Science vs politics: Kiwi’s long road to EU health-claim approval

In August 2025, Zespri, the world’s largest marketer of kiwifruit, announced that the European Commission had approved what it described as the first health claim for a fresh fruit, following more than 15 years of research funded by the company.

The claim, which states that eating two green kiwifruit a day, providing at least 200 grams of flesh, contributes to normal bowel function by increasing stool frequency, was approved years after a positive scientific opinion from the European Food Safety Authority (EFSA) in 2021.

At the time, Zespri CEO Jason Te Brake described the outcome as positive for the entire fresh produce industry.

“The approval not only validates Zespri’s health and innovation program, it also delivers tangible value to the industry and reflects the hard work of our green growers to produce nutritious, great-tasting kiwifruit,” he said.

But while the approval represented a milestone for Zespri, which cited 18 human studies in its application, the timeline highlighted just how difficult it is for science-backed health claims to make the journey from evidence to the market.

Bregt Raus, managing associate at Belgian law firm Altius, noted that the four-year wait showed that getting the science right is only part of the battle.

“The process’s length and complexity call into question whether the EU health claims framework works as it should,” he said. “The delay is both procedural and political; it is driven by a governance layer that operates without real-time pressure, even where the underlying science is no longer in dispute.”

Why are whole-food health claims rare?

Between 2008 and 2012, the EU carried out a major scientific review of food health claims to distinguish those supported by strong scientific evidence from those that were not

Health claims follow a clear process, Luca Bucchini, managing director at Hylobates Consulting, explained. Applicants define the food, benefit, target population and wording, and submit scientific evidence—also known as the dossier. EFSA then assesses whether the evidence supports the suggested claim, issuing a scientific opinion on whether the evidence establishes a cause-and-effect relationship. Finally, the European Commission and EU Member States decide whether to authorize the claim and set the conditions for its use.

Whole-food claims remain rare. Prunes, for example, can carry a claim relating to normal bowel function, while EFSA has rejected broader claims for foods such as berries where the proposed health outcome was not sufficiently specific.

Bucchini said whole foods can be harder to assess because their effects may arise from multiple compounds and mechanisms, making it harder to establish a precise cause-and-effect relationship.

Researchers link kiwifruit to a range of potential health benefits. It is high in vitamin C, fiber, potassium and antioxidants. Research has explored its potential role in heart health, blood sugar regulation, sleep and exercise recovery. Gold kiwi generally contains more vitamin C, while green kiwi tends to have more dietary fiber and higher levels of actinidin, the protein-digesting enzyme naturally found in kiwifruit that may contribute to some of the fruit’s effects on digestion.

The key difference in kiwifruit’s application was that its evidence could be translated into a precise, measurable and regulator-friendly claim, Bucchini noted.

The evidentiary bar is high—EFSA has evaluated more than 2,300 health-claim applications, and rejected more than 70% according to 2023 data.

Health claim approvals take years

The entire process from initial dossier submission to final authorization on average takes between 1.5 to 2.5 years.

In the case of Kiwi however, after EFSA delivered a positive opinion in July 2021, the applicant requested different wording for the health claim, requiring EFSA to be consulted again, Bucchini said.

The remaining delay was largely down to discussions among Member States and the scheduling of committees and working groups. The wording of the regulation can require considerable back and forth, as Member States seek to ensure the claim can be enforced and does not conflict with existing regulations or national legal requirements, he explained.

Member States wanted to ensure that the regulation could be enforced, did not conflict with existing or previous legislation, and was compatible with their national legal frameworks.

“Whenever a new concept comes forward, Member States tend to be a bit nervous, even if EFSA has said yes,” Bucchini said.

Comitology creates delays

For Raus, the lengthy process points to a broader problem with the EU’s approval system. That tension is not new. In previous cases, EU decision-makers have weighed broader consumer and public-health concerns even after EFSA issued positive scientific assessments.

For example, EFSA issued positive scientific opinions on claims relating to sodium and glucose and sports performance, but Member States ultimately rejected the claims because they conflicted with wider public-health policies on salt and sugar consumption.

A similar divide has appeared in debates over maximum permitted levels for vitamins and minerals, where national authorities have advocated for more precautionary limits than EFSA’s established safety thresholds.

While EFSA assesses the scientific evidence, the Commission and Member States also have to consider how a claim should operate within the wider EU regulatory and public-health framework.

