BOSTON —Global regulatory changes, particularly in the United States, are forcing food and beverage companies to analyze how they formulate products, including ingredient choices for colors, sweeteners and preservatives. A June 18 webinar from Boston-based Lux Research, Inc. gave insights on making those choices.

While the European Union generally has stronger ingredient laws, regulatory action has ramped up in the United States this year. The Department of Health and Human Services directed the Food and Drug Administration to explore rulemaking to stop self-affirmed generally recognized as safe (GRAS) pathways for new food ingredients. The HHS and the FDA announced plans to phase out petroleum-based synthetic dyes, and the Make America Healthy Again Commission released its report criticizing ultra-processed foods.

“What it really underscores, with all these developments, is really how rapidly policy is becoming a central force in building your ingredient strategy,” said Harini Venkataraman, PhD, associate research director for Lux Research, who added, “I think the US is becoming more like an EU.”

While startups face increased regulatory challenges in the United States, Asia Pacific has become a “hot spot” for startups thanks to feedstock availability and favorable regulations, according to Lux Research.

Elnaz Shabani, PhD, an analyst for Lux Research, said industry is dealing with a fractured regulatory world.

“Your strategy has to reflect that,” she said. “What works in one region may not work in another region.”

She added, “Global regulatory harmonization is kind of dead now, and companies need to really realize that and create their model based on that. Agility is now really important.”

Companies should keep track, either in-house or by employing a third party, on country-specific regulatory actions, she said.

Companies should follow a dual strategy, Shabani said. An example of a short-term strategy would be working with plant extracts already available, even though they may bring issues with heat stability and pH stability, to replace synthetic dyes as food coloring. A long-term strategy would be exploring how advances in precision fermentation may assist in developing colors to replace synthetic dyes.

Plant extracts are available to replace synthetic dyes as food coloring, but they may bring issues with heat stability and pH stability.

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“A lot of these technology categories, they are good at meeting the functionality needs for these colorants, but they are still under a lot of scrutiny around regulations, and costs in scaling up is also a challenge for them,” Shabani said.

Investments are needed in emerging technologies. Shabani pointed to Rich Products Ventures, the corporate venture capital fund of Rich Products, investing in Phytolon, an Israeli biotechnology food technology startup that is producing naturally sourced colors through precision fermentation.

In sweeteners, research has declined recently for newer options such as sweet proteins and rare sugars because problems have arisen in scaling up supply and dealing with regulatory issues, Shabani said.

“This is not because the interest is fading,” she said.

She pointed out that Ingredion, Inc. and Oobli have formed a partnership to accelerate production of healthier sweetener systems. Oobli sweet proteins brazzein and monellin, which are derived from precision fermentation, may be combined with stevia-based sweeteners from Ingredion. Shabani said two points stand out in the Ingredion-Oobli partnership: Precision fermentation is in the commercial deployment phase, and blended sweetener systems are becoming more prominent.

In preservatives, Shabani pointed to Corbion’s Verdad Essence WH100 based on a cultured wheat-based mold inhibitor for baked foods. The ingredient is clean label in that it does not need a preservative name, she said. Edible coatings and active packaging also may add to a product’s shelf life. Established players like Corbion and Cargill are active in the preservative category, Shabani said.

“Very few startups are active in this space,” she said.