The R-Nano Register

• In 2013, the first year of deployment, 3,400 reports were completed, via more than 930 reporting accounts, including more than 90 made by foreign suppliers and a total of 670 French entities participated. At the end of November 2013, an initial assessment was made public, reporting 500,000 tons of “substances in the nanoparticulate state” placed on the French market in 2012. In total, 279 substances had been identified after grouping… but no declaration on nano silver… As for carbon nanotubes, they did not appear either, some of them having been declared and merged in the “carbon” category in the public report.
• Mid-November 2014, the 2014 review was released. 400,000 tons of “nano substances” had been declared as produced or imported into France in 2013 – 100,000 tons less than the previous year, despite a tripling of the number of declarations. This time, nanosilver and carbon nanotubes were indeed included in the report, but in much smaller proportions (respectively less than 1 kg and less than 10 tons) than those supposedly present in the country.
• At the end of February 2016, the 2015 report was published: 416,000 tons were imported or produced in 2014, with about 300 categories of nano substances and a relatively stable number of registrants.
• In early November 2016, the 2016 report was published: more than 475,000 tons were imported or produced in France in 2015, more than 14,000 declarations were submitted and 1,516 French entities made at least one declaration.
• At the end of December 2017, the 2017 report was published: we noted a drop in the number of declarations (9,700 in total, i.e. 27% less than in 2016) and declarants (1,391) with an overall amount of slightly less than 425,000 tons imported or produced in France in 2016, i.e. a slight drop compared to the previous year (but a 10% increase in the amount produced in France).

• It was more than a year late, in December 2019, that the 2018 report was published, with a drop in total tonnage, below 390,000 tons of nanomaterials imported or produced in France in 2017.
  
• The 2019 report, which should have been published in November 2019, was published in June 2020, with a relatively stable total tonnage of around 400,000 tons.
• The 2020 and 2021 reports were released in April 2023, much later than the legal deadlines…

The main difficulties are generally related to:

• the problems of definition and characterization of nanomaterials making it difficult for some companies:
  – to know whether they should report or not
  – to provide some of the information (in particular concerning the physicochemical characteristics of nanomaterials).
• the unsuitability of the system in relation to the reality of supply chains, including
  – confusion about subcontractors
  – technical problems in importing data from suppliers located outside France: “a company can import a chemical mixture from Germany that has a premix composed in Russia with nanomaterials manufactured in Vietnam. The chain to be traced is complex” said Sonia Benacquista, in charge of the nano dossier at the Union of Chemical Industries (UIC)⁷Y voir plus clair dans le monde des ” nanos “, Sud Ouest, 11 Jan 2014 in 2014.
  – more intermediaries than expected but a single deadline for completing the declaration regardless of the category of declaring entities: the last link in the declaration chain, i.e. distributors to professional users, is in fact dependent on the declaration number provided by their suppliers upstream in the chain (producers, importers or processors who are themselves sometimes dependent on the declaration number that their own suppliers must send them).

> Staggering the declaration deadline according to the position of the declarants in the supply chain is strongly desired by distributors who are finding it difficult when they only obtain the numbers from their supplier(s) late. Furthermore, until the implementation of the declaration obligation in 2013, many of them were unaware that the products they were buying and distributing contained nanomaterials. The 2014 reporting deadline on 2013 data was extended, for distributors to business users only, to May 31, 2014. The same applied for the following years.

In spite of the advances made possible by the creation of this R-nano register, the general public cannot today identify the products in which nanomaterials are integrated by manufacturers and to which they are exposed.

