Chemicals Policy Reaches out

While it is true all 25 European Union member countries will face common challenges in making the REACH system work successfully, it is also undeniable that the 10 new members will have to simultaneously address a number of particular difficulties and disadvantages in preparing for and implementing REACH.” So observed Martin Seychell, head of the chemicals directorate of the Malta Standards Authority, part of that country’s Ministry for Competition & Communications.

Seychell was one of the speakers at the Conference on the New European Chemicals Policy within the Enlarged Union, held last month in Vienna. The conference was hosted by the European Commission, the administrative arm of the EU, in cooperation with the Austrian Ministry of Agriculture, Forestry, Environment & Water Management and the Austrian Environmental Office. It was also promoted by the European Chemical Industry Council (CEFIC).

REACH-the system for Registration, Evaluation & Authorization of Chemicals-is one of the most attention-consuming sets of laws currently facing the EU. The law’s rationale is to supersede the plethora of chemical registration plans that exist in the different EU member countries by bringing regulation into one program. Introduced in a discussion paper early in 2001, the law was prepared in draft form by the EC a year ago and then submitted to the European Council of Ministers and the European Parliament for discussion and amendment.

Legislative work on REACH has been temporarily suspended while the Parliament-newly elected this summer-is occupied by interviewing candidates for commissioners, who take up their posts in November for five-year terms. As interviews with commissioner appointees wrapped up earlier this month, the three candidates whose directorates touch upon REACH-Markos Kyprianou, commissioner-designate for health and consumer protection; Günter Verheugen, for enterprise and industry; and Stavros Dimas, for environment-each promised to support REACH.

Completion of the first reading of the draft proposal in the Parliament is not envisaged this year, many delegates at the conference agreed, but is expected early next year. Despite the delays, the EC and the national regulatory agencies that address chemicals are hard at work on REACH’s implementation. And the magic words that kept occurring at the conference echo the Boy and Girl Scout motto: “Be Prepared.”

“The successful implementation of REACH requires a simultaneous effort by public authorities and by industry,” Seychell said. “In Malta, we are convinced that it is the degree of preparedness that will make the difference as to whether REACH translates into a burden or an opportunity.”

The new member countries face considerable disadvantages in adopting REACH, he agreed, but on the other hand, they may have an advantage or two as well. “In a sense, REACH could not have come at a better time,” Seychell explained. “Unlike what happened during the adoption of the acquis communitaire”-the massive collection of EU laws and regulations that the new members had to transpose into their own legal systems-“we are no longer trying to catch up with the other member countries. REACH will require changes from all parties, and it may well be that the attitude in the new countries is more favorable to accepting change.”

He was supported by Semira Mehíc, a chemical inspector with Slovenia’s National Chemicals Bureau (NCB), who added that she could see problems with resources that the new member countries will face. Her bureau deals with both legislation and enforcement for a variety of products: biocides, plant protection chemicals, and dangerous products.

“We are in the final phase of the EU transposition process, with implementation in progress. This took a great deal of time and human resources,” she pointed out. “It has been a gradual inclusion in the ongoing integration into the EU. This is complex, and we have little experience-and no practical experience. NCB was chosen as the authority that will be responsible for REACH, based on existing national infrastructure. But we have only 25 people, including technical support,” with little prospect of that number being significantly increased.

“We are in the final phase of the EU transposition process, with implementation in progress. This took a great deal of time and human resources,” she pointed out. “It has been a gradual inclusion in the ongoing integration into the EU. This is complex, and we have little experience-and no practical experience. NCB was chosen as the authority that will be responsible for REACH, based on existing national infrastructure. But we have only 25 people, including technical support,” with little prospect of that number being significantly increased.

THAT IS ONE REASON, she added, that her bureau supports a strong European Chemicals Agency (ECA) to coordinate all national REACH activities.

Jerzy Majka, head of the Bureau for Chemical Substances & Preparations in Poland’s Ministry of Health, agreed that the early work-transposing EU laws into national systems-was extremely challenging to everyone concerned.

After Poland’s 1991 application to enter the EU, Majka said, the country “heard seven years of silence. But we began in 1993 to work in cooperation with Sweden’s chemical regulatory authorities” on a regulatory scheme. “By 1998, regulations came into force in Poland that enabled the Ministry of Health to require data sheets and similar registration materials. These were a total shock to people-‘What is our stupid government doing now?’ they asked.”

