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Don't let REACH become a stretch

May 13, 2004

 By Lynn Bergeson

Chemical regulation in the European Union (EU) will change radically when the Registration, Evaluation, and Authorization of Chemicals (REACH) Program is implemented. The program will mandate registration of chemicals that are manufactured or imported into the EU in quantities exceeding 1 metric ton, and will require further evaluation of those that surpass 100 metric tons. Certain "high concern" chemicals will require specific authorization.

Last October, the European Commission (EC) issued an extensive proposal to implement REACH. It would, once enacted, replace about 40 directives and regulations currently in force and would establish a new agency -- the European Chemicals Agency (ECA) -- to manage the REACH system. Much remains to be clarified, but the proposal lays out in considerable detail a program that would have global reach. Although the initial implementation target of early 2006 may slip, it is certain that some form of the program will become law.

The REACH system is intended to harmonize the regulatory framework for existing and "new" chemicals, meaning those not on the market as of September 1981. Now, chemicals classified as new may not legally be sold in the EU until extensive information about their production, use, properties and potential adverse effects are submitted to regulatory authorities for approval. Existing chemicals do not require pre-market approval.

The EC has urged European companies to take several steps now. This article briefly reviews those steps and outlines the reasons why the U.S. chemical industry should also prepare for REACH.

U.S. Implications

Exports to Europe are subject to REACH. Also, U.S. companies will be expected to contribute use and exposure data to facilitate the risk assessments that are required under the program. In addition, the information generated under REACH about specific chemicals will have immediate, global implications. For example, adverse toxicity results will certainly impact worldwide marketing of a material.

EU chemical manufacturers and importers are being encouraged to take several actions now. Briefly stated, they are as follows:

  • Preparation of an inventory of chemical substances that will be subject to REACH. This inventory should include the chemical identity, annual production volume and CAS number. Non-isolated intermediates (that is, intermediates that during synthesis are not intentionally removed) are exempt from REACH under the EC's October proposal. Polymers are included within the program's scope, but for now are excluded from the registration requirement.
  • Creation of a list of customers for each substance and their uses of the chemical, including whether it is sold to downstream users or to consumers through distributors. Several categories are recommended for the purpose of identifying main uses: non-isolated intermediates; on-site isolated intermediates; transported intermediates; substances incorporated into products from which environmental releases are substantially curtailed; substances used in such a way that only certain groups of workers are exposed; and substances used in activities that result in uncontrollable exposures, such as via painting or spraying.
  • Determination of the availability of additional information in certain categories, including hazard and exposure risks, safety data, and classification and labeling details.

    Companies should ensure that the data collected remain confidential. It is important to think through data sharing and cost allocation implications of producing data with others. This is an area that is expected to generate significant debate since data compensation and cost-sharing mechanisms are not yet developed.

    U.S. chemical producers and exporters would be wise to prepare for REACH as though they were subject to it. That way, they will be poised to respond to whatever questions, issues and market shifts that may arise.

    Contributing Editor Lynn Bergeson is a founding shareholder of Bergeson & Campbell P.C., a Washington, D.C.-based law firm concentrating on chemical and related products. The firm handles product approval and regulation, product defense and associated issues. The views expressed herein are solely those of the author. E-mail her at [email protected].

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