EFSA has updated its safety assessment of the food additive titanium dioxide (E 171), following a request by the European Commission in March 2020.
The updated evaluation reviews the outcome of EFSA’s previous assessment published in 2016, which highlighted the need for more research to fill data gaps.
Prof Maged Younes, Chair of EFSA’s expert Panel on Food Additives and Flavorings (FAF), said: “Taking into account all available scientific studies and data, the Panel concluded that titanium dioxide can no longer be considered safe as a food additive A substance deliberately added to foods or beverages for beneficial technological reasons (eg to preserve, flavour, color or ensure a particular texture). Food additives are not normally consumed by themselves nor used as typical ingredients in food.. A critical element in reaching this conclusion is that we cannot exclude genotoxicity When a substance is capable of damaging the DNA in cells. concerns after consumption of titanium dioxide particles. After oral ingestion, the absorption of titanium dioxide particles is low, however they can accumulate in the body.”
The assessment was conducted following a rigorous methodology and taking into consideration many thousands of studies that have become available since EFSA’s previous assessment in 2016, including new scientific evidence and data on nanoparticles.
Our scientific experts applied for the first time the 2018 EFSA Scientific Committee Guidance on Nanotechnology to the safety assessment of food additives. Titanium dioxide E 171 contains at most 50% of particles in the nano range (ie less than 100 nanometres) to which consumers may be exposed.
Genotoxicity Assessment
Genotoxicity refers to the ability of a chemical substance to damage DNA A complex chain-like molecule that carries the genetic material, present in living organisms and some viruses. DNA (deoxyribonucleic acid) is capable of copying itself and carries the instructions for all the proteins used to create and sustain life., the genetic material of cells. As genotoxicity may lead to carcinogenic effects, it is essential to assess the potential genotoxic effects of a substance to conclude on its safety.
Prof Matthew Wright, both a member of the FAF Panel and chair of EFSA’s working group on E 171, said: “Although the evidence for general toxic effects was not conclusive, on the basis of the new data and strengthened methods we could not rule out a concern for genotoxicity and consequently we could not establish a safe level for daily intake The amount of a substance (eg nutrient or chemical) that is ingested by a person or animal via the diet. of the food additives.”
Risk managers at the European Commission and in EU Member States have been informed of EFSA’s conclusions and will consider appropriate action to take to ensure consumers’ protection.
Backgrounds
Titanium dioxide (E 171) is authorized as a food additive in the EU according to Annex II of Regulation (EC) No 1333/2008.
The safety of the food additive E 171 was re-evaluated by the EFSA ANS Panel in 2016 in the frame of Regulation (EU) No 257/2010, as part of the re-evaluation program for food additives authorized in the EU before 20 January 2009.
In its 2016 opinion, the ANS Panel recommended new studies be carried out to fill the gaps on possible effects on the reproductive system, which could enable them to set an Acceptable Daily Intake (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.). Uncertainty Scientific concept used in risk assessment to describe all types of limitations in available knowledge at the time an assessment is conducted, with the agreed resources, that affect the probability of possible outcomes to the assessment. around the characteristics of the material used as the food additive (E 171) was also highlighted, in particular with respect to particle size and particle size distribution of titanium dioxide used as E 171.
In 2019, EFSA published a statement on the review of the risks related to the 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. to food additive titanium dioxide (E171) performed by the French Agency for Food, Environment and Occupational Health Safety (ANSES). In its statement, EFSA highlighted that the ANSES opinion reiterated the uncertainties and data gaps previously identified by EFSA and did not present findings that invalidated the Authority’s previous conclusions on the safety of titanium dioxide.
In the same year (2019), the Netherlands Food and Consumer Product Safety Authority (NVWA) also delivered an opinion on possible health effects of food additive titanium dioxide, which highlighted the importance of examining immunotoxicological effects in addition to potential reprotoxicological effects.