Regulator approves alternative proteins, but you can't try them yet

Prof. Tamir Tuller and Dr. Eyal Afergan  credit: Eyal Izhar
Prof. Tamir Tuller and Dr. Eyal Afergan credit: Eyal Izhar

As ImaginDairy becomes the third alternative protein producer to receive regulatory approval in Israel, why are promising food technologies finding it hard to get onto market shelves?

Dairy product alternatives company ImaginDairy has received regulatory approval from the Israeli Ministry of Health to market factory-produced beta-lactoglobulin (BLG), an animal-free whey protein. This is the third approval given in Israel for an alternative protein, preceded by ReMilk, which also produces BLG, and cultured meat producer Aleph Farms. All three Israeli companies have yet to see their products reach the market.

ImaginDairy was founded by its CEO Dr. Eyal Afergan, together with Dr. Arie Abo, within the framework of The Kitchen Foodtech Hub, an Israel Innovation Authority incubator founded in collaboration with Strauss Group. Since its inception, ImaginDairy has raised approximately $30 million from investors such as Target Global, MoreVC, Entree Capital, PeakBridge VC, FoodSparks, and multinational food company Danone. It employs dozens of workers in Haifa.

The company produces milk proteins from fungi that have been genetically engineered to express the whey protein. The microorganisms are placed in fermentation tanks where they breed, and produce the whey protein along with other substances. The protein extracted from the mixture created in the fermentation tanks can be added to food products, replacing animal-based milk proteins.

The goal, the company says, is to "enable food companies to produce substitute products for dairy products coming from cow's milk, with distinct advantages: cholesterol- and lactose-free, for example, and also environmentally friendly."

"We took a significant step"

In January of this year, ImaginDairy announced it had received FDA approval to market its product in the US, was negotiating contracts with several companies, and was setting up a production plant. "The existing agreements with food companies are confidential, and we are therefore unable to provide details at this time," the company told "Globes." "We are the full owners of dedicated production lines on an industrial scale, and we are the first company to achieve this in our field."

The company has not yet announced a product that has gone to market, but says it already has additional products in the pipeline that it has not yet revealed. When will it be possible to taste the product? The company says, "It’s now possible to taste products in our laboratories, such as cheeses, yogurt, ice cream and more. The regulatory approval is a significant step forward towards full commercialization of the product in the Israeli market."

ImaginDairy is among the technological leaders in alternative whey proteins. Like other companies in a sector that promises a new era for the food market, it faces commercialization challenges related to the ability to scale-up production while maintaining parameters such as materials cleanliness and stability, along with reasonable pricing.

What does regulatory approval mean if there’s no product yet? "This means there’s nothing on the health level that is currently preventing these products from reaching market shelves, only a commercial limitation," says Dr. Ziva Hamama, Head of the Food Risk Management Department at the Ministry of Health, who signed the approvals granted so far in Israel.

Commercially, ImaginDairy’s leading competitor is US-based Perfect Day, which has raised about $840 million to date, and whose protein is used in ice cream, chocolate, and cheese products. In January 2024, it reported that it was "moving to focus on executing scaled manufacturing", meaning that apparently its products are not yet produced in the quantity and at the price that would allow it to exploit the market’s full potential.

"We realized something was going on"

Until the foodtech era, Dr. Hamama was more or less alone in the Food Risk Management Department, but around the end of 2020, she understood there were new foods that needed a different approach. "We realized something was happening here that was going to change the world of food fundamentally," she says

At that time, several new food producers were already operating in Israel, with alternative proteins such as cultured meat, cultured milk, honey produced in artificial beehives, confectionery products made from unfamiliar raw materials, and more.

"We decided to create a 'sandbox' to test these new technologies, pilots that would allow companies to consult with us frequently," Hamama says. To this end, five more employees were hired for her department. The Ministry has a mandate to allocate regulatory approval of products independently of approvals issued by colleagues in other countries.

What are some of the concerns when testing a new food product?

Hamama: "Whey protein production utilizes microorganisms (for example, fungi or yeasts), to express a desired protein. This microorganism lives its life, and among other things it produces the substance we want, as well as other substances. So, one of the important things is to understand what the microorganism is, which substances we allow it to eat so that it grows, while making sure that the other substances it secretes aren’t toxic. We also make sure not to give blanket approval for use. We approve use of certain products in limited amounts."

How to label a new food

The company produces proteins that are a part of milk, but not all of it. How will they be marked for allergy warning purposes?

"This is an important issue. Consumers need to know what exactly they’re allergic to, and we need to label the products so that they know what’s in them. I estimate that we’ll first label each whey protein, so that those who are allergic to milk will understand that they may be in danger, and gradually people will learn to look for exactly which protein is in the product And if they are allergic to it, we also have to convey all information about the production method, so that people know if it is suitable for them in terms of vegetarianism, veganism, and kashrut."

Labeling cultured meat sounds more complicated.

"In this case, we check the source of the cells. We make sure the cells were taken from a healthy animal that was under veterinary supervision, and we also check the conditions under which the cells were kept, what food was given to cause them to multiply, and that no abnormal levels of food residue remained in the final tissue."

Some published papers claim that it’s necessary to examine whether cells growing under stressful conditions do not secrete histamines or growth factor substances that can be dangerous for certain people.

"Histamine poisoning is mainly linked to fish, and there is clear legislation that refers to the maximum levels permitted. Growth factors are secreted by the animal, and are therefore naturally present in conventional products."

Could, for example, a cancerous process develop in lab-grown cells that would endanger anyone eating that sort of tissue?

"We have no known reason to fear that consuming such cells would make one sick. But in any case, we examine the lab-grown tissue under a microscope to make sure the cells are growing according to expectations. Specifically, distorted proteins such as prions, which caused mad cow disease, are more likely to appear in a living body than in a controlled growth in the laboratory."

Published by Globes, Israel business news - en.globes.co.il - on November 28, 2024.

© Copyright of Globes Publisher Itonut (1983) Ltd., 2024.

Prof. Tamir Tuller and Dr. Eyal Afergan  credit: Eyal Izhar
Prof. Tamir Tuller and Dr. Eyal Afergan credit: Eyal Izhar
Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018