Übersicht über regulatorische & freiwillige Massnahmen in der Handhabung synthetischer Nanomaterialien in Europa
Regulierungen und gesetzliche Vorschriften haben unterschiedliche Funktionen. Aus Sicht der Behörden stehen Sicherheit und Schutz von Mensch und Umwelt im Vordergrund. Für Unternehmen bedeuten Vorschriften einerseits Einschränkungen (Compliance), zum anderen sind sie aber auch ein Orientierungsrahmen (Rechtssicherheit). Aus Sicht der Zivilgesellschaft und der Bürger wirken Vorschriften vertrauensbildend. Was reguliert ist, ist sicher. Wo Regulierungen fehlen, braucht es freiwillige Massnahmen, um dieses Vertrauen sicherzustellen. Der folgende Artikel leuchtet dieses Spannungsfeld aus und gibt einen Überblick über die momentane Situation der Nano-Regulierung in Europa. Artikel in englisch.
Legal regulations in Europe |
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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 |
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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: | |
Codes of Conduct (CoC) |
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Risk management systems |
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Voluntary reporting schemes |
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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. | |
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International Coordination Activities |
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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, Environmental Protection & REACH” 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. |