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anses

French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 19/06/2020

Nanomaterials

Presentation and ANSES's work

Keywords : Nanomaterials

Nanomaterials are increasingly being used in many everyday products, including foods, cosmetics, medications, etc. Their presence raises multiple questions about the risks they may pose to human health and to the environment. Below is a detailed review of ANSES's work on nanomaterials.  

What are nanomaterials?

Nanomaterials are very small materials that are 10,000 times smaller than the thickness of a human hair. This small size gives them physical and chemical properties different from those of “traditional” materials.

Nanomaterials are naturally found in the environment, for example in ash clouds from volcanoes and in smoke from fires. Some human activities also produce nanomaterials: smoke from candles, emissions from combustion engines, etc.

Over the past 30 or so years, it has become possible to produce nanomaterials in laboratories and industry. All of the techniques and processes enabling nanomaterials to be manufactured and handled are called nanotechnologies.

Nanomaterials are now ingredients in numerous everyday products: foods, medications, construction materials, cosmetics, etc.

The specific physico-chemical characteristics of nanomaterials (size, morphology, solubility, etc.) are exploited in many manufactured products. For example, nanomaterials can intentionally be used as food additives to improve a product's appearance or appeal (by modifying its structure, colour or texture) or to increase the bioavailability of certain nutrients by helping the body absorb them. In the medical sector, for example, nanomaterials are used to optimise the analytical performance of diagnostic tests and increase the efficacy of certain therapies.

However, the increased use of nanomaterials has raised many questions regarding the risks they may pose to human health as well as to the environment, especially since the regulatory framework governing their use is still being established.

 

Nanomaterials: assessing risks to protect humans and the environment

Since 2006, ANSES has issued several overall assessments concerning the risks to human health and the environment:

See the press kit “Assessment of the risks associated with nanomaterials: issues and update of current knowledge” from May 2014 (in french)

 

ANSES has also conducted more in-depth assessments on certain risks associated with specific nanomaterials:

One of the difficulties encountered when assessing the risks associated with nanomaterials is the inability to use methods developed to assess the risks associated with “traditional” substances, i.e. substances in molecular state. It is therefore necessary to develop new methods or adapt the existing methods to accommodate the specific characteristics of nanomaterials. To that end, ANSES has developed several methods for assessing the risks associated with nanomaterials.

 

Improving knowledge of the nanomaterials found in France

To best protect the population and undertake studies on the nanomaterials posing the greatest risk, it is necessary to have a global and detailed view of the nanomaterials most commonly used in France. In 2012, France introduced the mandatory reporting of substances with nanoparticle status, as is, in mixtures and in certain materials, for manufacturers, importers and distributors of more than 100 g of substances with nanoparticle status per year. The creation of the register and the collection of these reports were entrusted to ANSES via the R-Nano application.

 

According to Regulation (EU) No 1169/2011 on the provision of food information to consumers, the names of ingredients in the form of nanomaterials in food products shall be followed by "[nano]" on packaging.

Despite these obligations, the traceability of nanomaterials in the food industry is still incomplete and complicated. There may be non-compliance with the labelling rules due to different definitions of nanomaterials depending on the sector of use, resulting in a vague and ambiguous regulatory framework.

 

Defining and regulating the use of nanomaterials at European level

Defining nanomaterials

The European Commission's recommendation on the definition of nanomaterials (2011/696/EU) has served as a reference for various legislative texts in Europe. After several phases of discussion that began in 2012, the Commission is considering a 14-week public consultation on a revised definition. This revision should make it possible to obtain a harmonised definition that can be applied to all the different industry sectors.

In this context, ANSES received a formal request to assess the existence of measurement methods compatible with the future proposed definition and issue an opinion presenting adaptations to the current definition proposed in Recommendation 2011/696/EU as it deems necessary.

 

Adapting the REACh Regulation to nanomaterials

In the European Union, the registration, evaluation and authorisation of chemicals are regulated by the REACh Regulation. When it entered into force in 2007, the REACh Regulation did not include any specific provisions for nanomaterials.

In 2013, discussions were launched to amend the REACh Regulation with the aim of better taking nanomaterials into account.

ANSES provided scientific and technical support in the framework of the deliberations and the drafting of the regulation's amendments. New annexes taking nanomaterials into account entered into force on 1 January 2020.

ANSES also actively contributes to the work on nanomaterials undertaken by the European Chemicals Agency (ECHA).

 

ANSES and research on nanomaterials

Financing research on nanomaterials

As part of its missions to coordinate and support research, ANSES operates the National Research Programme for Environmental and Occupational Health (PNR-EST).

Every year, research projects on nanomaterials are financed through this programme.

 

Contributing to research projects on nanomaterials

ANSES has participated in various national and European research projects to contribute to assessing the hazards associated with nanomaterials and improve the tests used to that end:

  • 2010-2013: the Nanogenotox Joint Action in Europe, whose goal was to develop a method for detecting the genotoxic potential of nanomaterials. (in french)
  • 2013-2017: the European NanoReg project aiming to harmonise tests for the physico-chemical characterisation of nanomaterials and for the assessment of their toxicity.
  • 2013-2017: the French-German ANR SolNanoTox project with the assessment of the hazards associated with titanium dioxide and aluminium nanomaterials.
  • 2017-2019: the PNR-EST Enorpreg project with the assessment of maternal/foetal transfers of gold nanoparticles as well as their toxic effects.
  • ANSES is a partner of the NanoID nanoparticle identification platform dedicated to safety issues, approved by France's ‘Major Loan’ scheme (Equipex 2010 call for tenders) and coordinated by the CEA in Grenoble.

 

Nanomaterials: taking society's expectations into account

Faced with scientific uncertainties and societal questions raised by nanomaterials, ANSES created a dialogue committee on “Nanomaterials & health” in 2012.

This dialogue committee is a forum for discussions with stakeholders (environmental protection, patient and consumer associations, as well as trade unions, companies and industrial federations) on current scientific work and research needs. It also enables the Agency to be informed of civil society’s expectations and concerns in this area and helps guide its work programme.