Tag Archives: nanomaterial registry

Belgian register for nanomaterials (key dates: 2016 and 2017)

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Belgium will be the second country in the European Union (France being the first) to enact a mandatory register for nanomaterials. A Sept. 3, 2014 Nanowerk Spotlight article by Anthony Bochon (Attorney at the Brussels Bar, Associate at Squire Patton Boggs (UK) LLP Brussels office, Associate lecturer at the Université libre de Bruxelles and fellow at Stanford Law School) provides details (Note: A link has been removed),

On 7th February 2014, the Belgian federal government issued a press release declaring that the draft Royal Decree creating a Belgian register for nanomaterials has been approved. Although its not been formally enacted yet, its content has been disclosed to the European Commission on 19th February 2014. The Royal Decree would enter into force on 1st January 2016 for substances manufactured at the nanoscale and on 1st January 2017 for preparations containing a substance or substances manufactured at the nanoscale. [emphases mine]

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The scope of the Belgian nano register is twofold with the scopes by product and by activity that delineate the cases when a declaration or notification would be filled with the Ministry of Health.

Scope by product

The registration requirements will apply to products which are or which include substances manufactured at nanoscale. The central issue with the registration requirements was and remains the definition of the so-called “substance manufactured at nanoscale”. In absence of any common compulsory definition in EU law, the Belgian government has decided to adopt the definition proposed by the European Commission in its recommendation of 18th October 2011. The Royal Decree defines the “substance manufactured at nanoscale” as “a substance containing unbound particles or particles in the form of an aggregate or agglomerate, of which a minimum proportion of at least fifty per cent of the size distribution, by number, have one or more external dimensions within the range of one nanometre and one hundred nanometres, excluding chemically unmodified natural substances, accidentally produced substances and substances whose fraction between one nanometre and one hundred nanometres is a by-product of human activity. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below one nanometre shall be treated as substances manufactured at the nanoscale.”
Companies will have to determine with their counsel if their products fall within the product scope of application of the Belgian nano register. The choice of such definition has already faced some serious criticism during the preparatory phase of the Royal Decree. It is unsure whether this definition would survive a legality test or whether the federal government will not broaden the product scope of application. Unlike the Commission recommendation of 18th October 2011, the Belgian definition of nanomaterials does not encompass materials with a specific surface area by volume of the material greater than 60 m2/cm3 but which does not meet the 50% size distribution requirement.

A certain number of products will be excluded from the notification or declaration requirements set out in the Royal Decree:

Cosmetics products which have been notified in accordance with Regulation 1223/2009 on cosmetic products;

Biocides falling within the scope of Regulation 528/2012 (the Biocides Regulation) and which have been registered or authorized in accordance with the Royal Decree of 22 May 2003 concerning the placing on the market and use of biocides;

Medicines for human and veterinary use falling within the scope of Regulation 726/2004 or the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use

Foodstuffs and materials and objects intended to come into contact with foodstuffs referred to in Article 1, 1° and 2°, b) of the Law of 24 January 1977 on the protection of consumer health in regard to foodstuffs and other products

Animal feed, as defined in Article 3 of Regulation 178/2002

Medicines and medicated animal feed falling within the scope of the Law of 21 June 1983 on medicated animal feed;

Processing aids and other products which may be used in processing organically produced agricultural ingredients, mentioned in Part B of Annex VIII to Commission Regulation (EC) No 889/2008

Pigments, defined as substances which are insoluble in typical suspension media, used for their optical properties in a preparation or article.

It is important to point out that complex articles containing carbon black, amorphous synthetic silica or precipitated calcium carbonate, used as fillers, are excluded from the notification requirements laid down by the Royal Decree.

It’s fascinating to note the materials being excluded from this registry. I expect most of those materials/products are already covered under other regulations or decrees as are, for example, cosmetics, since the EU requires cosmetics companies to label (and, presumably, to register) products containing nanomaterials.

There’s a lot more to the article than the bits I have excerpted here so I encourage anyone interested in regulatory matters to read the piece in its entirety.

The author, Anthony Bochon, was last mentioned here in an Aug. 15, 2014 posting, about his forthcoming 2015 book, Nanotechnology Law & Guidelines: A Practical Guide for the Nanotechnology Industries in Europe.

For anyone interested here’s the Belgium’s Feb. 7, 2014 press release by Sarah Delafortrie and Christophe Springael. You will need your French language skills to read it.

