The last REACH deadline was in May 2018 and brought to a close the period of active information gathering on the safety of chemical products marketed in the EU/EEA. It has resulted in a massive database of safety information on a wide range of substances and heralds an exciting new phase of evolution in scientific and regulatory thinking. So, with the data in, the decision letters start to roll out.Continue reading
The New EU Nanotechnology Regulation
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.Continue reading
Avoiding obstacles with REACH Annexes VII-X
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).Continue reading
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