For regarding thirty years, it has now been possible to produce nanomaterials in the laboratory and in industry. All the techniques and processes used to manufacture and manipulate nanomaterials are called nanotechnology.
Nanomaterials are now used in the composition of many daily life products : food, drugs, construction products, cosmetics…
The specific physico-chemical characteristics of nanomaterials (size, morphology, soluble nature, etc.) are used in many manufactured products. For example, in thefeednanomaterials can be voluntarily added asfood additives to improve the appearance of a product, its palatability (modify the structure, color, texture) or the bioavailability of certain nutrients (by promoting the absorption by the body of certain nutrients). In the medical domainnanomaterials are used with a view to optimizing the analytical performance of diagnostics or even to improve the effectiveness of certain therapeutic treatments.
However, the use of nanomaterials raises many questions regarding health risks that they can entail, both for the human health only for theenvironmentespecially since the construction of the regulatory framework for their use is not yet complete.
Nanomaterials: assessing the risks to best protect humans and the environment
Since 2006, the Agency has issued several global assessments concerning the risks to human health and the environment:
> See the press kit “Assessment of risks related to nanomaterials, issues and update of knowledge” of May 2014 (PDF)
ANSES has also more precisely assessed certain risks associated with specific nanomaterials:
One of the difficulties encountered in assessing the risks associated with nanomaterials is the impossibility of using the methods developed to assess the risks associated with “classic” substances, ie substances at the molecular state. It is therefore necessary to develop new methods or to adapt existing methods to the particularities of nanomaterials. To this end, ANSES has developed several methods for assessing the risks associated with nanomaterials.
Better understand the nanomaterials present in France
To best protect the population and undertake studies on the nanomaterials most at risk, it is essential to have an overall and detailed view of the nanomaterials most used on French territory. Since 2012, France has made the declaration of substances in the nanoparticle state, as such, in mixtures or in certain materials, mandatory for manufacturers, importers and distributors of more than 100 grams of substances in the nanoparticle state per year. The setting up of the register and the collection of these declarations were entrusted to ANSES via the R-Nano system.
> Consult our opinion on the evaluation of the R-Nano national declaration system (2020)
According to Regulation 1169/2011 on consumer information on foodstuffs, the presence of nanomaterials in food products must also be indicated by the mention [nano] on the packaging.
Despite these obligations, the traceability of nanomaterials in the field of food still remains incomplete and complex today. Non-compliance with labeling can be explained by the existence of heterogeneous definitions for nanomaterials leading to vagueness and regulatory ambiguities.
Define and regulate the use of nanomaterials at European level
Defining nanomaterials
At European level, the European Commission’s recommendation for the definition of nanomaterials (2011/696/EU) has served as a reference on several occasions in the various legislative texts. After several phases of discussion initiated in 2012, the Commission launched from May 6, 2021 to June 30, 2021 a public consultation on a revised definition. This revision should make it possible to obtain a harmonized definition which would be applicable to the various sectors of activity.
ANSES received a request from its supervisory ministries to support them in responding to this consultation. In a first phase of work, it carried out a review of the analytical methods available for the characterization of nanomaterials.
2020: Review of the analytical methods available for the characterization of nano-objects, their aggregates and agglomerates in order to meet regulatory requirements
He was also asked to provide support to ministries in responding to the commission’s proposals for changes to the definition.
2021: Nanomaterials: for a more protective definition
Adapt the REACh regulation to nanomaterials
In the European Union, the registration, evaluation and authorization of chemical substances are regulated by the REACh regulation. When it was introduced in 2007, the REACh regulation did not provide for specific provisions for nanomaterials.
As early as 2013, discussions were initiated to modify the REACh regulation to better take nanomaterials into account.
ANSES provided its scientific and technical support in the various work of reflection and drafting of amendments to the regulation. New annexes taking nanomaterials into account will enter into force on January 1, 2020.
ANSES also actively contributes to the work on nanomaterials of the European Chemicals Agency (ECHA) (PDF)
ANSES and research on nanomaterials
Fund research on nanomaterials
As part of its mission to program and support research, ANSES leads the national Environment-Health-Work research program (PNR-EST).
Each year, research projects on nanomaterials are funded through this channel.
Contribute to research projects on nanomaterials
ANSES took part in various national and European research projects in order to contribute to the assessment of the danger of nanomaterials and to the improvement of the tests used for this:
- 2010-2013: the European joint action Nanogenotox which focused on developing a method for detecting the genotoxic potential of nanomaterials.
- 2013-2017 : the European project NanoReg aimed at harmonizing tests for the physico-chemical characterization of nanomaterials and for the assessment of their toxicity.
- 2013-2017 : the Franco-German ANR project SolNanoTox with the hazard assessment of titanium dioxide and aluminum nanomaterials.
- 2017-2019: the PNREST Enorpreg project with the evaluation of the mother/fetus transfer of gold nanoparticles as well as their toxic effects.
ANSES is a partner of the NANOID nanoparticle identification platform dedicated to security labeled by the Grand Emprunt (2010 Equipex call for tenders) and coordinated by the CEA of Grenoble.
Nanomaterials: taking society’s expectations into account
Faced with scientific uncertainties and societal questions raised by nanomaterials, ANSES set up a “Nanomaterials & health” dialogue committee in 2012.
This dialogue committee makes it possible to discuss with the stakeholders (environmental protection, patient and consumer associations, employee unions, companies and industrial federations) on the scientific work in progress and the research needs. It also helps to inform the Agency regarding the expectations and concerns of civil society in this area and to inform its work orientations.
