Norms and regulation on nano technology

Norms and regulation on nano technology

On this page we collect information on norms, guidelines and regulations in the field of nano technology that we believe to be relevant for our customers.

If you would like to see documents added because they are interesting for others, please let us know.

US Executive offices

Title

Memorandum for the heads of executive departments and agencies

Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of NanoTechnology and Nanomaterials.

 

Abstract

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Download:    http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf

Title

Scientific Basis for the Definition of the Term “Nanomaterial”

 

Abstract

With the expected increase in the applications of nanotechnology, more and more products will be manufactured containing components which will fit the commonly used definition of the nanoscale, as having a size between approximately 1 and 100 nanometre. There is no scientific evidence in favour of a single upper limit. Moreover, there is no scientific evidence to qualify the appropriateness of the 100 nm value. Notably, defining the nanoscale as having a size between approximately 1 and 100 nanometre would not be without problems within a regulatory setting. There is a need for a more elaborate description to identify unequivocally a nanomaterial or a product containing a nanomaterial for various EU regulatory bodies. In any regulatory setting, the most important terms that have to be described clearly to avoid misunderstanding and/or misuse are “size” (what is meant by “nanoscale”) and “nanomaterial” (what is meant by “nanomaterial”)....

Download:  

http://ec.europa.eu/health/.../scenihr_o_030.pdf

Title

Modified Opinion (after Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated With Engineered and Adventitious Products of Nanotechnologies

 

Abstract

Following from the conclusions of the Council of the European Union on the European strategy for nanotechnologies which highlighted the importance of the "assessment of potential risks throughout the life cycle of nanotechnology based products" and the nanotechnologies action plan, the European Commission asked the independent experts of the Scientific Committee on Emerging and Newly Identified Health Risks for a scientific opinion on the appropriateness of existing methodologies to assess the potential risks of nanotechnologies. The committee issued a report that complements current scientific background and contains an assessment of the gaps in knowledge required to address the risks of nanotechnologies and an examination of regulatory aspects related to risk assessment. In particular, the committee concludes that current risk assessment methodologies require some modification in order to deal with the hazards associated with nanotechnology, and in particular that existing toxicological and ecotoxicological methods may not be sufficient to address all of the issues arising with nanoparticles. It furthermore points to major gaps in the knowledge necessary for viable risk assessment.

Download:  

http://ec.europa.eu/health/.../scenihr_o_003b.pdf


Title

GUIDANCE WORKING SAFELY WITH NANOMATERIALS AND NANOPRODUCTS

THE GUIDE FOR EMPLOYERS AND EMPLOYEES

 

Abstract

This guide is based on the latest (scientific) knowledge and views that were available in October 2010. The knowledge on health and safety issues and the appropriate ways to deal with both knowns and unknowns in the field of nanotechnology is rapidly growing. Companies that work in this field are therefore recommended to stay informed about the latest developments. Growing insights may lead to the need to adjust the currently leading ideas about working safely with nanomaterials and –products, including the appropriate measures to reduce exposure. The manufacturer or supplier of the nanomaterial or –product should generally be the one to inform you on these issues.

Download:  

www.ivam.uva.nl


Title

CURRENT INTELLIGENCE BULLETIN 63

Occupational Exposure to Titanium Dioxide

Abstract

In this Current Intelligence Bulletin, the National Institute for Occupational Safety and Health (NIOSH) reviews the animal and human data relevant to assessing the carcinogenicity of titanium dioxide (TiO2) (Chapters 2 and 3), presents a quantitative risk assessment using dose-response data in rats for both cancer (lung tumors) and noncancer (pulmonary inflammation) responses and extrapolation to humans with lung dosimetry modeling (Chapter 4), provides recommended exposure limits (RELs) for fine and ultrafine (including engineered nanoscale) TiO2 (Chapter 5), describes exposure monitoring techniques and exposure control strategies (Chapter 6), and discusses avenues of future research (Chapter 7). This report only addresses occupational exposures by inhalation, and conclusions derived here should not be inferred to pertain to nonoccupational exposures.

Download:

http://www.cdc.gov/niosh/docs/2011-160/pdfs/2011-160.pdf


Title

Tijdelijke nano-referentiewaarden : Bruikbaarheid van het concept en van de gepubliceerde methoden


[ Provisional nano-reference values : Applicability of the concept and of published methods ]

Abstract

The current body of scientific knowledge is inadequate to enable health-based occupational exposure limits for nanomaterials to be derived. As an alternative, provisional nano-reference values can be used as pragmatic benchmark levels to reduce the exposure of employees to nanomaterials.
This was the primary conclusion of a study commissioned by the Ministry of Social Affairs and Employment and carried out by the Knowledge and Information Centre Risks of Nanotechnology (KIR-nano) of the RIVM in cooperation with the expert platform on working conditions. Little information is available at the present time on the possible health risks of nanoparticles. Consequently, the possibility that substances in nano form are more toxic than substances in
conventional (non-nano) form cannot be ruled out.

Download:

http://www.rivm.nl/bibliotheek/rapporten/601044001.pdf (in Dutch)


Title

Nanosafety Guidelines

Preventing exposure to Nanomaterials at the Faculty of Applied Sciences

Abstract

These guidelines contain concise instructions on how to protect the laboratory workers from exposure to nanomaterials.

Nanomaterials are defined as materials with primary particles smaller than 100 nm in at least one dimension. The toxicological effects of this new generation of materials are still uncertain and imply a precaution based risk strategy. The focus lies on the possibility to become airborne and thus be inhaled. This is the most probable exposure route on the workplace.

Delft University of Technology was one of the first to have its own guidelines. The document is sharpened periodically, based on gained toxicological information and new inputs of our researchers.  The guidelines are available on the internet (nanosafety guidelines TUDelft) or with the Safety, Health and Environment group.

Download:

from Nanosafety guidelines website

 


 Online information and guidelines

Nanosmile - Contribute to the understanding of risks related to nanomaterials, make science comprehensible in order to facilitate Public dialogue.

Goodnanoguide - The GoodNanoGuide is a collaboration platform designed to enhance the ability of experts to exchange ideas on how best to handle nanomaterials in an occupational setting. It is meant to be an interactive forum that fills the need for up-to-date information about current good workplace practices, highlighting new practices as they develop.

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