REACH – better informed about nanomaterials?

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Nanomaterials are already applied to numerous products today in order to equip them with additional properties.

This trend is surely on the rise. The Öko-Institut recommends adjusting the registration and testing requirements established by the European Union’s chemicals regulations – REACH and CLP – to do justice to the special characteristics of nanomaterials. Up to now, the potential impacts of these materials on human health and environment remain largely in the dark.

“When it amends the REACH Regulation, it is important that the EU considers which provisions can be used to give greater account to nanomaterials than has been the case in the past,” demands Andreas Hermann, researcher at the Öko-Institut and one of the authors of a new study on these issues. “Manufacturers and importers of nanomaterials…

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should be obliged to disclose differentiated information about them and to transmit this information to downstream users.”

Reducing tonnage thresholds

One weakness of REACH in its present form is that manufacturers and importers are only obliged to identify the risks posed by nanomaterials to human health and the environment if they put more than ten tonnes of a nanoscale substance on the market per year. Many of the nanomaterials circulating today do not reach these tonnage thresholds. However, due to their size they find many applications, which favours their widespread dispersal.

Hermann and the co-authors of the study commissioned by the German Federal Environment Agency urge that nanomaterials be treated as discrete substances under law when identifying their specific health and environmental risks. At present, such risk-related information on nanomaterials is either not gathered at all, or is stated together with the analogous bulk form of the same substance without differentiating sufficiently between the two. “This is a mistake,” warns Andreas Hermann, “for while nanomaterials have the same chemistry as the ‘analogous bulk material’, their size means that their properties and behaviour can differ substantially.”

Are nanomaterials discrete substances?

This is the pivotal question for any amendment to REACH and CLP: is a nanomaterial with the same chemical identity the same substance as its analogous bulk material? Or must nanomaterials be treated in all cases as discrete substances in REACH, with discrete provisions?

“That is not the route we recommend. Instead, we propose treating nanomaterials as discrete substances in legal terms with regard to certain requirements in REACH, although by definition they are not chemically discrete substances,” says Hermann. Such a legal fiction removes the need to redefine the concept of “substance” under REACH, while creating an obligation to treat nanomaterials separately. Moreover, is it important to refine the criteria by which nanomaterials are distinguished among themselves and from the analogous bulk material. A further point is that a definition of “nanomaterial” should be taken up in REACH.

More transparency for more protection

Such an approach is in line with the ultimate objective of REACH, namely to protect human health and the environment. Such a separate treatment concerns many of the items of information that the manufacturers and importers of chemical substances must provide. For instance, they must identify, by means of specific criteria, the substances they wish to place on the market. The scientists urge that information on nanomaterials be made a mandatory element of such disclosure.

A further drawback of REACH as it currently stands is that manufacturers and importers can use a joint safety data sheet for both nanomaterials and bulkmaterials to inform their purchasers about the risks, without having to distinguish in the individual sections of these sheets between the nanoscale substance and the analogous bulk material. In future, information should be provided in separate data sheets that also provide further types of information, such as any surface modification of the nanomaterial. This approach would provide information specific to the nanomaterial.

Further information

Final report of the research project “Legal questions regarding the application of the substance definition to nanomaterials within the framework of the REACH Regulation”

Contacts at Öko-Institut

Andreas Hermann
Researcher with the Environmental Law & Governance Division
Öko-Institut, Darmstadt office
Tel.: +49 6151 8191-0
E-mail: a.hermann@oeko.de

Rita Gross
Researcher with the Sustainable Products & Material Flows Division
Öko-Institut, Freiburg head office
Tel.: +49 761 45295-264
E-mail: r.groß@oeko.de

Oeko-Institut is a leading European research and consultancy institute working for a sustainable future. Founded in 1977, the institute develops principles and strategies for realising the vision of sustainable development globally, nationally and locally. The Institute is located in Freiburg, Darmstadt and Berlin.

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