Archives

April 10, 2015

SCENIHR Identifies Use of Nanomaterials for Medical Imaging and Drug Delivery and Graphene Nanomaterials as Emerging Issues

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 emerging issues in the non-food area that have been identified by SCENIHR members as having the potential to significantly impact human health...
January 13, 2015

SCENIHR Publishes Final Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

 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 a nanomaterial is used in a medical device.  The EC states that the Guidance addresses the use of nanomaterials in medical devices...
October 25, 2012

EC Begins Public Consultation On Discussion Paper Addressing The New Challenges For Risk Assessment

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 a joint working group to review risk assessment procedures and new challenges for...
August 13, 2012

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

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: The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by...
April 10, 2012

EC Scientific Committee Requests Information on Nanosilver

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...
December 12, 2011

EC Requests SCENIHR for Scientific Opinion on Nanosilver

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 humans, data are insufficient to carry out a full risk assessment. The EC states that indirect adverse effects on human...
December 20, 2010

EC Committee Approves Opinion on Scientific Basis for the Definition of Nanomaterial

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: To define an enforceable definition of “nanomaterial” for regulatory use, the opinion proposes to set an upper limit for nanomaterial size and to add to the proposed limit additional guidance specific for the intended...
July 15, 2010

EC Opens Public Consultation on Scientific Basis for a Definition of Nanomaterial

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 the consistency of forthcoming regulatory developments, to guide the effective implementation of existing...
March 10, 2010

EC Requests Accelerated SCENIHR Scientific Opinion on the Scientific Basis for the Definition of the Term “Nanomaterial”

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 of the term ‘nanomaterials’ to ensure the consistency of forthcoming regulatory developments to guide, as appropriate, the...
April 29, 2009

EC Begins Public Consultation to Prepare for Scientific Hearing on Nanotechnology

The European Commission (EC) will hold a scientific hearing on nanotechnology on September 10, 2009. The hearing will focus on the scientific aspects of the issues covered in the nanotechnology opinions issued by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Consumer Products (SCCP) (which is now replaced by the Scientific Committee on Consumer Safety (SCCS)). To prepare for the hearing, the EC is launching...