01/12/2020 4 min

Nanomaterials: assessment of R-Nano, the national reporting scheme

Used in a wide variety of everyday products, nanomaterials nevertheless raise many questions about the risks to human health and the environment generated by their presence. In this context, ANSES reiterates the importance of reporting substances in nanoparticle form – which has been mandatory in France since 2013 – for traceability, public information and risk assessment. The Agency is carrying out an initial assessment of its reporting scheme after eight years in operation, and stresses how much the insufficient quantity or quality of data provided hampers the traceability of nanomaterials and the use of these data by public health agencies. It suggests several areas for improvement to make the R-Nano register data more reliable, improve nanomaterial traceability and optimise the system's efficiency.

Nanomaterials are contained in a wide variety of everyday products such as sunscreens, textiles, food and paints. They are used for their specific properties (size, morphology, solubility, etc.) in many industrial sectors, including construction, automotive, packaging, agri-food, cosmetics and health products. The large number of existing substances, along with the lack of knowledge of their effects on human health and the environment and of the degree of exposure to them, still constitute major obstacles to risk assessment.

In 2013, France launched a national scheme making the reporting of nanomaterials mandatory for manufacturers, importers and distributors of more than 100 grams per year of substances in nanoparticle form. The data reported in the R-Nano register managed by ANSES provide a better understanding of the nanomaterials placed on the market, the quantities handled and the intended uses, enable traceability in the sectors using them, and bring together knowledge for risk assessment and public information purposes.

Now, eight years on, ANSES has examined the quality of the data reported and the analyses already performed by public health organisations. It has identified the main limitations of reporting and some ideas for improving the system's efficiency in the future.

R-Nano: an invaluable register for assessing the health risks of nanomaterials that still suffers from inadequate reporting

France was a pioneer in the implementation of this reporting system, and has now for the first time taken stock of the nanomaterials produced, imported and distributed in the country. The 52,000 reports received between 2013 and 2017 show the great diversity of nanomaterial categories (inorganic, organic, metals, etc.) present in France, produced or imported each year in non-negligible quantities (over 400,000 tonnes). They also reveal the large number of companies and research organisations using them.

The information collected also contributes to the work carried out by public health organisations to better understand population exposure levels.

However, during the processing of reports, ANSES noticed that data was missing. It has now shown, through a detailed analysis of the reported data, that the overall level of information in the reports is unsatisfactory, meaning that the traceability objective has only been partially achieved.

Improvements needed to make the system more reliable and optimise its use

Obtain reliable, high-quality data from reporting companies

Among the 52,000 reports analysed, 90% of the characterisation data for nanomaterials (on aspects such as size, specific surface area and surface charge) were unusable, while only 10% provided correct information on nanomaterial use. If the quantity or quality of data is insufficient, this has a significant impact on the opportunities for their analysis, particularly when assessing potential health risks. ANSES reiterates the need to mobilise reporting companies, under the aegis of the administrative authority in charge of the register, in order to find solutions to improve data collection.

The flexibility granted to reporting companies when the system was first set up, to help them with their declarations, now greatly undermines data quality. The Agency therefore emphasises the importance of ending the exemptions granted and increasing reporting requirements, in terms of the information to be provided.

A system for verifying the quality and relevance of the recorded data should also be considered.

Broaden the scope of reporting to improve traceability of nanomaterials

There is still room for improvement in the system. To obtain full traceability of the nanomaterials on the market, ANSES recommends considering:

  • broadening the reporting requirement: reporting does not currently target all the players in the transmission chain, from the company first placing the products on the market through to distributors and consumers. Reporting should also apply to substances exported outside France;
  • lowering the threshold for reporting nanomaterials; currently only nanomaterials in which at least 50% of the particles are in the size range 1-100 nanometres have to be declared. However, some nanomaterials with a nanoscale fraction below this threshold may still be of concern for health and the environment;
  • providing additional information such as the number of workers potentially exposed to nanomaterials and the quantities deployed by type of use. 

Improve data provision

The strict confidentiality requirements introduced in the regulations limit the opportunities for making data available. In fact, the regulations adopted under the Grenelle Acts have made confidential a great deal of information on the identity of substances. ANSES recommends that these texts be re-examined.

Lastly, ANSES emphasises the need to extend data access to public health players, and the decree listing the organisations with access should be revised to this effect.

Consideration of nanomaterials at European level

The regulatory framework for nanomaterials is still under development at European level.

A review of the recommendation on the definition of nanomaterials proposed by the European Commission has been pending for several years. ANSES will be issuing an opinion on this definition as part of the public consultation organised by the Commission.

Since 2020, although the European REACh Regulation requires specific information to be provided for substances in nanoparticle form, it does not provide the same level of information as obtained through the French reporting system. In addition, the tonnage threshold for registration under REACh (1 tonne) is much higher than the applicable threshold in R-Nano (100 grams). REACh is therefore unable to trace uses involving small quantities of nanomaterials, which are nevertheless very common. Moreover, because substance registration dossiers are submitted by consortia or groups of companies, the level of traceability of the players is far lower than that obtained with R-Nano.