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

In an October 9, 2009, speech at the stakeholder conference concerning nanomaterials on the market, Stavros Dimas, European Commissioner for the Environment, stated that the European Commission (EC) “will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle.” The EC’s review is in response to an April 24, 2009, resolution adopted by the European Parliament that questions whether current legislation covers the relevant risks relating to nanomaterials and asks the EC to consider whether revisions are necessary to address nanomaterials.  Dimas stated that the EC “has not made up its mind on how precisely to get the information needed.” The EC intends to look at measures taken by member states and non-European Union (EU) countries, including voluntary reporting programs.

Dimas examined whether the existing regulatory framework of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program is sufficient to ensure “a high level of protection of health, safety and the environment” from nanotechnology products. Dimas stated that nanomaterials are covered by REACH under the definition of a chemical substance, and the general obligations therefore apply as for any other substance. According to Dimas, the “important” question to ask is whether the one tonne threshold used by REACH is appropriate for nanomaterials. Dimas stated:

Once we have a better idea of the scope and nature of nanomaterials on the European market we can then take a step back and go through the rules.  We will need to consider whether registration of the majority of nanomaterials will take place in 2010 or only at the end of the registration timetable in 2018 and if there are some nanomaterials that will not be registered under REACH.  We will also need to look at other key provisions in REACH to see if they are adequate for nanomaterials.

• Email This
• Print
• Comments
• Trackbacks

On June 25, 2009, the Norwegian Board of Technology announced that the Norwegian Pollution Control Authority (SFT) has established “a scheme for Norwegian businesses to report their use of nanomaterials in chemical products.”  According to a spokesperson for the Board, until now the Norwegian market has “lacked oversight of nanomaterials.”  Under the scheme, information about nanomaterials in chemical products will be incorporated as a separate topic in declarations to the Norwegian Product Register, which is administered by the SFT. The initiative will supplement Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) due to its “focus on how substances are marketed and used in real life.”

The process is not completely mandatory. According to the Board, “a legal commitment to declare a product arises only if a significant risk has been identified. . . . [f]ew nanomaterials will qualify under this criterion in the short term.”  The Board advocates a mandatory scheme as soon as it is feasible, and urges industry “to embrace the initiative right away.”

• Email This
• Print
• Comments
• Trackbacks

On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1, 2012. According to Dancet, the review could cover both the scope and implementation of REACH. Dancet stated that “nanomaterials will be covered in a more systematic way” following the review. European Union (EU) Environment Commissioner Stavros Dimas stated that “further work needs to be done to consider if further legislation is needed” to regulate nanomaterials. After the Forum, Dimas stated that separate legislation could be necessary to ensure to protect the environment and human health. According to Dimas, ECHA could manage nanomaterials, or EU legislation concerning fine particles could be used to regulate nanomaterials. The fine particle legislation concerns particles in air rather than in products, however, and a spokesperson for Dimas stated that the EC is “looking at all sorts of possibilities” and that specific approaches are “unexplored as yet.”

• Email This
• Print
• Comments
• Trackbacks

During the June 29-July 1, 2009, meeting of the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Substances (GHS), the Committee will discuss a paper entitled “Ongoing Work on the Safety of Nanomaterials.” The paper provides a summary of current activities by the European Union (EU), including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, International Organization for Standardization (ISO), and the Organization for Economic Cooperation and Development (OECD). The paper includes the following questions:

• Can it be considered, for the same chemical (same [Chemical Abstracts Service (CAS) Number] and purity) that nanomaterials with new properties have the same hazards as conventional form?
• Is it possible to distinguish for a same chemical, the properties of its different nanoforms?
• How can this be done? Should new endpoints be determined?
• To which extent information about nanomaterials need be provided?
• What kind of information is needed?
• What kind of communication tool is needed for this purpose?
• What kind of collaboration can be suggested in order to contribute to clarification of nanomaterials hazard classification and indeed to heath safety and environmental issues of nanomaterials?

 

• Email This
• Print
• Comments
• Trackbacks

In an April 24, 2009, press release, the European Parliament (EP) calls for the provision of information to consumers on the use of nanomaterials in consumer products. According to the EP, all ingredients present in the form of nanomaterials in substances, mixtures, or articles should be clearly indicated in the product labeling. The press release also specifically calls for the European Commission (EC) to evaluate the need to review the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) concerning:

• Simplified registration for nanomaterials manufactured or imported below one tonne;
• Consideration of all nanomaterials as new substances;
• A chemical safety report with exposure assessment for all registered nanomaterials; and
• Notification requirements for all nanomaterials placed on the market on their own, in preparations, or in articles.

The EP also calls for the EC to evaluate the need to review worker protection legislation concerning:

• The use of nanomaterials only in closed systems or in other ways that exclude exposure of workers as long as it is not possible to detect reliably and control exposure;
• A clear assignment of liability to producers and employers arising from the use of nanomaterials; and
• Whether all exposure routes (inhalation, dermal, and other) are addressed.

 

• Email This
• Print
• Comments
• Trackbacks

On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the regulation, there is insufficient information for carbon and graphite to be listed in Annex IV, “in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.”

• Email This
• Print
• Comments
• Trackbacks

On June 26, 2008, the European Trade Union Confederation (ETUC) passed a resolution on nanotechnologies and nanomaterials, which calls for the application of the precautionary principle. The resolution states that application of the precautionary principle is necessary to avoid “past mistakes [made] with putatively ‘miracle’ technologies and materials. According to ETUC, the number of workers coming into contact with nanomaterials will increase sharply as nanotechnologies are applied to difference industry sectors, including the chemical, pharmaceutical, and electronics industries. The ETUC urges the European Commission (EC) to amend the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation “so as to give better and wider coverage to all potentially manufacturable nanomaterials.” Because nanomaterials are manufactured or imported below the threshold of one tonne per year and may evade the REACH registration requirements, “ETUC demands that different thresholds and/or units (e.g., surface area per volume) are used for registration of nanomaterials under REACH.”

The resolution sets out a series of demands in different areas related to nanotechnology development:

• Marketing:

• REACH’s “no data, no market” principle must apply: nanometer forms of chemicals should not be allowed on the market unless sufficient data are supplied to show no harmful effect for human health and the environment;
• All nanomaterials, including those produced or imported in quantities below one tonne per year, must come within the REACH registration requirements; and
• A chemical safety report must be produced for all REACH-registered substances for which a nanometer scale use has been identified.

• Worker protection:

• Amend Chemical Agents Directive 98/24/EC to require employers to implement risk reduction measures for substances not proven to be harmless;
• Involve workers and their representatives in the assessment and reduction of nanomaterial-related risks;
• Improve worker information about nanomaterials that may be present in products to which they are exposed: safety data sheets must state whether nanomaterials are present; and
• Provide training and health surveillance for workers exposed to nanomaterials.

• Research and Development:

• Earmark at least 15 percent of public research budgets for health and environmental aspects; and
• Make health and safety at work aspects a compulsory part of all research projects.

• Email This
• Print
• Comments
• Trackbacks

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

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks