당사가 지난 2023년 11월, 캐나다 정부(Health Canada, Health Products and Food Branch)에 제출한 헬스케어 신소재 다인나오의 NF(Novel Food, 신규 식품 소재) 신청을 엄격한 심사를 거쳐 특별한 이의 없이 수리하였다고 2025년 2월 6일 부로 통보 받았습니다.

Subject: Novel food submission 2023-090475 - Dyne Bio Neoagarooligosaccharide (Dyne-NAO®) as a food ingredient to be added to meal replacement products

This correspondence is in response to your Novel Food premarket notification dated November 26, 2023, concerning Neoagarooligosaccharides (Dyne NAO®) as a novel food in Canada.

Evaluators of the Food and Nutrition Directorate have reviewed the information provided by AceOne RS, Inc. (on behalf of Dyne Bio Inc.) for assessment of the acceptability of Dyne NAO® for human food use in Canada.

According to the submitted information, Dyne NAO® is manufactured from food grade agar through enzymatic hydrolysis using β-agarase DagA derived from Streptomyces coelicolor A3(2) M22-2C43. Dyne NAO® is composed of >90% carbohydrates, of which >69% in non-digestible. Approximately half (>45%) of the carbohydrate content of the Dyne NAO® preparation is made up of neoagarotetrose (NA4) and neoagarohexose (NA6) at a ratio of 1.1~1.4. The remainder of the carbohydrates are higher molecular weight neoagarooligosaccharides, and other smaller carbohydrates, including neoagarobiose (NA2). The preparation also consists of proximates (ash, moisture, crude protein, crude fat, ~9%) and naturally occurring minerals (<1.5%). The final Dyne NAO®, after filtration and concentration, is a spray-dried powder.

Dyne NAO® is intended for use in meal replacement products at a maximum of 7 grams per serving.

Based on our evaluation of the submitted data, the Food and Nutrition Directorate has no objection to the use of Dyne NAO® as an ingredient in meal replacement products in Canada.

(이후 내용 생략)

Director General

Food and Nutrition Directorate