New EU Regulations for Nanomaterials in Preparation

With the EU publishing an official definition of nanomaterials, changes to consumer product regulations are now expected to follow.

On October 18, 2011 the European Commission (EC) adopted recommendation 2011/696/EU, which now provides a clear definition of nanomaterials as: "A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range between 1 nm and 100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness, the number size distribution threshold of 50% may be replaced by a threshold between 1% and 50%. By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials."

Nanomaterials in the electrical and electronics industry

As key elements in the emerging nanotechnology field, nanomaterials are heralded as offering a variety of innovative applications, in particular for consumer electronics.

Nanomaterials possess unique physical, chemical and electrical qualities. For the electrical and electronics (E&E) industry, nanomaterials and their related nanotechnologies promise major improvements in the efficiency of a whole range of applications, including batteries, flash memory, processors, photovoltaics, lighting, displays for computers and mobile devices. Thanks to their properties they also offer unique opportunities for new applications in medical sensors and interfaces. As a result, the nanotechnology sector enjoys continued growth in value and importance.

Risks related to nanomaterials

The benefits of nanomaterials are being explored intensely, but so far relatively little is known of potential flaws. There are currently no international regulations restricting the use of nanomaterials. What is obvious is that the very same nanoscopic properties that make them so attractive may also pose risks to humans and the environment. For example, implications for health arise from their easy absorption into tissues, organs, the bloodstream and a possible broaching of the blood-brain barrier.

Concerns for the environmental include permeation of nanomaterials into the soil, water cycle and atmosphere. ELC, the food industry body, infer a low risk from the existing natural abundance of nanoparticles in the environment. They argue that since nanoparticles are already inadvertently produced by a number of simple and apparently harmless mechanical processes like the grinding of coffee and the milling of wheat, it would seem reasonable to expect nanomaterials to exhibit low levels of risk.

While such reassurances are nice to hear and the fact that when nanomaterials are embedded in E&E products they may come less into direct contact with consumers than textiles or cosmetics, the risk factors for E&E still demand close attention. As one example, the Environment Directorate of the OECD is already working on ways to deal with risks from nanoparticles in the disposal of batteries. Carbon nanotubes are highly promising for batteries, but can cause low-level damage to DNA under certain circumstances.

Nanomaterials also promise innovations in medical electronics, where living tissue is more directly exposed and the risks need to be investigated. By the same token, risk factors will need to be examined by the manufacturers of toys, where contact with or ingestion of nanomaterials present new risk factors for batteries, displays, coatings and other elements of toys.

Regulatory implications for E&E businesses

It remains largely unknown what future regulatory implications the new EU definition of nanomaterials will have; for the present it is seen as simply a tool to enable future legislation on the use of nanomaterials. However, not yet in place we may expect all materials classified as nanomaterials to require a risk assessment and be subject to REACH. These guidelines will likely be updated with a reference to the EU definition of nanomaterials and unique means of risk assessment for nanomaterials will be based on their unique properties.

For the present, E&E manufacturers will have to wait and see what emerges in the form of regulatory changes. One immediate concern raised about the EU definition is its scope. Some argue it may result in a number of well-established products which must now be classified as nanomaterials, including certain mineral pigments and fillers. The industry bodies who raised this concern are the German Federation of the Chemical Industry (VCI) and the European Chemical Industry Council (CEFIC).

Should you need further information, please contact:

SGS Consumer Testing Services
Dr. Udo Krischke
Global Technical Manager RSTS
Im Maisel 14, 65232 Taunusstein

t: +49 (0)6128 744 235

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.

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