After marathon talks, the EU's three lawmaking bodies - Parliament, Council and Commission - came to a compromise agreement on the draft REACH regulation on 30 November 2006.
The proposal, called REACH - Registration, Evaluation and Authorisation of CHemicals - will ensure that importers and producers of chemicals provide at least basic health and safety testing for their products. It will replace some 40 legislative texts with a single regulation.
Issues:
A compromise deal on the proposed REACH regulation was adopted by Parliament on 13 December with 529 votes in favour, 98 against and 24 abstentions.
The package will now be forwarded to the EU Council of Ministers for final approval on 18 December 2006 in what will be a formal rubber-stamping exercise.
The new rules, which will come into effect from June 2007, will require importers and manufacturers of chemicals to provide health and safety data for some 30,000 substances currently used in everyday products. These range from plastics used in computers and mobile phones to substances used in textiles, paints, furniture, toys and cleaning products.
All must be registered over an 11-year period within a new chemicals agency to be set up in Helsinki. The registration process will begin with the most toxic chemicals as well as those marketed in higher volumes.
Details of the compromise were unveiled on 1 December by Guido Sacconi, the Parliament's chief negotiator on REACH. Central to the agreement is the replacement of the most toxic substances with safer alternatives (EurActiv 4/12/06). If one exists at reasonable cost, dangerous substances will have to be replaced. If not, companies will need to produce either a substitution plan or an R&D plan to replace them at a later stage.
Despite warnings by environmental groups that the bill has been severely watered down after industry lobbying, MEPs managed to keep the fundamental part of the text intact - the reversal of the burden of proof from authorities to businesses.
"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," said Chris Davies, environment spokesperson for the liberal democrats (ALDE).
Positions:
The European Chemicals Industry Council (CEFIC) acknowledged the efforts made by EU institutions to arrive at a compromise acceptable to all stakeholders - industry, downstream chemical users and environmentalists.
"The challenge during the legislative period has been to ensure the workability of the legislation, so that it can deliver real improvements," said CEFIC Director-General Alain Perroy. However, he regretted the "unnecessary requirements added to the authorisation element of REACH" relating to the substitution of dangerous substances.
"It will clearly add to costs," said Perroy who denounced the "illusion" that substitution could be governed by a "command and control approach". The end result will be "legal uncertainty" for business and, consequently, reduced investments and innovation, Perroy warned.
CEFIC said that efforts should now focus on implementing the new rules. Perroy called on EU institutions "to continue developing the technical guidance and instruments needed to secure the successful implementation of REACH. In this context, it will be of paramount importance to establish an efficient and cost-effective agency".
Small-business organisations said that they appreciated efforts made to ease the bureaucratic burden for SMEs by cutting down on safety assessments for substances produced in smaller quantities. But overall, small business organisation UEAPME said the result is "quite disappointing."
"The issues of data sharing and data liberalisation have been sidelined during the debate, and legal certainty on cost sharing is left to future guidelines. More could have been done," said Guido Lena, environmental policy director at UEAPME.
The European trade union confederation (ETUC) said that it welcomed progress made on the management of chemical risks, but condemned "the chemical industry's seven-year lobbying campaign to get the European institutions to scale down the reform".
In particular, ETUC said that information vital to protecting workers' health in chemical safety reports "will now only be required for a third of the chemicals originally planned."
ETUC however welcomed that the burden of proof is now firmly placed on producers to prove that their products are safe. "That marks clear progress, because industry will now have to provide information on the safety of their chemicals before they can put them on the market," said Joel Decaillon of ETUC.
Environmental organisations were doubtful about the compromise. On the positive side, Greenpeace and the WWF welcomed:
* The fact that companies will now be responsible to prove the safety of chemicals produced or imported in large volumes (above 10 tonnes a year);
* that there is a mechanism to replace persistent and bioaccumulative chemicals if safer alternatives exist, and;
* that the public is allowed to request information about the presence of chemicals in products.
But on the negative side, they pointed to "major loopholes". These include:
* Less stringent safety requirements for carcinogens and chemicals which can cause birth defects and reproductive illnesses;
* substances imported in low volumes (below ten tonnes per year) for which "no meaningful safety data" will be required, and;
* provisions relative to 'high-concern' chemicals that will still be allowed onto the market if producers can prove that they can be "adequately controlled" when a "safe threshold" can be defined where their detection is considered as posing no threat to human health.
"The approach of adequate control - and safe thresholds - is premised on a risky gamble, given the unknown effects of chemicals in combination, on vulnerable hormone functions, and on the development of children from the earliest stages of life," the organisations said.
Ultimately, they say a lot will depend on the new chemicals agency to be set up in Helsinki, Finland. "The new EU Chemicals Agency in Helsinki will have to be closely monitored to ensure that REACH can deliver," WWF said. "Without the necessary support, hazardous chemicals will continue to contaminate wildlife, our homes and our bodies, and REACH will prove a failure."
http://www.euractiv.com/en/environment//article-160456