The objective of informing the public and consumers required by the legislator in 2009⁹There is progress compared to the Nano3 database, which remained confidential: this non-exhaustive inventory of products containing manufactured nanomaterials present on the French market had been carried out by Afsset between November 2008 and May 2009, in the context of the referral Nanomaterials risk assessment for the general population and the environment (Afsset report published in March 2010). It covered products available on the French market as well as those produced in France or in neighboring countries. It has not been made public: in February 2011, the VivAgora association publicly deplored the fact that the data in this database was not accessible to all (in a VivAgora’s contribution to the public consultation on the implementation decree on the annual declaration of nanoparticulate substances placed on the market dated February 24, 2011, which is no longer available online). is for the moment fulfilled at minima because it comes up against commercial and industrial confidentiality¹⁰Art. R. 523-18 of Decree No. 2012-232 signed on February 17, 2012 and published in the Official Journal on February 19, 2012. or military secrecy¹¹Cf. the order of January 24, 2013 defining the conditions for submitting and processing requests for exemptions relating to making the annual declaration of substances in the nanoparticulate state available to the public, issued pursuant to Article R. 523-20 of the Environmental Code. The industry federations have in fact obtained from the Ministry of Ecology that the quantities of nanomaterials are, for example, aggregated at the national level in public reports¹²Frequently Asked Questions on the declaration of substances in the nanoparticulate state, Ministry of Ecology, V2, March 2013. These do not contain the names of the manufacturers, importers, distributors or the brands concerned. They do not give any information on the properties of the nanosubstances declared (which are not even always declared as the “properties” field is optional).

As a result, the first assessments have proved to be very difficult to read and almost unusable.

The system does not go as far as the labeling of declared nanomaterials: once integrated into products, these nanomaterials “disappear” from the consumer’s view.

Only a few organizations can have access to only part of the information contained in the register: ANSM, Santé publique France, INRS, INERIS, the organizations in charge of toxicovigilance and, since 2017, the regional waste observatories¹³Since 2013 (Decree No. 2012-233 of February 17, 2012):
– the National Agency for the Safety of Medicines and Health Products (ANSM, which replaced the French Agency for the Safety of Medicines and Health Products (Afssaps) on May 1, 2012, taking over its missions, rights and obligations)
– the National Institute for Health Surveillance (InVS)
– the National Institute for Research and Safety (INRS)
– the National Institute for the Industrial Environment and Risks (INERIS)
– agencies responsible for toxicovigilance (i.e. poison control centers).
And since 2017, were added the regional waste observatories, “for the exercise of their missions and within the limits of information corresponding to their field of expertise”(Decree No. 2017-765 signed in extremis by the Minister of the Environment Ségolène Royal on May 4, 2017)..

Any person wishing to have information has no other solution than to rely on the existing inventories of nano-products which, far from being exhaustive, are elaborated from declarations of industrialists or hypotheses on the composition of products, without any possible verification, for lack of financial, human and / or technical means.

Many stakeholders are advocating for increased transparency. It would indeed be possible to go further in terms of transparency, as is the case for pharmaceutical products (directory of medicines), plant protection products (e-phy database) or polluting emissions (IREP register).

There is no incentive for companies and laboratories to respect the protection of the environment and of people likely to be exposed to the declared nanomaterials (consumers or workers in particular).

Concerning workers: the declaration filled out by the companies or laboratories does not include any indication of the total number of employees or the number of workers exposed to the declared nanomaterials. Nevertheless, thanks to the registration system and the transmission by suppliers of the declaration number to their customers, many professionals were informed by their supplier(s) of the presence of nanomaterials in the products they purchased and were then able to inform their customers. In the end, more stakeholders discovered, through this declaration, that they were handling products containing “nanosubstances”. As a result, one can hope that a certain number of them have started to (or will be able to) put in place measures to limit occupational exposure to these substances. Is this the case? We are interested to hear your testimonials (redaction(at)veillenanos.fr).

In the current state of the system, central purchasing agencies and distributors who supply “nano substances” to the general public in addition to professionals have not been subject to the declaration obligation (cf. Question 7 of the R-Nano website FAQ in its March 2014 version). DIY stores that sell to individuals and professionals, for example, do not have to declare.

French authorities reported in August 2014, that “if the last professional user were also subject to the declaration obligation, which is not the case at present, it would be possible to have more precise information on the uses, thus contributing to the objective of traceability as well as better information for the consumers”¹⁴Note from the French authorities and answers to the questions asked by the European Commission in its consultation on transparency measures for nanomaterials on the European market, August 2014.

Today, the “final” professional users are not subject to declaration: hairdressers, beauticians, garage owners, farmers, painters, builders, etc. handle products containing “nano substances” without being informed: the obligation to specify the presence of nanomaterials in safety data sheets (SDS) did not come into effect until 2021 and is still very poorly implemented. Environmental and Sanitary declaration sheets (ESDS) for materials are not covered by this obligation.

