The regulation, called Registration, Evaluation and Authorisation of Chemicals (REACH), transfers the burden of proof regarding testing and evaluation of the risks of chemicals from regulators to industry. Businesses will now need to prove the safety of thousands of chemicals previously not regulated by the bloc.
For the first time about 100,000 substances placed on the market before 1981 will have to be approved and registered with a newly created regulator. These are chemicals that did not have to undergo health and safety tests, which became mandatory in the EU for the 3,000 substances introduced for use from 1981.
For more hazardous substances, producers will have to submit a substitution plan to replace them with safer alternatives. When no alternative exists, producers will have to present a research plan aimed at finding one.
In the main the unified law would affect processors by applying to the chemicals used for making packaging. However it could also apply to cleaning chemicals and other substances used in plants. Workers unions have said the regulation is an important step forward in making manufacturing plants a more healthier environment for their members.
Business industry associations said the law would in some cases leave downstream users scrambling to find alternative suppliers for the chemicals used in their manufacturing operations.
"This will generate an additional burden for chemical producers and downstream users alike," the Confederation of European Business (UNICE), the European Association of Metals, The European Engineering Industries Association (Orgalime) and the European Chemical Industry Council said in a joint statement."It will equally affect the supply of raw materials for different sectors of EU industry, and this without any clear benefit for the end consumer."
This is because producers would be required to submit a plan for all substances that can be substituted with a suitable alternative, even if they are adequately controlled, said Orgalime secretary general, Adrian Harris.
"Substitution not only requires time, but does not automatically represent the best option in terms of safety, functionality or overall environment performance of a product," he said. "Besides, we yet have to be convinced that the provisions on substances in articles will be enforceable and workable in practice. Also, information communication obligations for article manufacturers have been extended. This risks multiplying existing communication obligations whilst causing confusion among consumers."
Reach also includes obligations of duty of care for the industry and of communication to the public about dangerous substances in products. It also includes safeguards for confidential information and provisions to avoid duplication of animal testing.
REACH replaces 40 legislative texts with a single single system regulated by a single EU Chemicals Agency, to be based in Helsinki, which will be responsible for the registration and authorisation process.
The authorisation process will initiall cover about 3,000 substances considered more risky than the rest. The agency will be responsible for authorising them and the producers will have to present either replacement proposals or research plans to develop alternatives. The authorisation will be for a limited time period.
Reach was approved in Parliament with 529 votes in favour, 98 against and 24 abstentions. Following expected passage through the European Council later this month, REACH is due to enter into force progressively from 1 June 2007.
The European Trade Union Confederation (ETUC) said it welcomes the REACH regulation's passage, but criticised the success of the chemical industry in restricting its scope.
"The law as adopted puts the burden of proof firmly on producers for the 30 000 substances covered by the reform," the association stated. "But the ETUC can only condemn the chemical industry's 7-year lobbying campaign to get the European institutions to scale down the reform. More specifically, European trade unions take issue with the fact that information vital to protecting workers' health given in the chemical safety reports will now only be required for a third of the chemicals originally planned."
Some 17,000 chemicals of low priority will now be excluded from onerous testing requirements, as originally proposed.