Manufacturers worldwide face REACH compliance

May 28, 2008

Editor's note: This information is taken from a release provided by the National Association of Manufacturers (NAM) May 28, 2008. Links to more information and to a Webinar on the subject, hosted by BASF, can be found at the end of this release.

REACH, which stands for registration, evaluation, and authorization of chemicals, is a chemicals management program adopted by the European Union (EU) in 2007 that also affects nonchemical manufacturers. Implementation begins June 1, 2008.

The REACH legislation took legal effect June 1, 2007, with the establishment of the new European Chemicals Agency (EChA) in Helsinki. From June 1 to December 1, 2008, companies have an opportunity to participate in a simplified pre-registration process at no cost and to receive permission to complete the full registration at a later date (as late as June 2018 for some products). Under the legislation, manufacturers worldwide are required to register chemical substances they export to the EU in quantities of one or more tons annually.

Even companies that do not trade directly with Europe may be affected by the program because their customers in the U.S. or around the world will continue inputs that comply with the EU requirements, or their suppliers may suddenly discontinue longstanding product lines that no longer are profitable with REACH restrictions.

REACH covers products or articlesthat:

  • Release chemical substances in normal or foreseeable use (e.g., textile products)
  • Release chemical substances in the disposal of the product (e.g., automobiles and auto parts)
  • Contain 0.1 percent by weight of substances of very high concern (SVHC) (e.g., substances in some electronic components

For articles, the one-ton minimum requirement applies to the amount of the substance that is expected to be released from the products either in use or disposal and notthe total weight of the products themselves. As a further clarification, the one-ton registration limit applies to the amount that eachmanufacturer or importer brings into the EU and not to total imports of the substance into the EU from all sources.

As an article maker, you may have to comply with REACH:

  1. If your product releases a substance—such as a printer that releases ink— and is imported to, or made in, Europe (REACH, Article 7).
  2. If your product contains an SVHC and is imported to, or made in Europe (REACH Article 33). SVHC-bearing products may incur additional obligations under REACH.
  3. If your customers import, or make, products in Europe.
  4. If your suppliers, or their customers, import products into Europe.

Even manufacturers that know their products are exempt from the requirements may be asked by customers exporting to the EU to document this fact. Manufacturers with no direct or indirect links to the EU also could be affected if their own suppliers discontinue products that may face restrictions in the EU and thus are no longer commercially viable.

Compliance involves four elements overseen by the European Chemicals Agency (ECHA):

  1. Registration—Manufacturers of substances imported into the EU in quantities of more than 1 metric ton per year must register these substances by submitting a dossier that includes data on the chemical's properties, uses, and safe management. The goal is to have one registration per substance, so companies may have to register jointly. Companies can begin through a simplified pre-registration process on June 1, 2008.
  2. Evaluation by ECHA.
  3. Authorization, which applies to SVHCs and does not consider the 1 metric ton threshold.
  4. Restriction—The goal of authorization is to find safe alternatives for the SVHCs and eventually restrict or ban them for specific uses.

To participate in pre-registration, non-European companies must either have an established business in the EU or contract with a European firm/entity to act on their behalf. The REACH program includes provisions for European firms to represent non-European firms in the pre-registration and registration process in "Only Representative" arrangements.

Options for non-European companies to achieve REACH registration are:

  1. Set up a European-based company, which can be costly.
  2. Work through importer(s) inside the EU, which can involve disclosing confidential information to each importer and may restrict future distribution channel development.
  3. Appoint an Only Representative, which means an independent third party takes on all importer obligations under REACH. Importers then become downstream users.

Additional information can be found on the following Web sites:

Chemical company BASF is hosting a Webinar Tuesday, June 3, 2008, 11:00 a.m. – 1 p.m. EDT for companies from all sectors, regardless of their size and position in the supply chain, to discuss REACH. You can learn more about and register for the Webinar here. The Webinar also will be archived and available after June 3.



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