On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing , amending the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, to directly address nanoparticles. The nanotechnology regulation applies to any substance that might be, or might contain, a nanomaterial (e.g., powder), whether or not it has been manufactured as a nanotechnology. Crucially the revised nanoparticle regulation applies to both new and registered substances and all dossiers will need to be updated with the necessary data.
Posted by Dr. David Howes, Expert Consultant
in Chemical Legislation and Chemistry, Covance
In the EU, the Registration, Evaluation, Authorization
and Restriction of Chemicals (REACH) regulations address the manufacturing and
import of chemicals to ensure they are safe for human health and the
environment. The registration dossier outlines the standard information
requirements for a substance and minimum data required that describe the
physicochemical, toxicological, environmental fate and ecotoxicological
properties of the substance.
With this information, the European Chemicals
Agency (ECHA) can make a decision regarding the safety of the substance. However,
data requirements vary with the amount of substance used. Often, more complex
information is required to manufacture or import a substance into the EU and
the European Economic Area (EEA).
REACH a Better Solution: in vitro Skin Sensitization Assays as Animal Testing Alternatives
Skin sensitization testing is a major gap for many companies addressing the 2018 REACH substance registration deadline. Join us for a Q&A session with our Covance experts as we review REACH requirements and focus on a better solution for skin sensitization studies: in vitro assays as new alternatives to animal testing.
Q: What do REACH regulations hope to achieve?
A: The European Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) places responsibility on companies to assess and manage risks posed by chemicals. They also have to provide appropriate safety information to users. The first purpose is to ensure protection of human health and the environment. Next, the regulation promotes using alternatives to animal test methods. Third, it seeks free circulation of substances to the market, with enhanced competitiveness and innovation. Continue reading →