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German Advisory Body Takes Precautionary Approach to Nano
Report says many questions on behaviour and effects of nanomaterials remain unanswered
01-Sep-2011
The German Advisory Council on the Environment (SRU), which advises the Environment Ministry, has published a comprehensive report providing policy recommendations for the control of risks associated with nanotechnology. Fundamental to the 600+ page report is how the precautionary principle should be applied to the sector to ensure people and the environment are protected from unknown risks.
The report states that many questions remain unanswered as to behaviour and effects of nanomaterials in the environment and on organisms – especially given the great variety of potential materials and products. It also notes that some characteristics of nanomaterials relevant for risk assessment cannot be inferred from the corresponding bulk material and that there are already data showing different absorption, distribution and reactivity characteristics between nano and bulk substances in organisms.
For example, the report points out that due to nano-specific properties, such as photocatalytic activity, nanoparticles and nanofibres can have a higher reactivity compared with the bulk material; in addition nanomaterials’ tendency to aggregate or agglomerate can lead to different dose-effect relationships.
As a result, the SRU report suggests that “assessment of the environmental and health risks of nanoparticles and nanofibres cannot be solely based on established methods for conventional materials and must currently be performed separately for each material and each product.”
At this stage, it says one of the great challenges is the identification of potential risks of new nanoscale materials at an early stage. It states this can be achieved by classification according to nano-specific risk criteria – but these are yet to be fully established. What work has been done indicates there are already serious concerns regarding a number of nanomaterials and that this is of concern from a legal perspective.
In SRU’s opinion: “In certain cases there is sufficient concern to justify a specific need for action. Such cases include… the use of nanomaterials in consumer sprays and growing sales of consumer products containing silver nanoparticles. In the case of CNTs, there are concerns that some of the materials involved are thought to have carcinogenic potential. As CNTs are currently restricted to products where they are bound within polymers, the concerns mainly relate to the possibility of exposure in production and processing. Use of nanoscale iron (oxide) in open-environment applications, as practised in some countries, would likewise be incompatible with the precautionary principle.”
The report includes a model for the identification of precautionary action by the state; it also refers to Germany’s NanoKommission Principles Paper, which it says should continue, but with additional actions taken.
Among the main recommendations for action are:
• Extensive changes to REACH that would see nanomaterials treated as
substances in their own right, with registration dossiers independent of the associated bulk substance and including a core data set that ensures observation or preliminary risk estimation, according to their size.
Quantity thresholds must be reduced for nanomaterials and the standard information requirements need to be supplemented. Authorisation should be based more closely on the precautionary principle and there should be the possibility for authorities to restrict or prohibit nanomaterials based on an abstract concern. In product legislation, existing authorisation procedures should ensure that nanomaterials are approved separately.
• Makers of nanomaterials should be placed under stricter obligation to
file data on the risks of nanomaterials. Risk research should be made to account for a considerably larger portion of publicly funded nanotechnology research.
• For an overarching definition of nanomaterials, an upper size limit of
300nm is recommended. A smaller size limit may be appropriate for specific regulatory purposes.
• Existing dialogue activities should be extended to a broader
cross-section of society.
• To enhance market transparency, existing labelling obligations should
require an additional ‘nano’ indication. Products that release nanomaterials or make use of them to achieve specific properties, such as antibacterials, should also require mandatory labelling. For other nanoproducts, a notification requirement should be introduced that feeds into a semi-public product register.
• Operators of industrial facilities should be obliged to minimise
emissions of nanomaterials for which there is an abstract concern. And further research is needed in the area of environmental impacts.
Responding to the SRU report, Federal Environment Minister Norbert Röttgen said that nanotechnology would only be successful if it was sustainable.
He added that the public would only accept nanotechnology if the risks were known and acceptable, but that this should be addressed at EU as well as national level.
On publication of the report, the NGO BUND repeated its call to Minister for Consumer Protection Ilse Aigner to ban the use of nano silver in consumer products immediately. Bund nano-expert Jurek Vengels said: “All products on the market should be safe for consumers. In nano silver-containing materials this is not guaranteed.” The group also welcomed the recommendation for nanomaterials to be identified to consumers and the authorities and the establishment of a national nanotechnology register. Its own database contains information on 600 products containing nanoparticles, including 60 that contain nano-silver.
The German Chemical Industry Federation (VCI) contended that many of the recommendations in the SRU report would hamper innovation in the nanotechnology sector. And while the VCI generally supports the concept of transparency regarding nanoproducts, Gerd Romanowski, director of science, technology and environment said there was concern that a requirement to register products to a database would be a duplication of effort with other legal requirements, and that labelling of nanoproducts would be seen by consumers as a warning.
Full Report (in German)
Executive Summary (in English)
Report conclusions and recommendations (in English)