EC Will Review Legislation to Ensure Safety of Nanomaterials

Posted on October 15, 2009 by Lynn L. Bergeson

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.
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Norway Asks Businesses to Report Presence of Nanomaterials

Posted on July 8, 2009 by Lynn L. Bergeson

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.”
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UN Committee Will Discuss Ongoing Work on the Safety of Nanomaterials

Posted on May 21, 2009 by Lynn L. Bergeson

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?

 

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European Parliament Urges the Labeling of Nanomaterials in Consumer Products

Posted on April 24, 2009 by Lynn L. Bergeson

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.

 

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