Tag Archives: Scientific Committee on Emerging and Newly Identified Health Risks

Calling all scientists with a good command of English and expertise on medical devices containing nanomaterials

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The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) needs experts because it has been asked by the European Commission to asses the use of nanomaterials in medical devices. From the Aug. 15, 2012 news item on Nanowerk,

The relevant SCENIHR working group has identified a need in the field of medical devices containing nanomaterials. In line with the Rules of procedure (pdf) of the Scientific Committees, a call for expression of interest for experts in this topic is launched.

To allow for a comprehensive assessment, experts in various scientific fields related to the safety of medical devices containing nanomaterials are encouraged to apply. Experience in risk assessment would be an advantage.

The deadline for submission for this call for experts is 1 October 2012 (kindly note that the registration to the database of experts with regard to the general work of the Scientific Committees is permanently open). Applicants are requested to indicate “SCENIHR: Medical devices Nano – call for experts” in the subject title of the message sent with their application.

The detailed description of the mandate for this request can be found here. It includes details such as this from the  introduction,

Today, a more widespread application of nanotechnologies and nanomaterials is imminent or already occurring in many areas, including health care. For nanomedicine, the three largest areas of application are diagnostics, drug delivery and regenerative medicine (ETP Nanomedicine 2009). In addition there are applications in surgery and thermotherapy (Vauthier et al. 2011). In the field of medical devices, the following cases of alleged use of nanomaterials have been identified by Notified Bodies:

– Carbon nanotubes in bone cements;

– Nanopaste hydroyapatite powder for bone void filling;

– Polymer setting material with nanoparticles in dental cements;

– Polycrystalline nanoceramics in dental restorative materials;

– Nanosilver or other nanomaterials used as coatings on implants and catheters;

– Nanosilver used as an antibacterial agent, for example in wound dressings (see also Wijnhoven et al. 2009).

Furthermore, there are reports on iron-oxide nanoparticles injected into tumour cells to be heated-up by radiation or an external magnetic field1. This type of use has not yet been clearly attributed to the legislation on medicines or to the legislation on medical devices. On one hand, the immediate effect is mechanical as the tumour cells burst. On the other hand, one might regard the legislation on medicines applicable as the burst cells are metabolised at a later point in time.

Although the general risk assessment requirements applicable for materials used in medical devices and previous scientific opinions on risk assessment of nanomaterials (see e.g. SCENIHR 2006, 2007 and 2009) are useful when assessing nanomaterials for medical applications, there is a need for further clarification in the risk assessment of such products. (p. 1)

The Terms of Reference include,

This evaluation shall take into account different categories of medical devices such as:

a.. Non-invasive medical devices, e.g. devices coming into contact with the

intact skin,

b. Invasive devices (surgical or not), e.g.:

o woundcare materials,

o implantable medical devices,

o dental and bone fillings and cements,

o injectable nanomaterials.

In this assessment, where relevant, the SCENIHR is invited to differentiate between free, fixed, and encapsulated nanomaterials. (p. 2)

The deadline listed in the mandate is March 2013. Presumably this is the deadline for the assessment itself while the deadline to apply as an expert is Oct. 10, 2012 according to the SCENIHR webpage for the August 2012 Call for Information on the Safety of Devices Containing Nanomaterials.

ETA Aug.15, 2012 11:20 am PDT: Given that I originally misspelled the word expertise in my headline for this post, maybe I need to check my own expertise … with English.

Europeans wrangle over nanomaterials definitiion

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There seems to have been a bit of kerfuffle in Europe about a nanomaterials definition for Europe at the 4th annual Nano Safety for Success Dialogue; Assessing the science & issues at the science/regulation interface workshop which took place March 29 and 30, 2011. From the April 12, 2011 news item on Nanowerk,

The European Commission’s hesitance to define nanotechnology underscores diverging opinions among stakeholders and is causing uncertainty in the sector.

Participants in a Brussels-based international conference, the Safety for Success Dialogue, discussed the Commission’s ongoing search to revise a draft definition of nano that went out to public consultation last year, but made clear that no answer has yet been found.

Henrik Laursen, coordinator of the nano team in the Commission’s environment department, said the EU executive had received around 200 replies to the consultation.

He said: “It is clear that at a certain level many stakeholders are saying different things, and there is no absolute scientific definition.” He said the Commission would not be rushed into making a decision because, once made, it would not be a working model but would immediately have a significant binding effect.

But Chiara Giovanini, a spokeswoman for ANEC, the European Consumer Voice in Standardisation, noted that the “lack of an agreed definition is creating legal uncertainties for regulatory purposes, and hindering the development of adequate safety test and measurement methods”.

She called on the Commission to adopt the draft definition of nanomaterials contained in the consultation at the end of last year “without further delay”.

Unusually for an item of this nature there’s reference to behind the scenes discussions. From the news item,

The Commission is believed to be attempting to frame a definition before the end of the summer. However, the finer detail of how to define nanomaterials is the subject of fervent [emhasis mine] disagreement between stakeholders behind the scenes.

Wim de Jong, vice-chair of the SCENIHR [Scientific Committee on Emerging and Newly Identified Health Risks], told EurActiv that his organisation had recommended to the Commission that the number of particles, rather than the weight of the particles, be used as a guide for determining the definition.

“This is important because the potential hazards of using these particles relates to the number of them within a particular product,” he said.

But other stakeholders are opposed to using numbers as a guide to defining nanomaterials. For example, the European Chemical Industry Council (Cefic) has recommended to the Commission that weight be used instead.

Cefic’s reply to the Commission consultation reads: “Weight is generally used in all chemical legislation and test procedures and should therefore be used instead of particle number concentration.”

Giovanini’s desire to adopt a draft statement for the purposes of getting something done seems similar to the approach Health Canada has taken with its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials.

Laursen’s comment that a draft statement would not be treated as such but instead would have a “significant binding effect,” certainly accords with my experience of how these things work. At the same time, I sympathize with Giovanini’s position as one can’t wait forever to come to an agreement.

I thought the introductory description for the workshop helped to illuminate why details of a dispute which usually remains somewhat behind closed doors have been made public (from the workshop’s introduction page),

Many market modelers identify nanotechnologies as drivers of economic growth. Consequently, most governments in the industrialized and industrializing world adopted ambitious strategic, research and innovation, plans to ensure the commercial success of nanotechnologies and to harvest their fruits.

Nanoscience and the nanotechnologies are progressing at a rapid pace. The number of potential and real applications is increasing rapidly, even when accounting for those claims relating to marketing rather than added-value.

…

The international community has organized itself to address the potential safety aspects of nanomaterials, in particular under the auspices of the OECD Working Party on Manufactured Nanomaterials, and with the support of national and European scientific advisory bodies like the Scientific Committee on Emerging and Newly Identified Health Risks of the European Commission. Moreover, a number of regulatory developments have taken place, while the science was also advancing. The European Commission is therefore convening this international conference
• to take stock of the fast advancing science needed for appropriate and effective policies; and
• to analyze how these advances allow progress with respect to intelligence gathering, risk assessment, risk management, and safe design …

It’s hard to tell if this is a new introduction or one that’s been used for all of the workshops regardless, it does convey a sense of urgency.

Note: I’ve added the OECD (Organization for Economic Cooperation and Development) link in particular as this has been an excellent source of material about the Canadian situation.