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Posted: May 08, 2008
Overview of regulatory and voluntary measures for the handling of engineered nanomaterials in Europe
(Nanowerk Spotlight) Regulations and legal provisions can serve several purposes. From a regulator’s perspective priority is given to aspects of human safety and environment protection. For commercial firms, regulations on the one hand imply restrictions (compliance) and on the other hand offer a frame of reference and predictability of legal decisions. From a civil society’s point of view regulations can be trust-building in the sense that it indicates a certain level of safety. A lack of regulations calls for voluntary measures in order to make sure that this kind of basic trust can be established. The following article aims at shedding light on this field of tension and gives an overview of the current state of European nanotechnology regulation.
Legal regulations in Europe
Nano-specific regulations have been called for from several parties with most controversies focusing on the topic of nanomaterials use in food products. It is criticized that consumers unwillingly have to take risks caused by the higher bio availability and bio activity of such materials. Against this background, some NGOs and consumer protection groups ask for a strict duty of declaration as well as systems and obligations to report on engineered nanoparticles in consumer products. However, most companies active in this area are not willing to discuss the topic publicly.
Regulatory frameworks for the handling of engineered nanomaterials already exist in Europe. In the EC they implicitly fall under the new regulation of REACH 1907/2006 (REACH: Registration, Evaluation, Authorization and Restriction of Chemicals) that came into effect on July 1st 2007 and explicitly mentions the precautionary principle. Manufacturers, importers and downstream users have to make sure that the substances they utilize and put on the market do not adversely affect human health or the environment. This should guarantee that risks emanating from dangerous substances are under control. Substances of concern are to be gradually replaced by alternative substances or technologies where suitable economically and technically viable alternatives are available. According to the requirements of this regulation engineered nanomaterials have to be checked for health and environment relevant properties if their annual production exceeds the threshold value of 1 ton.
REACH replaces many prior regulations. One of its main objectives is the determination of dangerous properties of substances and their uses, especially in the case of existing substances (phase-in-substances). The registration of existing substances follows a set of priorities, whereas the criteria are the annual production tonnage and potential hazards.
Another important aspect is the definition of duties and obligations for manufacturers, importers and downstream users of the substances used in preparations and manufactured items. Recommendations for risk management measures shall be passed on along the supply chain in a systematic way. This implies the adequate and transparent documentation and communication of risks adherent to specific substances. The aim of these provisions is to avoid impairments of human health and the environment under reasonably foreseeable usage conditions.
Nano-specific adaptations of the REACH regulation are currently still subject to investigations. It is known that the properties of engineered nanomaterials can differ significantly from those of the same substances on the micro scale. This raises the question, whether they should be treated as new substances (non phase-in substances) and consequently fall under the rule of “no data, no market” (market introduction only after prior registration) or whether they can benefit from the transitional regime for existing substances.
Besides posing risks to human health and the environment, the absence of nano-specific regulations can also be an obstacle for the economy. Industry is reliant on a predictable framework within which investments are fully protected. However, it is in the nature of regulation that the knowledge base must be relatively complete in order to develop rules. Since the basis for the assessment of nano-specific risks and for the creation of rules is rather incomplete while the market volume for nano products is constantly increasing, there is a special need for the creation of specific knowledge in the areas of risk research, risk assessment concepts and measurement methods. Currently, numerous programs are under way on the national, supranational and international level (OECD) with the objective of developing the necessary conditions for a responsible handling of engineered nanomaterials.
Voluntary measures in the management of engineered nanomaterials
Already today, several measures on a voluntary basis are being taken internationally. Some of these tools – that should be looked at in the light of the precautionary principle and the industry’s self-reliance – will be described in the following:
The UK´s Royal Society developed a CoC (Responsible NanoCode) for businesses involved in nanotechnologies. It is aimed at stimulating these organizations to consider all aspects of their involvement with nanotechnologies, including broader social and ethical issues.
Several manufacturers of nanomaterials have elaborated Codes of Conduct. An example is the CoC by BASF that comprises principles such as protection of employees, customers and the environment, participation in risk research as well as transparency and dialogue.
In Switzerland, the "Swiss Retailers Association has published a Code of Conduct for nanotechnology in consumer products. The members commit to the highest possible transparency for consumers and to the precautionary principle in the light of a lack of regulations.
Risk management systems
CENARIOS® is a certifiable risk management and monitoring system for nanotechnology, integrating the newest findings in science and technology as well as societal, legal and market related factors. This allows for an objective risk assessment in a market characterized by rapid developments and high uncertainties. It comprises the modules “Risk estimation and assessment”, “Risk monitoring”, “Issues management and communication” and “Certification”.
The NANO Risk Framework is a risk management system developed by DuPont and Environmental Defense and is intended for use by all parties interested in commercializing nanomaterials. It is based on a six-step process for the identification, assessment and management of potential risks with a focus on toxicity considerations.
Voluntary reporting schemes
In some European countries authorities intend to regularly receive information on the production and use of nanomaterials. This would represent a valuable supplement for their basic research activities.
The UK's Department for Environment, Food and Rural Affairs (DEFRA) has established a voluntary reporting scheme for engineered nanoscale materials that gives industry and research organization the opportunity to provide Government with information relevant to understanding the potential risks posed by free engineered nanoscale materials.
In Switzerland, companies were given the opportunity to report relevant data on their nano-specific activities in the context of a project called "Nanoinventory". This information will be combined with data about protection measures for humans and the aquatic and atmospheric environment, and with exposure profiles of typical workplaces to estimate the potential exposure of the Swiss working population to nanoparticles.
International Coordination Activities
On April 10th and 11th 2008 a meeting of authorities’ representatives from Germany, Austria, Switzerland and Liechtenstein on the topic of voluntary safety standards in nanotechnology risk management was held in Munich. Voluntary measures and the experiences made with them were discussed. The participants came to the conclusion that under the current conditions the concept of voluntary measures can be regarded as a sensible and forward-looking approach.
Since the scientific basis for a legal regulation is at least today missing to a large extent, voluntary safety standards represent a forward-looking instrument to protect humans and the environment while giving the necessary time to develop the necessary fundamentals for a legal regulation.
By Dr. Jean-Pierre Matthieu, Die Innovationsgesellschaft mbH
Jean-Pierre Matthieu is Head of the Competence Centre “Occupational Safety and Environmental Protection” at the Innovation Society Ltd. in St. Gallen (Switzerland). He has been a certified labor inspector with the State Secretariat for Economic Affairs (SECO) for more than 22 years. He also participated in the implementation of the European Chemical law in Switzerland. Jean-Pierre Matthieu is responsible for the specific aspects of health protection and occupational safety of nanoparticle handling. His Competence Centre offers services for producers and users of nanomaterials, retailers, insurers, associations and authorities that are confronted with questions of nanoparticle risks.
The Innovation Society Ltd, St. Gallen, is an international consulting firm. The company provides risk-management service (e.g. CENARIOS®), business information services (Nano-Monitoring) and communication services (Stakeholder-Management).