REACH has Arrived
Executive Advice
By Lynn L. Bergeson   
Sunday, 14 January 2007
smc Registration, Evaluation and Authorization of Chemicals (REACH)
U.S. manufacturers need to determine how the enactment of the Registration, Evaluation and Authorization of Chemicals regulation affects them.
The enactment of the registration, evaluation and Authorization of CHemicals (REACH) regulation signals the dawn of a new era in chemicals management law and policy, and its impact will be significant and global. REACH is the new chemical regulation system in the EU. When it enters into force in June, it will replace approximately 40 existing legal instruments and create a single EU regulatory scheme for all chemical substances, both new and existing. The REACH system will require:

· The registration of approximately 30,000 chemicals that are manufactured or imported into the EU in quantities exceeding one ton
· The evaluation of approximately 5,000 chemicals that are manufactured or imported into the EU in quantities exceeding 100 tons
· The explicit authorization of hundreds of so-called chemicals of “very high concern”

The pre-registration phase for existing substances will commence on June 1, 2007, and run through Nov. 30, 2008. Companies that pre-register will have – depending on the production/importation volume and “risk” that the particular substance is determined to pose – either three-and-a-half, six or 11 years from June 1, 2007, to complete the registration process. Pre-registration is, therefore, important, and companies doing business in the EU impacted by REACH should be assessing their chemical use patterns now to ensure all such uses are recognized and accounted for.

Registration – Under this REACH component, companies are required to register all substances manufactured in volumes of one ton or more per year per manufacturer or importer. REACH is “substance-based,” meaning that the substance itself must be registered, not the preparation or formulation in which the substance might be found.

Evaluation – Substances produced or imported in volumes greater than one ton must be evaluated. The type of evaluation is set forth in various annexes to REACH, and include various tests intended to characterize the toxicological and related properties of the substance.

Authorization – Manufacturers or importers of chemicals of very high concern (persistent, bioaccumulative, and toxic substances, carcinogens, mutagens, reproductive substances and targeted others) are required to submit an application for authorization, and specific authorization is required as a condition of marketing. Use may continue until a specified sunset date, after which the use of the substance in a particular application is no longer authorized.

Now that REACH is in place, guidance for the industry is imperative. According to the European Commission’s latest document, new guidance documents are currently being developed under REACH implementation projects (RIP). Once issued, they will help make the transition to the new system as easy as possible, or at least that is the hope. Guidance to assist registrants and users of chemicals reportedly will be made available, free of charge, through a Web site that will be launched in mid-2007. In the meantime, information on the RIPs, especially RIP 3, which addresses the development of guidance documents for the industry, can be obtained at the European Chemicals Bureau Web site at http://%20ecb.jrc.it/reach/.

Implications
REACH will impact chemical manufactures and business entities that produce products around the world. As noted, exports to Europe are subject to REACH. In addition, U.S. companies (and others exporting into the EU) are expected to contribute use and exposure data to facilitate the risk assessments that are required under the REACH program. Information generated under REACH about specific chemicals will be made public, and could therefore have fairly immediate implications in product markets elsewhere. For example, adverse toxicity results are expected to impact the worldwide marketing of a chemical substance and/or product line.

Companies must also be mindful of confidentiality concerns and data ownership issues. It is important to consider data-sharing opportunities, data production, cost-allocation implications and related data management issues invited by the business realities of producing data with others, potentially including competitors. This is an area that is expected to generate significant business uncertainty because data compensation and cost-sharing mechanisms developed to accommodate REACH-related business transactions are still evolving.

U.S. chemical producers, others with chemical products marketed in the EU and exporters to the EU need to begin now, if they have not yet done so, to be ready for REACH.

Businesses also need to prepare domestically for the implications of REACH. This includes being ready for the business implications of REACH on particular product lines, but also being ready to address the political implications of REACH on domestic chemicals management policies. Now that Congress is under Democratic leadership, some and perhaps many in Congress are likely to be more receptive to considering the application of REACH-type initiatives in the United States.

Lynn L. Bergeson is managing director of Bergeson & Campbell P.C., a Washington, D.C., law firm focusing on conventional and engineered nanoscale chemical, pesticide and other specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation and associated business issues. She is president of The Acta Group LLC and The Acta Group EU Ltd. with offices in Washington, D.C., and Manchester, U.K. She can be reached at 202-557-3800.
 
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