Industry has argued that many of the provisions in the Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach), would lead to huge costs and harm their competitiveness.
Yesterday the EU's Council of Ministers made further amendments in their favour. These include the relaxation of an amendment adopted last month by the European Parliament requiring companies to substitute hazardous chemicals with safer alternatives whenever possible.
The deal by EU government ministers rejecting mandatory substitution could lead to a showdown between governments and European Parliamentary members next year, when the bill is due to go back to MEPs for further debate.
In the main Germany, Poland and Ireland advocated pro-industry concerns, while Luxembourg, Denmark and Sweden want tighter environmental rules.
Under the European Council amendment removing the mandatory substitution clause, the new European regulator created by the law will 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 - commonly used in packaging and cosmetics formulation, are used with "adequate control" and to suggest potential alternatives.
The ministers representing the EU's member governments also voted to drastically reduce safety data that chemical producers would be obliged to supply. However they attempted to balance this by boosting information-sharing obligations for big firms. The changes would limit them from opting out from the one substance one registration (OSOR) principle under the rules.
OSOR requires companies to collaborate and share information on their testing with other firms so that costs are not duplicated. The rule is meant to help smaller firms.
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.
Günter Verheugen, the European Commission vice-president responsible for enterprise and industry policy, said the administrative body supported the changes.
"The Council’s agreement is a reasonable compromise," he said yesterday. "We have succeeded in making Reach more effective and more workable. And we have succeeded in maintaining the competitiveness of EU industry and – a crucial point- reducing the burden for small and medium-sized companies.”
However consumer groups say this change would lead to thousands of chemicals remaining in use in the market without adequate health safety information being available.
Greenpeace, the environmental advocacy group, said the changes leaves the door open for hazardous substances and potential carcinogens to stay in use on the market. These include the phthalate DEHP and hormone-disrupting substances such as bisphenol A. Both chemicals are used for food packaging.
The European Consumers Organisation (BEUC) also said the Council's decision was a further victory for industry in watering down the aims of the regulation in protecting human health and the environment.
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 cosmetics and cosmetic ingredients sectors, and to reduce requirements on safety testing.
"The Council succeeded in making things even worse than the European Parliament by weakening the registration of chemicals, the substitution principle and foreseeing even less information available for consumers," said Jim Murray, BEUC's director.
Reach would require a wide array of businesses to test and register the chemicals used in their processes, products and packaging to ensure their safety to humans and the environment.
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 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.
The regulator will also play an important role also in the evaluation and authorisation of substances. In its current form Reach will require manufacturers and importers to gather comprehensive information on properties of their substances produced or imported in volumes over one tonne per year and to submit the necessary information to demonstrate their safe use in a registration dossier to the agency.
A failure to register will mean the substance cannot be manufactured or imported to the EU market.
Industry will also be required to gain use-specific authorisations for chemicals that cause cancer, mutations or reproduction problems, or that accumulate in humans and in the environment.
Authorisation will be granted only to companies that can show that the risks are adequately controlled or if social and economic benefits outweigh the risks and suitable alternative substances do not exist. This measure will encourage substitution of unsafe substances by safer ones, Verheugen said.
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.
While new chemicals have to be tested, there are no systematic provisions for the existing substances. Consequently, in volume terms, safety information is sketchy for around 99 per cent of these existing chemicals, Verheugen stated.
"As national competent authorities are responsible for the risk assessment of new chemicals, the process is slow, cumbersome and resource-intensive," he stated in a press release yesterday. "For example, since 1993, 140 high-volume chemicals have been singled out for risk assessment, of which only a very limited number have completed the process. In addition, the existing system discourages the introduction of new and possibly safer chemicals – thereby giving no incentives for innovation."
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.
Other compromises reached in the package will reduce the amount of information that producers need to supply on chemicals produced in quantities between one to ten tonnes. A number of tests on chemicals in the ten to 100 tonne categories originally proposed by the Commission were scrapped.
The deal also allows countries to waive certain data requirement if suppliers can provide ‘adequate justification'. Under another amendment made by parliament, the European Commission will be required to adopt guidelines on what ‘adequate justification' will mean within 18 months of Reach coming into force.
MEPs also voted to strengthen the authorisation procedures for Reach, introducing stringent guidelines on substituting dangerous chemicals for safer ones.
Yesterday Greenpeace called for the restoration of the chemical substitution clause.
"After four years of Reach being watered down under chemical industry pressure, putting into practice a strong substitution obligation is the most important opportunity left to address the growing toxic chemical contamination and to ensure that human health and the environment are given the necessary protection," the group stated.