New Novel Food Rules Now In Force
Nutrition industry 'positive' on prospects for new novel foods regulation
Twice the number of people are positive about the changes to regulations than feel negative – with a (20%) of industry professionals surveyed suggesting the new rules would have a positive impact and just 10% expecting a negative impact.
According to the survey of 208 nutrition industry representatives commissioned by Vitafoods Europe more than a quarter of respondents (27%) said they had already taken action to prepare for the new rules, while 17% said they were now more likely to apply for novel foods status, compared with 12% who said they were less likely to do so.
Among several changes to the system is the major shift to centralise novel food approvals for the first time. This means that from now onwards all applications are submitted to the European Commission rather than individual member states.
The intention of the reformed rules are to streamline and speed up the application process. However, some experts have warned that there could be adverse implications for some companies’ intellectual property portfolios.
“On paper this is a very nice process. It’s more streamlined, it’s clearer and it should be faster. But like all legislation, the proof of the pudding is in the eating,” said Patrick Coppens, director of scientific and regulatory affairs at Food Supplements Europe – noting that another key change to the regulations is that authorisations will be generic, meaning that once a novel food is approved it will in most cases be authorised for anyone to market.
“Of course, that’s not an incentive for companies to invest in a lot of safety investigations for the product,” Coppens commented. “It will really depend on what companies can do to protect their intellectual property. If the return on investment is not certain, there will be some companies who don’t invest.”
Dr Steffi Dudek, senior scientific consultant at analyze & realize, added that the new regulations will bring progress for traditional foods from third countries or for relatively simple products such as exotic berries.
“But manufacturers of innovative synthetic or fermented ingredients who got authorisation under the old regulation after investing heavily in research will be disappointed that their proprietary data is not respected in the way we had hoped,” he noted.
EFSA involvement: Faster approvals?
Liza Van Den Eede, regulatory affairs director at Pen & Tec Consulting, added that the biggest problem with the old system was time – with an average of three and a half years needed to gain approval – and in some cases lasting up to five or six years.
“The better defined deadlines in the new process, as well as the guidance from EFSA, should hopefully mean faster approvals,” she said. “However, there are probably many companies that are pessimistic about the timescales based on past experience with EFSA, since unforeseen supplementary information requests can slow down the process considerably.”
Experts suggested that with the new regulations in place, we see an increase in number of applications for novel foods approval in 2018.
“It’s possible that a lot of companies have waited for the new regulations to kick in before submitting their applications,” said Dudek.
“The definitions are clearer and progress never stops. It’s hard to predict, but I suspect the number of applications will increase.”
