What framework for nanomaterials by REACH?

What framework for nanomaterials by REACH?

By AVICENN Team – Last added February 2023

Since 2020, the obligation to provide specific information on nano substances in REACH

Registration of nanoforms in REACH

According to Regulation n°2018/1881 amending the annexes of REACH, since 2020, specific information must be provided by companies on nano substances registered in REACH and placed on the market above one tonne per year (per company).

In addition to the data already required, it is now necessary to specify the physico-chemical parameters nanomaterials such as the particle size distribution in number, the functionalization or the surface treatment, the shape or the aspect ratio, the specific surface, …

The text thus brings clarifications and new provisions concerning:

• the characterization of the nanoforms or sets of nanoforms covered by the registration (annex VI);
• the chemical safety assessment (annex I);
• information required for registration (Annex II and VII to XI);
• the obligations of downstream users (Annex XII).

The impact analysis must take into account the entire life cycle of nanomaterials, with the possible physico-chemical transformations that the nano substance may undergo from its production until its end of life, including possible alterations due to use, etc.

The new text of the revised REACH annexes incorporates most of the requests made by Member States and European NGOs for several years (contact Avicenn via our contact address to access the archives).

The possibility for the European Chemicals Agency (ECHA) to request additional information, which the Commission wanted to limit only to substances produced above 100 tonnes, has been extended, thanks to requests from France and NGOs mobilized on the subject, to nano substances produced beyond 10 tonnes.

However, the January 1, 2020 deadline was missed by many companies (see below).

What is the definition of "nanomaterials" / "nanoforms" in REACH?

The revision of the Reach annexes was to integrate the revised recommendation for the definition of the term “nanomaterial”, expected since 2014 and announced as imminent (… since 2015!) but due to its postponement to the second half of 2019 (due to the European elections and the renewal of the European executive), it is still the 2011 recommendation which is still the reference definition today.

The fact that REACH, a Regulation co-signed by the European Parliament and the Council, refers to a definition recommendation drawn up by the Commission alone, without validation by the Parliament and the Council, could be a source of legal uncertainty for the Regulation, insofar as there is controversy over this definition. Indeed, the postponement of this revision, year after year, is explained in particular by the fact that this definition and its revision are sources of tension, because the repercussions can be very different depending on the terms and the quantified thresholds adopted.

Clarifications provided by ECHA

Beginning of December 2019, the European Chemicals Agency (ECHA) has published two updated guidance documents to help companies prepare REACH registration dossiers for their chemical substances covering nanoforms¹See Updated guidance for registering substances in nanoform, ECHA, 3 December 2019 and thus fulfill the new legal requirements in terms of nanomaterials applicable from January 1, 2020.

Since November 2020, manufacturers of nanomaterials must provide a name for the nanoforms or groups of nanoforms of their substance²See ECHA Weekly, ECHA, 30 September 2020 when they are registered (or when their file is updated) under the REACH regulation in order to remove any ambiguity in the regulatory documents (decisions, safety data sheets). An update of nanoform registration guide was published in January 2022³See Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification, ECHA, January 2022; this guide is added to the page Guidance and support on nanomaterials under REACH et Q&As on registering nanoforms, ECHA with guidance on preparing registration dossiers that cover nanoforms.

ECHA published at the beginning of 2023 the guide dated December 2022 entitled Guidance on information requirements and chemical safety assessment – ​​Appendix R7-1 for nanomaterials applicable to Chapter R7a Endpoint specific guidance (update, version 4.0).

Since 2021, information on nanoforms is mandatory on Safety Data Sheets (SDS) in Europe

“No data, no market”? : The shortcomings of a still inefficient system concerning nanomaterials marketed in Europe   

Deadlines, arrangements, non-registration of substances: a chemical industry that sometimes refuses to play the game of transparency 

The application of the Reach regulations is encountering resistance from certain companies and industrial federations: the European Council of the Chemical Industry (CEFIC) thus requested from 2019 delays in the implementation of the regulations and pleaded for relaxations⁴See on this subject:
-Luke Buxton REACH nanomaterial data deadline 'extremely tight' – Cefic, Chemical Watch, October 10, 2019
– Clotilde de Gastines, Nanomaterials: manufacturers are resisting, Health & Work, September 2, 2019
– David Azoulay Cefic interpretation of REACH 'nanoform' draws accusations of 'renegotiation' – NGO Ciel calls association requests unacceptable, Chemical Watch, July 12, 2019 (on the grounds that the "nanoforms" to be declared (individually or in group(s)), the information to be provided, the measurement and characterization methods to be used, etc., were not yet completely settled or available). Even though manufacturers could provide the data they have on January 1, 2020 and complete them later.

