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US, 12 other countries call for improvements to proposed EU initiative

BRUSSELS, Belgium - 06/16/06 - The US has reservations about the European Union's (EU's) proposed regulatory framework for the trade in chemical substances.

According to US Ambassador to the EU C. Boyden Gray, Washington has "serious concerns" about the workability of REACH - the EU's proposed system for registration, evaluation and authorization of chemicals - and its potentially disruptive effect on international trade.

REACH, says the EU, is intended "to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry."

The proposed initiative is also aimed at giving "greater responsibility to industry" to manage chemical risks and hazard communication. In addition, it would create a new European Chemicals Agency to administer the new regulatory system.

The US has joined with Australia, Brazil, Chile, India, Israel, Japan, Korea, Malaysia, Mexico, Singapore, South Africa, and Thailand in calling on the EU to seek more input from interested parties, especially those outside the EU, and review the legislation with a eye toward eliminating unnecessary overlaps and inconsistencies, and revisit the scope of proposed chemical authorizations and registrations.

Those EU trading partners have expressed concern that some provisions of REACH "would cause unnecessary market disruptions without clear environmental benefits" and have urged the EU to consider harmonizing REACH's requirements with existing international regulatory efforts, including the acceptance of test data developed under guidelines issued by Organization for Economic Co-operation and Development.

In addition, REACH could hinder development in low-income countries and possibly render EU markets inaccessible to exports from developing countries, the EU trading partners said in a joint statement issued last week.

The EU, Gray feels, needs to increase the transparency of its regulatory process. "I believe the more open the legislative and regulatory process is, the better the product will be," he said.

Specifically, the US ambassador is calling for using risk and environmental impact assessments to develop policy rather than justify decisions already made; opening European Council deliberations to the public; and allowing all interested parties to review official texts, rather than force them to rely on leaked documents.

In addition, making proposed changes completely public and regularly inviting trading partners and international organizations involved in chemical management to speak at conferences and hearings of EU institutions are also critical, he said.

Asserting that "no government has the resources to monitor all chemicals and substances that are sold in commerce," Gray said that "a scientific risk-based approach to chemical registration and authorization is crucial" and urged the EU to incorporate that approach into REACH.

Gray cited the agreement reached in Dubai in February as evidence of international support for this approach.

Under the Strategic Approach to International Chemicals Management, negotiators at the United Nations International Conference on Chemicals Management agreed to a voluntary global strategy for safely managing chemicals.

The agreement, the culmination of three years of talks, was designed to protect people and the environment from the potentially harmful effects of chemicals.

The ambassador also expressed concern over the potentially chilling effects REACH could have on development of new chemicals and chemical products. "When the associated costs of compliance become too high, and the market too unsure, valuable products will not be developed," he said.

The European Commission in Brussels has said it anticipates final adoption of REACH by the end of 2006. That would allow it to come into force around April 2007.

Under that timetable, the new agency to administer REACH would have to be fully operational by April 2008.

Gray made his comments at a recent event in Brussels, Belgium, organized by the American Chamber of Commerce to the EU.

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