The agreement on the proposed Registration, Evaluation and Authorisation of Chemicals (REACH) lawends years of dispute between concerns about balancing health and environmental issues withindustry's fears that the legislation would stifle business through excessive red tape.
The proposals agreed on yesterday represents a considerable watering down of the legislation asoriginally conceived by the European Commission, which in October 2003 published a draft law intended to ensure that the 30,000 chemicals in dailyuse present no long term risks to human health or the environment.
Industry and environmentalists have since argued fiercely over the cost of the new control regimes, the increase in animal testing required and whether the'substitution principle' should be introduced, requiring chemicals of very high concern to be taken off the market if safer alternatives exist.
Under the new agreement between the European Parliament and the Council of Ministers, persistent, bio-accumulative and toxic chemicals, plus hormone
disrupters, will now have to be taken off the market if suitable alternatives are available.
Chris Davies, a British Liberal member of the European Parliament who helped negotiate thecompromise text, said legislators have sent a clear message to industry that companies must give emphasis todeveloping safer alternatives to chemicals of very high concern.
Instead of national authorities having to justify concern about particular chemicals, the responsibility for proving that their products are safe will now rest
with the manufacturers, he said.
"We have struck a balance between the commercial interests of the chemicals industry and the need to provide better protection for human health and theenvironment from chemicals with unknown long term effects," he said. "More than 17,000chemicals produced in very small quantities will not have to undergo rigorous examination, but hazardous products will be subjected to greater control thanever before."
Under the agreement hormone disruptors, persistent, bioaccumulative and toxic substances as well as"very persistent and bioaccumulative" chemicals will not be authorised for use if suitable and safer alternatives exist.
Manufacturers of about 1,500 chemicals of high concern will be required to submit a substitution plan when they apply for authorisation ifthey identify alternatives that are safer and available at an economic cost.
Chemicals of high concern will normally be authorised for use if their effects can be 'adequately controlled'.Some 17,000 chemicals of low priority will now be excluded from onerous testing requirements,originally proposed, Davies said.
"It is now an objective of Reach to replace, refine and reduce animal testing,"he said. "The text promotes the validation of non-animal testing methods and seeks to avoid duplication of tests with the sharing of animal testing data becomesmandatory."
Parliament and Council, the EU's two highest decision making bodies, plan to review the scope ofReach after five years to determine whether any more substances should be excluded from its provisions.
The legislation will mainly affect the food industry by targeting the chemicals used in thepackaging for their products. Currently the EU relies on a negative list to regulate the use ofchemicals. This means any chemical not on the European Food Safety Authority (EFSA) blacklist cannormally be used for packaging food.
Current EU regulation requires that all food packaging materials shall be manufactured incompliance with what the law defines as "good manufacturing practice" (GMP).
Davies expects that the three main groups in the European Parliament - EPP, Socialists and Liberals -will unite to support the package which will be voted in the body's session this month.