Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

On July 7, 2010, the European Parliament (EP) voted that nanoscale ingredients should be banned from food in the European Union (EU) until the health and environmental risks they might pose are better understood, and that any nanoscale ingredients that are eventually authorized should be clearly labeled as such. The EP voted on several amendments to draft legislation concerning the authorization of novel foods, including a provision that would prohibit food from cloned animals or their offspring. The EP has been unable to reach agreement with the European Council on the legislation, largely because of the provision concerning cloned animals. The Council also disagrees that foods containing nanoscale ingredients should be systematically labeled, however. According to an EP spokesperson, the legislation likely will go to conciliation, during which the EP and European Council will attempt to negotiate a compromise after two readings have failed to produce an agreement. The legislation likely will be discussed again in the fall.

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On July 2, 2010, the European Commission’s (EC) Joint Research Centre (JRC) announced the availability of a reference report entitled Considerations on a Definition of Nanomaterial for Regulatory Purposes. JRC prepared the report in response to a request from the European Parliament (EP). JRC states that the aim of the report is to review and discuss issues and challenges related to a definition of “nanomaterial,” and to provide practical guidance for a definition for regulatory purposes. JRC suggests that a definition for regulatory purposes should:

• Only concern particulate nanomaterials;
• Be broadly applicable in European Union (EU) legislation, and in line with other approaches worldwide; and
• Use size as the only defining property.

 

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On June 2, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety approved the proposed recast of the Directive on the Restrictions of Hazardous Substances (RoHS) in Electrical and Electronic Equipment, with 55 votes in favor, one against, and two abstentions. The Committee adopted amendments adding nanosilver and long multi-walled carbon nanotubes (MWCNT) to Annex IV, despite the fact that nanomaterials were not included in earlier proposals. In effect, there would be no threshold, with equipment prohibited from the market if it contained either nanosilver or long MWCNTs at “detectable levels.” The Committee also adopted amendments that require equipment containing nanomaterials to be labeled, and for manufacturers to be required to provide safety data on the nanomaterials to the European Commission (EC). The Committee voted in favor of an “open scope,” meaning that the RoHS Directive would apply to all electrical equipment, unless specifically excluded. The EP plenary vote on the amended proposal is scheduled for July 2010.

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On April 27, 2010, ILO published a booklet entitled “Emerging Risks and New Patterns of Prevention in a Changing World of Work,” which summarizes new occupational safety and health issues, including those related to technical innovations such as nanotechnology. The booklet states:

There is a big knowledge gap between advances in the application of nanotechnology and its impact on health. Due to the extensive and highly diversified use of nanomaterials in industry, the number of workers exposed is also difficult to estimate. While little is known about the health and environmental impact of these new materials, it is likely that workers will be among the first to experience high rates of exposure.

According to ILO, the need to share information about emerging risks is “vital, at both the national and international levels.” ILO notes that “[t]he study of nanomaterials, for example, illustrates the importance of knowledge sharing in the development and application of new technologies, whereby the identification and assessment of associated hazards and risks need to be considered and communicated at a stage before widespread application in industry.”

 

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On March 1, 2010, Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy “is effective immediately.” In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other Canadian federal departments. Comments are due August 31, 2010, and Health Canada intends to use the comments to update the Interim Policy as necessary.

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On April 2, 2009, NanoCap and the European Parliament (EP) will hold a conference entitled “Working and Living with Nanotechnologies: Trade Union and NGO positions.” The conference objectives are to present positions and perspectives on nanotechnologies at the workplace and in the environment adopted by European trade unions and environmental non-governmental organizations (NGO), including:

• Setting priorities for the responsible development of nanotechnologies, especially regarding environmental and workplace safety;
• Exchanging views with nanotechnologies stakeholders and policymakers;
• Establishing pathways for implementing the precautionary approach; and
• Presenting a nanoethics portfolio.

 

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The International Agency for Research on Cancer (IARC) recently solicited nominations for substances for review in future IARC Monographs, which identify environmental factors that can increase the risk of human cancer. IARC states that it will select substances for review based on: (a) evidence of human exposure; and (b) evidence or suspicion of carcinogenicity. The 51 substances nominated include carbon nanotubes, which received three nominations: Continue Reading...

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On July 31, 2007, an international coalition of consumer, public health, environmental, and labor organizations issued the Principles for the Oversight of Nanotechnologies and Nanomaterials and called for strong, comprehensive oversight of the new technology and its products. According to the coalition, the manufacture of products using technology has “exploded in recent years,” while “evidence indicates that current nanomaterials may pose significant health, safety, and environmental hazards.” Continue Reading...

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According to a recent report entitled Nanomaterials in Consumer Products, the extent to which a variety of European regulations would manage potential risks of nanomaterials in consumer products cannot be assessed. The report was prepared for the European Parliament’s Committee on the Environment, Public Health, and Food Safety. According to the report, which is not publicly available, “[u]ntil there are data on which to determine the nature of any risks posed by nanomaterials, it is not possible to assess the full extent to which the implementation of current regulations addresses any potential risks.”  The report makes recommendations about policies that could be used if it is determined that existing European laws are inadequate.

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It has been suggested by some that REACH’s application to nanoparticles and nanomaterials is unclear.  While it is true that REACH does not specifically mention nanoparticles or nanoscale materials anywhere in its 800+ pages of text, we note that in December 2006, shortly after the regulation’s adoption by the European Parliament, the European Commission posted on its website a question-and-answer document that includes the following two exchanges: Continue Reading...

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Environmental Defense (ED) will hold a webcast regarding its recent report, Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, on May 24, 2007, from 3:00 p.m. to 4:30 p.m. (EDT). The webcast will include a 45-minute presentation and a question and answer period. Dr. Richard Denison, Senior Scientist at ED, will present the findings and discuss his report, which compares the European Union’s new Registration, Evaluation, and Authorization of Chemicals (REACH) regulation, the Toxic Substances Control Act (TSCA), and the Canadian Environmental Protection Act (CEPA). Continue Reading...

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