Under pressure from industry and politicians, the European Commission has watered down its proposals for a new regulatory framework on chemicals and their downstream uses.
However, for ink and coatings producers and many other manufacturing sectors, including the chemical industry itself, the Commission, which is the European Union’s executive, needs to do far more to make its plan acceptable to them.
As a result, the project, called REACH for the registration, evaluation and authorization of chemicals, will continue to be the center of considerable controversy both inside and outside Europe through to its scheduled approval in the next two to three years.
During the period of its implementation, which will be over 10 years, it is likely to continue to arouse hostility, particularly in countries outside Europe. The U.S. government has been severely criticizing the scheme on the grounds that it will be a barrier to trade, while the American Chemistry Council (ACC) has described it as “regulatory colonialism” and “more complicated than a Rubik’s cube.”
For downstream formulators of chemicals like ink, REACH could substantially raise costs, lead to shortages of raw materials and make their products more vulnerable to competition from imports.
“The Commission has been listening to us, so the final draft of the REACH legislation is an improvement on previous drafts,” said Jacques Warnon, technical director of the European Council of the Paint, Printing Ink and Artists’ Colour Industry (CEPE). “But there are still a number of outstanding issues to be resolved. The glass is only half full.”
Among the major concessions made by the Commission is that chemical producers will have to provide less data than previously planned for the registration of their products.
Under the plan, approximately 30,000 chemicals of an annual output of more than one metric ton will have to be registered.
“Five main types of information will be required (for registration) – properties, intended uses, likely exposure scenarios, potential risks to human health and the environment and how these risks are to be managed,” said Margot Wallstroem, EU commissioner for the environment.
The Commission has backed down from a previous demand that chemical manufacturers would have to provide detailed safety assessment of their products which would have necessitated new tests of many substances. Instead, chemical producers and importers registering substances should be able to use information already available or generated by computer simulating testing.
The amount of data to be registered will be linked to the volume of output. Thus, less information would be needed for substances of less than 10 tons a year than for bulkier products.
In addition, chemicals with a low production volume will have a registration deadline of as long as 11 years.
Polymers will be exempted altogether from the registration or evaluation process, meaning that most resins in inks should be excluded.
Ink Industry Concerns
The major worry of ink companies has been that the data requirements for registration would be so expensive that suppliers would withdraw their products from the market.
The ink sector is particularly vulnerable to high testing costs because of the large number of low-volume substances in its products. CEPE has calculated that a typical printing ink company uses approximately 3,000 raw materials to formulate up to 30,000 individual products.
The European Commission estimates that as a result of the simplification of data requirements for registration, the total costs to industry will be approximately 80 percent lower than previously expected. The costs to downstream users would be at the most E5.2 billion ($6 billion) over 11 years, it calculated.
The Commission also claims that only about 1 percent to 2 percent of substances currently on the market will be withdrawn. This figure, together with the Commission’s estimates on costs to industry, is disputed by CEPE and by the European Chemical Industry Council (Cefic), to which it has close links.
The ink sector feels there is now less of a possibility that a high number of low-volume ingredients for their products will stop being produced.
“There should be less of an impact than feared on the availability of chemicals with a low output,” said Mr. Warnon. “But withdrawals could still be a problem and ink makers could have to go through an expensive and time-consuming process of reformulating their products.”
“We don’t agree with the Commission’s estimate that production of only 1 percent to 2 percent of substances will stop,” he added. “It is likely to be more than 5 percent and could still be as high as 20 percent or more. It is something that is difficult to calculate and needs to be investigated further.”
One major concession by the Commission has been the abandoning of the idea of Chemical Safety Reports (CSRs) which would carry details of a “duty of care” for individual substances and would have to be passed down the supply chain. A product containing 25 different substances would have to be accompanied by 25 different CSRs.
Instead, the Commission has decided that information about chemical hazards, risks and risk reduction measures will be incorporated into the existing system of safety data sheets.
Nonetheless, the expense of registration and dissemination of additional information will almost certainly push up prices of many chemicals, which could have an effect down the chain.
“Higher prices seem almost inevitable,” said Mr. Warnon. “In some cases, customers of chemical producers may even have to contribute toward the cost of testing substances for registration.”
The increased costs will hit EU-based manufacturers of inks rather than importers of foreign-made inks, most of whom will not be burdened by any registration expenditure.
The Commission makes a distinction between articles containing chemicals of an intended and unintended release. An ink cartridge for an electronic printer would be an example of an article with a substance for an intended release. The ink, whether made inside or outside Europe, would have to be registered if it was considered to be potentially dangerous.
With an ink with an unintended release, such as ink on packaging, the importer will have to notify the European Chemicals Agency, which will be responsible for registration of chemicals, of this possibility. The agency may then decide registration is necessary.
“Importers of articles with inks will be getting more favorable treatment than EU producers of inks,” said Mr. Warnon. “All the chemicals EU ink makers use will have to be registered while that will not be the case for the chemicals in the inks being imported.”
EU ink manufacturers are also worried they could have difficulties with some of the 5,000 to 6,000 chemicals which the Commission believes will have to go through a further evaluation process after registration. Those which can cause cancer, mutations or are toxic to reproduction (CMRs) or are persistent, bio-accumulative or toxic (PBT) in the environment will have to be authorized individually. Others with potential hazards could have their uses restricted and could even be banned from use in inks.
The registration of substances will be for specific uses. So ink makers will have to rely on their suppliers to register chemicals for use in the production of particular types of inks. There could be problems when an ink company wants to switch a chemical to a use not given in the registration data.
“(The user) has to wait with his new use until it is registered by the supplier,” explained Juergen Strube, president of Union of Industrial and Employers’ Confederations of Europe (UNICE) and chairman of the supervisory board at BASF, one of Europe’s leading ink producers.
“If the supplier himself is not the registrant, the request goes up the supply chain,” he continued. “The data-gathering and the registration again might take time. During all this process, the new use cannot start. Yet success in innovation critically depends on the capacity to take swift technical and commercial initiatives.”
The chemical and downstream user sectors continue to remain deeply skeptical about whether REACH is workable. They also doubt whether it will achieve its main objective of providing greater protection to human health and safety and to the environment.
“Although the Commission has made a number of important corrections to its chemicals policy, the financial and bureaucratic cost to our industry is still too high,” Juergen Hambrecht, chairman of BASF’s management board, told a recent press conference in London. “Neither do we see the legislation providing any significant benefit to the environment or to consumers.”
Utz-Hellmuth Felcht, chairman of Degussa, a major supplier of inorganic pigments to the inks sector, said that the bureaucracy inherent in the REACH system and possible duplication with other EU safety regulations needs to be reduced if the scheme is to be cost-efficient.
There also needs to be clarification on whether REACH is compatible with the rules of the World Trade Organization (WTO).
The draft legislation on REACH will now go through a lengthy procedure of debate and approval by both the European Parliament and the Council of Ministers, representing the governments of the EU’s 15 member states, which is scheduled to be increased to 25 next year.
A key issue will be the impact on the international competitiveness of EU industry. But environmentalists will also be lobbying to keep the REACH proposals intact or even to make them tougher.
The chemical industry and ink and coatings manufacturers and other customers will also now have to mount a strong public campaign to ensure that REACH is made economically viable and does not become disastrous for the EU’s manufacturing sector.