By Peter O¿Donnell

BioWorld International Correspondent

BRUSSELS, Belgium ¿ ¿GM food and feed must not present a risk for human health, animal health or the environment,¿ insisted David Byrne, the European commissioner responsible for health and consumer protection, when he presented the just-published proposal for a new EU regulation on genetically modified food and feed to the European Parliament in Brussels last week.

On the basis of the U.S. experience with the StarLink corn product, the Commission wants to ensure that GMOs likely to be used as food and feed are authorized for both uses or not at all. ¿The intention is to prevent a StarLink type of situation from occurring in Europe,¿ Byrne said. He said the no-risk principle, while not new for GM food, will be given new force now because the EU will have ¿for the first time the same clear and stringent rules at the EU level for feed derived from GMOs.¿

The commissioner said his proposal, which will need backing from the Parliament, would help break the logjam of GM applications currently held up within the EU, particularly by modifying the rules on adventitious contamination, because the new rules set up ¿specific conditions under which technically unavoidable presence of unauthorized GMOs could be permitted.¿

EU scientific committees already have concluded that a number of GMOs they assessed pose no danger to the environment or to human health.

¿However, these GMOs are still pending final approval and some of them have now been awaiting approval for quite some time,¿ Byrne said. ¿The proposal allows for these GMOs, which have received a positive opinion from an EU scientific committee, to be present in a food or feed up to a maximum of 1 percent.¿

The commissioner said the new rules would help ¿build up public confidence by responding to questions and concerns raised by the general public. A high level of protection, consumer choice and transparent, uniform and efficient authorization procedures are key elements in fostering social acceptance and trust in the application of biotechnology to food and feed,¿ he said.

He confirmed he also was working on future proposals in the seeds sector, and that these agri-food proposals were part of ¿the strategic vision which I hope will contribute to a rational and balanced debate about the future of biotechnology in Europe and lead to increased public acceptance of the use of biotechnology.¿

The proposal ¿enables the consumer to exercise a freedom of choice by reinforcing current labeling requirements,¿ Byrne said. Labels will be required for all foods produced from GMOs, irrespective of whether DNA or protein of GM origin is detectable in the final product; and they will cover all genetically modified feed, so corn gluten feed produced from GM maize will have to be labeled accordingly.

Other key elements in the new rules are a mandatory scientific risk assessment prior to marketing any food or feed that is genetically modified or produced from GMOs, evaluation of the need for post-market monitoring during the risk assessment, and the possibility of imposing monitoring requirements as conditions of authorization. Companies wishing to market a GM food or feed will have to seek a favorable scientific opinion from the European Food Authority, which currently is being established. Applications must include a validated method for detection, as well as scientific data on product safety. Authorization decisions will be made at the EU level, and be valid for 10 years at a time. During the assessment procedure, a summary of the application and of the European Food Authority¿s opinion will be made public, and comments invited before the authorization decision. A new EU publicly available register of genetically modified food and feed will contain information on all authorizations.

The commissioner dismissed suggestions from the industry that costs will rise significantly because of the tougher rules. In addition, he said the new rules would streamline the EU procedures for authorization.