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"A change of paradigm for nanotechnology regulation in Europe"?

The June Newsletter of the Innovation Society (St Gallen, Switzerland, suggests that a series of legislative amendments adopted by the European Parliament over the past two months "might herald a change of paradigm for nanotechnology regulation in Europe, from a rather reluctant government position toward a more explicit approach on manufactured nanomaterials". The item is copied below, and the original can be viewed on the Innovation Society's website.

"According to a previous communication of the European Commission (EC) to the Parliament on regulatory aspects of nanomaterials [1], “current legislation covers in principle the potential health, safety and environmental risks in relation to nanomaterials”, and “the protection of health, safety and the environment needs mostly to be enhanced by improving implementation of current legislation”.

In a recent answer to this communication [2], however, the European Parliament (EP) has made clear that it takes a different stance on the issue of nano regulation by declaring the EC’s statement to be misleading. Swedish Member of Parliament (MP) Carl Schlyter from the Committee on the Environment, Public Health and Food Safety, who reported on the Parliament’s answer on regulatory aspects of nanomaterials to the Commission, said that “the Commission’s analysis is based on a one-dimensional, legalistic overview of the current rules, but those rules are about as effective in addressing nanotechnology as trying to catch plankton with a cod fishing net”. While 362 Members of the Parliament (MP) opted for the adoption of the resolution, only 4 were against it; a very clear vote in the light of the controversy of the debate.

In the report, which has been adopted on 24th of April 2009, the Committee considers it particularly important to address nanomaterials explicitly within the scope of at least legislation on chemicals (REACH, biocides), food (foodstuffs, food additives, food and feed products from genetically modified organisms), relevant legislation on worker protection, as well as legislation on air quality, water quality and waste.

In the same direction point a series of legislative amendments that have been adopted in April 2009 by the Parliament; the MP adopted significant amendments concerning nanomaterials in the context of the recast of the Cosmetics Directive [3], and, upon a legislative initiative of the Commission, further nanospecific amendments to the Regulation on Novel Food [4] have been brought into the co-decision procedure by the Parliament (see article (2) below).

Concerning worker protection in particular, the Parliament wants related legislation to be reviewed concerning a clear assignment of liability to producers and employers arising from the use of nanomaterials.

The MP also suggest the Commission to compile a publicly available inventory of the different types and uses of nanomaterials on the European market before June 2011, while respecting justified commercial secrets. At the same time, the Commission should report on the safety of these nanomaterials.

In respect of consumer protection and communication, the Committee is further criticizing the misleading use of the denotation “nano” as a commercial purpose, and, taking reference to the ongoing discussion about mandatory labelling of nanomaterials in consumer products, the Committee reiterates its call for a clear indication of any nanomaterial in the labelling of a product (e.g. in the list of ingredients, the name of such ingredients should be followed by the word 'nano' in brackets).

According to the report, the Parliament also assesses REACH in its current form to be at least partly inadequate to handle the peculiarities of manufactured nanomaterials. The Committee calls the Commission to be unable to address nanotechnology risks since it is disregarding the lack of appropriate data and methods to assess the risks.

* “Size matters, not weight”: REACH uses mass based thresholds based on annual production volumes to trigger registration and data submission requirements. However, the unique properties of substances at the nanoscale potentially resulting in increased activity and risks are determined to a greater extent by particle number, surface structure and surface activity and to a lesser extent by concentration and tonnage. Thus, the tonnage thresholds under REACH are considered inadequate for nanomaterials. The Committee is calling for a change of criteria regarding threshold values for nanomaterials.

* “No data, no risk”: nano-risks are out of REACH: The Parliament complains that the REACH requirements for the notification of substances in articles only concern substances of very high concern that are on a “candidate” list and that are present in concentrations above 0,1 % by weight produced in a total quantity above one tonne per manufacturer and year. So far, however, according to the Committee, not a single nanomaterial is on the candidate list. And in the light of current difficulties regarding risk assessment of nanomaterials and that many manufactured nanomaterials are currently used in small volumes only, it is feared that many manufactured nanomaterials will not be notified under REACH.

The Parliament refers to the well known principle of “no data, no market”. According to this principle, which is underlying REACH and established in § 5, chemical substances shall only be manufactured and placed on the market upon prior registration and submission of the necessary health, environmental and safety data to prove that a substance causes no harm.

In the report, the MP amongst other things suggest the European Commission to

* propose means of implementing the principle of "no data, no market" for all applications of nanomaterials in products with potential negative environmental, health and safety impacts,
* review REACH concerning consideration of all nanomaterials as new substances,
* request a chemical safety report with exposure assessment for all registered nanomaterials irrespective of hazard identification (which, according to REACH, in absence of specific concerns would only be necessary if production or import exceeds 10 tonnes per year),
* ensure that all ingredients present in the form of nanomaterials in substances, mixtures or articles should be clearly indicated in the labelling of the product (e.g. in the list of ingredients, the name of such ingredients should be followed by the word 'nano' in brackets),

In summary, the Parliament’s claims might herald a change of paradigm for nanotechnology regulation in Europe, from a rather reluctant government position toward a more explicit approach on manufactured nanomaterials. The Commission is now urged (although not in a legally binding way) to propose reviews of all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle, and to ensure that legislative provisions and instruments of implementation reflect the particular features of nanomaterials. It is clear that the Parliament’s claims are both very ambitious and sophisticated and would induce considerable efforts to fully comply with.

The 5th international NanoRegulation conference in Rapperswil (Switzerland) (November 25th / 26th, 2009) which is organised by the Innovation Society in collaboration with NanoEurope will have a closer look at these new developments. Please find more information on this in the Conference announcement below".

Article by Markus Widmer and Stephan Knébel (Innovation Society)

[1] COM (2008) 366 final: Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee: Regulatory aspects of nanomaterials, 17.06.2008.

[2] European Parliament: Report on regulatory aspects of nanomaterials (2008/2208(INI)). Committee on the Environment, Public Health and Food Safety. A6-0255/2009. Rapporteur: Carl Schlyter. 24.04.2009.

[3] Recast of the Cosmetics Directive: Link

[4] Novel Food Regulation: Link