In my previous post I introduced REACH and gave some examples of how some companies are responding to the challenges of this new chemical regulation – some successfully, some not. Today I’ll provide a more complete definition of REACH, its history, and how it’s influencing chemical regulations around the world.
What is REACH?
Laws banning toxic substances in products have been around for years, but historically focused on individual substances, products, industries, and uses. The groundbreaking ideas behind the REACH regulation – also known as Regulation (EC) No 1907/2006 – originated out of Europe’s desire to replace its patchwork of existing regulations with a more comprehensive law – one that encompasses all chemicals, including those placed on the market before 1981, when the industry did not systematically provide documented health and safety information.
REACH, which stands for “Registration, Evaluation, Authorization and Restriction of Chemicals,” went into effect on June 1, 2007. It takes a precautious stance, meaning the burden is placed on industry to prove that the chemicals it produces, uses, and places on the market in significant quantities are safe for humans and the environment.
An estimated 30,000 chemicals will be regulated by REACH. It’s expected that up to 3,000 substances will ultimately be banned, or “restricted,” under REACH. These so-called Substances of Very High Concern (SVHC) will include CMRs – substances that are carcinogenic, mutagenic, and toxic for reproduction – and other substances. (See the appendix at the end of this paper for the current list of SVHC.)
With such an ambitious agenda it’s not surprising that the REACH document itself is lengthy. It consists of hundreds of pages of legal text and technical annexes, and more than twenty individual technical guidance documents, each addressing the requirements of various stakeholders and elements of the law. In all, there are thousands of pages of supporting documents for REACH. It’s been called one of the most complex texts in the history of the European Union.
The 4 Elements of REACH
REACH sets up an agency – the European Chemicals Agency (ECHA) – to oversee the four key procedures of the law:
1.) Registration: Registration is an information gathering and risk management exercise. Manufacturers of substances that are imported into the EU in quantities over 1 metric ton per year must register these substances by submitting a dossier which includes data on a chemical’s properties, uses, and safe management. The goal is to have one registration per substance, so companies may have to register jointly.
2.) Evaluation: The Agency evaluates the registration information to determine the chemical’s hazards and risks.
3.) Authorization: Authorization applies to SVHC and will be company-specific, use-specific, and time-limited. Lists of candidate and official SVHC will be issued on a rolling basis. The 1 metric ton threshold doesn’t apply to authorization.
4.) Restriction: The goal of authorization is to encourage manufacturers to find and use safe alternatives to SVHC and to ultimately restrict the use of SVHC explicitly.
REACH-like Regulations around the World
REACH is a European Union (EU) regulation, but its influence extends far beyond Europe. The size of the EU market and the supply chain ripple effects of the regulation mean that manufacturers in nations around the world are essentially playing by European rules. Other countries – including the U.S. – are making moves to update their chemical regulatory regimes so they are more like REACH. The reasons have as much to do with national competitiveness as they do with protecting human health and the environment.
This CNN video explains how the U.S. may move from an “innocent until proven guilty” approach to a REACH-like “guilty until proven innocent” stance – which places a far greater burden on industry.
The “Kid Safe Chemicals Act” referred to in the video is now called the Safe Chemicals Act of 2010 and was introduced by Senator Frank Lautenberg (D-NJ) on April 15th.
Japan, Switzerland, Turkey, Canada, Taiwan, and China are also in the process of making their existing chemical laws more REACH-like.
Clearly, REACH is triggering a global regulatory trend. Manufacturers will face more restrictions on the use of substances in their products, more risks of compliance failures and supply chain disruptions, higher costs, and new legal and customer-related obligations regarding the substances in their products.
The rest of this series will describe these risks and obligations along with practical steps that your organization should take to meet the challenges of REACH. Please consider subscribing to this blog.
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