Dry Run for EU's Reach Program

The European Union's pending legislation on the registration, evaluation, and authorization of chemicals (REACH) is moving through the final stages of its formulation. Though the legislation is controversial, some version of REACH is expected to take effect in two years or so.

In the meantime, the European chemical industry and the governments of both the EU and its member states are starting to prepare for implementation of REACH. To do so, they are working together to test the workability of the registration of chemicals, to see how REACH might actually operate, and to identify solutions to any problems before the legislation is enacted. The European Commission--which is the EU's executive branch--several member states, and chemical companies recently conducted a pilot run of how chemicals will get registered under REACH.

The project, called the Strategic Partnership on REACH Testing (SPORT), is the brainchild of the European Chemical Industry Council, says Lena Perenius, director of REACH/chemicals policy for the industry association.

Perenius tells C&EN that this marks the first time pending legislation has been tested by the private sector in cooperation with national and EU governments. "We are breaking ground here," she says. According to the commission, participation in strategic partnerships such as SPORT is voluntary and will not lead to any legal consequences under current legislation for those involved.

SPORT is based on the October 2003 version of the REACH legislation. Work on the exercise began in September 2004 and concluded earlier this year. The results are now undergoing analysis.

In SPORT, chemical companies assembled the information they would need to register products under REACH. These packets, called registration dossiers, were provided to the commission, explain Perenius and an official at the EC's Directorate-General for Enterprise & Industry, who spoke with C&EN under the condition that he not be identified.

When REACH is implemented, the EC will set up an agency to review registration dossiers. But because that agency does not now exist, the EC provided initial review services for SPORT. The EC official says the commission, which acted primarily as an observer in the exercise, checked the dossiers only to verify that they were complete. It did not determine whether the information provided--including companies' plans to do toxicity testing of their chemical--was adequate, he adds.

That job fell, as it would under REACH, to EU member states.

In the exercise, the governments of one or two member states assessed the dossier for a chemical or category of substances and provided feedback on the quality of the submission, Perenius says. The member states also reviewed the type and number of tests planned by chemical companies. They could suggest more or different studies than those proposed by industry, the EC official says.

In addition to the dossiers, companies prepared safety data sheets for the SPORT chemicals and distributed them to their customers for comment, according to Perenius and the EC official. Under REACH, manufacturers and importers would have to ensure that end users of their products have sufficient safety data. 

PERENIUS SAYS SPORT was designed for diversity among chemicals and companies. "We wanted to test as many parameters as possible," she says, to "maximize the learning potential."

Some of the chemicals went through the exercise as a single substance for registration, while others were included under categories of related compounds lumped together in a single dossier. Some are intermediates used in the manufacture of other substances, whereas others are end products dispersed into the environment. Data were plentiful for some of the eight registration efforts and sparser for others, she says.

Companies participating in SPORT varied widely, too, with large and small EU producers, an importer, the European arm of U.S.-based Dow Chemical, and a consortium. Some of the registrations involved chemicals with a long supply chain, and others had a short one, Perenius says.

The EC official portrays SPORT as "a learning exercise" to understand more about the workability of REACH. The pilot run will help the EC identify areas in which it needs to provide guidance to companies when REACH comes into being, he adds.

Although SPORT demonstrates that the commission, member states, and industry can test-run pending legislation, the exercise had limitations, he continues. Companies were able to go through steps that, "to a certain degree, are consistent with REACH," the EC official says. He cautions, however, that these activities did not include everything needed to comply with the legislation. Plus, companies compiled the information in the absence of guidance and tools for preparing the dossiers, all while facing a tight deadline, a much briefer time than they would have under REACH, he says.

"It was an immense amount of work in a short time," Perenius acknowledges.

The exercise concluded earlier this year. The partners in the project are assembling the results of SPORT into a report they expect to unveil in July. They have pledged not to reveal the conclusions until the report is publicly released.

The SPORT report could influence the final shape of REACH. The European Parliament, which serves as the lower house of the EU legislature, is reviewing and amending the proposal this summer. The European Council, which is composed of ministers from national governments of the 25 EU member countries and functions as the upper house, is also studying REACH.

Perenius says that once the report is finalized, "we will have recommendations for the legislation" as well as for the development of EC guidance documents. SPORT, she says, "will have been a useful thing to have done."

TEST SUBJECTS

The chemicals covered in the exercise to try out the EU's pending chemical registration process varied from intermediates used to make other compounds to widely dispersed fragrances and surfactants