Reach provides global model for chemicals regulation, experts say

Trend setting

28 May 2010 11:44  [Source: ICB]

Speakers at the Helsinki Chemicals Forum discussed whether Europe's Reach legislation could provide a global model for regulation

EUROPE'S REACH chemical legislation is expected to lead to further convergence of global regulations, according to speakers at the Helsinki Chemicals Forum.

 The Finnish Fair Corporation/HCF 2010

"Reach provides a window of opportunity for more convergence in the coming years," stated Antonio Preto, head of the cabinet of Antonio Tajani, European Commissioner for industry and entrepreneurship.

Several countries, including the US, are reviewing their chemical strategies, Preto said. "I invite our partners to take advantage of what we have learned."

It is too soon, however, to start talking about introducing a globally binding agreement, speakers agreed. First, Reach needs to function properly in Europe, said Kaj Madsen, a senior program officer at the chemical branch at the United Nations Environment Programme (UNEP).

Although chemical legislation in developed countries is starting to become more harmonized, development of a global system would take decades, said Madsen.

Convergence in legislation covering chemical risk assessment and management is likely to take place in developed countries and the emerging BRIC economies of Brazil, Russia, India and China, but the process would take much longer in developing countries, he said.

"For a global system, you would need everybody on board," he told ICIS on the sidelines of the conference, which took place on May 20-21. "Developing countries could take years to converge towards such a system. It could take 30, 40 or 50 years."

Harmonizing chemical legislation in developing countries would be extremely complicated because of variations in government structures, scientific knowledge and financial support, for example, Madsen added.

Lena Perenius, executive director of the European Chemical Industry Council's (Cefic) product stewardship program and member of the International Council of Chemical Associations (ICCA) chemical policy and health leadership group, agreed that a "one size fits all" strategy would not be workable in the short term.

"Globally we have different strong points," she said. "I don't think the Reach blueprint can just be circulated."

The Reach legislation is complex and ambitious, particularly for small and medium-sized enterprises, observed Hubert Mandery, Cefic's director general. If a global harmonization of chemicals regulation did happen, "it would be unlikely to be on the ambitious level of Reach," he said. "Something more pragmatic would be required."

Reach is already making a global impact, said Geert Dancet, executive director of the European Chemicals Agency (ECHA), which is implementing the legislation. "We are noticing an ever increasing interest in Reach across the industrialized world and emerging economies."

About half of North America's chemical industry is already implementing Reach, because it is exporting into the EU, he noted.

ECHA, based in Helsinki, is in discussions with countries including the US and Canada about sharing ideas and information. Earlier in May, it signed an agreement with Canada on the sharing of information on chemical management. Dancet said the agreement would allow the exchange of non-confidential information between ECHA and Environment Canada, Canada's environmental protection agency.

ECHA is also discussing an information sharing agreement with the US, where the Environmental Protection Agency (EPA) is seeking a reform of the US Toxic Substances Control Act (TSCA). "We are very excited about the dialogue we are having with ECHA," said Jim Jones, deputy assistant administrator at the US EPA.

A key problem with the current US legislation is that it does not mandate the EPA to determine the safety of existing chemicals, he said. There are also difficult legal and procedural hurdles to limit or ban them. "There is wide stakeholder agreement on the need to reform TSCA," Jones told the delegates.

With many experts regarding Reach as a potential global trendsetter, all eyes will be on Europe to see whether it can implement the legislation successfully. "Reach is not business as usual. It is a highly ambitious project," insisted Preto. "We are all still getting to grips with it."


The European Chemicals Agency (ECHA) plans to give companies extra time to add information to incomplete registration dossiers.

Companies currently have four months to add the missing information and resubmit their registration dossiers, and only one chance to do so. But this could be extended to six months from October 1, 2010, ECHA executive director Geert Dancet told ICIS on the sidelines of ECHA's fourth stakeholder day in Helsinki on May 19.

The additional two months will provide more time for those substance exchange information forums (SIEFs) that are making slow progress to finalize their registration dossiers, he explained. SIEFs bring together companies registering the same substance.

Reach regulations state that substances that are manufactured or imported into the EU in quantities of more than 1,000 tonnes/year, and hazardous substances, must be registered by November 30, 2010. ECHA expects to receive about 5,000 substance registrations by this date.

The Agency is encouraging the lead registrants of each SIEF to submit registrations for these high tonnage substances before the end of July. This is important, Dancet said, because ECHA will also extend, from October 1, the time it takes to verify the completeness of the registration dossiers from three weeks to three months.

"Reach is not business as usual. It is a highly ambitious project"

Antonio Preto, head of cabinet of EU Commissioner Tajani 

Submitting their registration dossiers before the end of July would ensure that lead registrants have time to add any missing information and resubmit, Dancet said. "We advise that the re-submission takes place before the end of September because from 1 October the technical completeness check (TCC) deadline for us moves from three weeks to three months."

Then, once the lead registrant's dossier has been declared complete, the rest of the SIEF members will have time to submit their dossiers, he explained.

"If SIEFs want to do their job properly they should submit their registration dossiers by the end of July at the latest," Dancet said. "This is safer because if they registered in November we could give no guarantee that we would be able to complete everything in one go."

For SIEFs that do need more time, ECHA is adjusting its IT system so that from June 1, SIEF members can submit their registration dossiers at the same time as the lead registrant, Dancet said. Currently, the lead registrant has to submit its dossier first.

Many of the SIEFs still do not have lead registrants. In such cases, the ECHA is advising SIEF members to submit individual registrations.



The requirement under Europe's new classification and labeling regulations to notify substances intended for research threatens the competitiveness of Europe's chemical sector, warned Cefic director general Hubert Mandery.

Under the new rules, which are being introduced alongside the EU's Reach, all substances, including those used in research, must be notified by January 2011. The list would then be made public, potentially disclosing confidential information, he said.

"This is a fundamental flaw in the legislation that needs to be addressed before the deadline of January 2011," Mandery told delegates. "It's a huge burden at this stage because there is no minimum threshold in terms of quantity." This is one of the chemical industry's top concerns in relation to innovation and competitiveness, he added.

Cefic is in discussions with all relevant parties, including the European Commission, to find an interim solution, he told ICIS on the sidelines of the meeting. "I think we should be smart enough to find a solution," he said.

By: Anna Jagger
+44 20 8652 3214

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