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VeilleNanos - The R-Nano Register

The R-Nano Register

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The R-Nano Register

By the AVICENN team – Last modification April 2023

France, the first country to introduce mandatory declaration of nanomaterials

The first recommendation of the Prevention and Precaution Committee (CPP, attached to the Ministry of Ecology) in 2006 was to “identify nanoparticles from nanotechnologies and their production channels”1Prevention and Precaution Committee (CPP), Ministry of Ecology, Nanotechnologies, nanoparticles: what dangers? What are the risks?May 2006.

A year and a half later, the “Grenelle de l’environnement” committed to implementing a mandatory declaration of the presence of nanoparticles in consumer products by 20082Commitment 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 (as well as, starting in the same year, the requirement of a systematic cost/benefit assessment before products containing nanoparticles or nanomaterials are placed on the market).

We had to wait another five years, but finally, on January 1, 2013 , a mandatory declaration of “nanoparticulate substances” manufactured, imported or marketed in France came into effect, on the r-nano.fr portal.

This declaration is the result of a long process that led to public consultations and the creation of a multi-stakeholder working group dedicated to the system led by the Ministry of Ecology, which continues to meet once or twice a year. It was institutionalized by the Grenelle 1 law of 2009 and specified in the Grenelle 2 law of 2010 and in the decrees n°2012-232 and n° 2012-233 of February 2012, completed by the order of August 2012.

Despite this delay and the deviations from the initial Grenelle project, France is the first country to have adopted such a system, creating a knock-on effect in other European countries.

Who should complete this declaration?

The declaration concerns public and private companies and research laboratories with an activity involving a minimum quantity of 100 grams of a “substance in a nanoparticulate state”3“nanoparticulate substance” means an intentionally manufactured nanoscale substance containing unbound particles or in aggregate or agglomerate form, in which 50% of the particles, in the number size distribution, have one or more external dimensions between 1 nm and 100 nm. (This minimum proportion may be reduced in specific cases when justified for reasons of environmental protection, public health, safety or competitiveness. By way of derogation from this definition, fullerenes, graphene flakes and single-walled carbon nanotubes with one or more external dimensions of less than 1 nm are to be considered as substances in the nanoparticulate state)..

Each year, these companies and laboratories must declare the quantities and uses of nanomaterials they produce, distribute or import via the R-Nano.fr website.
The statutory reporting deadline is May 1, but the reporting deadline was extended by two months for all reporters in 20134 In 2013, the Ministry of Ecology, considering the diversity of stakeholders targeted by the reporting obligation, and at the request of several sectors of activity, decided to grant 2 additional months to make the declaration for this first year of reporting; thus, exceptionally, new declarations could be initiated and submitted up to June 30, 2013. Cf. Emerging risks: the declaration of substances in the nanoparticulate state comes into force on January 1, 2013, updated on May 7, 2013. Every year since, it has been postponed by one month, until May 31 (first for distributors to professional users only, then again for all stakeholders).

The declarations, as well as the data they contain, are managed by the French National Agency for Food, Environmental and Occupational Health Safety (ANSES).

A list of questions and answers (FAQ) is online on the Ministry of Ecology website to help companies concerned by the declaration or likely to be concerned by it understand the system.

For what purposes was this declaration put in place?

The device, in its current version, has the stated objectives5See decree n°2012-232 signed on February 17 and published in the Official Journal on February 19, 2012 to:

  • “better understand these substances and their uses”
  • “have a traceability of the channels of use, a better knowledge of the market and the volumes marketed
  • “collect available information on their toxicological and ecotoxicological properties”.

These objectives are not quite the same as those initially envisaged6See our paragraph below ‘Ambitions revised down compared to the Grenelle de l’Environnement commitment’.

An assessment of the first years since its implementation

Early Results of the R-Nano Register

All public reports can be downloaded from the Ministry of Ecological Transition’s website page dedicated to nanomaterials.

Year-by-year reports from 2014 to 2017
  • 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).
Reports from 2018 to today
  • 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…

We are still waiting for the publication of the 2022 report

What criticisms have been made of the system?

A “financial and bureaucratic burden” for registrants when initially setting up the declaration

On the reporting side, the initial set-up of the report represented a significant workload in the first year. However, with good organization and anticipation, and thanks to advances in the r-nano tool, the declaration becomes less burdensome once anchored in the practice of companies, since it is mainly a matter of updating the data every year.

The main difficulties in the declaration

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.

Ambitions revised down compared to the “Grenelle de l’Environnement” commitment

The first few years produced results that fell far short of the expectations of the participants to the Grenelle de l’Environnement in 20078Commitment 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”.

