EU Offers Standard Definition of Nanotechnology

One of the challenging aspects of attempts to regulate emerging nanotechnology is the definition.  Proposing a "definition" for nanotechnology is not as straightforward a process as it may seem; applying a strict, universal definition of nanotechnology to all applicable fields and products may not be an appropriate science-based approach.  Inclusion of nanometer-sized active ingredients or excipients in a product does not by itself determine a product's safety and efficacy (i.e. size alone is not always itself an indicator of toxicity).   Then there is the issue of distinguishing between engineered nanomaterials and those naturally occurring at the nanoscale.

Last week, the European Commission took another step in this debate, unveiling a new, common nanomaterial definition as a basis for regulation. Nanomaterials are defined as those whose main constituents measure between 1 and 100 billionth of a meter; that is, 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 target size range.

Thus, the new EU definition is based on an approach that considers the size of the constituent particles, rather than any other indicia of potential risk.  The EU did note that there is no evidence that nanomaterials are inherently hazardous. Technological development and scientific progress continue with great speed, noted the report. The definition including descriptors will therefore be subject to a re-review by December 2014. In particular, the review will assess whether the number size distribution threshold of 50 % should be increased or decreased and whether to include materials with internal structure or surface structure in the nanoscale such as complex nano-component nanomaterials including nanoporous and nano-composite materials that are used in some product sectors.


A Comment on the EU's Working Paper: "Towards a Coherent European Approach to Collective Redress"

Earlier this year, the Commission Staff of the European Union issued a Staff Working Document seeking public comment on the topic "Towards a Coherent European Approach to Collective Redress."

In an individual capacity, your humble blogger joined some other lawyers in providing comments recently.

As readers of MassTortDefense may know, collective redress -- aggregate litigation -- is not a novel concept in the European Union. Existing EU legislation and international agreements require Member States to provide for collective injunctive relief in certain areas. All Member States have procedures in place which grant the possibility of certain injunctive relief to enjoin some allegedly illegal practices. In the area of consumer law, as a result of the Directive on Injunctions, consumer protection authorities and consumer organizations have standing to seek an injunction regarding practices that allegedly breach national and EU consumer protection rules in all Member States. In the area of environmental law, the Aarhus Convention requires Member States to ensure access to justice against infringements of environmental standards. All Member States have implemented this by introducing some form of collective injunctive relief, whereby non-governmental organizations are given standing to challenge certain environmental administrative decisions.

In our comments, we warned that experience with overly robust collective redress procedures in some jurisdictions (such as the class action procedures as implemented in some courts in the United States) reveals significant risks inherent in such actions. These risks include the ability of collective actions to result in lengthy and costly litigation; their ability to trample the right of the entity accused of unlawful practices to a fair adjudication of the allegations; and their ability to actually encourage abusive, spurious, and non-meritorious complaints because of the economic incentives they provide. [Readers in the U.S. are well aware of the "Field of Dreams" effect-  "if you build it they will come."]  In particular, the EU needs to guard against “lawyer-created” litigation that is fueled by the prospect of large fee awards rather than a significant injury.

Any proposal for a holistic European approach towards collective redress actions thus must be analyzed in the context of not only the potential utility of collective actions but also the substantial risks they create. Collective redress, if ever widely adopted, should be limited to where the same breach of EU law harms a large group of citizens and businesses, and individual lawsuits and other legal remedies are demonstrated not to be an effective means to end ongoing unlawful practices or to obtain compensation for the harm caused by these practices.

Any European approach to collective redress must, as paramount concerns, preserve the parties’ rights to a fair trial or adjudication of the factual and legal issues, and not create any untoward economic incentive for the bringing of abusive claims.  While various procedural and substantive safeguards might be adopted to help avoid abusive collective actions, including those inspired by some aspects of the existing national judicial redress systems in the EU Member States, those may not be sufficient to the task. That is, the unavailability of punitive damages or the unavailability of contingency fees for claimant attorneys, while extremely important, may not alone sufficiently decrease the risk of abusive litigation and unfairness to an extent compatible with the European legal tradition and fundamental justice.

What may also be required are clear limitations with regard to standing to bring a collective redress action, should the decision be made to move the proposal forward. The risk of abuses and unfairness can relate in some measure to the role of the sophisticated and entrepreneurial plaintiff’s class action bar. In many jurisdictions, they serve not as “gatekeepers” to screen out frivolous claims and pursue meritorious actions, but as the “promoters” of claims. Quite often, they create claims out of whole cloth, seek out the plaintiffs to nominally prosecute the class action, while they fund the litigation, and manage the cases. If the decision is made to move forward with European collective redress actions -- despite the substantial risks they present-- one important way to preserve the balance between preventing abusive and unfair litigation, and ensuring the effective access to justice for EU citizens and businesses, is to create a system that does not rely on the private bar in the first instance. Thus, any new EU collective redress system should be handled by public bodies exclusively. Individuals and private organizations representing those who are allegedly harmed by illegal conduct on a mass scale would have the ability to petition the public body to screen the allegations, bring the action, and obtain proper compensation for the damages they suffered following successful litigation.

