After years of highly controversial negotiation, on December 18, 2006 the European Union formally adopted a Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals, better known as REACH. REACH fundamentally changes the landscape by shifting the burden of proving that chemicals aresafe from regulatory authorities to economic operators.
In a nutshell, the new obligations for industry will include:
- Registering substances manufactured or imported into the EU (either on their own or in mixtures or, under certain circumstances, in articles).
- Filing requests for premarket authorization of substances of “very high concern.”
- Generating and sharing information on chemical substances.
- Passing information up and down the supply chain by means of new tools such as “Chemical Safety Reports” and new Material Data Safety Sheets.
- Applying appropriate risk management measures.
- Identifying uses for each substance.
Obligations vary depending on whether a company qualifies as an importer, a manufacturer, a downstream user or a producer of articles. Often, companies have more than one role and qualification in regard to a substance, so they may be subject to different sets of rules simultaneously.
The REACH calendar is as follows:
- June 2007: REACH enters into force.
- June-November 2008: Preregistration of the so-called “phase-in substances,” which are primarily substances that are already present in the EU.
- June 2009: Publication by the Chemicals Agency of a list of recommended “priority substances” for authorization (the so-called “candidate list”).
- November 2010: Registration deadline for substances imported or manufactured in quantities of 1,000 tons or more and for certain substances of concern.
- June 2013: Registration deadline for substances imported or manufactured in quantities of 100 tons or more.
- June 2018: Registration deadline for substances imported or manufactured in quantities of 1 ton or more.
Most companies have been preparing for compliance with this new piece of legislation by developing clear strategies encompassing both its legal and technical aspects. Most plans include conducting regulatory risk assessments that will identify substances in a company’s portfolio that are subject to REACH requirements, creating compliance management plans and developing management information systems that will allow ongoing internal systems to track registration data. Focus should also be on ensuring appropriate and proactive communication with customers and suppliers aimed at ensuring that compliance will not result in operational disruption or liabilities (including contractual liabilities, e.g., in case of a substance’s discontinuation).
Continuing these efforts (or excluding them in some cases) will not only ensure compliance with REACH and reduce the overall regulatory burden on a company, but will also provide an invaluable competitive edge over companies that chose to wait.