But the result, he noted, was that industry began coming to grips with EU-compliant regulations. It quickly became clear, he said, that REACH would become one of the most important issues for the competent authorities-those agencies responsible for implementing it.

Majka sees a need for changes to REACH, as now proposed, to “make it more friendly for small to medium-sized enterprises and for companies with less expertise, as they would be able to rely on the experience of larger enterprises, particularly with the costs of development of the necessary information.”

Poland will support involvement of ECA in preparing guidance for sharing data, he said. “We support a stronger agency, although we recognize the political problems,” since national authorities would have to cede some power.

Majka also mentioned the “OSOR” proposal, which emerged this summer from the U.K. and Hungary and calls for “one substance, one registration.” This proposal “is most important for us,” agreed Karel Bláha, a chemical regulator in the Department of Environmental Risks in Prague’s Ministry of Environment.

The proposal aims to make registration more effective and less expensive by avoiding repetition of testing by numerous companies, adjusting rules for submitting core data, and dealing with potential future registrants. Bláha said his agency’s analysis is that it could save $150,000 per substance being registered.

The U.K. and Hungarian delegations had proposed their OSOR plan to the EC’s Competitiveness Council this spring. Country delegations found the concept interesting but problematic, and requested the two countries come back after a rethink. Accordingly, in July, the U.K. and Hungary sent a revised proposal to the Competitiveness Council.

“One substance, one registration,” the proposal argues, “will be good for business, minimizing overall costs and bureaucracy, and encouraging transparency; good for human health and the environment, creating consistency and high standards across Europe; and good for animal welfare, avoiding duplication of animal testing.”

The U.K.’s Department for Environment, Food & Rural Affairs (DEFRA) estimated that the total direct cost to EU industry of a system with complete data sharing would be roughly $4.2 billion, compared with more than $13 billion resulting from only 25% data sharing.

According to a spokeswoman for DEFRA, “We will seek the inclusion of as many elements of OSOR as possible during the Dutch presidency as, after this, the council will move on to other aspects of REACH.”

Bláha pointed out that the original proposal called for mandatory company sharing of all data required for registration, but that this has been modified to call for only “core data”-primarily that of hazards, rather than exposure, usage, and so on.

“THE VALUE of the data is not commercial-it is necessary for the next step of risk management,” he noted, but added that there “must then be some concept of recompense for those generating the data, with creation of an ombudsman for possible disputable cases, for new data or new chemicals in particular.”

The Association of Chemical Industry of the Czech Republic has agreed to take part in a study supported by the EC and by industry, which is represented by CEFIC and the EU-wide employers’ federation UNICE, Bláha said. And other studies, including an impact assessment on branches of the Czech economy that will be affected by REACH-including automobiles, textiles, and paper-are planned or under way.

Some of the studies will be carried out as SPORT-Strategic Partnership on REACH Testing-exercises. This program was developed by CEFIC, which maintains its secretariat, along with national authorities and the EC (C&EN, July 19, page 6). These projects test the workability of REACH and identify solutions where problems are found.

The exercises will involve manufacturers and importers as well as downstream users, and they will be facilitated by independent consultants, explained Thomas Jostmann, CEFIC director responsible for the SPORT program. They will supplement work that the EC itself is supervising through its REACH Implementation Projects (RIPs).

On Sept. 15, the SPORT steering group decided on nine projects and put together registration dossiers. Among them are the investigation of methanesulfonyl chloride, in a team led by Atofina and French authorities; disodium 4,5-dihydroxy-benzene-1,3-disulfonate, led by Fuji and Finnish and Dutch authorities; and a category of propylene glycol n-butyl ethers, led by Dow Chemical and Swedish and French authorities.

Jostmann was one of few industry representatives at the Vienna conference. And for the chemical industry, it was a relatively stern audience. Most of the delegates represented regulatory authorities in the new countries or were from environmental groups such as the World Wildlife Fund (WWF) International and the Regional Environmental Center, giving the conference a decidedly “green” atmosphere.

For these delegates, the question about REACH was not “if” but “When?” and “How much?”

Josef Pröll, Austria’s minister for agriculture, forestry, environment, and water management, opened the conference, reflecting Austria’s geopolitically pivotal role in Central Europe. He addressed the frequent complaint about the costs of REACH: “Current legislation is not for free. The baseline for calculating additional costs of REACH is compliance with current legislation.