Public bodies may be in the best position to overcome cross-border issues and coordinate the relevant actions. The alleged injuries that have arisen in an increasingly inter-connected European market are a primary reason an EU-wide collective redress system has become a focus of discussion. The use of public bodies would allow for consistent rules for choosing the appropriate venue in which to bring the collective redress actions.  The use of designated public entities is also one method of controlling the potentially crippling costs of discovery associated with class actions in some countries.  Should the decision be made to move forward with more systematic, broad collective redress, despite its many risks, this proposal may offer a way to address some of the specific concerns that cross-border collective redress actions present, while also adhering to the EU’s core legal principles.

European Regulators Reaffirm Stance on BPA

Readers of MassTortDefense are accustomed to European regulatory approaches that are much stricter than in North America, under a co-called "precautionary" approach.  So what does it say about the hysteria in the U.S. over BPA when the European Food Safety Authority (EFSA) concludes that there is no new evidence to suggest the tolerable daily intake (TDI) for bisphenol A  needs to be changed?  EFSA recently reconfirmed that current levels of exposure pose no significant threat to human health.

Bisphenol A is a chemical used as a monomer in polycarbonate plastic and epoxy resins, in food contact materials used in the manufacture of some plastic bottles and food and drink can linings.  EFSA had an expert panel perform a detailed and comprehensive review of recent scientific literature and studies on the toxicity of bisphenol A at low doses.  The latest work carried out by EFSA scientists followed a request from the European Commission to: a) carry out a review of recent scientific literature on the toxicity of BPA to assess whether the TDI should be updated; b) assess a new study on possible neurodevelopmental effects (i.e. possible effects to the brain and central nervous system) of BPA in rats, known as the Stump study; and c) advise on the BPA risk assessment by Denmark’s DTU Food Institute.

The agency reaffirmed its positions stated over the last couple years, and concluded that it would maintain the current TDI of 0.05mg/kg/bodyweight.  The scientists on the EFSA CEF Panel concluded they could not identify any new evidence which would lead them to revise the current Tolerable Daily Intake for BPA as set by EFSA in its 2006 opinion and re-confirmed in its 2008 opinion. (In 2006, EFSA set the TDI for BPA at 0.05 mg BPA/kg body weight (b.w.)/day. This is based on the No-Observed-Adverse-Effect-Level (NOAEL) of 5 mg/kg b.w./day that has been identified in multi-generation reproductive toxicity studies in rodents, where the critical effects were changes in body and organ weights in adult and offspring rats and liver effects in adult mice, respectively. In 2008, EFSA reaffirmed this TDI, concluding that age-dependent toxicokinetics differences of BPA in animals and humans would have no implication for the TDI.) 

Moreover, the research pointed to by those out to ban BPA had “many shortcomings” and uncertain relevance to human health.   In particular, the panel dismissed concerns over the alleged neurobehavioral toxicity of BPA attributed to the Stump study and a risk assessment by Denmark's National Food Institute,  finding the alleged link uncertain and pointing out a variety of flaws in the analysis of the Stump data after further evaluation from EFSA’s Assessment and Methodology group. The careful review of the scientific literature failed to provide any convincing evidence that BPA has any adverse effects "on aspects of behavior, such as learning and memory.”

EFSA's conclusions, after intense scientific scrutiny, get little play in the mainstream press, but continue to reaffirm the safety of BPA in food contact applications.


EU Council Adopts Regulations for Cosmetics with Nano-ingredients

We have posted about nanotechnology issues before. Readers following nano-issues will want to note that the Council of the European Union last week approved an updated set of regulations on cosmetic products, and they include a requirement that cosmetics containing nanoscale ingredients have that information on their labels. [In the European Union, regulations automatically apply to all  member states, while directives are implemented through national legislation. The regulation thus represents a common European code on cosmetic products, designed to reduce the uncertainties arising from a differentiated implementation of the previous directives in the 27 member states.]

Specifically, the regulation states that, “All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.”  see p. 61.  Some observers have questioned whether the mention of the term "nano" in labels will offer consumers much meaningful guidance. The FDA's 2007 Nanotechnology Task Force Report did not recommend labeling because current science did not support a finding that products with nanoscale materials necessarily present greater safety concerns than those without nanoscale materials.

The document indicates that the use of nanomaterials in cosmetic products may increase with the further development of technology. In addition, the EU Council suggest that in order to ensure a high level of consumer protection, free movement of goods, and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at the international level.  In the interim, "nanomaterial" for regulatory purposes means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.

The Council states that, at present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety, the Council calls for cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.

The new rule also will require manufacturers of new cosmetic products containing nanomaterials to notify the European Commission and to provide certain toxicological information before the products are placed on the market. Published reports suggest that manufacturers may have up to 3 years to comply with the new label regulations.