US and others protest EU's draft chemicals law

The US along with 12 other countries have issued a joint press statement calling for drastic changes to the proposed legislation, known as the Registration, Evaluation and Authorisation of Chemicals (Reach), arguing that the measures would harm developing countries and small businesses trading in the EU.

Underlying the appeal is the threat that the US and others will take action at the WTO level to block the legislation once it is approved.

Last week the US Mission to the European Union published a joint press release which it said also represented the positions of Australia, Brazil, Chile, India, Israel, Japan, Korea, Malaysia, Mexico, Singapore, South Africa and Thailand.

The countries called for the EU to use the second reading in Parliament to address the problems associated with the proposal. Specifically, they want a more risk-based authorization process for chemicals used in their products.

"Moves to require mandatory substitution or across the board uniform time limits would cause unnecessary market disruptions without clear environmental benefits,"​ the countries stated in the press release.

They also called for a review to remove what they see as "unnecessary overlaps and inconsistencies", and perhaps changing the scope of the authorisation and registration process.

They claim that everyday bulk commodities such as ores and ore concentrates are already adequately covered by existing EU workplace and environmental protection legislation.

The countries also raised questions about the environmental value of certain registration and notification requirements under a new regulatory agency to be created under Reach. They claim the requirements may end up "causing disparities between EU and non-EU businesses", a code phrase used to say Reach may unfairly disadvantage foreign companies, especially small and medium sized enterprises (SMEs).

"For example, many countries questioned the environmental value of registering reacted monomers in polymers when the low-risk polymers have no registration requirements,"​ the press release stated. "Such monomer registrations would not provide the agency with relevant risk data for the final polymer since the reacted monomers could no longer exhibit their original characteristics. The concern expressed about the disparity between EU polymer producers and polymer importers was in relation to the description 'by an actor up the supply chain'. 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."​

They suggest the legislation could be improved by bringing it into line with existing international regulatory efforts such as accepting test data developed under OECD guidelines and other international bodies.

The EU's Council of Ministers approved the draft text for Reach in December 2005. The draft legislation has now been sent back to the EU Parliament for a second reading, which is scheduled to take place in October this year.

The legislation relates to chemicals introduced before 1981 when a more rigorous evaluation and testing of such substances became compulsory in the EU. The legislation would bring such chemicals under regulatory control and make manufacturers perform the tests and seek regulatory approval. They would also have to substitute a chemical that has been rejected with an approved one.

Under its original form Reach would have required health and environmental safety checks on about 30,000 chemical substances out of the 100,000 estimated to be currently in use for daily household and industrial products.

Under an European Council amendment, the mandatory substitution clause was removed. The new European regulator created by the law would have to grant an authorisation under an "adequate control" procedure, even if safer alternatives are available.

Companies will have to replace about 200 of the most toxic substances with safer alternatives. Companies would also have to show that about 1,500 less hazardous substances, such as phthalates, are used with "adequate control" and to suggest potential alternatives.

The ministers also cut clauses that would have required firms to follow basic safety rules for chemicals outside the scope of Reach and to disclose safety data to consumers.

Consumer groups say the changes would lead to thousands of chemicals remaining in use in the market without adequate health safety information being available.

In the first reading of the controversial bill last month the European Parliament amended the Commission's original proposals to exclude certain industries, including the food and food ingredients sectors, and to reduce requirements on safety testing.

However some packaging chemicals used by the industry might still be caught up in legislation.

The new legislation will reverse the burden of proof for the testing and risk assessment of chemicals from the authorities to the companies themselves. The legislation, in effect, transfers the costs and responsibility of testing chemical substances to industry.

The European Commission first adopted the Reach in October 2003 as a means of forging a new policy to replace the current dual system for assessing risks of "existing" and new chemical substances.

The law will replace 40 existing legal acts and create a single system for all chemical substances in the EU. It will introduce a new regulatory body, the European Chemicals Agency, which will manage the registration of substances, through the setting up of a database.

A failure to register will mean the substance cannot be manufactured or imported to the EU market.

The Commission argues that Reach will improve the current EU chemicals legislation, which distinguishes between so-called "existing" and "new" chemicals.

All chemicals that were put on the market before 1981 are called "existing" chemicals. They amount to around 100,000. Chemicals introduced after 1981, numbering around 4,300, are called "new" chemicals.

The Commission expects that the final decision on Reach will be made by the European Parliament and Council in autumn 2006. The Commission expects 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.