Reducing animal testing for nanotoxicity—PETA (People for the Ethical Treatment of Animals) presentation at NanoTox 2014

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Writing about nanotechnology can lead you in many different directions such as the news about PETA (People for the Ethical Treatment of Animals) and its poster presentation at the NanoTox 2014 conference being held in Antalya, Turkey from April 23 – 26, 2014. From the April 22, 2014 PETA news release on EurekAlert,

PETA International Science Consortium Ltd.’s nanotechnology expert will present a poster titled “A tiered-testing strategy for nanomaterial hazard assessment” at the 7th International Nanotoxicology Congress [NanoTox 2014] to be held April 23-26, 2014, in Antalya, Turkey.

Dr. Monita Sharma will outline a strategy consistent with the 2007 report from the US National Academy of Sciences, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” which recommends use of non-animal methods involving human cells and cell lines for mechanistic pathway–based toxicity studies.

Based on the current literature, the proposed strategy includes thorough characterization of nanomaterials as manufactured, as intended for use, and as present in the final biological system; assessment using multiple in silico and in vitro model systems, including high-throughput screening (HTS) assays and 3D systems; and data sharing among researchers from government, academia, and industry through web-based tools, such as the Nanomaterial Registry and NanoHUB

Implementation of the proposed strategy will generate meaningful information on nanomaterial properties and their interaction with biological systems. It is cost-effective, reduces animal use, and can be applied for assessing risk and making intelligent regulatory decisions regarding the use and disposal of nanomaterials.

PETA’s International Science Consortium has recently launched a nanotechnology webpage which provides a good overview of the basics and, as one would expect from PETA, a discussion of relevant strategies that eliminate the use of animals in nanotoxicity assessment,

What is nano?

The concept of fabricating materials at an atomic scale was introduced in 1959 by physicist Richard Feynman in his talk entitled “There’s Plenty of Room at the Bottom.” The term “nano” originates from the Greek word for “dwarf,” which represents the very essence of nanomaterials. In the International System of Units, the prefix “nano” means one-billionth, or 10-9; therefore, one nanometer is one-billionth of a meter, which is smaller than the thickness of a sheet of paper or a strand of hair.  …

Are there different kinds of nano?

The possibility of controling biological processes using custom-synthesized materials at the nanoscale has intrigued researchers from different scientific fields. With the ever increasing sophistication of nanomaterial synthesis, there has been an exponential increase in the number and type of nanomaterials available or that can be custom synthesized. Table 1 lists some of the nanomaterials that are currently available.

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Oddly, given the question ‘Are there different kinds of nano?’, there’s no mention of nanobots.  Still it’s understandable that they’d focus on nanomaterials which are, as far as I know, the only ‘nano’ anything tested for toxicity. On that note, PETA’s Nanotechnology page offers this revelatory listing (scroll down about 3/4 of the way),

The following are some of the web-based tools being used by nanotoxicologists and material scientists:

Getting back to the NanoTox conference being held now in Antalya, I noticed a couple of familiar names on the list of keynote speakers (scroll down about 15% of the way), Kostas Kostarelos (last mentioned in a Feb. 28, 2014 posting about scientific publishing and impact factors’ scroll down about 1/2 way) and Mark Wiesner (last mentioned in a Nov. 13, 2013 posting about a major grant for one of his projects).

The Australians want one; the French and the Dutch each have one; a nanomaterials registry

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The July 25, 2012 news article by Rachel Carbonell for ABC (Australian Broadcasting Corporation) discusses the current situation in Australia,

The ABC’s revelations that some sunscreen brands are inaccurately promoting themselves as nanotechnology-free have prompted calls for better regulation of nano-materials.

But the push for a mandatory register has suffered a blow, with a Federal Government report labelling it questionable.

The Australian Council of Trade Unions (ACTU) is among those calling for a register, saying the potential risks posed by nano-particles are still unknown.

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The Federal Government recently released a study it commissioned to look at the feasibility of a mandatory nanotechnology product register.

The study concluded: “It is clear that some nano-materials behave differently to bulk-form materials and there are associated health, safety and environmental risks.”

“However the challenge presented by nanotechnology can be met through existing regulatory frameworks.

“It is therefore difficult to see a nano-products register delivering a net benefit to the community. The feasibility of a nano-product registry is questionable.”

But groups pushing for a register disagree.

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The feasibility report points to the challenge of ensuring safety without stifling innovation, saying nanotechnology is potentially worth $50 billion a year to the Australian economy.

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“But the fact that France is already implementing their mandatory register of nano-materials and the Netherlands is following closely, surely demonstrates that it must be possible.” [said Gregory Crocetti from Friends of the Earth]

The discussion presented in Carbonell’s piece is more involved than what I’ve excerpted for this posting so you may want to read her full article.

