---
title: "Regulation of nanotechnology"
chunk: 1/6
source: "https://en.wikipedia.org/wiki/Regulation_of_nanotechnology"
category: "reference"
tags: "science, encyclopedia"
date_saved: "2026-05-05T04:27:37.701684+00:00"
instance: "kb-cron"
---

Because of the ongoing controversy on the implications of nanotechnology, there is significant debate concerning whether nanotechnology or nanotechnology-based products merit special government regulation. This mainly relates to when to assess new substances prior to their release into the market, community and environment.
Nanotechnology refers to an increasing number of commercially available products – from socks and trousers to tennis racquets and cleaning cloths. Such nanotechnologies and their accompanying industries have triggered calls for increased community participation and effective regulatory arrangements. However, these calls have presently not led to such comprehensive regulation to oversee research and the commercial application of nanotechnologies, or any comprehensive labeling for products that contain nanoparticles or are derived from nano-processes.
Regulatory bodies such as the United States Environmental Protection Agency and the Food and Drug Administration in the U.S. or the Health and Consumer Protection Directorate of the European Commission have started dealing with the potential risks posed by nanoparticles. So far, neither engineered nanoparticles nor the products and materials that contain them are subject to any special regulation regarding production, handling or labelling.

== Managing risks: human and environmental health and safety ==

Studies of the health impact of airborne particles generally shown that for toxic materials, smaller particles are more toxic. This is due in part to the fact that, given the same mass per volume, the dose in terms of particle numbers increases as particle size decreases.
Based upon available data, it has been argued that current risk assessment methodologies are not suited to the hazards associated with nanoparticles; in particular, existing toxicological and eco-toxicological methods are not up to the task; exposure evaluation (dose) needs to be expressed as quantity of nanoparticles and/or surface area rather than simply mass; equipment for routine detecting and measuring nanoparticles in air, water, or soil is inadequate; and very little is known about the physiological responses to nanoparticles.
Regulatory bodies in the U.S. as well as in the EU have concluded that nanoparticles form the potential for an entirely new risk and that it is necessary to carry out an extensive analysis of the risk. The challenge for regulators is whether a matrix can be developed which would identify nanoparticles and more complex nanoformulations which are likely to have special toxicological properties or whether it is more reasonable for each particle or formulation to be tested separately.
The International Council on Nanotechnology maintains a database and Virtual Journal of scientific papers on environmental, health and safety research on nanoparticles. The database currently has over 2000 entries indexed by particle type, exposure pathway and other criteria. The Project on Emerging Nanotechnologies (PEN) currently lists 807 products that manufacturers have voluntarily identified that use nanotechnology. No labeling is required by the FDA so that number could be significantly higher. "The use of nanotechnology in consumer products and industrial applications is growing rapidly, with the products listed in the PEN inventory showing just the tip of the iceberg" according to PEN Project Director David Rejesk.
The Material Safety Data Sheet that must be issued for certain materials often does not differentiate between bulk and nanoscale size of the material in question and even when it does these MSDS are advisory only.