As things stand, neither consumers nor health authorities are able to identify objects that contain nanomaterials or the risks that are possibly associated with them.

a) Was public information withheld in order to preserve industrial and commercial confidentiality?

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).

b) Nothing on the protection of employees and the environment

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”.

c) No limit to the commercialization of nanomaterials

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.

A “filtering effect”

Many nanomaterials are exempt from declaration. There is a strong “filtering effect” that comes from the very restrictive definition of “substances in nanoparticulate form” used by the legislator:

  • R-Nano does NOT (or not necessarily) include nanomaterials that are supposed to remain in the products in which they are incorporated16The decree n°2012-232 signed on February 17, 2012 and published in the Journal Officiel of February 19, 2012 defines the substances in nanoparticulate state as “substances intentionally incorporated into a mixture without being bound to it” (i.e. “from which they are likely to be extracted or released under normal or reasonably foreseeable conditions of use”) (this remains a point to be clarified). However, nanosilver in textiles can, for example, be detached from textiles during washing and carbon nanotubes, although contained in a matrix, can be released into the environment under the effect of sunlight and moderate humidity or abrasion.
  • R-Nano also does NOT include the many nanomaterials that are incorporated abroad into the many finished products that are then imported into France.
Other technical considerations…

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.

New or old nano substances?

80% of the substances that were declared in 2013 on the r-nano.fr website were already on the market before 1981 without us knowing if they were already in the nano state before. Industrialists confirmed that the most common nanomaterials and those used as pigments or colorants have been on the market for many years20Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market – Evaluation Report, BiPro and RPA, June 2014.

This figure, as well as the tiny quantity of nanosilver declared, raises the question of the distinction between “new” nanomaterials and “older” nanomaterials, which is difficult to make today: it is unclear how to quantify new nanomaterials used for new purposes (including the relatively recent anti-UV or antibacterial or stain-resistant or waterproof nano-coatings).

Penalties too low?

The fine foreseen in case of non-compliance with the legal obligation, amounting to 3,000 euros, with a daily penalty of 300 euros, is considered to be of little deterrent21“Cf. Risk Analysis of Nanomaterials: Exposing Nanotechnology’s Naked Emperor, Miller G and Wickson F, Review of Policy Research, 32(4): 485, July 2015 (p. 500).

By way of comparison, Belgium, for its part, has provided for penalties ranging from eight days’ imprisonment to three years and/or a fine of €160 to €4,000,000.

Lack of controls?

Public authorities have long been powerless to control the implementation of the law:

  • At the scientific and technical levels, detecting nanomaterials in products is complex (a fortiori when they are not declared and their nature and physicochemical characteristics are unknown) and requires expensive instruments;
  • Until 2022*, no specific device existed to monitor the proper application of the law. The control bodies traditionally used in the context of chemical controls were not equipped to do so, leading some to consider that the declaration was therefore “just pressure on the industrialists to declare information that environmental associations cannot do much with”22“No serious analysis, just putting pressure on manufacturers,” Interview with Alain Lombard, Techniques de l’Ingénieur, March 21, 2013.

* At the end of December 2021, a circular from the Ministry of Ecological Transition announced inspections in 2022 to verify compliance with the reporting obligations for nanomaterials in the French r-nano register (and in REACH). The targeted establishments will be the companies likely to manufacture substances in a nanoparticulate state. The list of targeted companies will be established by the DGPR on the basis of data to which it has access, within the limit of ten per region. As part of this action, samples of some pure substances may be taken and analyzed by the Joint Laboratory Service (JLS) to detect the presence of nanoparticulate forms of the substance.

How can we improve a system that is still too limited?

What prospects? What are the uses of the data?

The public reports leave many stakeholders frustrated because of the very general and not very usable nature of the data disclosed.

According to the Ministry of Ecology23Nanomaterials, Ministry of Ecology website > Risk prevention > Chemical management > Nanomaterials, page accessed on 11/18/14:

  • In 2014, the data reported on carbon nanotubes and titanium nano-dioxide were communicated to InVS within the framework of the Epinano project for the follow-up of cohorts of workers exposed to nanomaterials.
  • In 2014, INERIS also had to use some data from the R-nano database as part of its support programs for the Ministry of Ecology, particularly for the evaluation of accidental risks (flammability, explosiveness).
  • In 2015, ANSES relied on a working group to identify and list the uses that can be made of the data collected as part of the Agency’s assessment work. This group met 6 to 8 times without succeeding in establishing lists of priority substances.

This brings another question: does ANSES have sufficient means to analyze the information collected?

What improvements can be made to the system?

