BRUSSELS, Belgium - European Environment Commissioner Margot Wallstrvm said Thursday she was determined to overcome the deadlock in European Union approvals of biotechnology products.

There is a need for "political leadership," she said, disclosing that the European Commission was now ready to provide this. The commission had just, she revealed, agreed on an overall approach to developing a coherent framework for biotechnology products.

"We have already waited too long to act," she said, pointing out that there is "no legal basis for the standstill" imposed by EU member states in mid-1999 on approvals of biotechnology-derived products, because of their anxieties over loopholes in the current legislation. Eighteen GMOs were approved between 1992 and the imposition of the de facto moratorium, and there are 14 formal applications pending, and a backlog of products waiting to enter the approval system, Wallstrvm said.

No GMO food has been authorized so far in the EU, and there are nine applications pending. It was time to unblock the process, she said, by persuading reluctant member state governments and reluctant members of the European Parliament that the proposed modifications to the legislation will be sufficient to protect public interests. "We need to restore public confidence in the authorization procedure," and to offer to consumers the possibility of making "an informed choice," Wallstrvm said.

As long as the moratorium goes on, companies could take the commission to court for failure to live up to its responsibilities, she pointed out. Meanwhile, the European biotechnology sector suffers as a consequence: there was a real risk that the potential of biotechnology would not be developed because of public concern, particularly over the health and environmental risks that might arise from genetically modified organisms.

"Not to act provides no solution," she said. "We cannot refuse to act because not all answers are known to all possible questions".

At a joint press conference in Brussels with Wallstrvm, David Byrne, the European commissioner responsible for public health, consumer protection and food safety, said the commission would now be trying to agree with member states and the European Parliament on detailed revisions to be made to the basic 1990 EU rule on placing biotechnology products on the market. The commission wanted to see a final text that provided high standards of protection for human health and protection of the environment, limits for the duration of authorization, and effective labeling, monitoring and traceability rules. Over the coming weeks the mechanics would have to be discussed between all parties, he said, and a formal conciliation procedure will be launched in September to unblock the legislative progress of the draft.

The commission also will aim "to avoid any gap in the legislation," Byrne said, by proposing in September sectoral legislation on novel feeds, to accompany the horizontal directive on biotechnology authorizations and the existing vertical directives covering novel foods and novel seeds. He would also produce a strategy paper to ensure a good fit between the horizontal and vertical legislation, and to take environmental liability and biodiversity into account, as well as research and public information needs.

Byrne said he thinks the lack of information (81 percent of EU residents said in a recent survey they had insufficient information on biotechnology) was closely linked to the current level of concern (61 percent) over biotechnology products.

What the commission is hoping to do is to give a clear signal to member states that progress can be made and must be made. If agreement can be reached on a text, the applications currently waiting in line could then be dealt with prior to the new rules coming into force, Byrne said, provided companies are prepared to comply with the new, stricter provisions. Neither commissioner was prepared to give a target date for when this might happen, but the intention is that once agreement is reached at EU level, processing of applications could resume during the one or two years that normally is allowed for member states to put the new rules into effect at national level.

Wallstrvm said that agreement on a revised text for the biotechnology authorizations directive could provide a stricter regulatory framework, which would then allow EU member states to resume approval of products without any loss of public confidence. She planned to seek a first reaction from member states at an informal meeting of environment ministers this month. And she planned to win over biotechnology skeptics in the European Parliament by "better information," which would make clear that the revised proposal met their concerns.

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