Jul. 9 – EU: What You Should Know About REACH

From Life Science Reader:

According to KPMG, some experts have suggested that compliance with REACH may cost several billion euros. “We are really only finding out about the costs of REACH now,” explains Dr. Joanne Lloyd, Ph.D., of the information provider REACHReady (www.reachready.co.uk), a wholly owned subsidiary of the Chemical Industries Association. “The ECHA [European Chemicals Agency] originally thought that there were about 30,000 substances relevant to REACH and expected to get about 180,000 preregistration applications in the first six months. Instead, it received around 2.7 million preregistration applications, relating to about 150,000 substances.”…

Under the terms of REACH, non-EU companies that wish to import nonexempt substances produced at levels over one metric ton/year into the EU will need to register them. “The preregistration process is required if companies will secure access to the EU market,” says Hans Schoolderman, director of sustainability & climate change services, PricewaterhouseCoopers Netherlands.

Companies based outside the EU cannot themselves register or preregister chemicals and must use an “only representative” for this process. These are individuals or companies who must be based in the EU, and who are empowered to act on behalf of the non-EU company, and create and submit the required documentation. These people also participate in the SIEF (Substance Information Exchange Forum) on behalf of U.S. companies. There is some concern that this adds an extra step to the process, increasing costs, as well as increasing the risk of security breaches.

For more information, click on the above link.

Relevant Nexreg Compliance Links: Nexreg, REACH Compliance, EU SDS Authoring.