The health authorities are not currently able to identify all the professions concerned.

Interviewed by AVICENN in February 2016, Gérald Hayotte, in charge of the “Nanos” mission at the CFDT Confederation, deplored the fact that “The results of the mandatory declaration (R-Nano) still do not allow us to know how many employees are directly or indirectly exposed to nanoparticles in France. As it stands, it is difficult, not to say impossible, to follow a precautionary approach or define prevention actions”.

As the system currently stands, there is no provision for a “cost/benefit assessment before products containing nanoparticles or nanomaterials are placed on the market”, as the participants in the Grenelle de l’Environnement had committed to do in 2007¹⁵Commitment n°159 of the Grenelle de l’Environnement, November 2007: “the declaration of the presence of nanoparticles in consumer products will be mandatory as of 2008; systematic cost/benefit assessment before the marketing of products containing nanoparticles or nanomaterials, as of 2008; ensuring the information and protection of employees on the basis of the AFSSET study”, p.23/35. The declaration that companies and laboratories must complete concerns nanomaterials manufactured, imported or placed on the market during the past year: it is not part of a registration process prior to a marketing authorization. Nanomaterials therefore continue to be marketed with no better supervision than before, without any protection for consumers or the environment.

• Contrary to the definition used by ISO, the nanomaterials that fall under the definition of “substance in the nanoparticulate state” used by France exclude internally structured nanomaterials. ANSES had suggested that substances with an internal structure at the nanoscale be covered by the register¹⁷Opinion of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail on version 2 of March 28, 2011 of the draft decree on the annual declaration of substances in the nanoparticulate state placed on the market, April 18, 2011 but without success.
• In addition, the definition retained mentions a “substance intentionally manufactured at the nanoscale”: some companies could avoid their declaration obligation by claiming that their substances are not intentionally nano…
• As at the European level, the threshold retained is that of 50% of the particles measured between 1 and 100 nm in the size distribution in number, which potentially leaves out many nanomaterials:
  – Regarding the 1-100nm range, even the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has pointed out that there is no scientific basis for the 100nm limit. Results of toxicological studies show toxic effects specifically at the submicron scale exceeding 100 nm, especially up to 600 nm. The American Food & Drug Administration (FDA) has thus chosen to define a nanomaterial as a material with at least one dimension smaller than 1000 nm ¹⁸Cf. Reporting Format for Nanotechnology-Related Information in CMC Review, Office of Pharmaceutical Science (FDA), June 2010.
  – As for the 50% rate, it is more than 333 times higher than the one defended by SCENIHR (0.15%) at the European level¹⁹See our article: EUROPE – Adoption of the new definition of nanomaterials by the European Commission: first reactions and analyses, Veillenanos.fr, 19 Oct. 2011.

As a result, for example, substances composed of 45% of particles smaller than 95 nm and 55% of particles larger than 105 nm will not be subject to the reporting requirement.

• Ensure that the obligation to declare nanomaterials that may be released outside of “normal conditions of use” is included in the scheme, in order to include products containing nanomaterials that may be released as a result of wear, abrasion or washing of the products but which are not currently registered in R-nano.
• Integrate into the R-Nano system the nanomaterials that are integrated into finished products manufactured abroad before arriving in France (because they are currently not registered!)
• Extend the obligation to declare to mixtures and not only to nano substances, as is the case in the Belgian and Danish systems?

In the r-nano tool, there is no way to quantify, for a given use, the weight of nano substances involved, which is a very damaging limitation for traceability and risk assessment.

• Since 2016, it has been mandatory to fill in, in addition to the “sector of use” (SU), which was until then the only descriptor required, other descriptors used by ECHA: “chemical product” (PC), “process” (PROC), “article” (AC) and “release into the environment” (ERC). This is a step forward that has refined the knowledge of the uses of declared nanomaterials, but there is still a need to adopt another typology that is more relevant and more “meaningful” to the general public.
• The NACE and/or NAF code of the customers of the last professional distributor declarants should also be requested.
• Linking quantities to their uses would allow a quantification of nanomaterials by type of use, because in the current state of the system, even the administration cannot determine, for a given type of nanomaterial, which quantity is used for what.
• In the long term, if we progress also on the labeling project, we can imagine that a mention [nano] will be compulsorily affixed in front of the name of the substance concerned in the list of ingredients and that a QR-code could also be added to the label of products and refer to a section to be created on the R-nano site containing more precise information on the nanosubstance in question and its risks for health and the environment. Without waiting for the creation of an hypothetical European register, a national register of products containing nanomaterials could eventually be set up by pooling information from the Belgian and Danish registers where similar initiatives have been taken.