I  don’t believe I’ve come across that information about nanomaterial registries in France and Holland (Netherlands) before. I’ll see if I can find more about them to confirm their existence and exactly what is being documented.

Figuring out our knowledge gaps (European Agency for Safety and Health at Work) and fillng them (Nanomaterial Registry beta version launched)

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You (well, I do) get sick of hearing that nanotechnology awareness is low in the general public. Awareness is low in a lot of areas not just nanotechnology. There’s much to choose from and  it takes a lot of work becoming aware let alone becoming knowledgeable, so one tends to pick and choose.

The June 20, 2012 news item on Nanowerk doesn’t provoke much excitement until,

There are serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces, according to a new literature review(pdf [Risk perception and risk communication with regard to nanomaterials in the workplace {European Risk Observatory, Literature Review}]) from the European Agency for Safety and Health at Work (EU-OSHA).

We are facing nanotechnology in our everyday life in many products and applications. Although health and environmental hazards have been demonstrated for some manufactured nanomaterials, they are used in food, cosmetics, textiles, paints, sporting goods, electronics, detergents, and many health and fitness products. And they are present in many workplaces, too.  …

In its review of current research on the subject, EU-OSHA found that communication of the potential risks posed by such materials is still poor, with a majority of Europeans (54%), not even knowing what nanotechnology is. Even in workplaces where manufactured nanomaterials are found, the level of awareness is low. For example, 75% of workers and employers in construction are not aware they work with them. [emphasis mine]

Given that the folks who are at most risk (assuming there is any risk) are the ones who work with the materials, this is disturbing.

The workers who have produced the materials (coatings, etc.) being used by the construction workers are at the most risk as they are exposed to the ‘raw’ nanomaterials.

Once the materials have been constituted as part of a product, the risk level will likely dissipate. Still,  construction workers who apply coatings to various surfaces (e.g. windows) would seem to be at higher risk than people who work in a building with nanotechnology-enabled coated windows that have dried and cured. In any event, the construction workers might take greater care with their industrial hygiene practices if they knew they were working with nanotechnology-enabled products.

The EU-OSHA has an online set of case studies, with a nanotechnology category, illustrating Good Occupational Practices. You can find out more here.  (This reminds me of the International Council on Nanotechnology’s [ICON] Good Nano Guide, which I’ve not mentioned in quite some time. It too focuses on how to handle nanomaterials in an occupational setting.)

This next item is not directly related to occupational health and safety although there could be some crossover. RTI (Research Triangle Institute) International has launched their beta version of a Nanomaterial Registry. From the About the Registry page,

Registry Purpose The purpose of the Nanomaterial Registry project is to:

  • Build a repository of curated nanomaterial information by pulling data from a broad collection of publicly available nanomaterial resources
  • Deliver authoritative and useable information on the biological and environmental interaction of well-characterized nanomaterials
  • Provide tools for matching and analyzing nanomaterial data
  • Improve the quality of nanomaterial information by driving standards of accepted procedures and reporting requirements
  • Promote the use of well-defined minimal information standards framework and common nanomaterial standards
  • Identify reliable information that can be used in regulatory decision making

The June 19, 2012 news item on Nanowerk provides more information,

“The quantity of publicly available literature on nanotechnology is staggering, but until now there has not been a centralized authoritative resource dedicated to nanotechnology research and its implications to biological and environmental systems,” said Michele Ostraat, Ph.D., senior director of the Center for Aerosol and Nanomaterials Engineering at RTI and the project’s principal investigator. “This registry will provide a valuable resource for nanotechnology stakeholders to find and investigate nanomaterials across diverse test methods, protocols and data sources in this field.”

Sponsored by the National Institutes of Health, the registry is designed to improve the quality of and standardization of available methods regarding nanomaterials. This resource will also help researchers create new models, standards and manufacturing methods for nanomaterials and accelerate the development and evaluation of nanomaterials for biomedical and environmental applications.

I have posted about RTI International in the past, most recently in a May 2, 2011 posting.

Women in Europe for a Common Future advises precautionary principle for manufacture nanomaterials

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Another organization advises the precautionary principle when dealing with nanomaterials. This time it’s the Women in Europe for a Common Future (WECF) organization and they’ve just released a position paper. From the March 30, 2012 news item on Nanowerk,

Women in Europe for a Common Future, an international network of over 100 women’s, environmental and health organisations implementing projects in 40 countries and advocating globally for a healthy environment, has released a position paper on nanoparticles and nanotechnology: Nano – The great unknown (pdf).

