Commission mulls law changes to cover nanomaterials 

The current EU legislative framework "covers in principle the potential health, safety and environmental risks in relation to nanomaterials," concludes a Commission Communication on regulatory aspects of nanomaterials , published on 17 June 2008. 

However, the Commission states that "current legislation may have to be modified in the light of new information becoming available, for example as regards thresholds used in some legislation". 

The communication covers nanomaterials currently in production and/or placed on the market, but does not address nanomaterials or -particles that occur naturally or are unintentionally produced through, for example, combustion.

Based on the EU executive's regulatory review  of EU legislation in relevant sectors, the communication finds that nanomaterials are covered under current EU laws on:

• Chemicals, namely REACH, consisting of specific rules on the manufacture and market authorisation of substances on their own, in preparation or in articles;
• health and safety of workers, and;
• product requirements for health and safety of workers, consumers and protection of the environment: 
  • Groups of products: plant protection products, biocides, new approach legislation, cosmetics, aerosol dispensers, medicinal products and cars; 
  • food legislation: general food law, novel food, food contact materials, food additives, food supplements, feed legislation; 
  • General Product Safety Directive on consumer products not covered by specific regulation, and;  
• environment: directives on Integrated Pollution Prevention and Control (IPPC), major accidents (Seveso II Directive), water, waste, air quality, soil protection and environmental liability.

According to the communication, the best place to start in order to enhance the protection of health, safety and the environment is simply to improve implementation of current legislation by reviewing existing elements supporting implementation. The elements in need of review include the different test and risk assessment methods that serve as a basis for implementing legislation, administrative decisions and manufacturer's and employer's obligations. 

Meanwhile, "authorities and agencies in charge of implementing legislation should continue to carefully monitor the market, and use Community market intervention mechanisms in case risks are identified for products already on the market," notes the EU executive.

As for labelling of products, the Commission does not exclude the possibility "that a need would be identified for specific labelling requirements" for nanomaterials. Until then, it says, nanomaterials must comply with the existing EU law on the labelling of products, warnings and other information for consumers on the properties of products.

The regulatory review also identified a number of domains in which more research on nanomaterials will be conducted to improve the scientific knowledge basis in support of the regulatory work. These include: 

• Developing reliable measurement methods, reference materials and materials characterisation; 
• review and development of test methods for human health, safety and the environment;  
• developing exposure information throughout the life-cycle of nanomaterials,
• review of existing risk assessment methods;
• risk management for workers' protection purposes;
• networking existing and establishing new infrastructures to examine health, safety and environmental aspects of nanomaterials.

"A reliable and stable regulatory framework is essential for enabling the EU's industry to fully exploit the advances of nanotechnologies" and to boost innovation, growth and job creation, said EU Commissioner for Enterprise and Industry Günter Verheugen. 

Meanwhile, Environment Commissioner Stavros Dimas highlighted the need to fully apply the precautionary principle with regard to nanomaterials as "the regulatory challenge is to ensure that society benefits from novel applications of nanotechnologies, while ensuring a high level of protection of health, safety and the environment".