German Chemical Industry Association Releases Nanomaterials Product Stewardship Document

Posted on April 18, 2008 by Lynn L. Bergeson

On March 11, 2008, the German Chemical Industry Association (VCI) released a report entitled Responsible Production and Use of Nanomaterials, which is a series of documents intended to provide guidance on all aspects of a good product stewardship on nanomaterials. The documents include joint papers prepared by VCI and the German Federal Institute for Occupational Safety and Health (BAuA) and the German Society for Chemical Engineering and Biotechnology (DECHEMA). The report includes the following documents:

Principles Document:

  • Implementing Responsible Care® for a Responsible Production and Use of Nanomaterials

Regulatory Documents:

  • Requirements of the REACH Regulation on Substances Which Are Manufactured or Imported also as Nanomaterials
  • Guidance for a Tiered Gathering of Hazard Information for the Risk Assessment of Nanomaterials
  • Guidance for Handling and Use of Nanomaterials at the Workplace
  • Guidance for the Passing on of Information along the Supply Chain in the Handling of Nanomaterials via Safety Data Sheets
  • Strategy Paper of the German Chemical Industry on the Standardization of Nanomaterials

Documents on Safety Research:

  • Roadmap for Safety Research on Nanomaterials
  • Environmental Aspects of Nanoparticles

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Greenpeace Releases Activists' Guide to REACH, Which Addresses Nanomaterials

Posted on September 12, 2007 by Lynn L. Bergeson

On August 30, 2007, Greenpeace International (Greenpeace) issued a report entitled Navigating REACH: An Activists’ Guide To Using and Improving the New EU Chemicals Legislation (Guide), which is intended to explain how the European Union’s (EU) Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation will work, what main issues are at stake, and how the law will be implemented. The Guide highlights provisions that non-governmental organizations (NGO) and citizens can use to promote safer chemicals and lead ultimately to better protection of human health and the environment from the adverse impact of hazardous chemicals. The Guide includes nanomaterials among the issues for NGOs:

  • Adding nanomaterials to the scope of the legislation: The NGOs will keep working to highlight the need to improve current legislation to control the risks and manage this rapidly expanding industrial sector. According to the Guide, one of the windows of opportunity is the review of the scope of the legislation, as well as the review of information requirements for substances between one and ten tonnes (both in 2012). The Guide states that “this may be too late to start gathering data and limiting exposure to the rapidly increasing quantities of manufactured nanomaterials,” however.
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Study Recommends Amendments to EU Legislation to Address Nanomaterials

Posted on June 11, 2007 by Lynn L. Bergeson

The July 2007 issue of Regulatory Toxicology and Pharmacology includes an article entitled “Limits and Prospects of the ‘Incremental Approach’ and the European Legislation on the Management of Risks Related to Nanomaterials.” According to the authors, the European Commission (EC) has adopted an incremental approach, focusing on adopting existing laws to regulate nanotechnologies. The authors concluded that the current regulations fail to address the environmental, health, and safety risks posed by nanomaterials and recommended specific revisions to European regulatory policies and the information on which they are based.

The authors analyzed in a life cycle perspective three commercially available products containing fullerenes to map current applicable regulations, determine their applicability to nanomaterials, identify their gaps, and suggest proper solutions. After mapping the life cycle of the three products, the authors reviewed applicable regulations in the order in which they became relevant in their life cycle, i.e.:

  • The Safety at Workplace Directives;
  • Directive 61/1996 on the Integrated Pollution Prevention and Control;
  • The European Union’s Directive on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH); and
  • The Waste Management Directives.
The authors concluded that the applicability of environmental laws is limited due to difficulties in generating sufficient data on the nanomaterials residing in the products according to their life cycles.  Further, metrology tools, which measure nanoparticles in the environment or at the work site, are unavailable; thresholds are not tailored to the nanoscale and are based on ecotoxicological and toxicological data from larger chemicals; and occupational exposure limits cannot be established with existing methodologies.  According to the authors, the incremental approach can be applicable only with the implementation of due amendments.
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REACH and Nano

Posted on May 23, 2007 by Lynn L. Bergeson

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:

Will the use of hazardous substances be restricted or banned?

. . . Both the restriction and authorisation processes can also be applied to substances produced or imported in volumes below 1 tonne per year. This would for instance allow addressing risks from particles on a nano-scale. . . .

How will nanoparticles be treated under REACH?

Substances in the nano-scale fall under the scope of REACH and their health and environment properties must therefore be assessed following the provisions of this Regulation.  However, methodologies for identifying hazards and evaluating risks of substances at the nano-scale need to be further refined over the next few years.

The European Commission is funding research projects to assess the health and environment impacts of nano particles under the 7th Research Framework Programme.  It will also be necessary to carefully monitor over the next few years whether the [1 tonne per year] threshold for registration and the information requirements under REACH are adequate to address potential risks from particles on a nano-scale.

In view of this guidance, our view is that REACH does indeed apply to nanoparticles.

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ED Will Hold Webcast on REACH, TSCA, and CEPA Best Practices

Posted on May 15, 2007 by Lynn L. Bergeson

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).

Best practices for and a comparison of how each of these policies addresses the following “core functions” will be presented:

  • Identify and prioritize chemicals of concern;
  • Track chemicals and their production and use;
  • Foster the generation and submission of risk-relevant information;
  • Assess information to determine hazard/exposure/risk;
  • Impose controls to mitigate risk; and
  • Share and disclose information while protecting confidential business information.

Implications of the findings for chemicals policy reform will also be discussed.

To participate, contact Cathy Malina by COB May 22, 2007. Details and a toll-free call-in number will then be forwarded prior to the call. In addition to a telephone line, Internet access is needed to view presentation materials. If this is not possible, please advise Ms. Malina so alternative arrangements can be made.
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