This Opinion is the first of a set of three Opinions addressing a mandate on Synthetic Biology (SynBio) from Directorates Health and Consumers (SANCO), Research and Innovation (RTD), Enterprise and Environment requested to the three Scientific Committees (SCs). This first Opinion concentrates on...

In this second Opinion (Opinion II), the Scientific Committees (SCs) addressed the five subsequent questions focused on the implications of likely developments in SynBio on human and animal health and the environment and on determining whether existing health and environmental risk assessment pr...

One of the Directives regulating the placing on the market of medical devices in the EU is Directive 93/42/EEC on medical devices. This Directive distinguishes between those devices that are intended by the manufacturer to be reused and those which are intended for single-use. Both types of devi...

The purpose of the present opinion is to update the conclusions of the SCENIHR opinion on Light Sensitivity as appropriate and to carry out an analysis of a wider range of lighting technologies and of associated potential health risks. In addition, if available data do not allow such analysis, t...

Breast implants can fail, regardless of manufacturer, and the probability of failure increases with time since implantation. This phenomenon is true for all types of implants used in humans. In most cases, breast implant failure appears to be without identifiable health consequences for the pati...

The purpose of this Opinion is to update the SCENIHR Opinions of 19 January 2009 'Health effects of exposure to EMF' and 6 July 2009 'Research needs and methodology to address the remaining knowledge gaps on the potential health effects of EMF' in the light of newly available information since t...

Surgical meshes have been used since the 1950s to repair abdominal hernias and were then used in the 1990s for the treatment of male and female stress urinary incontinence (SUI), female pelvic organ prolapse (POP) and colorectal functional disorders (CFD). More recently the use of synthetic mesh...

This Guidance addresses the use of nanomaterials in medical devices and provides information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. According to the EU Recommendation for the definition of a nanomaterial (Commission Rec...

Bisphenol A (BPA) is a key building block of polycarbonate plastic and a precursor for the manufacturing of monomers of epoxy resins. The BPA exposure of the general population is via food as a result of the use of BPA in food packaging and via skin as a result of contact with thermal paper. The...

European Commission asked the SCENIHR for a scientific opinion to assess the safety of Metal-on-Metal joint replacements with a particular focus on hip implants. There are two commonly used types of total hip arthroplasty (THA) (i) "stemmed" implants consisting of a ball head (either small-head ...