European Chemicals Overhaul Reaches Legislative Stage

BRUSSELS, Belgium, October 29, 2003 (ENS) - The European Commission today delivered on its promise to propose a thorough overhaul of EU chemicals regulation, tabling draft legislation that would radically shift the burden of responsibility for assessing and managing chemical safety onto industry. Enterprise Commissioner Erkki Liikanen said the package representes the "biggest challenge so far in implementing the EU's sustainable development strategy."

The new regulations are known as REACH, which stands for Registration, Evaluation and Authorization of Chemicals.

"Striking a balance" was the watchword from the Commission as it formally proposed its EU REACH chemicals policy. Its attempt to reconcile business and environmental interests is about to be severely tested.

REACH is arguably the most significant piece of European environmental legislation for business in decades. In addition to the EU's estimated 34,000 chemical firms it will affect many manufacturing industries. Its effects will be felt around the world.

The Commission's bid to thread a middle way between ensuring high levels of protection for health and environment while keeping down costs to business has been the central theme in the debate leading up to Wednesday's proposed regulation. Neither industry nor Europe's environmental movement is happy with the result and both will exert strong pressure for change.

Chemical Works, Seal Sands, River Tees, Teesmouth, England (Photo by Ian Britton courtesy FreeFoto)

All these factors have given a powerful following wind to calls by certain EU governments, key European trading partners and European chemical and manufacturing companies for dilution of REACH's requirements. The Commission has already moved significantly towards these critics this autumn. Initial reactions suggest that their campaign for more "workability" and less bureaucracy will continue.

Set against this, the environmental movement claims that large loopholes have already been driven into the proposals. It will fight tooth and nail any further watering down of REACH's requirements while urging introduction of tougher chemical registration requirements and cast iron requirements for hazardous chemicals to be substituted by safer alternatives.

Despite the Commission's protestations, finding a compromise between the extra chemical tests REACH will require and minimization of laboratory animal testing also looks difficult to achieve.

Lurking in the background is the potential for trade tensions with EU partners. Many countries suspect the bloc of "green protectionism" and REACH has the potential to fuel these criticisms despite the Commission's insistence that there will be no discrimination against non-Europeans. Countries ranging from the United States to China have already expressed concerns over REACH.

The fundamentals of the reform remain similar to plans put forward in a February 2001 white paper, though the Commission made significant concessions to industry critics of the plan in September, when it excluded polymers and cut the need for downstream users and small volume producers of chemicals to produce safety reports when they register substances.

This has slashed the projected costs of the regulation by 80 percent, the EU executive claims, though business remains sceptical. On the other hand, Environment Commissioner Margot Wallstrom insisted at the regulation's launch that the changes would not diminish REACH's environmental benefits.

Environment Commissioner Margot Wallstrom (Photo courtesy European Commission)

Second, it is promising "strategic partnerships" with industry before the legislation is finally adopted to test how the REACH mechanisms will work in practice. EU industry association Cefic has argued for both initiatives but wanted them launched before REACH itself rather than in parallel.

It is far from certain how REACH will emerge from the legislative scrutiny that will now begin. Three key EU leaders recently launched a strong attack on the plans, albeit before last month's changes. Two weeks ago all 15 leaders called for a "comprehensive impact assessment" on REACH at their European Council of Ministers meeting.

And the draft law must also travel through the European Parliament, which will expand to include members from the ten accession countries and undergo elections while deliberating the plan. Up to now it has tended to back or strengthen the Commission's environment policy proposals. Whether its new MEPs will continue this trend is an open question.

In the European Parliament, Italian socialist MEP Guido Sacconi of the Environment Committee has already been chosen as rapporteur and thus the prime target for lobbying efforts from all sides. Sacconi wants the first reading completed by May, when the parliament suspends for elections.

Member of the European Parliament Italian socialist Guido Sacconi (Photo credit unknown)

The backbone of REACH will be a requirement for chemical manufacturers and importers to formally register all chemicals produced in volumes above one metric ton, according to a staged timetable lasting 11 years.

Some of these substances will then be evaluated and if necessary subject to controls. The most hazardous will be authorized for market access only if industry convinces authorities that they can be used safely in particular applications.

The main driver behind the revolution is the slow progress made over the last 10 years in assessing around 140 priority chemicals deemed potentially risky for health and the environment. The Commission also wants to spur innovation by relaxing regulatory hurdles for novel chemicals compared with the current system.

How REACH Will Work

Manufacturers and importers of chemicals will have to register all substances they want to market. They will have three years after the regulation enters into force for substances produced in volumes above 1,000 metric tons per producer, and for any carcinogenic, mutagenic or reprotoxic (CMR) substance over one ton.

They will have six years to register after the regulation enters into force for volumes between 100 and 1,000 tons, and 11 years for volumes from one to 100 tons.

Registration dossiers must provide information on the intrinsic properties and hazards of substances, plus the uses that have been identified.

