The European Union’s legislation on the registration, evaluation and authorization of chemicals, called
The two main arms of the EU’s legislature – the European Parliament and the Council of Ministers, representing the governments of the Union’s 25 member states – seemed a few months ago to be heading for deadlock over the controversial legislation.
But a compromise agreement was thrashed out in December behind closed doors by representatives of the parliament, council and the European Commission, the EU executive. This opened the way to the approval of the plan without the need for months of argument within the EU’s conciliation process for sorting out differences between the parliament and council.
However, the compromise deal will almost certainly cause additional problems for ink producers and their customers because of the threat that an even higher number of chemicals than expected will be withdrawn from the European market.
REACH will cover approximately 30,000 chemicals produced and imported into the EU in amounts of one metric ton or more a year, equivalent to nearly a third of the total number of chemicals available in Europe.
Around 5 to 10 percent of the chemicals or substances in the REACH plan are considered to be so dangerous that they will have to go through an authorization procedure, the outcome of which could be enforced substitution by safer alternatives.
As a result, ink makers could find that some key chemicals they use will no longer be available and that they will have to go through the costly exercise of reformulating some of their inks. The first substitutions could take place within a few years.
“Some chemical companies with products which will have to be authorized may want to start replacing them as soon as possible,” said Jacques Warnon, technical director at the European trade association for coatings (CEPE), which includes the European Printing Inks Association (EuPIA).
What has been excluded from the agreement between the parliament and EU governments could also be as significant as what has been included.
Ink companies had been hoping that the legislation would make clear that the main responsibility for gathering safety data for the registration of substances would rest with the chemical manufacturers. Registration of substances will have to include information on their uses as well as data on their chemical and other characteristics.
But the final version of REACH leaves enough loopholes for the chemical producers to be able to leave some of the work of collecting safety information on uses to their downstream customers.
Non-governmental organizations (NGOs) which have been campaigning for strict rules within REACH for the protection of health and the environment had been pressing for the inclusion of a Duty of Care concept in the legislation. This would have placed a legal obligation on chemical manufacturers to ensure that their products are used safely. It would have placed the main onus on the chemical companies to provide the necessary safety data.
Under the agreement, the Duty of Care principle has been placed in the recital to the legislation, which gives it far less legal strength than if it had been placed in the main text of the law.
The negotiators of the deal did, on the other hand, drop a proposal by the parliament’s environment committee that registration data for chemicals with a one- to 10-ton annual output should include detailed information on the assessment of risks to human health and the environment. The one- to 10-ton band is the one containing the majority of substances applied in the production of inks. Small- and medium-sized companies are strongly opposed to this demand because of the expense and time needed to collect the extra data.
The compromise was supported by the three main political groups in the parliament, accounting for three-quarters of the members. It was not backed by the environmentalist Greens. The final draft of REACH was approved in mid-December by an overwhelming majority of the 651 members, with only 98 voting against.
Within the Council of Ministers, the backing for the compromise version of the legislation was so strong that its approval by the government representatives has been a virtual formality.
The introduction of the legislation will be the culmination of eight years of discussions on the plan by EU officials, politicians, business leaders, NGOs and other interested parties.
REACH, whose primary objective is the improvement of health and the environment through increased knowledge of chemicals on the market, will replace more than 40 legal instruments covering chemicals with one single regulation.
“(It) will give the European Union the world’s most ambitious legislation on chemicals,” said Guido Sacconi, rapporteur on REACH in the parliament’s environment committee and one of the main instigators behind the compromise.
Although unhappy with some parts of the compromise deal, particularly those regarding authorization, the European chemical industry has committed itself to making the scheme work. “The industry will see REACH as an opportunity to demonstrate that companies have a solid knowledge of chemicals and strong product management practices to ensure chemical safety,” said Alain Perroy, director general of Cefic, the European Chemical Industry Council.
Organizations representing SMEs are especially critical of the final REACH text because small companies stand to be hit the hardest by the costs of complying with the legislation.
“The overall results for SMEs are quite disappointing,” said Guido Lena, environment policy director at UEAPME, one of Europe’s largest small company organizations “More could have been done to increase both competitiveness and competition in all business sector working with chemicals in Europe.”
SMRs are particularly displeased about the details of a system within REACH for the sharing of safety data – called One Substance, One Registration (OSOR) – which was drawn up to reduce costs for small companies. Large chemical producers, which tend to have the most safety data on individual substances, will be able to opt out of OSOR. The costs of OSOR programs will be shared equally among participants rather than on their sales.
Those most unhappy with the compromise have been the Greens and environmental NGOs, despite the agreement on a more restrictive system for authorizations and substitution of the most hazardous chemicals. The World Wildlife Fund (WWF) has called the compromise a “disgrace.”
Both the Greens and the NGOs can wield considerable political influence in Europe. Over the next few years, they should be able to take advantage of the opportunities offered by the REACH rules for chemicals arousing concern to be evaluated for authorization and hence possible substitution. This process will be carried out by the European Chemical Agency, a new body being set up to run REACH, although the final decisions on authorization and substitution will be taken by the Commission.
“The adoption of REACH is not the end of the story,” said Jim Murray, director of the European Consumers’ Organization (BEUC), one of the NGOs which has been pressing for a rigorous REACH. “What has been agreed must now be implemented properly and we will actively monitor the situation.”
Under REACH, chemicals needing possible substitution will be those categorized as being carcinogenic, mutagenic and toxic for reproduction (CMRs), persistent, bioaccumulative and toxic (PBTs) and very persistent and very bioaccumulative (vPvBs).
As a result of the compromise, use of these chemicals will only be allowed when safer and economical alternatives are not available. Adequate control will also have to be demonstrated to ensure the chemicals remain within approved safety thresholds.
Dangerous substances without safety thresholds will only be authorized if a social-economic analysis (SEA) shows that the benefits of their continued availability on the market outweighs the effects of a ban.
A key part of the deal is an obligation on applicants for authorizations to submit substitution plans giving details of how they hope to replace the chemicals with safer alternatives.
CEPE fears that a relatively large number of chemicals contained in existing inks and coatings formulations may ultimately be substituted.
“Several hundred chemicals used in inks and coatings may have to be replaced,” said Mr. Warnon. “This could be difficult for SMEs because they will need time to find alternatives which are less dangerous while they will require resources to do all the necessary testing of replacements.”
A large number of chemicals may also be taken off the market by producers who decide registration costs no longer make them commercially viable. The average expense of registering a substance in the one- to 10-ton range will be €20,000-€50,000 ($25,000-$60,000) and in the 10- to 100-ton range €240,000-€350,000 ($300,000-$440,000), according to figures from the German chemical industry association (VCI).
In a recent report, Frost & Sullivan, the market research organization, warned that a large proportion of the substances used in the manufacture of a typical ink may no longer be available because of REACH.
It stated that in the inkjet ink sector, the registration costs of the raw materials would account for nearly 5 percent of sales. An average reformulation would take a company 35 days, including time for the creation of a new recipe and its testing. The development of new formulations would need five to 10 staff per ink company, according to Frost & Sullivan.
One of the key issues for chemical producers and ink producers over the next few years will be how these registration costs will be shared out. Suppliers and users will have to work closely together to make sure the registration process operates smoothly.