12.19.17
Many people working in the nutrition industry feel positive about the EU’s new process for the approval of novel foods, according to research by the organizers of Vitafoods Europe. However, experts are warning there could be adverse implications for some companies’ intellectual property portfolios.
The new regulations on novel foods, defined as anything without a significant history of consumption in the EU before May 15, 1997, come into force on Jan. 1, 2018. For the first time, the approval system will be centralized, with applications submitted to the European Commission rather than individual member states.
There appears to be a degree of optimism about the new regime. One fifth (20%) of industry professionals surveyed by the organizers of Vitafoods Europe said they thought the new rules would have a positive impact. This was double the number who expected them to have a negative impact (10%). (Vitafoods Europe commissioned a survey of 208 nutrition industry representatives between Nov. 14 and Dec. 14, 2017.)
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.
A Quicker Process?
Reforming the novel foods regulation is intended to streamline and speed up the application process. “The biggest problem with the old system was time,” said Liza Van Den Eede, regulatory affairs director at Pen & Tec Consulting, who is presenting an update on the new process at Vitafoods Europe 2018. “It took an average of three and a half years to get a novel food approval and in some cases it was five or even six. The better-defined deadlines in the new process, as well as the guidance from EFSA, should hopefully mean faster approvals. 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.”
Patrick Coppens, director of scientific & regulatory affairs at Food Supplements Europe, added: “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.”
Intellectual Property Concerns
Another key change is that authorizations will be generic. This means that once a novel food is approved it will in most cases be authorized for anyone to market. “Of course, that’s not an incentive for companies to invest in a lot of safety investigations for the product,” said Mr. Coppens. “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, also expressed concerns. “The new regulations certainly represent progress for traditional foods from third countries or for relatively simple products—exotic berries for example. But manufacturers of innovative synthetic or fermented ingredients who got authorization 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. I’m also concerned that some products that should be subject to their own authorization might enter the EU market under a generic authorization. It remains to be seen how companies will take the responsibility to assess the status of their products.”
More Applications in 2018?
Could there be an increase in the 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 Dr. Dudek. “The definitions are clearer and progress never stops. It’s hard to predict, but I suspect the number of applications will increase.”
The new regulations on novel foods, defined as anything without a significant history of consumption in the EU before May 15, 1997, come into force on Jan. 1, 2018. For the first time, the approval system will be centralized, with applications submitted to the European Commission rather than individual member states.
There appears to be a degree of optimism about the new regime. One fifth (20%) of industry professionals surveyed by the organizers of Vitafoods Europe said they thought the new rules would have a positive impact. This was double the number who expected them to have a negative impact (10%). (Vitafoods Europe commissioned a survey of 208 nutrition industry representatives between Nov. 14 and Dec. 14, 2017.)
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.
A Quicker Process?
Reforming the novel foods regulation is intended to streamline and speed up the application process. “The biggest problem with the old system was time,” said Liza Van Den Eede, regulatory affairs director at Pen & Tec Consulting, who is presenting an update on the new process at Vitafoods Europe 2018. “It took an average of three and a half years to get a novel food approval and in some cases it was five or even six. The better-defined deadlines in the new process, as well as the guidance from EFSA, should hopefully mean faster approvals. 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.”
Patrick Coppens, director of scientific & regulatory affairs at Food Supplements Europe, added: “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.”
Intellectual Property Concerns
Another key change is that authorizations will be generic. This means that once a novel food is approved it will in most cases be authorized for anyone to market. “Of course, that’s not an incentive for companies to invest in a lot of safety investigations for the product,” said Mr. Coppens. “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, also expressed concerns. “The new regulations certainly represent progress for traditional foods from third countries or for relatively simple products—exotic berries for example. But manufacturers of innovative synthetic or fermented ingredients who got authorization 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. I’m also concerned that some products that should be subject to their own authorization might enter the EU market under a generic authorization. It remains to be seen how companies will take the responsibility to assess the status of their products.”
More Applications in 2018?
Could there be an increase in the 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 Dr. Dudek. “The definitions are clearer and progress never stops. It’s hard to predict, but I suspect the number of applications will increase.”
