The French Agency for Food, Environmental and Occupational Health & Safety’s (ANSES) method proposes specific adaptations related to regulatory definitions, particle size measurements, dissolution properties and hazard identification.
The method is specifically adapted to the minute levels of nanomaterials contained in manufactured food additives and thus is only applicable to oral exposures.
"Nanomaterials require a “nanospecific” risk assessment approach due to their complexity, properties and behaviour,” explains Bruno Teste, Scientific Coordinator at ANSES.
“For example, nanomaterials readily interact with other substances, which can change their stability and their fate in the body."
The use of titanium dioxide (E171) in France has been suspended since January 2020, following the opinions published by the Agency in 2017 and 2019.
In 2019, the Netherlands Food and Consumer Product Safety Authority (NVWA) also highlighted the importance of examining immunotoxicological effects in addition to potential reprotoxicological effects.
EFSA opinion
In its opinion of May 2021, EFSA indicated that E171 could no longer be considered safe when used as a food additive.
When used as a white pigment, titanium dioxide has proved useful in boosting the brightness and opaque properties of supplements.
Earlier this month, its use reached another milestone as Stella Kyriakides, the European Commissioner for health and food safety confirmed titanium dioxide’s ban as a food additive from 2022.
“The safety of our food and the health of our consumers is not negotiable,” she said. “Today, we act decisively with our Member States, based on sound science, to remove a risk from a chemical used in food.”
In order to mitigate the potential impact of the Regulation on food business operators, transitional measures allow them to continue placing on the market food containing E171 for a limited period of time.
Thus, the Regulation will allow to place on the market foods containing titanium dioxide until six months after the Regulation enters into force. Those foods can continue to be marketed until their date of minimum durability or ‘use by’ date.
This guide follows on from the work undertaken by the Agency over the last ten years. Specifically, ANSES’ first phase of its appraisal identified 30 substances suspected of being used as food additives or ingredients.
Further work needed
The authority reiterated the need to conduct physico-chemical characterisation studies for these substances as soon as possible using electron microscopy approaches.
“This is because measuring size and particle size distribution is an essential preliminary step before assessing the risks of these nanomaterials,” ANSES explains.
“In addition, the test conditions for physico-chemical characterisation, exposure calculations and toxicological studies need to be standardised, to facilitate the acquisition of appropriate and usable data for risk assessment.”
Lastly, until their safety can be demonstrated, the Agency stressed the need to limit exposure of workers, consumers and the environment to nanomaterials.
To this end, the agency recommends the use of ‘safe’ products that do not contain these substances and are equivalent in terms of function, effectiveness and cost.
