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French Agency for Food, Environmental and Occupational Health & Safety

Nanomaterials in food: ANSES's recommendations for improving their identification and better assessing consumer health risks

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News of 09/06/2020

Since the late 1990s, because of their specific properties, an increasing number of nanomaterials have been incorporated into everyday products, particularly foods. Now, faced with the proliferation of engineered nanomaterials in our daily lives, many questions are being asked about their identification, their impacts on human health and the environment, and how to regulate them. ANSES is particularly interested in this topic and has published several expert appraisal reports on nanomaterials since 2006.  In line with this, the Agency now offers a review of the presence of engineered nanomaterials in food, along with a method to determine the best approach for assessing the health risks of foods containing such materials.

Over the last thirty years, industry – particularly the food industry – has been developing the use of engineered nanomaterials because of their specific nanoscale properties. In view of the concerns about their use, ANSES received a formal request to investigate the matter from the Directorate General for Food (DGAL), Directorate General for Health (DGS), Directorate General for Labour (DGT), Directorate General for Risk Prevention (DGPR) and Directorate General for Competition, Consumer Affairs and Fraud Control (DGCCRF). The Agency's expert appraisal work has now identified the main uses of engineered nanomaterials in the food industry:

  • As an additive, to improve the appearance and palatability of the food product (by modifying its structure, colour or texture, e.g. E341iii – tricalcium phosphate – or E551 – amorphous silica);
  • As food contact materials, to improve packaging safety (e.g. the antimicrobial function provided by nano-silver);
  • Lastly, ingredients with a nutritional function which may be found in nanoparticle form were identified (e.g. calcium carbonate used in infant formula to achieve an adequate calcium content).

In France, reporting of substances with nanoparticle status, which has been mandatory since 2013 via the R-Nano register managed by ANSES, requires manufacturers, importers and distributors of more than 100 grams of nanoparticle substances per year to declare the identity of the substances, the quantities handled and the intended uses. Despite these obligations, identification and traceability of nanomaterials in the food industry are still currently limited. They are, however, an essential step in health risk assessment.


Thirty-seven engineered nanomaterials referenced and most food categories involved

Based on data published in the scientific literature, the Agency has referenced 37 substances, used as food additives or food ingredients and for which it considers the presence of nanoparticles to be proven (seven substances: calcium carbonate, titanium dioxide[1], iron oxides and hydroxides, calcium silicate, tricalcium phosphates, synthetic amorphous silicas, organic and composite compounds) or suspected (30 substances, including aluminium, silver, gold, magnesium phosphates, ferric ammonium citrate, sodium, potassium and calcium salts of fatty acids, etc.).

The presence of nanomaterials in food can be characterised using advanced analytical technologies such as electron microscopy. These tools can then identify engineered nanomaterials, either when incorporated intentionally as food additives or intrinsically present in the ingredients. However, the physico-chemical heterogeneity (size, particle size distribution, etc.) observed for a given substance, as well as the lack of information on declarations and labelling, mean that it is not possible to extrapolate the presence of nanomaterials to all batches and finished products containing this same substance.

According to the food databases (OQALI and the GNPD), nearly 900 food products incorporate at least one additive or ingredient classified as "substances for which the presence of engineered nanomaterials is proven". However, this does not necessarily mean that nanomaterials are present in every product or batch. The food sub-sectors most concerned are infant formula (25.6%), confectionery (15.6%), breakfast cereals (14.8%), cereal bars (12.9%), and frozen pastries and desserts (10.9%). ANSES points out that this survey was carried out before the suspension of E171 in France.

For this stage of the appraisal, ANSES conducted a review of the use of nanomaterials in food. The next step will be to study the potential consumer health risks posed by these substances.

Given the uncertainties about the risks of nanomaterials in food, ANSES reiterates the recommendations of its previous expert appraisals on the subject. In particular, it calls for consumer exposure to be limited by avoiding unnecessary uses of nanomaterials in food and by promoting safe products, free of nanomaterials, that are equivalent in terms of function and effectiveness.


Better assess the health risks of nanomaterials for consumers

ANSES believes that the properties of engineered nanomaterials call for a tailored approach to assessing the health risks of substances containing them in food. In this context and following EFSA's publication of guidance on assessment of the application of nanoscience and nanotechnologies, ANSES is proposing an approach that helps determine the risk assessment best suited to the manufactured substance. This approach can therefore be used to decide whether a standard or nanospecific risk assessment is required.

ANSES plans to apply this approach to a selection of substances and to offer a nanospecific risk assessment methodology. The first results are expected by early 2021.

Within the framework of this expert appraisal, the Agency relied on its own classification of the term "engineered nanomaterial":

An engineered nanomaterial is a material of an organic, inorganic or composite nature, produced by humans for application purposes and comprised wholly or partly of constituent particles with at least one dimension between 1 and 100 nm (nanoscale).

The dimensions of the constituent particles may be greater than 100 nm if these particles have a large specific surface area or nanoscale properties.

Constituent particles can be found in the form of aggregates or agglomerates whose dimensions can be much larger than the nanoscale.

Materials for which the nanoscale fraction was not intentionally produced during the manufacturing process are included in the scope of this classification.

[1] For which the placing on the market in France of foodstuffs containing the additive (E171) has been suspended for one year starting from 1 January 2020