REACH Article | EPA News | Recent EPA Rules

Environmental News

Volume 8, Issue 10

March 13, 2007

REACH Article

New European Union Regulations REACH Your Chemicals

The U.S. EPA isn’t the only authority determined to find better ways of protecting human health and the environment: the European Union (EU) is building on its recent Waste Electrical and Electronic Equipment (WEEE) and Restriction of Hazardous Substances (RoHS) Directives with a new and sweeping policy on chemicals: REACH. REACH, which stands for Registration, Evaluation and Authorization of CHemicals, promises a higher level of safety in dealing with both new and existing chemicals.

Many U.S. companies, especially in California, have already been affected by the electronic equipment recycling requirements imposed by WEEE and RoHS (which targets toxic substances contained in electronic waste). REACH is expected to have an even broader global impact.

REACH regulation was formally adopted on December 18, 2006. The directive enters into force on June 1, 2007, forming a European Chemicals Agency, which will be operational by June 1, 2008. REACH, as its acronym indicates, encompasses several methods whereby manufacturers and importers will be held responsible for their chemicals, including:

Registration of chemicals, and provision of information on their properties, uses, and safe handling
Evaluation of registration information by public authorities
Authorization requirements for chemicals that are endocrine disruptive, cancer-causing, mutagenic, or bio accumulative, limiting their use to companies with demonstrated risk controls
Restrictions on certain dangerous substances, allowing for quick action and control by appropriate authorities.

The overarching goal of REACH is similar to EPA, OSHA, and consumer product safety objectives in the U.S. All are concerned with providing the safest available products and the most thorough information about chemicals to downstream manufacturers and consumers.

How does REACH Affect U.S. Chemical Manufacturers?
REACH does not distinguish between chemicals based on their origins. If your chemicals enter the EU, they will be subject to all of the REACH requirements, just like chemicals that are manufactured in the EU. This may mean much stricter requirements for both the properties of the chemicals you produce, and for the amount and type of information you are required to provide to those who purchase your chemicals.

Additionally, REACH requirements are not just a fact of life in the EU; many other nations are also in the process of investigating and implementing similar chemical control programs. If you are involved in any level of international trade, it may be necessary for your facility and your chemicals to comply with the most stringent set of international requirements. Even closer to home, some U.S. states (which may have stricter environmental standards than the federal government) are considering REACH-like regulations, and legislation calling for a similar system on the federal level has recently been introduced to the Senate.

Although it is not yet possible to determine how much REACH will change global commerce, there are many potential trickle-down effects. For example:

You may be required to provide much more thorough information on products you export yourself or sell to importers
Increased international safety standards mean you might have to use or consider using alternate chemicals in your production processes
Other U.S. manufacturers who use your chemicals in products they export may require you to give them additional test data about the properties of your chemicals and may not use your chemicals if safer ones are available.

What do You Need to Know to Comply with REACH?

REACH believes that communication throughout the chemical supply chain is vital. Companies that manufacture chemicals must be prepared to provide downstream users, such as other production processes and consumers, with detailed information about how these chemicals could affect their businesses and lives. If your company manufactures chemicals, this applies to you.

As a U.S. company involved in international trade, you have two primary responsibilities:

To provide thorough and accurate information about all substances imported to the EU, and
To either appoint an EU-based representative for your company, or rely on your EU-based importer to fulfill REACH’s chemical registration requirements. (If you choose the latter option, be prepared to provide your importer with all of the chemical information that will be required for registration.)

Under REACH, all companies in the EU that manufacture or import 1,000 kg (2,204.6 lbs) or more of a chemical in a year must register data about its physical and chemical properties with EU authorities. Additionally, companies that manufacture or import 10,000 kg (22,046 lbs) or more of a registered chemical in a year must provide a Chemical Safety Report (CSR) outlining data on its health and environmental effects, including such factors as toxicity and long-term biological effects. The CSR must also outline intended uses of the substances and recommend waste management measures for downstream users, including consumers.

Some chemical substances are exempt from REACH registration because they are regulated under other legislation. These include radioactive substances, wastes, basic elemental substances (such as hydrogen), and substances necessary for national defense, among others. Additionally, medicinal, cosmetic, and food products are regulated elsewhere.

What are the Registration Requirements for Pre-Existing and New Chemicals?

One of the goals of REACH is to remove differences in the management of new and pre-existing chemicals. Under REACH, all companies in the EU that manufacture or import at least 1,000 kg of a chemical in a year must register it, whether or not it has previously existed in the European market. The EU estimates that there will be approximately 30,000 such existing chemicals initially registered under REACH.

For newly developed chemicals, REACH is making greater allowances for research on amounts up to 1,000 kg per year. It is hoped that the REACH directive will eventually lead to better chemicals, and therefore registration will not be required for every small variation in testing. New chemicals (i.e., chemicals not previously marketed in the EU) manufactured or imported in amounts greater than or equal to 1,000 kg per year will be subject to the same registration and evaluation requirements as existing chemicals.

REACH also requires chemical companies to immediately notify EU authorities in writing of any significant changes in the properties or uses of existing chemicals. Although EPA requires inventory reporting every 5 years on existing chemicals produced over a threshold amount, there is no comparable blanket requirement to make new uses immediately known.

What is REACH’s Ultimate Goal?

Ultimately, REACH seeks to provide better protection of human health and the environment via increased communication about chemicals. Over the next five to ten years, the EU hopes to see an increase in both the amount of information that consumers have about their chemicals, and the amount of information that research and development companies share.

With careful implementation throughout the international community, REACH may soon result in the development of safer alternative substances and alternative test measures, as well as a reduction in animal testing via industry data sharing, and increased generation of information about chemicals for review and development. It is planned that an annual report of progress in chemical evaluation will be published on the web annually on February 28.

In the end, it’s all about supplying the supply chain—with information. REACH will provide the best and most protective information possible about chemicals to everyone affected by them. If your company has this information, you may well be called upon to help the international chemical community REACH its goal.

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