Following media coverage in France, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) announced that the question of nanomaterials in food products will be addressed in 2017. An opportunity to take stock of the situation with regard to nanomaterials.

Nanomaterials as substances

Nanomaterials are regulated as substances under the overarching REACH Regulation, despite not being mentioned. They are consequently subject to its general procedures: registration for quantities of one tonne or more per year and authorisation in case of inclusion in the list of Substances of Very High Concern (SVHC).

In 2010, France went beyond REACH registration standards by requiring specific information from manufacturers, importers, and downstream users of nanomaterials with a threshold of 100 grams. Through the « R-Nano » website set up by the Ministry of Environment, they have to report each year on the identity of the substance, its quantity and use as well as the identity of the buyers.

ANSES is responsible for managing these declarations and data, the information resulting from these being made available to public.

Nanomaterials as novel food products

Procedure. Engineered nanomaterials present in food products are subject to the specific “novel food” regulatory framework (Regulation EU 2015/2283). Only authorised novel food can be marketed, the EU list being established by the Commission.

In order to market a novel food product containing nanomaterials in France, companies must apply directly to the EU Commission, the 2015 Regulation having centralised the procedure, submit scientific information as well as a safety assessment report, and demonstrate up-to-date testing methods. The food product will only be approved if it does not present a risk to public health, is not nutritionally disadvantageous when replacing a similar food and is not misleading to the consumer. Companies have to market the food product according to the conditions specified in the authorisation.

All ingredients present in the form of engineered nanomaterials must be clearly indicated on a label in the list of ingredients with the word ‘nano’ put in brackets. It has to be noted that a French NGO published last June a study demonstrating that certain food products marketed in France, scientifically analysed as containing nanomaterials, were in breach with this requirement. A proven breach shall be subject to fines.

Risk Assessment. According to its 2017 work program, ANSES will conduct a risk assessment on agri-food industry workers’ and food products consumers’ exposure. Following a French scientific study released on 20 January 2017 in Scientific Reports, the open access journal from Nature, showing that food-grade titanium dioxide (TiO²) has adverse and carcinogenic effects on rats, ANSES will also analyse the feasibility of a specific TiO² risk assessment on humans.

A reinforcement of EU nanomaterials regulation has been asked for years by ANSES and should consequently be foreseen at some point.