“The gap highlights that comitology is the real bottleneck,” Raus said.

Comitology, the procedure through which Member States oversee and approve the European Commission’s use of implementing powers, is inherently political because Member States must reach consensus, he explained.

“During comitology [during the kiwi case], there were discussions about limiting the claim to sales units of 200 grams,” he said. “That approach was later dropped because the notion of a ‘sales unit’ was not considered sufficiently clear for consumers.

“Some Member States also raised sustainability concerns, questioning whether such an approach would lead to increased use of packaging. There was also the practical question of how to deal with loose, non-prepacked fruit.”

These discussions showed how quickly the process can move beyond the scientific assessment into detailed implementation issues, Raus explained, which he said raised questions about whether regulatory discussions are needed for smaller details.

“Do we really need political oversight through comitology at this level of granularity? In a prior authorization scheme, the implications are immediate: Until agreement is reached, the claim cannot be used,” Raus said.

“That kind of oversight makes sense for sensitive or high-risk matters. But in the context of health claim authorization, its proportionality is open to question. Where a claim has already been scientifically validated by EFSA, what remains to be assessed is limited.”

Persistence secures health claims

Getting the claim approved ultimately came down to Zespri staying the course.

“Zespri invested heavily—both in time and resources—over many years,” Raus said. “By their own account, this was a 15-year effort.”

Substantively, the case challenges the common perception that EU health claims must relate to specific nutrients or isolated substances.

“In that sense, the kiwi claim sets a precedent but more in an informal way,” Raus added. “It serves as a reminder that whole-food claims are possible under EU law, even if they are rarely pursued or successfully authorized.”

The case also illustrated the challenge of translating scientific conclusions into regulatory wording that works in practice. Future health-claim applicants should think ahead about the conditions of use, Raus suggested, noting that companies can propose these conditions in their applications and may benefit from anticipating the issues that could arise during the comitology process.

“For example, applicants could proactively include wording on intake and presentation similar to what was ultimately required in the kiwi case,” he said. “This may help reduce friction later, although it will not eliminate the political dimension of the process.”

However, if securing a whole-food health claim requires this level of time and persistence, it may make companies less likely to pursue innovation.

“Lengthy approval processes are problematic; they serve no one,” Raus said. He suggested that the system could better serve innovation by recognizing traditional use as evidence for established foods such as fresh fruit and allowing companies to use claims after EFSA clearance with a clear ‘claim pending’ label.

Bucchini added that the length of the kiwifruit approval process revealed a structural weakness in the EU health-claims system, particularly because it could discourage companies from investing in research into food-based health benefits.

“It is a very well-known weakness of the EU system, and it is very discouraging,” he said. “There are very few health claims approved, and while the system is highly trusted, the process does not encourage companies to invest in research.”

Science is only half the battle

Zespri funded and pursued the application, but the authorized health claim applies to green kiwifruit generally rather than specifically to Zespri. That means competitors can also use the claim, provided their products meet the conditions of use.

However, some authorized health claims are rarely used in the market because companies need a strong commercial strategy to turn them into a competitive advantage, Bucchini said. He added that he believes Zespri still has a advantage in having the claim.

Zespri’s latest annual report showed $5.9 billion in global kiwifruit sales revenue and $6.1 billion in global operating revenue in 2025–26, surpassing the company’s $4.5 billion global sales ambition for 2025. Global green kiwifruit volumes rose 8.6% to 70.6 million trays in 2025–26, up from 65 million the previous year. At the kiwi industry’s two-day Momentum 2026 Conference in Mount Maunganui, Zespri announced its 2035 strategy to become “the world’s healthiest fruit brand”.

“Consumers are seeking healthier food choices, our markets are becoming more complex, and technology is transforming how people shop and how businesses operate,” Te Brake said.

“Our industry has succeeded by being forward-looking, innovative and working together. Our 2035 strategy captures that and sets us up to keep growing value for New Zealand and our global partners, and to deliver the healthiest fruit experience to consumers around the world.”

According to Bucchini, despite the system’s shortcomings, the kiwi case has offered a reason for optimism, showing that science-backed innovation can still make its way to consumers.

“It remains a very difficult place to do science in a way that can be brought to the market in the nutrition space, but this case also shows that there is hope,” he said.