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On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the attention of the European Commission.  The primary purpose of the paper is to draw the attention of the EC to…

 On January 13, 2015, the European Commission (EC) and its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published the final opinion “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.”  According to the EC, the Guidance provides information on how to evaluate the risk when…

On October 19, 2012, the European Comission (EC) began a public consultation on a preliminary opinion entitled Addressing the New Challenges for Risk Assessment. The Inter-Committee Coordination Group of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Committee on Consumer Safety (SCCS), and Scientific Committee on Health and Environmental Risks (SCHER) established…

On August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials:

  • 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; and
  • Nanosilver used as an antibacterial agent.

The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field, although this use has not yet been attributed clearly to the legislation on medicines or the to the legislation on medical devices. 

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Continue Reading SCENIHR Issues Call for Information and Experts on Health Effects of Nanomaterials Used in Medical Devices

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…

On March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC’s request, in the field of medical devices, the following cases of alleged use of…

The European Commission (EC) requested on December 9, 2011, that the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. According to the EC, while recent review papers suggest that nanosilver may not be hazardous to…

On December 8, 2010, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) approved its opinion on the scientific basis for the definition of the term “nanomaterial.” The opinion concludes that:

  • Whereas physical and chemical properties of materials may change with size, there is no scientific justification for a single

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On July 12, 2010, the European Commission (EC) opened a public consultation on the pre-consultation opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) entitled “Scientific Basis for the Definition of the Term ‘Nanomaterial.’” The EC states that its services need a working definition for the term “nanomaterial” to ensure…

On March 1, 2010, the European Commission (EC) issued a request, via the accelerated procedure, for a scientific opinion on the scientific basis for the definition of the term “nanomaterial” from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). According to the EC, its services “urgently need to elaborate a working definition…