The 1997 novel foods regulation is set for a revamp, with an amendment making its way through the lawmaking process in Brussels. The aim is to speed up the process, which has been criticised for staunching innovation, and take into consideration emerging areas of science such as nanotechnology.
In the pesticides and pharmaceutical sectors an approval in one member state holds true for all other members of the EU. But the principal of mutual recognition between member states has “fallen apart” for novel foods, said Nigel Baldwin, a consultant at Cantox Health Sciences.
Every novel foods approval by a member state under the current system has had one or more other member question it, so has had to pass via the European Food Safety Authority (EFSA).
This means that “any traditional product will get at least one member state objecting to it,” he said.
Thus, what is meant to be a fast track system will not work unless the principle of mutual recognition is reinforced.
Third country certification
Baldwin added that the alternative process for traditional foods eaten in a third country should apply only to foods and food ingredients that have certification from that country’s government.
“It’s like me saying fish and chips are safe,” said Baldwin, using the example of a traditional British meal. “It is not the same as the Department of Health saying it considers them to be a safe and suitable part of the traditional diet.”
In order to reach such a safety conclusion, a government would measure factors like population intake levels, safe maximum intake, and toxicity data.
While the current novel foods regulation allows for the filing of ‘substantial equivalence’ applications following the initial approval, the proposed new system would give an applicant that provides its own proprietary data exclusivity for a period of five years.
“Substantial equivalence will be dead,” said Baldwin. “The idea is to reward innovation.”
He added that it is possible for more than one company to have rights for a novel food, but only if they have conducted their own unpublished studies.
“It’s about rights to data.”
The Swedish presidency has signalled that the novel foods amendment will be debated in the second half of this year. Baldwin said it could be in place in the first half of 2010, but a two-year implementation period will follow.
This time frame means that companies considering making an application in the near future will therefore need to consider whether they want to be considered under the new system or the old one.
With approvals taking up to 36 months or longer, according to industry members, they could be pushing on time for the switch over. They can withdraw and resubmit at any time however.