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