3 September 2024
Agronomics Ltd
("Agronomics" or the "Company")
Solar Foods obtains Self-Affirmed GRAS status for Solein® in
Agronomics (LON:ANIC), a leading listed company in the field of cellular agriculture, is pleased to report that its portfolio company Solar Foods Oyj ("Solar Foods") has announced that it has obtained self-affirmed Generally Recognized as Safe ("GRAS") status in the US for the sale of its single-cell protein, Solein®.
Solein, produced by Solar Foods, is a novel food requiring regulatory approval in most markets before it can be sold and used in food and beverages. To achieve GRAS status, Solar Foods has conducted large-scale scientific research, and the results pertaining to food safety have been published in peer-reviewed scientific journals. Additionally, a qualified panel of experts has compiled a statement on the product's safety and intended use based on determined food categories and Solein concentrations.
Achieving GRAS status is a major step towards Solein's commercialisation and entry into the US market. This is the second approval Solar Foods has secured after the sale of food products containing Solein was approved in
The next step for commercialising in the US involves registering the Solar Foods production facility, Factory 01, with the US Food and Drug Administration ("FDA"), which requires a food safety plan fulfilling specific regulatory requirements. This will enable Solar Foods to start exporting products from Factory 01 in
Solar Foods also aims to obtain FDA-Notified GRAS status, which entails receiving a No Questions Letter from the FDA. FDA-Notified GRAS status is likely to broaden the list of potential customers given that many will require this status to introduce foods and ingredients into product lines. Solar Foods estimates it will obtain the No Questions Letter by the end of 2026.
Chief Commercial Officer, Juan Benitez-Garcia at Solar Foods said:
"Obtaining self-affirmed GRAS status is the first step towards entering
Jim Mellon, Co-Founder and Executive Chair of Agronomics, said:
"We are delighted that Solar Foods has successfully achieved another significant milestone in the approval process for the commercialisation of Solein. The US regulations for food safety are both stringent and well respected globally and this approval is likely to aid the company in achieving regulatory approval in other jurisdictions. This landmark accomplishment indicates the company is on track to soon deliver products directly to customers and key retail suppliers in one of the world's largest markets.
As Agronomics' portfolio matures, we look forward to seeing other companies gain approval for their respective products in jurisdictions around the world"
For Solar Foods' full press release please see the following link: https://solarfoods.com/solar-foods-obtains-self-affirmed-gras-status-for-solein-in-the-united-states/
About Solein®
Solein is an all-purpose protein grown with the air we breathe: The unique bioprocess takes a single microbe, one of the billion different ones found in nature, and grows it by fermenting it using air and electricity. Solein is a nutritionally rich and versatile ingredient which can replace protein in virtually any food. Solein can also be used as a fortifier to complement the nutritional profile of various foods: it can be a source of iron, fibre and B vitamins, and it can also bring different techno-functionalities into food products. Solein is suitable for any food or product, regardless of diet. Learn more about Solein at www.solein.com.
Solar Foods produces protein using carbon dioxide and electricity. Solein production, irrespective of weather and climate conditions, liberates global protein production from the constraints of traditional agriculture. Solar Foods, founded in 2017 in Espoo,
About Agronomics
Agronomics is a leading
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