The EU’s long-winded novel foods rules have long been viewed as an innovation-crimping legal structure, but a stream-lining of the process means companies should not fear it, a consultant says.
“The entire process is more transparent – there is no need to fear it,” said Inga Koehler, PhD, from German consultancy and contract research organisation (CRO), analyze & realize, ahead of a presentation at Vitafoods Europe on May 14.
European Union novel foods rules require any food or ingredient that cannot demonstrate a history of use prior to May 1997 to verify its safety and intended use.
Such an approval process typically took years as approval from all EU member states was required, but now the process has been modified so that approval in one member state is valid in all unless an objection is raised. Processing time depends on the nature of the substance, the intended use and the quality of the submitted application, as well as the member state authority.
Koehler said there could be ambiguity about whether an ingredient or food required novel foods approval, but companies with novel foods approval offered genuine business advantages.
“There are some ingredients where it is not clear if they really fall under the novel foods regulation but if the company but if the company decides to file for Novel foods this can give them a market advantage because they are the first with a safe ingredient on the European market.”
“Other companies have to provide some documents showing substantial equivalence showing their ingredient is also safe and that can take some time.”
Facing novel food issues early on
Koehler emphasised that companies needed to carefully check if novel foodss approval was required, but turning a blind eye to the situation was not advised, even if many companies had adopted the approach in the past.
Speaking of past behaviour, Koehler noted, “I think even if they were aware of the novel foods risk they tried to circumvent it if they could. So they would think if no one touches on the novel foods issue we will not bring that on the table.”
“Now companies are aware that if there is a certain novel food risk they are facing it at a very early stage of the product development process and that will give them a market advantage. This is the major change from a few years ago.”
“Now we also have more examples of successful novel foods filings. The entire process has become more and more transparent.”
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In 2009, the European Parliament agreed on a simplified authorisation or notification procedure for foods and ingredients from those third countries with a safe history of use which could cut processing times from three years or more to around one year.