Overview

Since physicist Richard Feynman first introduced the notion of nanotechnology in his 1959 lecture, There’s plenty of room at the bottom, its development has been dramatic. Today, many consumer products on the market involve the use of nanotechnology. As an enabling technology, nanotechnology is expected to have an impact on all industry sectors. Its emergence is, therefore, often referred to as a new industrial revolution.

There are, however, significant knowledge gaps concerning the technology’s environmental and health risks. The safety of nanomaterials cannot be taken for granted. According to an opinion of the Scientific Committee for Emerging and Newly Identified Health Risks (‘SCENIHR’), published in January 2009, risk assessment methodologies related to nanomaterials still require further development. With respect to food safety, the European Food Safety Authority recommended in its opinion of February 2009 that action should be taken to survey the use of nanomaterials in food and feed, to assess their exposure to consumers and to generate information on the materials’ potential toxicological effects.

Regulatory pressure  

To address the potential risks posed by nanotechnology, the EU currently relies on its existing regulatory framework for chemicals, worker protection, specific product legislation (such as that concerning medicinal products, plant protection products, cosmetics, food and feed additives) and environmental legislation.

At the 3rd NanoSafety Conference in November 2009, Robert Madelin, former Director General of DG Sanco, highlighted further, equally important, challenges beyond the environmental, health and safety risks:

  • First, he concluded that the EU is confronted with an innovation risk, referring to the danger of hampering innovation of an emerging technology by failing to build consumer trust (cf. the development of biotechnology).
  • Second, he identified a political risk, as third countries are heavily investing into the development of nanotechnology which may potentially result in the presence of unsafe products on the European market.
  • Third, industry is facing a business risk if consumers lose confidence in the safety of the new technology.

Nevertheless, the European Parliament (“EP”) has challenged the EU’s present approach towards nanotechnology regulation in its Resolution of 24 April 2009. The EP does not consider the current legislative framework as sufficient to cover nanotechnology risks. The Resolution calls on the Commission to review all relevant legislation within two years.

REACH

Specifically, the EP has focused on the regulation of nanomaterials under REACH:

  • The EP heavily criticises the one metric tonne per year threshold for substance registration; to ensure safety, nanomaterials produced in quantities of less than one tonne should also be registered.
  • All nanomaterials should be considered as new substances.
  • A Chemicals Safety Report including an exposure assessment should be obligatory for all registered nanomaterials.
  • All nanomaterials placed on the market should be subject to a notification requirement.  

The first major review of the REACH Regulation is due for June 2012, and is likely to contain specific nano provisions.

Cosmetic products

Turning its requests into practice, the EP has inserted nano-specific provisions in the scope of Regulation (EC) 1223/2009 on cosmetic products (“the Regulation”). A definition is provided of “nanomaterial”: “an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”. However, the definition will be adapted “to technical and scientific progress and to definitions subsequently agreed at international level”.

Importantly, the Regulation provides that the list of substances in Annexes III to VI (substances prohibited except subject to restrictions, and permitted colorants, preservatives, and UV filters) do not cover nanomaterials “except where specifically mentioned”.

In addition to the general notification requirement for cosmetic products, a nano-specific notification requirement has been introduced. From 11 January 2013, cosmetic products containing nanomaterials will have to be notified to the Commission by the responsible person six months prior to being placed on the market (except where they have already been placed on the market by the same responsible person before 11 January 2013, in which case the notification must be submitted between 11 January 2013 and 11 July 2013). The information notified must include at least the IUPAC name and other descriptors; the specification of the nanomaterial including size of particles, physical and chemical properties; an estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year; the toxicological profile of the nanomaterial; the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products; and the reasonably foreseeable exposure conditions.

By 11 January 2014, the Commission will produce a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section (which are currently excluded from the whitetext notification requirement listed above), indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions.

In addition, all ingredients in cosmetic products present in the form of nanomaterials will have to be clearly indicated in the list of ingredients, followed by the word “nano” in brackets.

Novel foods and RoHS

Nanotechnology is receiving a similar degree of attention in the context of current legislative revisions of the EU regimes on novel foods and restriction of the use of certain hazardous substances in electrical and electronic equipment (“RoHS”). Civil society is becoming increasingly aware of this debate. The Commission is under increasing pressure to act.

The way forward

The Commission has committed itself to review the relevant legislative framework by 2011. The public consultation for the new Nanotechnology Action Plan for 2010 to 2015 closed on 19 February 2010. The Action Plan is expected to be adopted in 2010. To support the regulatory efforts, the Commission requested the SCENIHR to adopt an opinion concerning the scientific basis for the definition of the term “nanomaterial” via the accelerated procedure by May 2010.

At this stage of the policy process, it is crucial to avoid the development of an immature regulatory framework that will be unduly restrictive and may well result in regulatory discrepancies between the EU, the US and other major trading partners. This is particularly true as long as there is no international consensus on definitions and appropriate testing methods. It is important to create a regulatory framework which balances the technologies’ safe development and encourages innovation and technological progress.

To reach this objective, the Commission’s response should, in our view, include an appropriate blend of both voluntary measures and mandatory requirements, building on a duty of care for manufacturers who place nanotechnology-based products on the European market.

Business challenges

The uncertain business and regulatory environment for nanotechnology raises several related challenges:

  • The emerging regulatory framework should support the development and commercialisation of compliant nanotechnology-enabled products.
  • The development, exploitation and protection of intellectual property rights must be supported.
  • Risk assessment will have to improve in order to encourage insurance coverage on the commercial market.
  • Potential litigation risks will have to be actively managed across jurisdictions.