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Tag Archives: EU

Riding the waves of U.S. data privacy legislation

privacy legislationMuch has been written about the European General Data Protection Regulation (GDPR). Commentators have touted the EU’s supposedly superior data protection regimen. But don’t lose focus on what is happening within the U.S. and the implications for U.S. companies that may not be focused on GDPR requirements. Even companies that are GDPR focused may not meet the upcoming requirements. At least three significant privacy legislation fronts in the U.S. bear mentioning:…

New European Unitary Patent and Unified Patent Court are on the horizon

Soon, a new unitary patent system will bring reduced cost and greater uniformity to European patents. The Unified Patent Court Agreement was signed Feb. 19, 2013 at the Council of the European Union meeting in Brussels, Belgium. At the meeting, ministers from 24 contracting EU member states signed on to the agreement establishing a Unified Patent Court (UPC). The Unified Patent Court Agreement represents one of the final major steps in forming a unitary patent system for Europe. The development of a European unitary patent system has been under discussion and development since the 1970s. The signing of the UPC agreement follows the adoption in December 2012 and entry into force of two regulations related to the unitary patent system. These two regulations pertain to unitary patent protection and the translation arrangements associated with the unitary patent, and came about through use of the enhanced cooperation procedure.

The European patent with unitary effect (“unitary patent”) will be a European patent granted by the European Patent Office (EPO) under the provisions of the European Patent Convention. The unitary patent will not replace national patents and classical European patents, but will instead offer another option for parties seeking patent protection. The EPO will continue with its existing search, examination and granting procedures. Following patent grant the patentee may request unitary effect for the member states participating in the unitary patent, and will be able to maintain a classical European patent for the European patent convention contracting states that are not participants in …

Women in Europe for a Common Future Issues Position Paper: Nano the Great Unknown

Women in Europe for a Common Future, (WECF) founded in the Netherlands in 1994, " is a network of 100 member organizations and individual members who share a common concern to promote a healthy environment for all, strengthen the role of women and promote a gender and rights based approach in environment and sustainable development policy and implementation." Recently, WECF issued a position paper, "Nano: The Great Unknown". WECF takes the position that "Neither the industry nor public authorities have shown adequate leadership and willingness in addressing" the possible toxic effects of manufactured nanomaterials (MNMs) on humans and the environment.

After briefly surveying European Union (EU) and non-EU regulatory efforts and finding them all lacking, the WECF calls for applying the precautionary principle and the principle of "no data, no market" for all nanomaterials and products containing nanomaterials.

WECF demands that full information about possible risks of nanoparticles as well as access to information on which products contain nanomaterials should be provided to the public, including developing countries) without delay.

The position paper then presents seven additional demands or "actions" by WECF:

1- "WECF demands that manufactured nanomaterials are treated as totally new substances."

2- " WECF demands the application of "no data, no market" – and in the case of REACH, this is to be independent of tonnage. Registration of nanomaterials under the corresponding bulk chemical should by default be prohibited."

3- "Nanosubstances should be subject to a far reaching health assessment (health, environment)."

4- "WECF asks decision-makers …

European Parliament Members Vote for Ban on Nanomaterials, Including Nanosilver and Carbon Nanotubes

The Members of the European Union’s (“EU”) Environment Committee (“MEPs”) recently voted in favor of proposed amendments to the EU’s Restriction of Hazardous Substances Directive, first passed in 2002, banning the use of nanosilver and long multi-walled carbon nanotubes in electrical and electronic products. The legislators also approved language requiring that any electrical or electronic materials containing nanomaterials should be labeled as such and that manufacturers who use nanomaterials would be required to provide the European Commission with safety data on any materials used. Commentators have noted that the MEPs’ definition of nanomaterials is unclear and the current interpretation could require labeling for every electronic product, such as every transistor in a computer chip. A vote on the proposal is expected in October.…

