Masterarbeit

Regulatory Assessment of Nanotechnology in Different Areas of Application -an Example of Regulating Emerging Sciences ***

Natascha Nickelt (2011)

New sciences and technologies enter our everyday surroundings from basic research to applications used in our daily life. Such emerging sciences have to be included into the regulatory environment. The missing scientific and regulatory knowledge is compensated for by the careful assessment of all available information from all areas. The international exchange of information plays a vital role in this gap filling process. One of the first steps in regulation is to establish a legally clear and enforceable definition for the new technology. It is then necessary to take a closer look at the applications of the emerging technologies while evaluating their risks. Based on these evaluations the current regulation requires careful examination. Furthermore considerations need to be made to determine whether the current regulation is also sufficient to embrace the new technology.

Even if the current regulation appears to be adequate for the provision of these new technologies, considerations should be made in a foresighted manner while observing the precautionary principles to avoid risks.

Nanotechnology is one of these new technologies for which these considerations have to be made. With the number of applications constantly growing, it is essential to collect scientific information, evaluate risks, and give considerable thought to definitions and regulations.

Nanotechnology has also entered medical applications, sometimes referred to as nanomedicine. Fact is applications and benefits exist. To date reasons for concerns have not yet revealed themselves. Nanotechnology raises concerns about the toxicity and environmental impact of nanomaterials. Expected risks are seen in the accumulation of nanoparticles in brain and lungs, in immune response, the increases in biomarkers for inflammation and oxidative stress response in the body, and an accumulation in the environment. These concerns have led to the debate on whether or not special regulation of nanotechnology is proving to be necessary after all.

Special attention has to be given in relation to the treatment of vulnerable groups like patients with their underlying diseases. Likewise certain areas of industry and patient organisation groups hope that guidelines and regulations could facilitate the implementation of new technologies.

The all-embracing question of nanotechnology, and especially applicable for nanomedicine, can be found on the website of the DG Environment: "Nanotech: Panacea or Pandoras box?"

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