Chemical industry braced for fresh battle over testing

Date: 05/07/01

By Laurence Frost

AS THE riot shields came out at Göteborg last month, the dust had already begun to settle on another struggle: the failed attempt by European chemical companies to water down the sweeping new policy review proposed earlier in the year.

But the strength of EU leaders' endorsement of the Chemicals White Paper has provoked renewed activity in the camps. The €400-billion industry and the European Commission are heading for a fresh showdown over the form and content of the first wave of legislation, due to be unveiled by the end of 2001.

Industry is warning of the damage that could be done by excessive regulation. Some point to another chemistry-based sector, pharmaceuticals, where tighter research requirements in Europe have coincided with falling world market share. "The new policies will certainly have an impact on competitiveness," says Uta Jensen-Korte, head of product regulation at the European Chemical Industry Council (CEFIC). "The legal environment was uncertain [in pharmaceuticals] - that's led some companies to build their research facilities in the US and Japan, where the climate is better."

The Commission's strategy set out to respond to growing public concern that far too little is known about most chemical substances. Environmental organisation Greenpeace has fronted the campaign to force firms to research and explain their products' effects on health and the environment. "Most of the chemicals on the market are untested," says Wytze van der Naald, a Greenpeace International campaigner. "At the moment it's up to governments or the general public to come up with the proof that a certain chemical can be dangerous. In future the industry should be able to show that a substance isn't hazardous before it can be marketed - there needs to be a reversal of the burden of proof."

Such a reversal is exactly what the new policy envisages. Tabled jointly by Environment Commissioner Margot Wallström and her industry counterpart, Erkki Liikanen, it places the onus firmly on industry to organise and fund the testing of around 30,000 chemicals that were introduced before 1981, when EU testing rules were first imposed for new products. These still account for 99% of susbstances currently sold in significant quantities.

The White Paper also gives the Union executive the authority to supervise further evaluation of high-volume chemicals, and sets out a strict authorisation process for some 1,350 'substances of high concern'. The latter group includes those strongly suspected of causing cancer (carcinogenic), birth defects (mutogenic) and fertility problems (repro-toxic). Companies will in future have to prove that chemicals from this category are safe, or stop producing them.

A series of four deadlines is laid down for the basic information about properties to be handed over. The first is in 2005 for the estimated 2,600 chemicals of which more than 1,000 tonnes are sold every year. The other deadlines are: 2008 for volumes between 100-1,000 tonnes; 2012 for 10-100 tonnes and 2018 for 1-10 tonnes.

The Commission predicts that for 80% of all chemicals produced only these basic data sets will be required, covering physical, chemical and toxic properties as well as a 'preliminary risk assessment'. It estimates the cost to industry at €2.1 billion.

CEFIC puts the figure much higher. Jensen-Korte believes the testing will cost €7-10 billion and use up to 13 million research animals. The discrepancy, she explains, results partly from the EU executive's failure to account for industrial chemicals that are not marketed as final products.

But industry's main worry is that it will be unable to meet its deadlines. Although sanctions are not dealt with explicitly in the White Paper, officials confirm that the failure to hand in data on time would result in a ban on marketing the substance. Once registration information for a high-volume chemical had been submitted by the 2005 deadline, a firm would have another five years to conduct further analyses. But with hundreds, if not thousands, of chemicals to test for dozens of different properties, companies say they face an impossible task. "If you have to do thorough tests for carcinogenicity, for example, it can take three to five years to get a good result," says Jensen-Korte.

Europe's top firms have begun taking stock of the challenge. For Wim Jetten, leader of the regulatory strategy team at Dow Europe, the problem appears simple. "The [laboratory] capacity is simply not there to get all this testing done," he says. "Our current view is that if these deadlines were applied, we couldn't meet them - products might even have to be dropped."

Since Dow makes around 10% of the high-volume chemicals affected by the legislation, Jetten says, the company could be facing a testing bill of up to €200-300 million. But the Dow strategist is confident the EU executive will back down rather than see widespread failure to meet its deadlines. "The Commission will think twice," Jetten explains. "We're not just talking about the credibility of the industry but the credibility of the authorities."

That view is echoed by UK MEP David Bowe, who is drafting the Socialists' position on the White Paper. "It's going to produce lots of data that's not much use to anybody," says Bowe. "It will take so long and be so expensive that it's not going to get to what we really want, which is to eliminate chemicals that are a serious concern." Wallström's department remains dismissive of industry's preoccupation with deadlines. "They always say that," says one Commission source. "These chemicals have been on the market for more than 20 years - they've had some time to collect information on them. They haven't even tried."

But as work starts on the legislation - including the extension of the Commission's watchdog, the European Chemical Bureau - tensions are bound to resurface within the Union executive. Liikanen's officials are seeking to limit the damage by taking control of risk management, traditionally the preserve of Wallström's department.

Environment officials believe chemical companies are now caught in a paradoxical position. "They can't now come back with thousands of substances which they suspect may cause cancer and will need further tests," the same source says. "Under current legislation any [such] substances should have been tested already - that's the law."

Green campaigners agree the firms are having their bluff called. "According to industry, they already did a lot of testing before they put chemicals on the market," says van der Naald. "They claim to have a lot of information - so let's see it."

Van der Naald believes the process will cast new light on the health effects of the unregulated chemicals released in large volumes into the environment over recent decades. "At the same time we've seen lots of diseases on the rise - cancers, endometriosis, falling sperm counts," he says. "There are a lot of health indicators that show there's something wrong. Basically what we know is only the tip of the iceberg."

Dow's Wim Jetten maintains that his company keeps detailed information on all of its products' properties, which is the basis for the safety notices issued to users. And the data itself? "That's confidential," he says, adding that it would be of little use to the public. "These are toxicologial reports which are even difficult for an average chemist to read."

However complex and complete Dow's information, there is clearly room for doubt over whether any of its products could turn out to be cancer-causing. "I don't think there are any, but you never know," says Jetten. "With some chemicals it's only after some time that you become fully aware of their properties."

But as far as CEFIC's Uta Jensen-Korte is concerned, to focus purely on the chemicals and their properties is to miss the big picture. "People's lifespans have increased considerably in the past 50 years," she says. "This is largely due to better hygiene, better chemicals and pharmaceuticals."

The message from industry is clear: over-zealous regulation might damage its ability to deliver more of the same.

Major feature on the Chemicals White Paper.