How are nanomaterials regulated under REACH?

What does REACH say regarding nanomaterials?

By the AVICENN team – Last added June 2024

In force since 2007, REACh is the European regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals. It defines the rules for the marketing and use of chemical substances imported or produced in Europe, with two conflicting objectives: a high level of protection for health and the environment AND increased competitiveness and innovation. To achieve this, REACh requires manufacturers and importers to register the substances they produce or market, and to ensure that they have no harmful effects on human health or the environment.

From 2007 to 2017, ten years of arm wrestling over nanomaterials regulation (or lack thereof) under REACH

When it was created, REACh did not include any specific provisions for nanomaterials; by default, nanomaterials were considered by the European Commission to be covered by this regulation in the same way as other chemical substances. In practice, however, this was not the case, and for years many stakeholders asked in vain for a specific framework for nanomaterials¹See :
– Resolution on regulatory aspects of nanomaterials, European Parliament, 2009
– Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information, DG Environment (DG ENV) and the Joint Research Centre (JRC), Commission européenne, March 2012
– ECHA and MSCAs pave the way for further assessment of nanomaterials under REACH, European chemicals agency (ECHA), June 2012
– Law and innovation in the context of nanomaterials: Barriers to sustainable development? Results of an empirical study, Julian Schenten and Martin Führ, Environmental Law Network International, 2012
– High time to act on nanomaterials – Proposal for a ‘nano patch for EU Regulation, Center for international environmental law (CIEL), ClientEarth and Friends of the Earth Germany (BUND), 2012
– National Action Plan for the safe use and handling of Nanomaterials, Ministère de l’Environnement suédois, October 2013 (in Swedish, English summary starting page 31)
– Nanomaterials and REACH Background Paper on the Position of German Competent Authorities, the Federal Institute for Occupational Safety and Health (BAuA), the Federal Institute for Risk Assessment (BfR) and the Federal Environment Agency (UBA), January 2013
– Information Requirements for nanomaterials – IRNANO, January² 2013
– Examination and assessment of consequences for industry, consumers, human health and the environment of possible options for changing the REACH requirements for nanomaterials, IHCP, BiPRO, January³ 2013
– Letter from ENVI committee (European Parliament) to the European Commission, July 2013
– Exploring building blocks for amending EU regulation of nanomaterials, RIVM, August 2013
– Avis relatif à la modification des annexes de REACh en vue de la prise en compte des nanomatériaux, ANSES, 2 April 2014
– Position paper on the regulation of nanomaterials, CIEL, ClientEarth, EEB, ECOS, ANEC, HCWH and BEUC, April 2014
– Nanomaterials: getting the benefits, controlling the risks – the Austrian way, ECHA Newsletter, October 2014
– Key issues in chemicals policy on the road to a non-toxic environment – Information from the Austrian, Belgian, Danish, German, French, Dutch and Swedish delegations, and Norway, supported by the Croatian and Luxembourg delegations, 5 December 2014
– Press release – 3363rd ENVIRONMENT Council meeting (provisional version), 17 December 2014
– Chemicals chief calls for REACH nano clarity, ENDS Europe, 13 October 2015
– Dancet asks EU Cmmission to speed up nano work, Chemical Watch, 4 December 2014
– Hazardous chemicals in products – The need for enhanced EU regulations, ANEC, June 2016.

It was not until 2016-2017 that the Commission finally agreed that things needed to change.
→ It has to be said that the Board of Appeal of the European Chemicals Agency (ECHA) had then validated the appeals of manufacturers opposing ECHA’s requests for information on the nanoparticles they were manufacturing, on the grounds that the terms “nanoforms”, “forms” and “grades” used by ECHA were not sufficiently well defined⁴– Board of Appeal annuls Echa nanomaterials compliance check decision, Chemical Watch, 13 octobre 2016 → silicic acid, aluminum sodium salt nanoforms
– Decision of the Board of Appeal of the European Chemical Agency, ECHA, 2 mars 2017→ titanium dioxide nanoforms
– Decision of the Board of Appeal of the European Chemical Agency, ECHA, 30 juin 20177 → silica nanoforms!

After producing an initial working document, the content of which was criticised by the NGOs⁵Cf. Letter to REACH Committee, 8 February 2017, the European Commission launched, in October 2017, a very short consultation (four weeks only) and then presented a new proposal in April 2018 that was more in line with Member States’ demands⁶Cf. ECHA welcomes improved clarity on nanomaterials in the EU – Member States vote to amend REACH Annexes, ECHA, avril 2018. The possibility for ECHA to request additional information, which the Commission wanted to limit to substances produced in quantities of over 100 tonnes, was granted under pressure from France and 7 NGOs⁷Cf. Communiqué interassociatif adressé au REACH Committee, 23 avril 2018 to nano substances produced in quantities exceeding 10 tonnes – which is still more than France and the NGOs had hoped for. Nevertheless, the text as a whole represents a major advance on the previous situation and the Commission’s previous proposals. In an official statement, Nicolas Hulot, then Minister for the Ecological Transition, “welcomed” this “decisive amendment (which) will make it possible to fill, in the coming years, a large part of the gaps in our knowledge of the dangers and the possibilities for action by the health and environmental authorities for these nanomaterials”.

Regulation n°2018/1881 amending REACH annexes was adopted on the 3rd of December 2018 to come into force on 1 January 2020.

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 nanoforms⁸Cf. 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 substance⁹See 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 2022¹⁰See 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 is reluctant 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 flexibility¹¹See 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.

Since then, the number of substances registered has been much lower than expected (~300 expected) and has grown only very slowly:

• At the end of February 2020, ECHA had indicated that by 1 January it had received 95 registration dossiers for nanomaterials involving just 36 substances. ECHA therefore urged companies to submit registration dossiers as soon as possible for the “nanoforms” that had not yet been registered¹²Cf. Companies need to provide more data on nanoforms, ECHA, 24 Febuary 2020.
• At the end of May 2020, ECHA reported that 37 registrations of nanoforms had been submitted since 1 January 2020, bringing the total number of registered nano substances from 34 to 54.
• By September 2021, 130 chemical substances with “nanoforms” had been registered under REACH, rising to 150 by the end of November 2021, half the number in the French r-nano register…
• By July 2022, the number had risen to 165.
• Almost two years later, in June 2024, only 4 more substances had been registered, bringing the total to 169¹³Test method design hampers scrutiny of nanomaterials, ECHA says, Chemical Watch, 10 June 2024.

→ Other (unregistered) nanomaterials are therefore illegally on the market under the “no data, no market” principle of the European REACH regulation.

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 2019¹⁴Cf. REACH Action Plan for Review/Improvement of Registration Dossiers, CEFIC, June 26, 2019
• nor in ECHA’s REACH Action Plan unveiled in 2019¹⁵See 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 recommendations¹⁶Cf. 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 year¹⁷Cf. “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” nanomaterials¹⁸See 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.