In addition, for substances produced in volumes over 10 tons firms will have to draft a chemical safety report including a risk assessment. These substances comprise only a third of the 30,000 substances that REACH will cover, but the vast bulk of market tonnage.

Registration will be overseen by a new EU chemicals agency. The agency will then share responsibility with member state authorities in evaluating the registration dossiers for completeness, demanding extra data from industry if necessary. It will then decide whether the sum total of information justifies further action.

Substances which are clearly shown by the evaluation to pose unacceptable risks will be banned or restricted through a fast-track process governed by the European Commission.

Those chemicals revealed to have very hazardous properties - that is, those which are CMRs, persistent bioaccumulative and toxic, or very persistent and very bioaccumulative - will need special authorization before use. So will some other chemicals such as endocrine disrupters. Around 1,500 chemicals already known to have these properties will require immediate authorization.

Wilton International petrochemicals complex, UK (Photo FreeFoto)

If the firm says a substance cannot be adequately controlled, authorities will weigh the socioeconomic benefits of the chemical against the risks its poses, including a consideration of whether less dangerous chemicals might be substituted. The Commission will then decide whether to authorize the substance or not.

Strong early reactions emerged today immediately after publication of the European Commission's draft REACH proposals. Nongovernmental organizations on one side of the debate and industry organizations on the other were quick to welcome the plan as "an important step" in European chemicals policy but also eager to highlight its shortcomings.

The environmental group Greenpeace UK accused the Commission of putting "the interests of the chemical industry ahead of public health and the environment."

Greenpeace was particularly critical of provisions allowing hazardous substances to continue to be produced under "adequate control" conditions. Oliver Knowles, Greenpeace Toxics Campaigner, said, "Unless REACH specifically requires dangerous chemicals to be substituted with safer alternatives, then this legislation will do nothing to protect either human health or the environment."

Knowles called on Members of the European Parliament (MEPs) and national governments to close loopholes that will allow the production of harmful chemicals to continue."

REACH currently contains a loophole that means even if a safer alternative is available, at a comparable price, production of a "chemical of very high concern" - those chemicals that can cause cancer, damage genetic material, interfere with the body's hormone system or is a reproductive toxin - can continue as long as the producer can demonstrate "adequate control." However, "adequate control" is based on an acceptable level of risk from this exposure.

Knowles said, "There is no need whatsoever to take the enormous risks associated with dangerous chemicals when a safer substitute exists. The idea of "adequate control" is a complete anomaly because there is simply no way to effectively control these hazardous substances."

While welcoming the publication of the draft law, which it says should enable society to reduce the risk to wildlife and humans from harmful chemicals by identifying and phasing out some of the worst ones, WWF, the conservationi organization, believes that the European Commission has weakened the policy as a result of "persistent and misleading lobbying from the chemicals industry."

WWF called for more information to be made available on the production, use and safety of chemicals. The organization urged ministers and MEPs to increase information requirements for the two-thirds of the 30,000 chemicals on the EU market that - being produced in quantities under 10 tons - will have lighter registration requirements.

A cloud of chemical pesticide is sprayed on dwarf fruit trees near Lake Constance, Germany. (Photo courtesy Living Lakes)

Imported chemicals should meet the same safety standards as those produced within the European Union, said the WWF, otherwise imported goods could lead to the exposure of wildlife and consumers to chemicals with unknown hazards.

MEPs in the Greens/EFA group said they regretted that the draft had been "undermined [by] bullying and blackmail" on the part of industry and member states. They pledged to work hard in the European Parliament to ensure that higher data requirements and tougher substitution rules be added to the proposal.

Most industry associations limited their comments to a cautious welcome of the proposals and a pledge to cooperate with the EU institutions to bring them to completion. Europe's chemical industry association, Cefic, reiterated its position that the plan must "strike a balance between protection of human health and environment, and the competitiveness of the European industry."

Associations representing European small and medium enterprises voiced "regret" at the belated commissioning of an extended impact assessment on the costs and impacts of REACH.

The Union of Industrial and Employers' Confederations of Europe said the REACH system will "impact negatively on the flexibility of the production system" and put "confidentiality aspects at risk."

Echoing the position of some EU member states and of large sections of industry throughout the consultation period, UK Conservative MEPs warned of the danger that the EU's leading chemical companies "may be forced out of Europe" by the new rules.

Retail and wholesale organisation EuroCommerce insisted that the system "must be manageable, enforceable and should not constitute barriers to trade."

The organization representing U.S. companies in the European Union, AmCham EU, complained in a statement of "still an excessive burden imposed as well as exaggerated costs on industry." The mandatory data sharing rules contained in the proposal "will not be workable," it said.

{Published in cooperation with ENDS Environment Daily, Europe's choice for environmental news. Environmental Data Services Ltd, London. Email: envdaily@ends.co.uk}