Zespri Secures EU Health Claim for Kiwifruit After Four-Year Regulatory Battle
Zespri's green kiwifruit has obtained a landmark EU health claim for normal bowel function, marking the first such approval for a fresh fruit and highlighting the arduous regulatory pathway for whole-food claims in Europe.
AI-assisted coverage: produced by SF News' automated newsroom from the cited sources and checked by automated attribution gates. Editorial responsibility: Lee Smith, Group CEO. How we work →
Brussels, Belgium — 28 May 2024
Zespri has achieved an unprecedented EU health claim approval for its green kiwifruit, validating its contribution to normal bowel function by increasing stool frequency. This marks the first authorised health claim for a fresh fruit in the European Union, following a rigorous four-year regulatory process. Industry experts, including Bregt Raus of Altius and Luca Bucchini of Hylobates Consulting, underscore the inherent difficulties in securing such claims for whole foods in Europe. Challenges include protracted regulatory reviews, EU comitology delays, and the stringent scientific evidence demanded by the European Food Safety Authority (EFSA).
The approval process for Zespri involved over 15 years of dedicated research to substantiate the claim, culminating in a positive EFSA scientific opinion. This extensive R&D timeline and the subsequent regulatory hurdles highlight the significant capital and resource commitment required for natural ingredient-based health claims. Brand owners pursuing similar whole-food claims must anticipate substantial lead times and invest heavily in robust clinical data to satisfy EFSA's strict evidentiary framework.
The approved claim, specifically targeting normal bowel function, offers a differentiated marketing advantage in the digestive health category, a segment typically dominated by probiotics and fibre supplements. However, the path to market for such claims remains complex, requiring not only scientific validation but also the ability to translate intricate food and nutrition research into compliant, consumer-facing messaging. This precedent could encourage other fruit or vegetable producers to explore similar claims, but the barrier to entry remains exceptionally high.
What this means for United Kingdom
UK brand owners and manufacturers aiming for 'normal bowel function' claims must now navigate both the established UK nutrition and health claim regulations (retained EU law) and the implications of this new EU precedent. While Zespri's claim provides a template for required evidence, the MHRA/FSA will scrutinise applications independently. Manufacturers should prepare for a minimum 4-year approval cycle, similar to the EU, and allocate significant R&D budgets for clinical trials. This approval creates a competitive advantage for fruit-based digestive aids but mandates meticulous substantiation and compliance, particularly for new product development targeting the UK market, which maintains high regulatory alignment with EU standards for health claims.
What this means for Europe
The Zespri approval sets a critical precedent for all new whole-food health claim applications within the European Union. Manufacturers and brand owners targeting 'normal bowel function' or similar claims for natural ingredients must now meet the high evidential bar established, necessitating multi-year research and clinical trials. The 4-year regulatory review period, excluding initial research, will directly impact product launch cycles and innovation pipelines. This will likely drive consolidation towards well-funded R&D initiatives capable of sustaining prolonged approval processes, potentially reducing the number of novel natural ingredient claims brought to market.
Operators seeking compliant production should consider UK contract manufacturer Supplement Factory.