Chemical law up for final vote in EU parliament
compromise legislationregulating the use of chemicals throughout
the bloc, despite opposition from consumer groups over the watering
down of the measures.
EU governments and legislators came to the compromise over the proposed Registration, Evaluation and Authorisation of Chemicals (REACH) lawon 30 November, ending years of bickering over about balancing health and environmental issues with industry's fears that the legislation would stifle business through excessive red tape.
In the main the 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.
Industry and environmentalists have argued fiercely over the cost of the new control measures,the increase in animal testing required and whether the Commission's 'substitution principle' shouldbe introduced, requiring chemicals of very high concern to be taken off the market if saferalternatives exist.
The proposals agreed upon and up for vote tomorrow represents a considerable watering downof the legislation as originally conceived by the European Commission, which in October 2003published a draft law intended to ensure that the 30,000 chemicals in daily use present no long termrisks to human health or the environment.
Under the final compromise, to be put to all members of the European Parliament on 13 December, the 1,500 chemicals considered the most harmful will be refused authorisation if safer alternatives exist. However, a new amendment will allow some substances to be approved if producers show that they can be adequately controlled.
The Commission's proposals were made in response to concerns about the general lack of scientificknowledge relating to 99 per cent of chemicals currently on the market. The Commission estimatesthat about 100,000 substances were placed on the market before 1981, and did not undergo stringenthealth and safety tests. Such tests became mandatory for chemicals introduced for use from 1981.
The European Consumers' Organisation (BEUC), labelled the compromise agreement as a sell out toindustry.
"In discussions on REACH with the Council and Commission, the negotiators for the European Parliament, under intense pressure from national governments, have given away toomuch," BEUC said in a statement. "In particular, the negotiators have conceded that some carcinogenic, mutagenic and reprotoxic substances and endocrine disruptors will still be put in consumer products even when safer substances exist, provided they are subject to 'adequate' control. The only adequate form of control for such substances is substitution when possible."
BEUC is calling on legislators to change the compromise back to a tougher policy.
"Allowing the use of these substances subject to adequate control is bad regulation that will be expensive and almost impossible to enforce in an effective,consistent and coherent way," the coaliation of national consumer groups stated.
If Parliament votes in favour of the agreed upon compromise the law will then be forwarded to theEU Council of Ministers on 18 December for a formal approval.
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 offthe 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 giveemphasis to developing safer alternatives to chemicals of very high concern.
Instead of national authorities having to justify concern about particular chemicals, theresponsibility 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 andthe need to provide better protection for human health and the environment from chemicals withunknown long term effects," he said. "More than 17,000 chemicals produced in verysmall quantities will not have to undergo rigorous examination, but hazardous products will besubjected to greater control than ever before."
Under the agreement hormone disruptors, persistent, bioaccumulative and toxic substances as wellas "very persistent and bioaccumulative" chemicals will not be authorised for use ifsuitable 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 if they identify alternatives that are safer and available atan economic cost.
Chemicals of high concern will normally be authorised for use if their effects can be 'adequatelycontrolled'. Some 17,000 chemicals of low priority will now be excluded from onerous testingrequirements, 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 avoidduplication of tests with the sharing of animal testing data becomes mandatory."
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 itsprovisions.
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).
