The controversial Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) bill, which would require 30,000 chemicals produced or imported in the EU to be registered with a central agency in Helsinki, has been under fire from both inside and outside Europe.
One of the most vocal opponents has been US ambassador to the EU Boyden Gray who has questioned the EU's ability to monitor all the chemicals and substances that are sold in commerce.
In a joint statement with diplomatic missions from twelve more countries, including Brazil, India, Japan, Singapore and Australia, the US raised fears about "REACH's workability, its potential effects on international trade, and the opacity of the regulatory process and implementation preparations."
Of particular concern is the impact of REACH on SMEs (small and medium-size enterprises), an issue close to the heart of many developing countries.
"Registration and notification of substances embedded in articles when no potential risks have yet been identified could cause many entities including numerous SMEs from developing countries to forego the EU market without corresponding environmental benefit," their statement warned.
"Creation of a candidate list not informed by risk considerations could easily be misinterpreted by the wider public without providing additional value to regulators."
A mandatory substitution measure proposed by the European Parliament that would require companies to replace dangerous substances with safe ones when alternatives are available has also been criticised on the grounds that mandatory substitution or across-the-board uniform time limits would cause unnecessary market disruptions without clear environmental benefits.
The ambassadors ask the EU to use the second reading in Parliament to address the "problematic aspects" of the legislation.
That reading is scheduled to take place in October 2006, when several remaining disputes will have to be resolved.
In December 2005 the European Council removed the mandatory substitution clause the Parliament had approved in its first reading, setting the stage for a showdown later this year.
While REACH was designed to protect citizens from the adverse effects of chemicals found in a wide range of products like paint, detergents, cars and computers, one of its unintended consequences may be to make the cost of pharmaceutical raw materials higher.
The European Commission now expects that the final decision on REACH will be made by the European Parliament and Council in autumn 2006 and anticipates the regulation to come into force during spring 2007.
Since it will take about a year for the regulator to be operational, the Commission expects the law's requirements to be applied from 2008 onwards.