A singular approach to assessing the health risks of engineered nanomaterials across food and nutraceutical ingredients is not enough, according to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES). 

The authority has now published a scientific guide on conducting risk assessments for engineered nanomaterials used as food additives and ingredients with a nutritional function.

This move follows the European Food Safety Authority (EFSA)’s latest safety assessment for the food additive titanium dioxide (E171) – also labeled as TiO2  – which deems the potentially carcinogenic white colorant unsafe.

“Nanomaterials require a ‘nanospecific’ risk assessment approach due to their complexity, properties and behavior,” explains Bruno Teste, scientific coordinator at ANSES.

“For instance, nanomaterials readily interact with other substances, which can change their stability and their fate in the body.”

Use of TiO2 in France has been suspended since January 2020, following the opinions published by ANSES in 2017 and 2019.Screening for safety
ANSES’ new nclick="updateothersitehits('Articlepage','External','OtherSitelink','ANSES calls for uniform approach to screening nanomaterials like TiO2 in new safety assessment','ANSES calls for uniform approach to screening nanomaterials like TiO2 in new safety assessment','324499','https://www.anses.fr/fr/system/files/ERCA2016SA0226.pdf', 'article','ANSES calls for uniform approach to screening nanomaterials like TiO2 in new safety assessment')">methodology will initially be tested on a range of engineered nanomaterials. 

The methodology proposes specific adaptations related to regulatory definitions, particle size measurements, dissolution properties and hazard identification.

Engineered nanomaterials are currently used for a range of purposes. For example, they’re used as food additives to improve a product’s appearance and palatability by modifying its structure, color or texture.

As technological additives in the formulation of food contact materials, they modify the properties of these materials, indicate the presence of any pathogens, or improve the organoleptic quality and shelf life of food.

Nanomaterials are also used in ingredients with a nutritional function. One example is calcium carbonate, which is used in infant formula to achieve an adequate calcium content.

In the first phase of its appraisal, ANSES has already identified 30 substances suspected of being used as food additives or ingredients. 

Therefore, it reiterates the need to conduct physico-chemical characterization 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.

Assessing titanium dioxide
At this stage, titanium dioxide appears to be the nanomaterial with the best-documented exposure and hazard data. This would allow a full risk assessment to be conducted for a nanomaterial used in food.

Use of this additive in France has been suspended since January 2020, following the opinions published by ANSES in 2017 and 2019.

In the food supplement space, TiO2 is mostly used for its ingredient-masking capabilities.In its opinion of May 2021, EFSA indicated that E171 could no longer be considered safe when used as a food additive. The decision-making process at European level has just reached a new stage, which should lead to this chemical being banned in the EU from 2022. 

Prior to ANSES’ release of its methodology, EFSA published a guide in 2018 to assess dossiers on nanoscience and nanotechnologies in applications such as food additives, pesticides and food contact materials.

Clean label alternatives in the spotlight
In the food supplement space, titanium dioxide is mostly used for its ingredient-masking capabilities. With the white pigment – often used in sunblock and cosmetics – under scrutiny, clean label alternatives are seeing inflated demand.

ANSES is also calling for industry to limit the exposure of workers, consumers and the environment to nanomaterials until their safety can be demonstrated. To this end, it recommends promoting the use of safe products that do not contain these substances and are equivalent in terms of function, effectiveness and cost.

In February, Colorcon expanded its Nutrafinish Film Coatings portfolio to include “Label Friendly” and “TiO2-Free” coatings for the nutritional and dietary supplements market.

Lonza’s Vcaps Plus White Opal capsules were released in 2019 and use calcium carbonate to avoid TiO2. 

In food ingredient launches, Döhler’s White Diamond is marketed as a cost-effective natural alternative to titanium dioxide. Applicable in confectionery, hard candies, icings and alcoholic beverages, the pigment is readily metabolizable, free of nanoparticles and contains additional nutritional benefits.

Meanwhile, Sensient offers a global suite of titanium dioxide alternatives named Avalanche. This portfolio of options is designed to best match the performance of titanium dioxide and the solutions are customized and application-specific depending on customers’ needs.