The challenge is therefore to remedy the weaknesses of this highly commendable system in order to consolidate it, because in the opinion of a growing number of associations and scientific experts24See for example When enough is enough, J. Hansen & A. Baun, Nature Nanotechnology, 7, 409-411, 2012, it is urgent to act.

A revision of the decree instituting the mandatory declaration had been envisaged for 2015 to clarify certain points of the text but it was put on hold pending the decision that the European Commission was to take following the consultation in 2014 regarding the creation of a possible Europe-wide nano register. As the Commission has not decided to set up a European register similar to R-Nano, different national registries (French, Belgian, Danish, Swedish, …) coexist, with a non-optimized interoperability.

AVICENN has been putting forward proposals for improvement for several years

Since 2013, AVICENN has been issuing concrete recommendations aimed at improving access to the register, as well as the nature and quality of the data collected via R-nano25Cf. 20 proposals compiled in June 2019 by AVICENN as part of the prefiguration of the 4th National Health and Environment Plan (PNSE4).

a) Expand the registry to include nanomaterials that are currently undeclared
  • 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?
(b) Improve the identification of end uses of declared nanomaterials and products containing these nanomaterials

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.
(c) Allow the register to be used for monitoring and prevention purposes
  • 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.
d) Extend the access rights to data to other risk assessment or management stakeholders

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.

e) Mutualize information in the agricultural sector
(f) Establish a system for monitoring the declarations

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.

In December 2020, ANSES published an evaluation of r-nano

At the end of 2020, Anses published an edifying diagnosis and strong recommendations to improve the r-nano registry, with which AVICENN completely agrees. It remains to be seen if, how and when these recommendations will be implemented.

In May 2021, improvements of r-nano registered in the PNSE 4

The onus is on the Ministry of Ecological Transition to pilot, within the framework of the PNSE4, actions aimed at “improving the quality of the data reported in the R-Nano register and optimizing the access to the register data by scientific or expert organizations as well as the publication of the data”.

ANSES has set up a working group on “the consolidation and exploitation of data reported on substances in the nanoparticulate state” which began its work in March 202228A call for applications was launched between September and November 2021.

In 2022, HCSP also insisted on the improvements to be made to the r-nano system

The High Council for Public Health (HCSP), in its evaluation of the National29Health and Environment Plans (PNSE 1, 2 and 3) published in 2022, considered30Cf. Global evaluation of the National Health and Environment Plans (2004-2019), HCSP, March 2022 that “the r-nano register must be improved because it is poorly filled out by industrialists and difficult to use because access is too restrictive. It should be opened up more widely and, in particular, to researchers working on the relationship between exposure and health effects in epidemiological studies“.

HCSP is also in favor of increasing the resources dedicated to r-nano:“Anses has only one person to manage the R-Nano register, respond to requests from registrants, accompany them and produce the annual report, which is notoriously insufficient to steer and lead this action.

Other similar mechanisms exist in several European countries

The R-Nano register set up in France in 2013 is spreading: several other Member States have set up similar systems.

The creation of a European register of products containing nanomaterials marketed in Europe has so far always been postponed by the European Commission.

Yet even Chinese scientists advocate for mandatory registration of nanomaterials31Cf. Regulation of engineered nanomaterials: current challenges, insights and future directions, Environmental Science and Pollution Research, 1-18, 2017: “Compulsory reporting schemes (registration and labeling) for commercial products containing ENMs should be adopted.”.

Any questions or comments? This information sheet compiled by AVICENN is intended to be completed and updated. Please feel free to contribute.

Upcoming Nano Agenda

6
Juin
2024
Managing the risks associated with nanomaterials (CEA, Grenoble)
Grenoble
Training
  • Awareness-raising aimed at personnel in contact with nanomaterials during research, formulation, production, maintenance, cleaning, upkeep, etc., as well as safety coordinators or engineers, facility managers, heads of laboratories where nanoparticles are handled.
  • Organizers: INSTN Grenoble (CEA)
  • On the agenda: potential impact on health; metrology and protection; control of potential risks associated with nanomaterials; consideration of societal aspects.
  • Website: https://instn.cea.fr/formation/maitrise-des-risques-lies-aux-nanomateriaux-sensibilisation
6
Juin
2024
Nanomaterials and Health (ANSES, Maisons-Alfort)
Maisons-Alfort
Dialogue Committee
10
Juin
2024
Nanoparticles NPC-24 (ETH, Zurich)
Zurich
Conference
  • 27th ETH Nanoparticles Conference
  • Organizer: ETH Zurich
  • From June 10 to June 14, 2024
  • Website: https://npc24.scg.ch

This sheet was originally created in February 2019


Notes and references

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