The European Union (EU) is striving to reach consensus over a new system for updating ways of assessing the safety of chemicals.
Proposals put forward last year by the European Commission, the EU executive board, in a White Paper or consultation document have run into a barrage of criticism from the chemicals sector, its customers, end-users and environmentalists.
The ink and coatings industry has warned that its proposals could have a disastrous impact on downstream sectors like itself. Small ink makers would be burdened with the costs of having to test their own formulations to ensure that they are not prohibited from marketing them.
Far worse is the threat that chemical producers will stop manufacturing some key raw materials because of the high cost of testing them.
On the other hand, environmental groups have accused the commission of being too timid. “It has rolled over and allowed the chemical industry to tickle its tummy,” commented Michael Warhurst, safer chemicals campaigner at the Friends of the Earth, after the publication of the White Paper.
The EC has now set up seven working groups, six of which have representatives of ink and coatings producers, to consider the responses to its consultative document. It is hoping that the groups, which are due to report in the spring of 2002, will come up with recommendations for legislation which will win broad support.
However, the ink and coatings industry and other downstream sectors have to tread carefully. They will have to come up with their own ideas for a viable means of testing and evaluating substances and products which does not leave them isolated.
Improving the System
At the moment, practically everyone, including ink and coatings producers, agrees that the present system for registering and authorizing chemicals needs to be changed. But it will take a supreme effort to reconcile the differing views on what is the best way forward.
“The underlying concept to introduce a system of scientifically sound risk assessments is fully in line with (our) demands,” said Klaus Matthias, chairman of the safety, health and environment operating group of the European Council of the Paint, Printing Ink and Artists’ Colours Industry (CEPE). “However, the ultimate success of the new strategy will depend very much on how it will be put into practice.”
Under the White Paper’s proposals, the EU’s current dual system for monitoring new substances and ‘existing’ chemicals introduced to the market before September 1981 would be scrapped. Instead, the vast majority of eligible substances – all those with an annual production of more than one metric ton by a manufacturer – would be assessed under a single system.
At present, only new substances have to undergo detailed tests and risk assessments in a system which is so cumbersome that only 2,700 chemicals have been scrutinized since 1981, much lower than the number in the U.S. “The current notification system is overly bureaucratic and time consuming and thus hampers innovation,” said Mr. Matthias.
Of the thousands of chemicals already on the market, there is little data publicly available. “For only a very limited number (do) we have sufficient information about the risks they pose to human health and the environment,” said Margot Wallstroem, the EU’s environment commissioner.
The key feature of the new plan is the abolition of the distinction between new and existing substances. It also shifts much of the responsibility for preparing risk assessments from EU member states and the commission to producers and customers
“The ‘burden of proof’ needs to be reversed so that the producers, manufacturers and downstream users are responsible for proving the safety of the chemicals they want to place on the market,” Ms. Wallstroem said.
“Downstream users will be obliged to assess the safety of their products for that part of the life cycle to which they contribute,” she said.
REACH-ing OutThe system will comprise three steps – registration, evaluation and authorization of chemicals (REACH). Nearly 80 percent of 30,000 substances above the one ton per year output threshold, or nearly 24,000, will only have to be registered with basic information in a central data base.
Most of the remaining 20 percent, which are considered to carry a risk of long-term and chronic effects such as cancer, will have to be submitted to in-depth and tailor-made evaluations.
Specific authorization will have to be given to substances identified as being carcinogenic, mutagenic or toxic to reproductive organs (CMR) or as being persistent organic pollutants (POPS). These are likely to amount to a maximum 5 percent of the total, according to the commission.
The REACH project will be carried out in stages. The commission is suggesting that all substances will have to be assessed by 2012.
The European Parliament’s environment committee sent shock waves through the chemical industry in October when it voted in favor of substances below the one ton per year threshold being registered and also for an expansion of the categories of chemicals requiring authorization.
A few weeks later, the full parliament rejected most of the committee’s main demands. But it did support a recommendation by the committee that hazardous chemicals of “very high concern” be phased out by 2020 and substituted by safer alternatives.
More significantly for ink producers, it also decided that manufactured products containing chemicals above the one-ton threshold should be registered.
Chemical producers are still worried that the REACH program could weaken their international competitiveness and trigger trade conflicts.
The EC believes that the new system will put the EU at the forefront of global efforts to ensure the use of safer chemicals, and will increase the competitiveness of the EU chemical sector because it will force it to be more innovative.
Downstream Users ReactInk makers and other downstream manufacturers claim that the commission is too concerned about the attitude of chemical producers, especially major companies, to its REACH plan and not enough about the views of the chemical sector’s customers.
“A fundamental shortcoming of the White Paper is that its proposals are geared to large companies of the chemical industry producing single chemicals in big quantities,” Mr. Matthias told a recent CEPE press conference in Brussels.
“The structure of the downstream user industries is completely different,” he continued. “Many companies produce a large variety of different and highly specialized products, often in small volumes.”
CEPE estimates that its members, comprising 1,300 companies, use nearly 10,000 different raw materials, many of them in small quantities, to make millions of different products.
“A typical printing ink company, for example, used approximately 3,000 raw materials to formulate up to 30,000 individual products, each designed to meet a specific customer requirement,” said Mr. Matthias. “The White Paper does not take this situation into account and leaves many questions unanswered.”
One of these is the matter of intended use. The White Paper proposes that when registering products, chemical manufacturers should provide risk assessment data on the intended uses of substances. CEPE said it is asking too much of manufacturers to know all the thousands of different products in which their products are used.
“Downstream users do not necessarily want to publicize the use of a certain additive,” said Mr. Matthias. “In the highly competitive paint and printing ink market, a secret product formulation often represents the decisive advantage of a company over its competitors.”
Companies May LeavePerhaps the biggest anxiety about the REACH system among ink producers and their coatings counterparts is that chemical companies will stop producing important raw materials because they generate insufficient returns to cover the costs of collecting registration data.
“Chemical suppliers will be looking very closely at the costs of testing,” said Moira McMillan, director of the British Coatings Federation (BCF), which represents ink makers and paint producers. “A huge amount of testing and administrative work will be required to enable substances to be registered.”
Some large chemical companies are, in fact, warning that they might have to cut back their portfolio of products once the REACH system begins to operate.
“We have already started to consider how this will affect the economic viability of our products,” said Juergen Strube, chairman of BASF, a manufacturer of both ink and raw materials. BASF estimated that the new regulatory system could cost the company EUR 500 million ($445 million) over 10 years.
“It is clear that low production volume products in particular are unlikely to cover costs and would therefore become unprofitable for BASF,” Mr. Strube added.
Trade OrganizationsOne option for registering of low-volume products is for the testing work to be done by organizations such as trade associations. Organizations representing chemical and downstream producers are already involved in preparing data for risk assessments.
Under an eight-year-old regulation on the investigation of substances considered to be potentially dangerous, the EU has been investigating a priority list of 150 substances. CEPE has been collecting data on a third of these.
“Data collection is a very resource-intensive task,” said Jean Schroder, CEPE’s secretary general. “Therefore, CEPE advocates in meetings with the commission that the results of these risk assessments also be accepted for evaluation under the REACH system.”
Trade associations could become data collection agencies under REACH. This may not only solve a major problem for downstream users like ink makers, it might also give trade associations a new role in safety matters.