EFSA finds “no safety concern” in naringenin food flavoring with respect to genotoxicity

30 May 2024 --- The European Food Safety Authority (EFSA) has given the nod for the use of naringenin extract as a flavoring substance in foods based on Spain-based ingredient formulator HealthTech Bioactives’ (HTBA) scientific dossier. Naringenin is a bioactive polyphenol found in citrus fruits and used as a “taste modifier” in beverages, dairy and plant-based products.

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of naringenin [FL-no: 16.132] as a new flavoring substance, in accordance with Regulation (EC) No 1331/2008.

The panel considered the manufacturing process, composition and the stability of the ingredient to study and found “no concern” with respect to genotoxicity.

“EFSA’s recent scientific opinion on the safety of naringenin is an important breakthrough for the whole food industry but is of course, particularly exciting for us,” Tom D’Hoore, chief commercial officer at HTBA, tells Food Ingredients First.

“Naringenin is a flavonoid and back in 2010 the European Commission asked EFSA to evaluate a group of flavonoids, which led to a “no safety concern” opinion seven years later. But since 2017, EFSA has not approved any new flavonoids as flavoring substances.”

Based on EFSA’s positive opinion, HTBA’s European customers will soon be able to use naringenin to “modulate taste in their products and gain consumer acceptance,” he continues.

F&B formulators can label the ingredient as a “natural flavor,” once it is officially included in the Food Flavouring Regulation.

Regulatory landscape
The use of flavorings in food is regulated under Regulation (EC) No 1334/2008 1 of the European Parliament and Council of  December 16, 2008 on flavorings and certain food ingredients with the flavoring properties for use “in and on foods.”

Taste modifiers in less creamy, low-sugar shakes can help F&B formulators tackle mouthfeel challenges (Image credit: HTBA).“In 2016, sensing the potential of naringenin for food and beverage formulators, HTBA submitted an application to the European Commission for authorization of naringenin as a new flavoring substance,” reveals D’Hoore.

“After eight years of hard work, naringenin itself has received EFSA’s “no safety concern” scientific opinion.”

The current EFSA procedure evaluates each compound “individually” and requires “in vitro and in vivo” toxicity studies, acute, subchronic and multigenerational studies, which have all been carried out by HTBA, he explains.

HTBA has pioneered regulatory approvals for naringenin as a flavoring substance for over a decade, including in the US (FEMA), Latin America, Japan, Southeast Asia and the Middle East.

The EFSA previously also issued an opinion regarding the safety of naringenin for its use in food in 2017.

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated naringenin in 2022.

Eyeying “sweetness balance”
Almost all added sweeteners pose taste challenges to F&B manufacturers, flags D’Hoore.

“Natural sweeteners like stevia and monk fruit tend to have off notes and their sweetening profile is different from sugar (the sweetness onset is later and it lingers longer).”

In 2010, following stevia regulatory approvals, there was a significant need for natural taste modifiers, says HTBA.Taste modifiers or flavors with modifying properties (FMPs) help to address these issues, bringing a product’s sweetness profile “closer to sugar,” he explains.

Natural taste modifiers like naringenin have no intrinsic sweet notes of their own, yet they have a “sweetness synergy” with sugar and high-intensity sweeteners. 

“They enable a sweetness balance without using undesirable high intensity sweeteners.”

HTBA formulates naringenin through a natural and proprietary process and offers F&B companies to “strategically uncouple taste modulation from the aromatics.”

Beyond sweetness
D’Hoore further sheds light on FMPs role beyond enhancing sweet profiles in food.

“Reducing salt in savory products often requires potassium chloride, which imparts strong metallic notes and off tastes. Taste modifiers can mask these too.”

FMPs also help F&B formulators with mouthfeel challenges in low-sugar shakes, which can be  less thick and creamy. 

“But some flavor modifiers enhance mouthfeel, by increasing the perceived body in sugar-reduced beverages, for example, or masking astringency and metallic notes in the presence of natural sweeteners,” he adds.

FMPs also target “passive health” or the lowering and removal of “unhealthy” ingredients from recipes, he adds.

As consumer awareness rises, unrecognizable ingredients are "out of favor" with them.D’Hoore also points to active health or the fortification of foods with vitamins, minerals, proteins or botanicals as another area with taste challenges which FMPs can help address.

Pushing for healthier F&B
Amid the regulatory approvals for taste modifiers, D’Hoore believes the clean label trend is pushing innovation in the segment.

“Artificial additives with unrecognizable names, whether they’re sweeteners, preservatives, flavor enhancers or anything else — are firmly out of favor with consumers. And so formulators are seeking more “natural” alternatives.”

For instance, sugar, which has been used safely for thousands of years, is also “incompatible with both modern lifestyle choices,” where consumers are cutting calories and policies. This has led to governments and NGOs pushing for healthier food and drink formulation,” he concludes.

By Insha Naureen