The Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) Regulation entered into force in 2007. Since its inception, manufacturers and importers have registered more than 22,000 unique substances; over 200 substances have been added to the Candidate List, and many amendments to the lists of restrictions and substances subject to Authorisation have been made. Although we have seen progress in terms of the tightening chemical legislation to regulate the manufacture and importation of chemical substances to the EU, there is still a lot more to be done.
Evolving from a European Commission draft with inputs from industry, Member States, the European Parliament and environmental organisations, REACH has become one of the most complex and farreaching pieces of legislation to ever originate from Brussels. It is a Regulation, rather than a directive, meaning that it acts directly in each Member State without the need for national implementation.
REACH aims to protect human health and the environment from the risks arising from the use of chemicals whilst maintaining the free movement of goods on the EU market and enhancing competitiveness and innovation. It intends to achieve its goal by requiring industry to determine and make public the risks posed by the use of chemicals, according to the precautionary principle. Unlike prior legislation which placed the onus on the regulatory authorities to ensure the safe use of chemicals, REACH places the burden on EU substance manufacturers, EU importers (if you buy substances from non-EU suppliers, you are an importer), and downstream users (if you buy from EU suppliers but your use is not supported by your supplier) to ensure the responsible supply and use of substances.
As part of their registration, manufacturers and importers must define the uses in their supply chain which they can support, and detail the specific conditions of use which allow for safe handling. For hazardous substances which are manufactured or imported at 10 tonnes or more per year, the manufacturer or importer must extend their safety data sheet, using “exposure scenarios” setting out the appropriate operational conditions and risk management measures to be employed.
Authorisation is a process in REACH to identify and manage substances of very high concern (SVHCs) by promoting their substitution with less hazardous alternatives. The SVHCs which are subject to Authorisation are listed in Annex XIV to REACH, commonly known as the Authorisation List. Each entry in Annex XIV includes ...