At the end of February 2020, the European Chemicals Agency (ECHA) indicated that it had received no 1er January that 95 registration files for nanomaterials concerning Only 36 substances (against ~300 expected). The other (unregistered) nanomaterials are therefore illegally on the market according to the “no data, no market” principle of the European REACH regulation. ECHA has therefore urged companies to submit registration dossiers for "nanoforms" that have not yet been registered as soon as possible.⁵See Companies need to provide more data on nanoforms, ECHA, 24 February 2020. At the end of May 2020, the European Chemicals Agency (ECHA) made a new point: 37 registrations of nanoforms had been submitted since January 1, 2020, increasing the total number of registered nano substances from 34 to 54. This increase, although significant, is however far from closing the gap with the expected number of substances (around 375). In September 2021, 130 chemical substances with “nanoforms” were registered under REACH, then 150 end of November 2021Either half less than in the French r-nano register… In July 2022, the number rose to 165.

Which ECHA checks?

ECHA has stated, in its action plan, that it aims to focus its compliance checks for the period 2019-2023 on substances produced or imported above the threshold of 100 tonnes per year. Nanomaterials therefore risk going by the wayside!

Why ? Because they are produced in smaller quantities in their category: the r-nano balance sheets in France published since 2014 show that more than half of the declarations are less than one tonne.

Among the elements that fuel our fears about the weakness of controls, comes the fact that we did not find any mention of the case of nanomaterials:

• nor in the CEFIC action plan of June 2019⁶See REACH Action Plan for Review/Improvement of Registration Dossiers, CEFIC, June 26, 2019
• nor in the ECHA action plan on REACH unveiled in 2019⁷See in particular: REACH Review actions – status of our work, Newsletter Issue #3, ECHA, September 2019

Does ECHA have sufficient and appropriate means of control, in terms of technical, human and financial resources? It is possible to doubt it...

Still major gaps in the assessment of the environmental risks posed by nanomaterials

In March 2020, experts from the German Environment Agency (UBA) and the Dutch National Institute for Public Health and the Environment (RIVM) requested a update of the risk assessment protocols for nanomaterials in order to reduce uncertainties and fully take into account their impact on the environment. The experts, involved in the European NanoFASE project, consider in particular that despite the data specifically required on nanomaterials since January 1, 2020 under REACH, strong uncertainties remain concerning the assessment of their environmental risks. Their academic article published in the journal Integrated Environmental Assessment and Management offers various recommendations9.

What avenues for improvement?

Controls planned in France from 2022

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

When will there be a specific device for nanomaterials produced or imported below one tonne per year?

Mid-2019 the Council of the European Union has asked the European Commission to extend the mandate of European Chemicals Agency (ECHA) so that it can collect and make available research data on the characterization, hazard and potential exposure of nanoforms of substances which were hitherto not registered under REACH, their annual tonnage being below the threshold of one tonne per year⁸See Environmental Risk Assessment of Nanomaterials in the light of new obligations under the REACH regulation ‐ Which challenges remain and how to approach them?, Integrated Environmental Assessment and Management, Schwirn K et al., March 2020 and Experts call for updated guidance on nanomaterial risk assessment, ChemicalWatch, March 26 2020.

The establishment of r-nano register in France, fed by a mandatory declaration from 100 grams per year, shows that it is possible . A Europe-wide register of nanomaterials has been requested by Member States and NGOs for several years. It is high time for the European Union to give itself the means for this system if it wants to claim to strengthen citizens' confidence in public authorities and European procedures for the protection of health and the environment.

A fund supplemented by companies that import, produce or use these manufactured nanomaterials, would make it possible to pool the financing of characterization tools and independent research on the risks associated with nanomaterials and thus compensate for the lack of means necessary for the work of characterization of nanomaterials and risk assessment. Entrusted to a public intermediary who would play the role of "firewall" before directing funding to independent laboratories and based on a robust and transparent evaluation procedure for projects and results (with an opening to NGOs and citizens), this “nanosafety” account would also make it possible to guarantee better reliability of the results and restore confidence.

Necessary attention for so-called “advanced” materials

In addition to nanomaterials in the strict sense, it is necessary to incorporate so-called "advanced" materials into the regulations, many of which also display specific properties at the nanoscale ("advanced" ceramics & polymers, reinforced with biofibres and /or nanofillers, "intelligent" composite materials, bio-active materials, nanosensors, etc.)

According to a report commissioned by the European Observatory for Nanomaterials (EUON) and published on September 19, 2019, the current regulations of the European Union would provide an adequate regulatory framework to characterize and identify "next generation" nanomaterials.⁹See A state of play study of the market for so called “next generation” nanomaterials, European Union Observatory for Nanomaterials (EUON) – Risk & Policy Analysts Ltd and RPA Europe Srl., September 2019. Of the eight experts interviewed, half came directly from industry. On the health protection side? No expert interviewed. In terms of environmental protection? Only one civil servant (German). The experts in our network share our skepticism about the analysis offered by this report. Health and environmental democracy is better than that.