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Legal Spotlight: Nanomaterials: can EU States take laws into their own hands?

At the time the REACH Regulation was negotiated, the issue of nanomaterials was only in its infancy and no specific provisions were adopted to address their potential risks. While everyone recognises the important industrial and competitiveness potential of nanomaterials, uncertainties as to their potential impact on human health and the environment have come to the fore, triggering calls for a review and possible adaptations to the regulatory system in place. Jean-Philippe Montfort and Claire-Marie Carrega discuss.

The Commission has started reflecting on possible changes to the REACH Regulation that are likely to take several years to materialise. In the meantime, however, some Member States are taking initiatives to impose national rules, including reporting schemes and labelling requirements.

As we analyse in a legal article published in the first edition of the European Journal of Risk Regulation¹, the legality of these measures is questionable, considering that REACH applies today to nanomaterials, as it does to any other chemical substance and that the Regulation is considered to harmonise market access conditions for chemical substances in the EU.

Our article summarises the current regulatory status of nanomaterials under REACH and specifies the legal framework under which the legality of national initiatives contemplated by the Member States to regulate nanomaterials must be reviewed. In our opinion, Member States cannot use as an argument for national controls the facts that REACH neither contains specific provisions on nanomaterials, nor requires registration of substances manufactured or imported below one tonne per annum (tpa).

Nanomaterials under REACH

There is no specific reference to nanomaterials under REACH. However, to the extent that nanomaterials are considered chemical “substances”, they fall within the scope of REACH. What does that mean in practice?

Essentially, this means that a legal entity producing or importing a nanomaterial in the EU will be required to register that substance, provided that it is produced or imported by that legal entity at or above one tpa. Above 10 tpa, a chemical safety report (CSR) will need to be prepared. Some nanomaterials could also be considered to be of “equivalent concern” to substances of very high concern and be subject to the authorisation process, even if produced, imported or used below one tpa. To the extent that articles contain nanomaterials above 0.1% that are selected as candidate substances for authorisation, the provisions of REACH on substances in articles would also apply. Finally, authorities can subject nanomaterials, as other substances, to the REACH restrictions process, again without any specific thresholds.

Does that mean that nanomaterials are adequately regulated under REACH? In its June 2008 Communication on “Regulatory aspects of nanomaterials”, the European Commission stated that “overall, it can be concluded that current legislation covers to a large extent risks in relation to nanomaterials and that risks can be dealt with under the current legislative framework”. However, the Commission also acknowledged that “current legislation may have to be modified in the light of new information becoming available, for example, as regards thresholds used in some legislation”.

The application of REACH to nanomaterials indeed raises a number of issues: The first is whether and in what condition a substance that exists in both nano and other “bulk” form is considered one and the same substance. A second issue is that current production volumes of nanomaterials are generally lower than the one tpa REACH registration threshold, which would mean that few manufacturers or importers of nanomaterials would be subject to registration unless they also produce or import the same substance in bulk form. Assuming that a given nanomaterial is subject to registration under REACH, a third issue is the absence of specific test protocols and risk assessment methodologies regarding nanomaterials.

Commission initiatives

Since 2004, the Commission has taken several initiatives on nanomaterials, including in the framework of REACH, some of which tried to address the questions discussed above. Most recently, the Commission created a subgroup on nanomaterials to address implementation issues, and launched three “REACH Implementation Projects” on nanomaterials or RIP-oNs, designed at adapting existing ECHA technical guidance documents to the specificities of nanomaterials (CW 8 March 2010).

It remains uncertain whether and when the Commission plans to make proposals to adapt the REACH Regulation to the specifics of nanotechnologies. This will probably depend upon the input from the RIP-oN projects and the initial information on nanomaterials that will be collected early in 2011 following the initial registration phase and notification of classification and labelling under the EU classification, labelling and packaging Regulation (CLP). It will be interesting to see how these initiatives will be coordinated with the review of the scope of REACH pursuant to Article 138.2 of REACH. This process has also started and should lead the Commission to make legislative proposals by June 2012 (CW 11 March 2010).

National initiatives

In the meantime, some Member State authorities have been taking national initiatives and others are likely to do so given that it will take some time to elaborate and eventually adopt amendments to the REACH Regulation. For instance, significant developments are taking place in France, within the framework of the “Grenelle project” launched in 2007, which seeks to include a mandatory reporting scheme whereby any person who manufactures, imports or places on the market nanomaterials must periodically declare to the administrative authority the identity, quantities and uses of these substances (CW 24 September 2009).

Does REACH harmonise?

Whether Member States are permitted to adopt national provisions on nanomaterials depends upon whether REACH does or does not “harmonise the requirements on manufacture, placing on the market or use” of nanomaterials. Under Community law, the legality of a national measure will be appreciated differently, depending upon whether or not the matter that the national measure intends to regulate is subject to complete harmonisation under Community Law.

Our article reviews the objectives, legal basis and provisions of REACH, as well as applicable case law, to conclude that REACH does fully harmonise the conditions related to the manufacturing, placing on the market and use of substances, either on their own, in preparations or in articles. There is therefore no scope for Member States to maintain or introduce national provisions intended to directly or indirectly influence the conditions for the manufacture, placing on the market or use of chemical substances, including nanomaterials.

Legality of national measures

For example, a Member State cannot argue that it is entitled to adopt national controls because REACH does not require registration for substances manufactured or imported below one tpa. This is the case for all substances – substances in bulk form can have proven serious hazardous properties and are also not subject to registration below the one tpa threshold.

Does that mean that Member States can take no initiatives? No, but any such initiative should be taken using the specific processes allowed for under the REACH Regulation.

First, a Member State could prepare a dossier in accordance with Annex XV of REACH for substances which in its opinion meet the criteria set out in Article 57 of REACH for substances of very high concern – irrespective of tonnage . This would apply to nanomaterials which meet the authorisation criterion that states: “there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances (listed above) and which are identified on a case-by case basis (...)”.

Also, the restrictions process under REACH enables Member States (or the European Chemicals Agency on behalf of the Commission) to prepare an Annex XV dossier demonstrating that the manufacture, placing on the market or use of a nanomaterial “poses a risk to human health or the environment that is not adequately controlled and needs to be addressed”. Here again, this dossier may lead to the adoption of a restriction applicable to substances at any tonnage threshold.

Another option for Member States is to use the safeguard clause provided by Article 129 of REACH where it has “justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance (...)” even if the substance satisfies the requirements of the REACH Regulation.

The final option is for Member States to apply Article 114 (5) of the Treaty on the Functioning of the EU which allows Member States to introduce national provisions but only based on new scientific evidence relating to the protection of the environment or the working environment on the grounds of a problem specific to that Member State arising after the adoption of a harmonised measure.

As hard as it seems, Member States cannot simply adopt measures on nanomaterials on the grounds that REACH is not specific enough to regulate nanomaterials. If they want to improve the specificity of controls for nanomaterials, Member States will have to negotiate amendments to legislation at EU level.

For further information contact Mayer Brown
Jean-Philippe Montfort leads the REACH team of Mayer Brown. Claire-Marie Carrega is an intern at Mayer Brown, also based in Brussels.

Mayer Brown is a global law firm with extensive experience in the field of chemicals regulation.