A novel solution?

No piece of legislation from Brussels has ever been greeted with unbridled joy. But EC Regulation 258/97 is regarded by those subject to it with a sense of frustration almost unprecedented in the field of EU food regulation. And there is a lot of competition, observe the cynics.

The main problem is that the spirit of the Regulation is not being observed, claims regulatory consultant Nigel Baldwin, who has helped several companies to navigate its application procedure.

Technically, he says, it should take four months to process an application to market a novel food in Europe - but, in practice, companies are looking at anything up to four years, and a bill running into millions of euros. "This is one of the worst pieces of legislation in Europe. It has all the transparency of a black box."

Properly defining the scope of the Regulation is therefore crucial when the European Commission finally publishes a revised version - which it has promised to do this year, says Baldwin. "In some cases, companies have spent more than a year arguing whether their ingredients are actually subject to the Regulation or not."

However, the biggest frustration has been the current system of allowing every member state to comment individually on applications, even after they have been rigorously scrutinised by the expert committee of one Member State, says the European Starch Industry Association (ESIA). "The 60-day consultation period for other Member States nearly always results in reasoned objections... there has been insufficient mutual recognition between the safety assessments by national food safety authorities, which has hampered the effective functioning of the current system."

Like most respondents to last year's consultation on revising the Regulation, ESIA wants the risk assessment and authorisation process to be handled centrally by the European Food Safety Authority (EFSA).This would stamp out duplication and dramatically speed up the whole process.

There should also be a facility to provide generic authorisations, says ESIA. "But, in order to reward innovation, the revised draft should also grant the first applicant a reasonable period of exclusivity, in compensation for the costs engaged in the authorisation procedure."

The other burning issue is the status of foods that have been consumed safely outside Europe for centuries, but are deemed novel simply because they have not been consumed to a "significant degree" in Europe before May 1997.

The arbitrary nature of the Regulation also makes it highly discriminatory, claim critics. "Traditional food exporters and importers perceive this as a very real barrier to trade," complains dairy co-operative Fonterra. "Foods with a long history of safe use are facing difficulties because of this Regulation. For example: Indian gooseberry (India), Lucuma (Peru), Araza (Ecuador). The requirements for these traditional foods are disproportionate to the potential risk, given their history of safe use outside Europe."

The revised Regulation should therefore differentiate between genuinely new foods and those that are merely new to Europe, adds Unilever, which is currently seeking approval under the Regulation to use its genetically modified ice-structuring protein in low fat desserts and ice creams in Europe.

Perhaps the most fundamental question that has arisen from the recent consultation, however, is whether such legislation is actually necessary in the first place.

Starch giant Avebe takes a bold stance: "Industries [already] have the obligation to produce safe products and the EU and national authorities have the possibilities [sic] to take unsafe [food] off the market. "Is there still a need for a novel food regulation?"