Policy News - December 4, 2003

EU stands firm on chemical regulation overhaul

Legislation that radically overhauls chemical regulation in the European Union (EU) passed a big hurdle in late October, when it was approved by the European Commission (EC). However, before the program can go into effect, it must be approved by the European Parliament and Council, likely a two-year process, according to Robert Donkers, counselor for transportation, energy, and the environment at the EC’s office in Washington, D.C.

The legislation, which is based on the precautionary principle, shifts the burden from government to industry to prove that individual chemicals can be used safely before they are marketed. Introduced last spring (Environ. Sci. Technol. 2003, 37, 241A–242A), the bill eliminates the distinction between new and “existing” chemicals that were first marketed before 1981 and therefore have not been held to the same higher testing requirements as newer chemicals. Existing chemicals make up more than 99% of total volume currently on the European market, according to EC estimates.

Under the new Registration, Evaluation, and Authorization of Chemicals system, known as REACH, companies will be required to register in a central database all substances that they manufacture or import in volumes of one or more metric tons annually. A new government chemicals agency will manage the database. Information required for registration includes details on chemical properties and hazards, uses, and safe handling procedures. The EC estimates that for 80% of all registered substances, no further action will be required. But for substances of very high concern—including potentially carcinogenic, mutagenic, persistent, bioaccumulative, or reproductive toxicants—companies must seek government authorization for particular uses.

Because of intense opposition to the plan—in particular, from the United States—the EC opened the draft bill to an unprecedented two-month public Internet consultation last summer. More than 6000 comments were received. None of the stakeholders, however, is satisfied with the final bill. Environmentalists charge that the EC succumbed to industry and U.S. pressure, whereas the latter parties maintain that the new system is still too costly and bureaucratic to work.

In response to industry concerns, the EC agreed to reduce testing requirements and simplify registration procedures for low-volume chemicals, exclude polymers from registration, and not require downstream users to file chemical safety assessments. The EC claims that these changes will lower costs by 82% from what the previous draft would have required and estimates the total price tag of reach at €2.3–5.2 billion over 11 years. Conversely, the EC estimates the legislation’s health and environmental benefits to be €50 billion over a 30-year period.

Industry representatives on both sides of the Atlantic say that the changes have made the REACH program more realistic, but that they’re not enough. The American Chamber of Commerce to the EU stated that “there is still an excessive burden imposed, as well as exaggerated costs on industry, and an overwhelming amount of bureaucracy that will stifle innovation.” During an October 16 hearing in the U.S. Senate, testimony by U.S. state and commerce department officials was equally negative, portraying REACH as “ultimately unworkable”.

Industry’s primary concern centers on the authorization process, which requires companies to seek government authorization and provide data showing that specific uses of chemicals on the list can be “adequately controlled”. Joe Mayhew, vice president of regulatory policy for the trade group American Chemistry Council, says, “It’s a hazard-based procedure, and we think to really understand products and how they’re used, you’d have to use a risk-based procedure” and tailor the test data to use and exposure patterns.

Donkers concurs that the list is based on hazards. “If they’re carcinogenic or persistent, that’s a reason to single them out for the authorization procedure,” he says. But he maintains that the authorization procedure itself is risk-based, “because you’re taking use and exposure patterns into account, as well as socioeconomic effects.”

Joel Tickner, a research professor at the University of Massachusetts, points out that the U.S. Toxics Release Inventory is set up the same way. “If a chemical is on the list, you have to report your emissions, not the risk,” he says. Likewise, under the U.S. Toxic Substances Control Act, EPA requires companies to submit reporting and testing data on chemicals falling under certain categories.

Meanwhile, environmentalists decry the concessions in the current REACH proposal, but they maintain that the basic framework still exists. The U.S.-based Environmental Health Fund released a report in September documenting U.S. government meddling with EU efforts to reform its chemical policy and called for a congressional investigation.
For more information, go to http://europa.eu.int/comm/enterprise/chemicals/chempol/whitepaper/reach.htm. —KRIS CHRISTEN