Nanomaterials are used in the composition of a wide variety of everyday products: sun creams, textiles, foods, paints, etc. Used for their specific properties (size, morphology, soluble nature, etc.), nanomaterials concern many industrial sectors such as construction, automotive, packaging, agri-food, cosmetics or products health. The multiplicity of existing substances, the lack of knowledge regarding the effects on human health and the environment and the exposures to which they lead still constitute a major obstacle to risk assessment.
France has created a national system making the declaration of nanomaterials mandatory for manufacturers, importers and distributors more than 100 grams per year of substances in the nanoparticle state. The data declared in the registers R-Nanoof which ANSES has been appointed manager, make it possible to better understand the nanomaterials placed on the marketthe quantities handled and the intended uses, to have a traceability of the sectors of use and to gather knowledge for risk assessment and public information purposes.
After eight years of existence, ANSES has assessed the quality of the data reported and the analyzes already carried out by public health bodies; it has thus identified the main limits associated with the declaration and the avenues for improving the efficiency of the system in the future.
R-Nano: an essential register for the assessment of health risks related to nanomaterials but still too poorly informed
Pioneer in setting up this reporting system, France now has a first state of knowledge of nanomaterials produced, imported and distributed on its territory. THE 52,000 declarations recorded between 2013 and 2017 thus reveal that a very great diversity categories of nanomaterials (inorganic, organic, metals, etc.) are present in France, produced and imported each year in significant quantities (more than 400,000 tonnes) and that many companies and research organizations use them.
The information collected also contributes to serving the works conducted by public health agencies to better understand the exposure levels of populations.
However, ANSES noted missing data when analyzing the declarations. It demonstrates today, by the detailed analysis of the declared data, that the overall level of information of the declarations is not satisfactory. The traceability objective is therefore only partially achieved.
Improvements needed to make the system more reliable and optimize its operation
Obtain reliable and quality data from declarants
Of the 52,000 declarations analysed, 90% characterization data nanomaterials such as size, specific surface, surface charge are not usable and only 10% correctly indicate their use. Lack of or poor quality data significantly impacts the possibilities of exploitation, particularly in terms of the assessment of potential health risks. ANSES reminds the necessary mobilization of declarants, 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 declarants during the implementation of the system to help them with their declaration now greatly hampers the quality of the data. The Agency therefore stresses the importance of put an end to the exemptions granted and of render the more demanding declaration in terms of the information to be provided.
A system for verifying the quality and relevance of recorded data should also be considered.
Broaden the scope of the declaration for better traceability of nanomaterials
The system can still be improved and to obtain full traceability of the nanomaterials present on the market, ANSES recommends considering:
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d’expand the reporting requirement : nowadays, the statement does not target all players in the transmission chain from the first marketer to distributors and consumers. The declaration should also apply to substances exported outside the national territory;
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of lower the threshold from which nanomaterials must be declared; today, only nanomaterials containing at least 50% of particles whose size is in the range 1-100 nanometers must be declared. Certain nanomaterials whose nanometric fraction is below this threshold might nevertheless be of concern for health and the environment;
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of provide additional information such as the number of workers potentially exposed to nanomaterials and the quantities deployed by type of use.
Improving data availability
The high confidentiality requirements introduced in the regulatory texts limit the possibilities of making data available. The regulatory texts taken in application of the Grenelle laws have in fact made confidential a great deal of information concerning the identity of substances. ANSES recommends re-examining these texts.
Finally, ANSES stresses the need to extend access to data to public health actors, the decree listing the organizations having access to it should be revised accordingly.