• Identification of sites where nanomaterials are handled
• Mandatory information on the number of workers potentially exposed to nanomaterials and enroll in the EpiNano cohort workers exposed to carbon nanotubes, nano-titanium dioxide, silica nanoparticles and carbon black
• Obligation for the last registrants to communicate to the professional users to whom they supply the “nano substances”, in addition to the declaration number (cf. Order of August 6, 2012, Art. 3, II), information on the rationale for the R-Nano program and the risks associated with these substances.

Preventionists and in particular occupational health services (CARSAT but also the DREETS (former DIRECCTES, now Regional Directorates for the Economy, Employment, Labor and Solidarity), which lead the regional occupational health policy in companies, and the DETSPPs at the departmental level, which house the labor inspectorate,) do not have regulatory access to R-nano data They cannot therefore use it to identify sites at risk or exposed workers.

It is becoming essential to extend it to other public stakeholders or those carrying out public service missions, so that they can identify and protect exposed workers and sites. More broadly, researchers and environmental or public health professionals should be able to obtain extracts from the R-nano register, which would allow the consolidation of vigilance efforts. The problem of emerging risks is an occupational health concern in many regions and they have included it in their regional occupational health plans (PRST). However, without visibility on the companies concerned, information campaigns are not possible or at least difficult.

Mutualizing information from the existing records of the e-phy register and the national sales database Phytodata would be useful for the agricultural sector.

It took almost ten years for a monitoring system to be put in place to ensure that companies complied with their reporting obligation.

The problems of metrology and the slow progress of the standardization groups in developing measurement methodologies for nanomaterials, although encountering major obstacles, do not explain the lack of control.

The industrialists know that the technical capabilities are lacking today and there is a lack of political will to monitor compliance with the law.

The OECD recalled at the end of 2015 that the identification and quantification of manufactured nanomaterial are priority issues to be addressed urgently²⁶Cf. Nanomaterials in Waste Streams, OECD, November 2015. A lot of work remains to be done to refine the improvements to be made to the R-nano register. In addition to the above, however, progress should be made on the following aspects:

• what additional data to collect? or take out? or collect differnetly?
• how to better leverage them? (As of 2015,  ANSM had not yet retrieved the data from the R-nano register)
• how to better use the R-nano register to issue recommendations and targeted prevention or surveillance actions?
• how can the register allow for better traceability and identification of exposed workers – not only in the production/handling phase of nanomaterials, but also downstream of the production chain (professional users at the end of the chain: builders, mechanics, hairdressers, farmers, bakers, hospital staff, etc.)?

Once reconfigured, the “R-Nano 2.0 Register” could also allow manufacturers and distributors to recall marketed products in the event of health or environmental problems.

On the technical side, some scientists asked to add, among the parameters to be entered in R-Nano, the solubility of the nanoparticulate substance (as recommended by ISO and OECD) – see also the recommendations concerning the implementation of a universal material description system for the nanoscale (UDS).

Even if the tools and methods to detect, measure, monitor and control nanomaterials are still to be improved, it is already technically possible to take and store samples while waiting for appropriate analysis tools and methods to be developed²⁷See Nanomaterials: A review of definitions, applications and health effects. How to implement a secure development, Eric Gaffet, Comptes Rendus Physique, Volume 12, number 7, pages 648-658, September 2011.

The idea is to be able to correlate the volumes of nanomaterials released afetr use to the possible problems that could be observed in the short, medium and long term. By setting up various mapping and experimental tools, it could be possible to build a collective and operational vigilance associating nanomaterial suppliers and the purchasing centers of large consumer product distributors. This would allow us to record the flow of products containing nanomaterials sold (starting with nanosilver), to map the places of distribution and potential release, and then to proceed with a long-term observation on the ground, for example on a watershed with the participation of water managers.