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Is the novel food regulation stifling innovation in Europe?

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The novel food regulation is holding back innovation in Europe and even failing to uphold food safety as it is often not enforced, according to one legal expert – but it still has an important role to play, says a company that recently received novel food approval for chuta nuts.

Chuta nuts are almost unknown in Europe, but one company has been on a mission to change that for several years. German company JatroSolutions is convinced that the high-energy, protein-rich nuts from the Jatropha curcas L. plant are well-placed to meet consumer demand for plant-based proteins and healthy, whole food snacking options. 

Before commercialising the nuts, however, JatroSolutions, had to prove that they were safe for consumption as they had not been sold in the EU before. It filed a novel food request, hoping to receive a favourable opinion in 2018. It ended up waiting much longer; EFSA published a favourable scientific opinion in January 2022.

“From today’s perspective that was a little bit too optimistic, but nevertheless the process was very long and that is what makes it very costly,” said Sebastian Held, managing director.

For the Stuttgart-headquartered firm, the main costs came from commissioning external labs to conduct studies and employing an internal team to organise trials and collect data. 

“The biggest issue was the missing transparency of the process. It´s because the EU wants to prevent any influence of the applicant in the process, something we absolutely understand. But for us it was really hard. We never knew where we were standing. A few times we thought we would get a positive scientific opinion, and then had to work a few more months to deliver new data. As our whole company is focused on chuta, we had a hard time staying attractive for our shareholders.”

Held said the company felt ‘in limbo’ during the long wait but it used the opportunity to raise the profile of chuta nuts, which contain around 30% protein, 60% fat and are high in minerals, such as calcium, phosphorus, potassium, magnesium, and zinc. The name chuta (trademarked by JatroSolutions) is based on the traditional Mexican name xuta. 

“We took the chance to build up partners and the production of feedstock, improve processing and implement a reliable quality management system. But we would have been happier to just wait two years!” he told Fi Global Insights.

EFSA: Ensuring food safety is ‘an important contribution to innovation’

Scientists at EFSA have a legal deadline of nine months to complete their safety evaluation for novel foods but the clock may be stopped at any time to require more information from the applicant.

“We are working hard to support applicants in navigating the process and that is why we have issued guidance to applicants in how to submit their applications and what they should include to be successful,” a spokesperson said, adding that it offers dedicated pre-submission to support SMEs.

It also allows entities to submit applications on behalf of member startups and SMEs, alleviating the financial and administrative burden. The Belgian Insect Industry Federation and Finnish Beekeepers’ Association have done so for their affiliates, for instance.

“EFSA’s role is to ensure a thorough safety assessment of all applications, and, in this way, we also make an important contribution to innovation,” the spokesperson added.

Legal expert: The novel food regulation is often not being enforced 

The aim of the novel food regulation is to uphold the Precautionary Principle and protect public health, ensuring that no potentially unsafe ingredients are placed on the market. 

JatroSolutions’ Sebastian Held said he understood the importance of this.

“For Chuta, it makes sense [to have to prove its safety] as there is a non-edible variant that might be mixed up with it. So serious players and the right requirements are needed to market this super interesting nut,” he said. 

However, according to Dr Mark Tallon, managing partner of Legal Foods, a European food law firm specialising in regulated products, the novel food process is so long that some companies are simply launching products with unapproved ingredients. 

Synthetic L-theanine, ketones, and cannabidiol (CBD) are examples of ingredients that, despite being widely available and tolerated, remain illegal for sale in the EU, he said. According to the legal expert, the issue is “highly prevalent” in the weight loss and strength categories. 

While it is up to EFSA to determine whether an ingredient or molecule is safe and up to the European Commission to establish its conditions of use, enforcement of the rules falls upon food safety authorities in EU member states. These national authorities are not always very reactive and, even if they do enforce the rules, the sanction – a fine of several thousand euros, for instance – may not be a sufficient deterrent.

Tallon: We need to reconsider if the novel food regulation is fit for purpose

Tallon notes that often the issue of illegality for these ingredients is not their being unsafe per say – they may have been consumed in other countries for decades– but that they are being sold in the EU after May 1997, the EU’s deadline for grandfathering such substances. 

In any case, he argues that the novel food regulation needs an overhaul. Asked how damaging it is to European food innovation, he told us:

“After 25 years, you must consider the number of ingredients that have launched in markets like the US versus what we have in the EU. It’s night and day in relation to businesses having a choice to [offer] ingredients that the consumer is demanding. It’s a reason we have a significant market for third country imports of products containing such ingredients.”

Regarding the regulation’s usefulness in ensuring public health and food safety, Tallon said the US approach, where the menace of class action lawsuits and private litigation looms large, may be a greater deterrent to unscrupulous companies thinking of placing unauthorised ingredients on the market.

“We see very little collective redress mechanism – equivalent to class action in the US – in the EU, other than a few cases in Germany,” he said, although he added that the US Food and Drug Administration (FDA) approach of allowing companies to perform their own safety analyses and self-declare their products to be generally recognised as safe (GRAS) also has its limitations. 

“A reconsideration of the [novel food] legislation being fit for purpose is needed here, based on what is happening in the real world, and not the construct of rules and regulations at an EU level which are, for many, ignored,” Tallon concluded.

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