On April 10, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) invited interested parties to submit any relevant information that could assist it with its assessment of the safety, health, and environmental effects of nanosilver. In particular, SCENIHR states, it is interested in receiving any scientific information related to the “nano” forms of silver. The EC requested on December 9, 2011, that SCENIHR prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. The EC requested SCENIHR “to assess whether the use of nanosilver, in particular in medical care and in consumer products could result in additional risks compared to more traditional uses of silver,” and “to assess whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” The deadline for SCENIHR’s opinion is early 2013. All information submitted to SCENIHR is considered public unless otherwise stated by the provider. Information is due to SCENIHR by June 4, 2012.
The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”:
2. “Nanomaterial” means 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 size range 1 nm - 100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.
3. By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.
On October 11, 2011, Health Canada announced the availability of its Policy Statement on Health Canada’s Working Definition for Nanomaterials. Health Canada received 29 comments from stakeholders on its March 2010 Interim Policy Statement, which it revised based on stakeholders’ feedback. According to Health Canada, other revisions were prompted by developments in international norms, evolving scientific evidence, and regulatory program needs. Health Canada states that it will update its Policy Statement “as the body of scientific evidence and international norms progress.” The Policy Statement on Health Canada's Working Definition for Nanomaterial, summary of comments received, and frequently asked questions are available online.Continue Reading...
In an October 5, 2010, Chemical Gazette notice, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced that it is introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:
. . . industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer (nm)] and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).Continue Reading...
On July 7, 2010, the European Parliament (EP) voted that nanoscale ingredients should be banned from food in the European Union (EU) until the health and environmental risks they might pose are better understood, and that any nanoscale ingredients that are eventually authorized should be clearly labeled as such. The EP voted on several amendments to draft legislation concerning the authorization of novel foods, including a provision that would prohibit food from cloned animals or their offspring. The EP has been unable to reach agreement with the European Council on the legislation, largely because of the provision concerning cloned animals. The Council also disagrees that foods containing nanoscale ingredients should be systematically labeled, however. According to an EP spokesperson, the legislation likely will go to conciliation, during which the EP and European Council will attempt to negotiate a compromise after two readings have failed to produce an agreement. The legislation likely will be discussed again in the fall.
On July 2, 2010, the European Commission’s (EC) Joint Research Centre (JRC) announced the availability of a reference report entitled Considerations on a Definition of Nanomaterial for Regulatory Purposes. JRC prepared the report in response to a request from the European Parliament (EP). JRC states that the aim of the report is to review and discuss issues and challenges related to a definition of “nanomaterial,” and to provide practical guidance for a definition for regulatory purposes. JRC suggests that a definition for regulatory purposes should:
- Only concern particulate nanomaterials;
- Be broadly applicable in European Union (EU) legislation, and in line with other approaches worldwide; and
- Use size as the only defining property.
On June 2, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety approved the proposed recast of the Directive on the Restrictions of Hazardous Substances (RoHS) in Electrical and Electronic Equipment, with 55 votes in favor, one against, and two abstentions. The Committee adopted amendments adding nanosilver and long multi-walled carbon nanotubes (MWCNT) to Annex IV, despite the fact that nanomaterials were not included in earlier proposals. In effect, there would be no threshold, with equipment prohibited from the market if it contained either nanosilver or long MWCNTs at “detectable levels.” The Committee also adopted amendments that require equipment containing nanomaterials to be labeled, and for manufacturers to be required to provide safety data on the nanomaterials to the European Commission (EC). The Committee voted in favor of an “open scope,” meaning that the RoHS Directive would apply to all electrical equipment, unless specifically excluded. The EP plenary vote on the amended proposal is scheduled for July 2010.
On April 27, 2010, ILO published a booklet entitled “Emerging Risks and New Patterns of Prevention in a Changing World of Work,” which summarizes new occupational safety and health issues, including those related to technical innovations such as nanotechnology. The booklet states:
There is a big knowledge gap between advances in the application of nanotechnology and its impact on health. Due to the extensive and highly diversified use of nanomaterials in industry, the number of workers exposed is also difficult to estimate. While little is known about the health and environmental impact of these new materials, it is likely that workers will be among the first to experience high rates of exposure.
According to ILO, the need to share information about emerging risks is “vital, at both the national and international levels.” ILO notes that “[t]he study of nanomaterials, for example, illustrates the importance of knowledge sharing in the development and application of new technologies, whereby the identification and assessment of associated hazards and risks need to be considered and communicated at a stage before widespread application in industry.”
Health Canada Adopts Interim Policy Statement on Health Canada's Working Definition for Nanomaterials
On March 1, 2010, Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy “is effective immediately.” In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other Canadian federal departments. Comments are due August 31, 2010, and Health Canada intends to use the comments to update the Interim Policy as necessary.
On April 2, 2009, NanoCap and the European Parliament (EP) will hold a conference entitled “Working and Living with Nanotechnologies: Trade Union and NGO positions.” The conference objectives are to present positions and perspectives on nanotechnologies at the workplace and in the environment adopted by European trade unions and environmental non-governmental organizations (NGO), including:
- Setting priorities for the responsible development of nanotechnologies, especially regarding environmental and workplace safety;
- Exchanging views with nanotechnologies stakeholders and policymakers;
- Establishing pathways for implementing the precautionary approach; and
- Presenting a nanoethics portfolio.