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WECF recognizes that nanotechnologies could bring long-term profits and overall societal benefits. However, in order to make an overall judgment, data is needed regarding the hazards, exposure, risks and ethical consequences for humans, the environment and our society as a whole.

Maybe I’m getting grumpy these days but It seems to me that the time for describing ‘nanotechnology as the latest buzzword’ has passed. Here’s the opening sentence from the position paper,

Nanotechnology, the latest buzzword in the global technology revolution, is the science of ‘small things’: the de­signing, manipulating and engineer­ing of materials at nanoscale. (p. 1)

Also on page 1 is a claim as to the number of nanotechnology-enabled products on the market,

The number of consumer products on the world market claiming to contain nanomaterials exceeded 1300 already by 2010, and there are probably more, as the actual presence of nanomaterials is dif­ficult to identify.

The source for the number of nano products is not cited although WECF does list the Project for Emerging Nanotechnologies (PEN) and its product inventory in the bibliography. PEN’s inventory has no oversight (PEN has always been quite frank about this); anyone can register a product and claim there are nanomaterials in it.

Further in the position paper, Canada and California are mentioned,

Other regulatory entities too are work­ing on developing the first laws that can address the concerns on nanomaterials. Canada and the state of California, for example, took the step of imposing mandated disclosure requirements on nanomaterial use and toxicity assess­ment. Canada’s law of January 2009 targets domestic companies and institu­tions that manufacture or buy more than 1 kilogram of nanomaterial per year. According to these new regulations, these entities must now reveal how much nanomaterial they use, how they use it, and what they know about its toxicity. (p. 3)

I’m not familiar enough with the situation in California to comment on it but I am somewhat puzzled by the description of a Canadian law targeting domestic companies and institutions that manufacture or buy more than 1 kilogram of nanomaterials per year. There was a one time only requirement to report on how much nanomaterial was being imported into Canada but, as far as I’m aware, there is no law or regulation which states that this must be done on an ongoing basis. (You can read more about the reporting scheme in my April 12, 2010 posting.) This statement was not cited and I can’t find anything in the bibliography that might be the source for this information.

My problem with this position paper is that I can’t trust any of the information because the little I am familiar with contradicts their statements and they don’t support those statements with sources that I can research.

World’s first mandatory reporting of nanotechnology use in Canada?

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Maybe. This bit of news was first reported (near as I can tell) on the Canadian Press news wire and on the Project on Emerging Nanotechnologies (PEN) website on January 28 and, after much hunting, I determined that the Canadian Press article was written by John Cotter. Earlier (Jan.12.09), I posted about a story of his here where I analyzed what seemed to be a flurry of interest in a failure by the Canadian government to respond to a nanotechnology report. This latest story would seem to be related.

Here’s the story lede from this article which is the only one I could find which included  Cotter’s byline,

Canada is poised to become the first government in the world to require companies to provide information about their use of potentially harmful nanomaterials in their products.

The other articles open with similar ledes. here (Google News) and here (CBC News).  The lede differs somewhat here (Project on Emerging Nanotechnologies [PEN]); the writer  is more nuanced in their approach.

Other than John Cotter’s authorship of the ‘source’ article this time and last, there are another couple of interesting points. The announcement is being made by PEN (located in Washington, DC) and not by any Canadian government agency. Although Environment Canada  officials did not comment directly on the PEN announcement, they did say that there is a plan to send out a notice requiring companies and institutions that used more than 1 kilogram of nanomaterial in 2008 to provide information that may include: how the nanomaterials are managed, data on chemical and physical properties, and any other information that could be helpful.

It sounds a little vague and there’s no indication that this is anything more than a once only request. Plus, I’m wondering how the officials are going to define the terms. Is one company’s quantum dot another company’s nanoparticle?

That earlier article by John Cotter citing a nanotechnology report for the Canadian government? One of its authors, Dr. Andrew Maynard, Chief Science Advisor for PEN and Dr. Pekka Sinervo, another of the authors, are the only two experts listed in this latest article.

The whole thing smacks of a campaign (public relations, communications, or whatever else you want to call it). In principle, I think it’s useful to have a registry of products using nanomaterials (unfortunately this whole project seems a bit tenuous). I also find it interesting to note how various agencies and special interest groups get their points across in the media. One final thing, the announcement on PEN’s website points to reports about how the US Environmental Protection Agency and the US Administration should be applying oversight to nanotechnology use in the US.