanium dioxide (E171) as a food additive

Background

Titanium dioxide has been authorised for use in food in the European Union for many years. The new assessment by the ANS Panel is part of the re-evaluation of all food additives authorised before January 2009 (Regulation EU (No) 257/2010).

Under Commission Recommendation 2011/696/EU, for a compound to be considered a nanomaterial, nanoparticles should account for at least 50% of the particles in the number size distribution, with one or more dimensions in the size range 1-100 nm (100 nanometres equal to 0.0001 mm).

While there are no specific limits on the particle size of titanium dioxide used as a food additive, food-grade titanium dioxide consists mainly of larger granules, with limited nanoparticle content.