Regulating in Thin Air: Nanotechnology Regulation in the European Union

• DOI: http://doi.org/10.1111/reel.12032
• Author: Sebastian K. Mielke
• Date: 01 July 2013
• Published date: 01 July 2013

Regulating in Thin Air: Nanotechnology Regulation

in the European Union

Sebastian K. Mielke

This article analyzes the challenges faced by

regulators in the European Union when dealing

with nanotechnology. By examining the status quo of

nanospecific regulation as well as current proposals

for future legislation, the article shows the difficulty of

adapting the main regulatory tool – the precautionary

principle – to challenges in areas such as chemicals,

novel food, cosmetics, medical devices or biocides.

Designed to work in areas in which there is only a very

limited knowledge base, regulators are forced to apply

the precautionary principle in a way that achieves a

balance between the protection of human health and

the environment, on the one hand, and the promotion

of wealth and technological progress, on the other.

INTRODUCTION

The European Union (EU) has taken the lead in pursu-

ing (precautionary) regulatory measures on nanotech-

nology. In doing so, it faces multiple hurdles due to a

variety of reasons, such as the very limited knowledge

about the potential risks (and actual benefits) of this

new technology,1or the fact that nanotechnology is not

limited to a single production sector but is cross-

sectoral in its approach and application possibilities.

This article is dedicated to new developments in nano-

technology regulation in the EU. In particular, it

focuses on how these developments reflect the precau-

tionary principle and illustrate a classic regulator’s

dilemma not limited to nanotechnology: how can a new

technology be regulated when its possible hazards are

not yet known and, moreover, the effectiveness of the

preventative measures is still unknown? A possible

deterrent effect of regulatory measures has to be

weighed against possible risks of the new technology.

The regulator thus has to work in thin air.

In a first and rather brief step, this article will outline

efforts by the European Commission to define ‘nano-

material’. After discussing the concept of the precau-

tionary principle in the EU, regulatory measures

already taken by the European legislature concerning

chemicals, food and cosmetics will be explored to deter-

mine the status quo. Subsequently, the article will

discuss new developments in the fields of biocides and

medical devices regulation, followed by a conclusion.

DEFINING A ‘NANOMATERIAL’

‘Nanotechnology’ is an umbrella term for technologies

based on the deliberate und purposeful use of (not

necessarily manufactured/engineered) nanomaterials.

Therefore, it does not define a closed set of common

techniques or standard procedures used in every sector

of production or research. A ‘nanomaterial’, according

to the European Commission’s Recommendation 2011/

6962on the Definition of Nanomaterial,3has to be

interpreted in a wide sense, and covers

natural, incidental or manufactured material containing

particles, in an unbound state or as an aggregate or as an

agglomerate and where for 50% or more of the particles in

the number size distribution, one or more external dimen-

sions is in the range of 1 nm – 100 nm.4

The Recommendation states that this definition should

be based on available scientific data,5and harmonized

measurement methods have to be developed to ensure

that the application of the definition leads to consistent

results across materials and over time,6making it clear

that the definition is considered work in progress.

Moreover, the definition is not mandatory for future

pieces of legislation, but is supposed to provide a

common understanding of the term ‘nanomaterial’ that

can be adapted when necessary. Critics7point out that

the definition covers both natural and manufactured

1Royal Commission on Environmental Pollution (RCEP), Novel

Materials in the Environment: The Case of Nanotechnology (RCEP,

2008), at 40ff.

2Recommendation 2011/696/EU of 18 October 2011 on the Defini-

tion of Nanomaterial, [2011] OJ L275/38. For a genesis of the Rec-

ommendation, see: G. Lidén, ‘The European Commission Tries to

Define Nanomaterials’, 55:1 Annals of Occupational Hygiene (2011),

1.

3According to the Recommendation, special nanomaterials, such as

fullerenes, graphene flakes and single wall carbon nanotubes with

one or more external dimension below 1 nm, are considered nano-

material as well. Recommendation 2011/696/EU, n. 2 above, at para-

graph 3.

4Ibid., at paragraph 2.

5Ibid., at recital 5.

6Ibid., at recital 6.

7See, e.g., G. Lidén, n. 2 above, at 3.

bs_bs_banner

Review of European Community & International Environmental Law

RECIEL 22 (2) 2013. ISSN 0962-8797

© 2013 John Wiley & Sons Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA.

146