Small Steps Taken by EU Towards Nano Regulation, Still Leaves Much to be Desired

This post is the first in a series of updates on the current situation regarding the contentious technological development known as nanomaterials, a topic that has spurred heated debate as policymakers, industry, and environmental health experts weigh its potential to help versus harm.

Reliable power on the go / BASF, The Chemical Company / via Flickr Creative Commons
Reliable power on the go / BASF, The Chemical Company / via Flickr Creative Commons

In response to intense lobbying and activism by NGOs and several European Union (EU) member states, the EU is timidly moving forward to adapt its regulatory framework for nanomaterials.

Nanotechnology regulation has been largely neglected because its unique properties and ability are unseen and there is a lack of political will to put human and environmental health concerns above the potential short-term benefits of nanotechnology and industry’s interest. As nanomaterial exposure proliferates, the time for nano regulation couldn’t come sooner.

The EU Commission has finally come forward with suggestions for the revisions of the annexes of REACH, the EU’s flagship chemical regulation, to adapt to the specificities of nanomaterials. Although a revision of REACH annexes is highly necessary, it is unlikely to be sufficient to guarantee that nanomaterials will undergo a thorough risk assessment before reaching European markets. In a so-called “non paper” of suggestions for nano-related REACH annex revisions circulated to a selected group of stakeholders in May, the Commission is even considering exempting a large number of nano forms from providing basic composition information. The official proposal for the amendments to the REACH annexes should be made public in the fall, though the Commission has an extensive track record of never making this kind of deadline.

It is also hesitantly considering the question of transparency and access to information by assessing the impacts of a possible nano registry and aiming to present a formal proposal in 2015. Current information available on nanomaterials and products containing them are insufficient to ensure informed consumer choice and proper oversight by the regulator. France has already established a national nano registry for nanomaterials along the supply chain, Denmark has adopted one focused on products containing nanomaterials, and Belgium is planning to follow suit this year. This impact assessment is coupled with a public consultation process, both of which are led by the DG Entrerpise, the Commission department in charge of promoting a growth friendly framework for European enterprise. DG Trade of the Commission is conspicuously dragging its feet at the prospect of establishing such an EU-wide registry, and doing its best to water down whatever would come out of this process. However, it is likely to be misjudging the industry’s own interest in a pursuit of a purely ideological position; state initiatives for national registers will only multiply, increasing the administrative burden for all industries unless an EU wide solution can be found.

The recent, albeit insufficient, advances by the EU coincide with the release of the Swedish Society of Nature Conservation (SSNC) Report: Managing the Unseen—opportunities and challenges with nanotechnology this month, drafted by CIEL Attorney David Azoulay.

The report provides a detailed overview of nanotechnology, providing a definition, basic toxicology and ecotox (toxicity to humans and to the environment), market analysis, both worker and consumer exposure issues, and an overview of legal frameworks regarding nanotechnology around the world. The report also addresses the specific and disproportionate risks born by countries in the Global South that cannot afford complex and expensive oversight and which risk receiving an increasing amount of nano waste. The report highlights the risk and temptation of using nanotechnology as technological “quick fix” rather than looking into more sustainable and possibly cheaper solutions to health and environmental problems.

The report concludes with a detailed assessment of the EU regulatory framework and suggests possible reforms, only some of which the EU Commission is now tentatively considering.

The EU public consultation on an EU wide register will end in August 2014, and the open discussion on the REACH annex revision should start in the fall. The EU can and must continue to take the global lead in developing an adequate regulatory framework for nanomaterials. Decisions have been delayed too long, and we can only hope that when decision time eventually comes, the EU Commission will remember that its responsibility is not only to facilitate business operations but first and foremost to protect the health and environment of its citizens.

Originally posted on July 13, 2014.