16/12/2022 3 mins

First application of ANSES's methodology for assessing the risks of nanomaterials in food

Conventional methodologies are not always suitable for assessing the potential health risks to consumers of nanomaterials used in food. In 2021, ANSES therefore proposed a "nanospecific" risk assessment methodology, which it has just tested on the food additive E171, or titanium dioxide (TiO2), which is the most widely studied nanomaterial. Its use in food has been prohibited in Europe since August 2022. This practical application has shown both the method's validity and the extent of the lack of data for conducting an adequate risk assessment of nanomaterials in food. 

A "nanospecific" approach is essential

Nanomaterials are used in numerous food products to improve their appearance and palatability, or to facilitate the absorption of certain nutrients. Because of their characteristics (size, morphology, etc.), nanomaterials can spread through the body and accumulate in certain organs in the form of nanoscale particles. For this reason, a "nanospecific" approach is needed to assess the potential health risks associated with their ingestion. In 2021, ANSES published a scientific guide for specifically assessing the health risk associated with the nanoscale fraction of nanomaterials in food products.

Nanomaterials used as food additives were previously assessed using standard methodologies, but these did not take into account the particularities of the nanoscale. Indeed, if they are not dissolved in the digestive system, nanoparticles have different properties and behaviour in the body than those observed with conventional substances. The nanospecific approach proposed by ANSES enables these particularities to be taken into account to ensure a more tailored assessment.

First test applied to the food additive E171

The methodology developed in 2021 has just been tested on the food additive E171, or titanium dioxide (TIO2), the nanomaterial for which the most data are available. This test has confirmed the relevance of ANSES's methodology and the need for a nanospecific approach. It has enabled exposure levels to be calculated for different populations and led to the identification of several potential health effects.

This application to a specific nanomaterial has also shown that much work remains to be done to obtain all the toxicological data needed to properly assess a nanomaterial. Indeed, it was not possible to complete the risk assessment of the additive E171 because some data were missing. "The experts identified all the data that will need to be produced on this nanomaterial; they concern general toxicity, genotoxicity, carcinogenicity, neurotoxicity and reproductive and developmental toxicity" explains Bruno Teste, coordinator of the expert appraisal and Scientific Project Leader in ANSES's Food Risk Assessment Unit.

Avoid using nanomaterials in food

Based on its findings, ANSES is reiterating its recommendation to limit exposure of workers and consumers to nanomaterials until their safety can be demonstrated, and avoid the dispersal of these particles in the environment. To this end, the Agency recommends promoting the use of products that do not contain nanomaterials and are equivalent in terms of function, effectiveness and cost.

Harmonise the assessment methodology at European level

The Agency will work with its counterparts, in particular the European Food Safety Authority (EFSA), to advance risk assessment methodologies and harmonise testing protocols for the physico-chemical characterisation and toxicology of nanomaterials. In 2018, EFSA published a guide to assessing dossiers on nanoscience and nanotechnologies in applications such as food additives, pesticides and food contact materials. Although the methodologies developed by EFSA and ANSES are based on similar concepts and risk assessment methodologies, ANSES's approach proposed specific adaptations related to regulatory definitions of nanomaterials, particle size measurements, dissolution properties and hazard identification.