The REACH chemicals regulation aims for better protect humans and the environment in the European Union (EU) against risks connected with the use of chemicals.
Responsibilities of manufacturers, importers and processors of chemical substances have increased in the EU. I.a., they have the duty to register (Registration) substances imported or manufactured at more than 1 tonne per year.
The European Chemicals Agency (ECHA conducts spot checks on at least 5% of submitted registrations (Evaluation). An actual Authorisation of CHemicals is necessary only in the case of substances of very high concern. Authorisation decisions are made by the European Commission.
Use and exposure are relevant
The REACH approach consists in assessing chemical substances not just based on their intrinsic toxicity but in requiring comprehensive information regarding specific uses along their entire life cycle.
A safety data sheet (SDS) is required for hazardous substances and preparations. Such SDS is mandatory even for the use of quantities below 1 tonne. The SDS must be made available to professional and commercial users unsolicited and free of charge.
For quantities of 10 tonnes or more, the registration must include a chemical safety report with exposure scenarios for the various uses. These exposure scenarios are also to be added to the SDS in annex.
Alternative test methods
For many substances, it is assumed that the hazard they represent for humans and the environment in their specific uses has not yet been sufficiently clarified. Instead of conventional animal testing, REACH generally expects hazard assessments for substances below a production volume of 10 tonnes to be made through in vitro testing.
Innovation and competition
This procedure requires the research community, the authorities and the chemical industry to be innovative. On the one hand, new test procedures need to be developed in lieu of animal testing. On the other, new substances or chemical compounds need to be researched and developed if a chemical substance is revealed to no longer be admissible for its existing purpose.
Last modification 05.06.2018