Ink producers and their suppliers in Europe gave a collective sigh of relief in November when the European Parliament voted in favor of changes to new European Union (EU) legislation on a controversial scheme on the safety of chemicals.
However, ink and other major downstream users of chemicals still face a difficult lobbying battle to ensure that the project called REACH (for registration, evaluation and authorization of the chemicals) does not cause serious damage to their businesses.
Without the alterations to the proposed legislation which have just been backed by the parliament, ink makers would have had to carry out some drastic reformulations of their products because of withdrawal of certain raw materials and intermediates. Nonetheless, the threat of shortages of ingredients still remains.
The ink sector is one of a number of downstream segments which could have been hit hard by proposed provisions in REACH for the registration of up to 30,000 chemicals with data based on safety tests of the substances. It would have been the expense of carrying out these tests and gathering the data from them which could have jeopardized the continued availability on some chemicals on the market, particularly those of small volumes and low margins. Producers would have stopped making them rather than undertake the extra cost of conducting safety trials.
In a first reading of the legislation, the European Parliament voted in favor of amendments which will simplify the registration procedure for substances with an annual output of one to 10 metric tons. Existing rather than new safety data will be able to be used, except for chemicals which are know to have serious health and safety risks.
Altogether 20,000 chemicals or two-thirds of the total covered by REACH could be exempted from the full testing and registration requirements. Even for many substances between 10 and 100 tons, some expensive tests will be waived.
Environmental groups sharply criticized the parliament for severely weakening REACH. The European Bureau for Consumer Organisations (BEUC) stated that many problematic chemicals would now not be assessed at all.
Furthermore, producers also won a concession from parliament that they would be able to combine together under a “one substance, one registration (OSOR)” system to make joint submissions on single substances so that registration costs can be shared.
There will also be a pre-registration procedure so that formulators will know which substances would be taken off the market well ahead of their actual withdrawal.
“People in inks and coatings sectors and their suppliers like pigment makers will be glad that the lobbying on the registration issue has met with some success,” said Robert Fischer, director of Eurocolour, which looks after the interests of manufacturers of pigments, dyes and colorants in Europe. “Because of the changes to the data requirements, registration will be easier – at least for small volume products. But there are still other difficulties to be sorted out.”
In an assessment of the implications of REACH before the debate in parliament, the management consultancy KPMG concluded that pigments were among the chemicals most likely to be seriously affected by the regulations. The plan would make the production of some inks more expensive since pigments can account for more than 30 percent of the total costs of inks, according to KPMG.
It warned that pigment makers themselves may have to reformulate their products because of the withdrawal of non-critical, low volume substances which were too costly to register. These withdrawals would have a much bigger impact on ink producers who would have to reformulate a much higher proportion of their products because of the disappearance of a relatively small number of pigments. In the flexible packaging sector, some ink producers may have to reformulate as much as a third of their inks, KPMG estimated.
The Swiss-based Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD), which represents pigment producers throughout the world, calculated that as many as 30 percent of dyes and organic pigments currently available on the European market would probably have to be withdrawn unless the REACH proposals were modified.
Both ink producers and pigment and other suppliers are now hoping that as a result of the latest votes in the parliament, these worse-case scenarios will not occur.
The EU’s legislature has two branches – the parliament and the Council of Ministers, representing the governments of the union’s 25 member states. The majority of the parliament generally takes a hard, anti-business line on environmental and safety matters while the Council of Ministers is usually more sympathetic to the needs of industry.
Now that the parliament has turned out to be less strict than anticipated on REACH, the council is expected to have more freedom to make further changes to the scheme which will make it even more acceptable to business.
The council is expected to vote on a common position on the legislation by the end of the year. The parliament will then vote on the council’s amendments, after which any differences will have to be thrashed out in a conciliation procedure.
“On some important issues which went against industry in the parliament, the majorities were smaller,” said one inks sector representative. “We are now hoping that the council will feel strong enough to back changes favored by industry in these areas.”
The chemical industry and its downstream customers are anticipating that the council will reject the parliament’s decision on the requirement that chemicals posing carcinogenic, mutagenic and reproduction toxic risks have to go through a special authorization procedure. The parliament decided that authorizations would be given only for five years, after which the permits would have to be renewed for another five years.
“Users of chemicals will not commit themselves to a substance in the knowledge that it might have to be taken off the market within five years,” said Mr. Fischer. “We would expect the council to take an approach which reflects a greater understanding of how industry works.”
The council may be less willing to support industry’s demands that the assessment of the risks of a substance in the authorization process should take into account the level of exposure to it. Nor is it likely to back the industry’s objection to being forced to switch to safer alternatives to potentially dangerous chemicals. “The problem with that is that the alternative can be far more expensive,” said one chemical industry executive.
Downstream users and some chemical producer organizations will also be lobbying the council on the issue of data sharing under the OSOR system after the parliament supported the provision of an opt-out for companies not wishing to participate in joint registrations of substances.
The opt-out clause is favored by the European Council of the Paint, Printing Ink and Artists’ Colours Industry (CEPE), which embraces the European Printing Ink Association (EuPIA), which represents ink makers. CEPE believes that the opt-out is necessary to protect intellectual property rights.
But opponents argue that a mandatory OSOR scheme is required if the registration costs of REACH are to be kept down.
Some critics argue that the opt-out merely gives advantages to the larger chemicals producers at the expense of downstream customers, particularly small- and medium-sized companies (SMEs).
“The simplified procedures for chemical registration introduce some welcome proportionality to REACH but the broad exemptions from the OSOR principle will compound the disadvantages faced by small businesses under REACH and represent a triumph for big chemical manufacturers,” said Hans-Werner Mueller, secretary of the European small and medium business association UEAPME. “All the evidence confirms that small businesses will be the real losers from a burdensome registration process, so it is regrettable that parliament has chosen to support such extensive opt-outs for data sharing.”
Before the parliament’s vote backing a simplified registration process, research showed that registration costs of substances could amount to as much as 20 percent of an average SME’s turnover. Compulsory data sharing would significantly reduce that cost, according to UEAPME.
Another issue bothering ink makers and their suppliers is the position of imports of finished articles from outside Europe. Many could contain chemicals which, if the products had been made in the EU, would have had to be registered under REACH. Parliament wants imported chemicals to be registered like those produced in the EU, but if they are part of finished articles, they would be exempted, unless they contain persistent bioaccumulative substances or ones with endocrine disrupting properties.
“We’re not happy with the solution adopted by parliament because it does not give enough protection to EU-based industries,” said Jacques Warnon, CEPE’s technical director. “Imported finished articles like packaging could contain non-registered chemicals, even potentially dangerous ones. This is unfair because similar articles in the EU would have been produced under more severe regulatory conditions.
“There is some good things in the parliament’s decisions and others not so good,” he added. “At least there is less danger that inks and coatings producers will have to reformulate their products. Probably around 80 percent of the regulations on REACH have now been fixed. The trouble is we don’t know how much of the other 20 percent will be changed to our satisfaction.”