How are nanomaterials regulated under REACH?

What does REACH say regarding nanomaterials?

By the AVICENN team – Last added October 2023

Since 2020, REACH requires specific information on nanosubstances

The registration of nanoforms in REACH

According to Regulation No. 2018/1881 amending the REACH annexes, since 2020, specific information must be provided by companies on nanosubstances registered in REACH and where more than one ton per year (per company) is placed on the market.

In addition to the data already required, it is now necessary to specify the physicochemical parameters of nanomaterials such as particle size distribution in number, functionalization or surface treatment, shape or aspect ratio, 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);
• chemical safety assessment (Annex I);
• the information required for registration (Annexes II and VII to XI);
• the obligations of downstream users (Annex XII).

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

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

Thanks to requests from France and NGOs mobilized on the subject, the possibility for the European Chemicals Agency (ECHA) to request additional information has been extended to nano substances produced in excess of 10 tons, while the Commission wanted to limit this to substances produced in excess of 100 tons.

However, the January 1, 2020 deadline has not been met by many companies (see below).

What 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 because of its postponement after 2019 European elections, the 2011 recommendation is still the reference definition today.

While REACH is a regulation co-signed by the European Parliament and the Council, it refers to a definition recommendation established by the Commission alone, without validation by the Parliament and the Council. This could be a source of legal insecurity of the regulation, insofar that this definition is being challenged. One of the reasons for the yearly postponement of this review is that this definition and its revision are sources of tensions, as the implications can be very different depending on the terms and the threshold figures used.

Clarification from ECHA

In early December 2019, the European Chemicals Agency (ECHA) published updated guidance documents to help companies prepare REACH registration dossiers for their chemical substances covering nanoforms¹Cf. Updated guidance for registering substances in nanoform, ECHA, 3 December 2019 and thus meet the new legal requirements for nanomaterials applicable as of 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 registering (or updating their dossier) under the REACH regulation in order to remove any ambiguity in the regulatory documents (decisions, safety data sheets). An update of the nanoform registration guide was published in January 2022³See Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification, ECHA, January 2022; this guidance is in addition to the Guidance and support on nanomaterials under REACH and Q&As on registering nanoforms, ECHA with advice on how to prepare registration dossiers that cover nanoforms.

ECHA published in early 2023 the guidance 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 system that is still not very effective for nanomaterials marketed in Europe

Delays, adjustments, non-registration of substances: chemical industry sometimes fails to be transparent

The application of the REACH regulation is encountering resistance from certain companies and industry federations: the European Chemical Industry Council (CEFIC) has called for delays in the implementation of the regulation as early as 2019 and for greater flexibility⁴See on this subject:
– Luke Buxton, REACH nanomaterial data deadline ‘extremely tight’ – Cefic, Chemical Watch, 10 October 2019
– Clotilde de Gastines, Nanomaterials: industrialists are putting up resistance, Health & Work, September 2, 2019
– David Azoulay, Cefic interpretation of REACH ‘nanoform’ draws accusations of ‘renegotiation’ – NGO Ciel calls association requests unacceptable, Chemical Watch, 12 July 2019 (on the grounds that the “nanoforms” to be declared individually or in groups, the information to be provided, the methods of measurement and characterization to be retained, etc., were not yet fully clarified or available). However, manufacturers had the possibility to provide the data they have by January 1, 2020 and complete it afterwards.

By the end of February 2020, the European Chemicals Agency (ECHA) had reported that as of January 1, it had received 95 nanomaterial registration dossiers for only 36 substances (compared to ~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 as yet unregistered “nanoforms” as soon as possible⁵Cf. Companies need to provide more data on nanoforms, ECHA, 24 February 2020. At the end of May 2020, the European Chemicals Agency (ECHA) provided a new update: 37 nanoform registrations had been submitted since January 1, 2020, bringing the total number of registered nano substances from 36 to 54. This increase, although significant, is 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 by the end of November 2021, half as many as in the French r-nano register… By July 2022, the number had risen to 165.

What means of control does ECHA have?

In its action plan, ECHA has stated that its objectives for the period 2019-2023 are to focus its compliance monitoring on substances produced or imported above the threshold of 100 tons per year. Nanomaterials are therefore in danger of being left out.

Why? Because they are produced in smaller quantities in their category: the r-nano assessments in France published since 2014 show that more than half of the declarations are for less than one ton per year.

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

• neither in the CEFIC Action Plan of June 2019⁶Cf. REACH Action Plan for Review/Improvement of Registration Dossiers, CEFIC, June 26, 2019
• nor in ECHA’s REACH Action Plan unveiled in 2019⁷See in particular: REACH Review actions – status of our work, Newsletter Issue #3, ECHA, September 2019

Does ECHA have sufficient and appropriate technical, human and financial control resources? One is allowed to doubt it…

There are still major gaps in the assessment of the environmental risks posed by nanomaterials

In March 2020, experts from the German Environmental Agency (UBA) and the Dutch National Institute for Public Health and the Environment (RIVM) called for an update of risk assessment protocols for nanomaterials to reduce uncertainties and fully account for their environmental impact. The experts involved in the European NanoFASE project consider that, despite the data specifically required on nanomaterials since January 1, 2020, within the framework of REACH, major uncertainties remain concerning the evaluation of their environmental risks. Their academic paper in the journal Integrated Environmental Assessment and Management offers a number of recommendations⁸Cf. Environmental Risk Assessment of Nanomaterials in the light of new obligations under the REACH regulation ‐ Which challenges remain and how to approach them?, Schwirn K et al., Integrated Environmental Assessment and Management, mars 2020 et Experts call for updated guidance on nanomaterial risk assessment, Chemical Watch, 26 mars 2020.

What are the possible improvements?

Controls planned in France starting in 2022

At the end of December 2021, a circular from the Ministry of Ecological Transition announced inspections starting in 2022 to verify compliance with the reporting obligations of nanomaterials in REACH (and in the French r-nano register). 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 based on available data, up to a 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) to detect the presence of nanoparticulate forms of the substance.

When will there be a specific system for nanomaterials produced or imported in quantities of less than one ton per year?

Mid-2019, the Council of the European Union asked the European Commission to extend the mandate of the European Chemicals Agency (ECHA) so that it can collect and make available research data on the characterization, hazard and potential effect of exposure of nanoform substances that were not previously registered under REACH, their annual tonnage being below the threshold of one ton per year⁹Cf. Cf. “Council conclusions on chemicals”, Council of the EU, 26 June 2019.

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

A fund financed by the companies that import, produce or use these manufactured nanomaterials, would allow to mutualize the cost of characterization tools and independent research on the risks associated with nanomaterials and thus remedy the current lack of means. Entrusted to a public intermediary that would act as a “firewall”, the funds would be directed to independent laboratories. Together with a robust and transparent evaluation procedure for projects and results (with openness to NGOs and citizens), this “nanosafety” account would also guarantee better reliability of results and restore confidence.

Particular attention needed for “advanced” materials

In addition to nanomaterials in the strict sense, it is necessary to integrate into the regulations the so-called “advanced” materials, many of which also display specific properties at the nano scale (advanced ceramics & polymers, reinforced by biofibers and/or nanofillers, “intelligent” composite materials, bioactive materials, nanosensors, etc.).

According to a report commissioned by the European Nanomaterials Observatory (EUON) and published in September 19, 2019, current EU regulations already provide an adequate regulatory framework to characterize and identify “next generation” nanomaterials¹⁰See 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 the industry sector. What about health protection? No experts heard. What about environmental protection? Only one official (German). The experts in our network share our skepticism about the analysis proposed in this report. Health and environmental democracy deserve better than that.