European Parliament votes on measure to regulate food nanotechnology

Members of the European Parliament’s environment, public health and food safety committee have voted to control the use of nanotechnologies in foods for humans. The proposed measure entirely excluded entry onto European Union (“EU”) markets of any food derived from cloned animals as well as food produced by nanotechnology processes, unless such food has undergone a specific risk assessment regarding possible impact on health. Those risk assessment methods must also have been approved for use, i.e., not imply the use of vertebrate animals for testing. The measure also required all ingredients containing nanomaterials to be clearly labeled by listing the names of the ingredients followed by the word ‘nano’ in brackets. A definition of nanomaterials was included in the proposed text as: “nanomaterial means an intentionally manufactured material with one or more external dimensions or an internal structure, of order of 100 nm or less.” The new regulation can only be adopted after co-decision by both the European Parliament and Members States and must be endorsed by the whole parliament in July.…

“Nano Risk Governance: Current Developments and Future Perspectives”

Nanotechnology Law & Business just published its new edition.  For those who might be interested, Volume 6.2 contains an article I co-authored with several nano-friends entitled: "Nano Risk Governance: Current Developments and Future Perspectives."  You can find the article here.  An abstract follows.

As with many new technologies, developing a framework for making risk management decisions for nanotechnology is a challenge. Risk assessment has been proposed as the foundation for many regulatory frameworks for nanomaterials. Although the traditional risk assessment paradigm successfully used by the scientific community since the early 1980s may be generally applicable, its application to nanotechnology requires a significant information base. The authors’ experience supporting federal agencies in the United States, Canada, and the European Union—as well as state agencies in Massachusetts and New York and cities such as Berkeley and Cambridge—suggests that nanomaterial regulatory frameworks could be built upon existing regulatory approaches with the addition of a more rigorous and transparent method for integrating technical information and expert judgment. The authors argue that the current focus on studying the amount of risk acceptable for a specific technology or material should be shifted toward comparative assessment of available alternatives, and the use of science and policy to identify alternative nanotechnologies and opportunities for risk reduction and innovation. This approach involves the use of both quantitative and qualitative decision analysis tools, offering roadmaps for assessing different information sources and making policy decisions. Two representative methods presented are the Alternatives Assessment method and the Multi-Criteria Decision Analysis method.…

Are Nano Consumer Products Headed Underground? (EU News, Policy Positions, and EU Actions on line) published an article on June 15, 2009 entitled "Nanotech claims ‘dropped’ for fear of consumer recoil." 

The article reported on a nanotechnology conference which took place in Brussels during the week of June 10 at which a scientist from the Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies maintained that some of the current environmental, health, and safety controversy accompanying certain nanoscale materials is not grounded in scientific fact, but has nonetheless led some manufacturers to remove "nano" from their product labels and advertising. He further stated that "we have seen some companies drop the ‘nano’ claim while continuing to use nanotechnology. This suggests nanotechnology is going underground."

Providing a counterpoint, the Director of the European Nanotechnology Industries Association said that "[v]arying definitions [of nanotechnology] leads to claims that the industry is not open to information. But nobody is lying and nobody is misleading the public or authorities. Let’s agree on what we’re talking about and work together to inform consumers."…

EC Official Urges International Cooperation

According to a FDAnews Device Daily Bulletin dated October 30, 2006, Philippe Martin, principal administrator for the EC’s nanotechnology and policy efforts, recently advocated international cooperation and self-regulation in the world-wide nanotechnology industry. Martin was quoted as saying that the “U.S. industry’s ‘catch me if you can’ approach to dealing with regulators is not useful.”

I am sure U.S. industry takes issue with Martin’s characterization of its self-regulation efforts.  

For proposed international approach to nanotechnology regulation see: (1) Abbott, Kenneth W., Gopalan, Sandeep, Marchant, Gary E. and Sylvester, Douglas J., "International Regulatory Regimes for Nanotechnology" (June 8, 2006); (2) Sylvester, Douglas J., Abbott, Kenneth W. and Marchant, Gary E., "A Framework Convention for Nanotechnology?" (August 21, 2006); and (3) Marchant, Gary E. and Sylvester, Douglas J., "Transnational Models for Regulation of Nanotechnology" Journal of Law, Medicine and Ethics, Forthcoming .…