EU EFSA Confirms Safety of Extended Uses of Galacto-Oligosaccharides as a Novel Food

Scientific Assessment and Scope

EFSA assessed the identity, production process, specifications, anticipated dietary intake, nutritional considerations, and available toxicological and human data for GOS. Based on this comprehensive review, EFSA concluded that the proposed extension of use is safe under the proposed conditions of use. 

The extension would permit GOS use in additional food categories, including non-alcoholic beverages, confectionery, chewing gum, cocoa and chocolate-based products, and protein products, with FoodEx2 surrogates applied where appropriate.

Dietary Intake and Safety Considerations

EFSA estimated a highest 95th percentile (P95) intake of up to 48.5 g/day in adults, with the proposed extension contributing up to a 17% increase compared to currently authorised uses at the highest P95. EFSA found that the proposed use levels and anticipated intake do not raise safety concerns, and no new genotoxicity or toxicity signals were identified through updated literature searches.

At high intake levels, any potential effects are expected to be limited mainly to gastrointestinal intolerance, such as bloating or flatulence, which are typical of fermentable fibres and may naturally limit consumption.

Data Protection Assessment

EFSA also determined that it could have reached its safety conclusion without the proprietary data submitted by the applicant, including certificates of analysis, for which data protection under Article 26 had been requested.

Feedback Deadline

No feedback or consultation deadline applies, as this publication reflects a final EFSA scientific opinion rather than a draft or public consultation.

Why It Matters

This opinion provides regulatory clarity on the expanded safe use of an already authorized novel food ingredient. It supports digital and regulatory alignment for product development planning, enables efficient innovation in functional and fortified foods, and does so without introducing additional compliance or health-related burdens for the food industry.

Who This Update is Relevant For

This update is relevant for regulatory affairs, quality assurance, product development, nutrition science, and compliance teams involved in novel foods, functional ingredients, and EU market access planning.

Next Steps

Organizations should review the EFSA opinion to understand the confirmed scope of safe use, assess portfolio or pipeline products that may benefit from the extended authorizations, and align internal regulatory and product strategies accordingly. While no immediate action is required, timely internal assessment can support informed decision-making and market planning.

As companies evaluate how EFSA scientific opinions translate into practical regulatory and portfolio decisions, RegASK supports teams by connecting timely regulatory intelligence with workflow orchestration. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely, predictive, actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 157 countries.  

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FAQs

What did EFSA conclude about galacto-oligosaccharides (GOS)?

EFSA concluded that the proposed extension of use of GOS as a novel food is safe under the proposed conditions, with no new safety concerns identified.

Which new food categories can include GOS under the proposed extension?

The extension covers non-alcoholic beverages, confectionery, chewing gum, cocoa and chocolate-based products, and protein products, using FoodEx2 surrogates where applicable.

Does the extended use of GOS raise dietary intake or toxicity concerns?

EFSA estimated a maximum P95 intake of 48.5 g/day in adults, with no genotoxicity or toxicity concerns identified. Potential effects at high intakes are limited to typical gastrointestinal intolerance.

How can RegASK help companies track and assess EFSA novel food opinions?

RegASK enables teams to monitor EFSA scientific regulations, assess regulatory and portfolio impact, and translate scientific conclusions into actionable regulatory and product planning insights across global markets.