“If the EU member countries would fully comply with existing chemical legislation, the gap between existing legislation and REACH would be narrowed down dramatically,” he argued.

Pröll also contended that potential benefits of the REACH system are being increasingly demonstrated with substitution of high-risk chemicals by innovative products and technologies.

In fact, “REACH is good for industry,” agreed Michael Warhurst, director for EU toxics policy in the European policy office of WWF. “The environmental benefits of REACH are currently ignored, but clearly these will be significant,” he said, ticking some off. “There will be new markets for safer and more environmentally friendly products. It will be easier for new products being introduced, as the need for new, safer products encourages R&D. It will be a more predictable regulatory system, which will enable better planning by companies. It will reduce risks of liability. And it will help restore trust in the industry,” he argued.

"THE ECONOMY is flexible-if there are restrictions, people do other things,” he added.

Eva Csobod, a director of the Hungarian branch of the Regional Environmental Center, near Budapest, agreed that a successful REACH program will help restore a chemical industry image that is badly battered. “What we need is ‘green’ chemistry for healthy markets with safer chemicals,” she said. “REACH will improve knowledge and confidence of the public in chemicals.”

Her organization’s position, she noted, is that REACH should resolve problems with regulations, data gaps, and poor safety data of chemicals. “Now that we are part of the EU, we can participate in discussions on REACH, to enable national dialogue and public awareness.” In fact, she added, “we are proud that old and new countries can work together-for example, the U.K.-Hungarian proposal.”

One of the points that the U.K.-Hungarian OSOR proposal acknowledged was the potential problem of language in the operation of REACH.

And language is not a theoretical problem, Poland’s Majka pointed out. “It is a saving of time if you have standard phrases,” he conceded. “But you must remember, languages have different structure. We need to try to develop standard phrases, particularly for, say, risk and safety. If you just use a computer program, it is a tragedy. For example, since May, we have had EU phrases for pesticide registrations. I don’t know who did the translations, but in Polish, they are not understandable,” he complained. “REACH is a very complicated legislation, so any proposal to simplify it will be very welcome.”

Simplification, through amendments to the draft REACH plan, will be the responsibility of the European Council of Ministers and the Parliament. The EC, on the other hand, is concerned with making the plan work.

The EC sent to the conference specialists from two directorates-Eva Sandberg, chemical policy specialist at the Environment Directorate, and Elina Karhu, in the Enterprise Directorate-to report on the commission’s work to ready national authorities for REACH.

As Sandberg pointed out, an interim strategy has already started, based on a three-phase timeline: an interim period that began last November and runs to March 2006; a transition period from April 2006 to September 2007, when current legislation is repealed; and the operational period from October 2007 onward, by which time ECA will be functioning.

“The interim phase provides a framework for arriving at a balance between implementation of current legislation and preparing for REACH,” she said. “We just can’t sit and do nothing.” REACH, Sandberg pointed out, will be a regulation, coming into effect 20 days after publication in the official EU journal.

The EC is funding six categories of RIPs, with subprojects, she explained. The six categories cover process description of how the system functions; informatics; guidance documents and training material to assist industry in preparing for REACH; guidance and procedures on technical and administrative issues, such as dossier evaluation; transformation of current structures to those needed for the new legislation; and development of administrative routines and organizational structures for ECA.

“All these RIPs are out for tender,” Sandberg said. In fact, Jostmann said, CEFIC is bidding to conduct three projects: two regarding guidance of chemical safety reports and one regarding guidance on information requirements.

Karhu described the registration dossiers and enhanced safety data sheets that will supersede the current safety data sheet requirements. “Manufacturers and importers already have current obligations to comply with restrictions on manufacturing and use, on classifications and labeling of substances, so there is no reason just to sit and wait,” she emphasized.

“REACH places some new obligations on industry, that is clear,” she said, so companies have time to do the preparatory work. “Check what are the obligations. Start data assessment-generate this in time. Strengthen communication with suppliers and customers. Are consortiums a good option? If so, find partners. Unpreparedness will have a heavy cost,” she cautioned. “Prepare now to eliminate those costs.”

Malta’s Seychell added: “No one is ready for REACH, although some are in a better position than others. REACH will happen-it’s time to be preparing.”