ZMUni Compliance Centre

On August 26, 2024, the National Center for Food Safety Risk Assessment of China released a collections of FAQs, addressing common questions about "Three New Foods" and food-drug substances. The collection highlighted key issues related to 25 new food ingredients, new varieties of food additives, and food-drug substances.

ZMUni Compliance Centre has selected a few typical issues from the collection to share here, aiming to assist international stakeholders looking to enter the Chinese market.

Q1: What are "Three New Foods" and How Does China Manage Them?

A: As defined in Article 37 of the Food Safety Law, "Three New Foods" includes:

China implements an administrative licensing system for "Three New Foods." Companies using new food ingredients or producing new food additives and food-related products must submit safety assessment materials to the health administrative department of the State Council.

The National Health Commission (NHC) of China oversees this licensing process, with the China National Center for Food Safety Risk Assessment (CFSA) handling technical evaluations.

Q2: How are new food ingredients and food-drug substances defined and managed?

A：New food ingredients are defined under Administrative Measures on Safety Examination of New Food Ingredients as items without a traditional consumption history in China, including:

l Animals, plants, and microorganisms;

l Components isolated from these sources;

l Food components with altered structures;

l Other newly developed food materials.

Microorganisms approved as new food ingredients will be included in the List of Cultures Available for Food and the List of Cultures Available for Infant and Young Children’s Food.

Substances traditionally recognized as both food and Chinese medicine are those that have historically been used as food and are included in the Pharmacopoeia of the People's Republic of China. Substances that meet the requirements outlined in the Administrative Measures for the List of Substances Traditionally Considered as Both Food and Chinese Medicine will be published China NHC and the Chinese State Administration for Market Regulation (SAMR) and can be used in food production according to regulations.

Q3: Can Food Extracts Be Used as Food Ingredients?

A: Food extracts have complex compositions and varied extraction processes, and their management is handled on a case-by-case basis. The use of new food ingredients should comply with official announcements of "Three New Foods".

Q4: Are the Recommended and Maximum Usage Limits for New Food Ingredients Mandatory?

A: The recommended intake, usage scope, and maximum limits for new food ingredients are based on consumption data, toxicological studies, and research on nutritional effects, along with international approvals. These limits are established through safety assessments to ensure public health.

Companies must strictly adhere to the specified intake and usage limits, while regulatory authorities will oversee compliance. Consumers are advised to follow the recommended intake outlined in the announcements.

Q5: Can New Food Ingredients Be Used in Special Dietary Foods (Including Sports Nutrition Foods)?

A: According to the National Food Safety Standard Labeling of Prepackaged Foods for Special Dietary Uses (GB 13432-2013), special dietary foods are designed to meet specific physical or physiological conditions and to address dietary needs related to diseases or disorders. Main categories include infant formula, complementary foods for infants, foods for special medical purposes, and other special dietary foods (including sports nutrition foods).

New food ingredients listed in official announcements can be used as sources for special dietary foods. Their usage must comply with relevant standards and regulations. Food production and operations should strictly adhere to applicable laws, regulations, standards, and announcements.

New food ingredients that have been approved with use in special dietary foods may be used as ingredients for special dietary foods, provided they comply with relevant standards and regulations.

Q6: What is the Definition of Infants and Children in New Food Ingredient Restrictions?

A: In announcements for new food ingredients, terms like "infants," "children," "young children," and "children under 14 years old" are used. Infants are defined as those aged 0-36 months (including 36 months). "Children," "young children," and "children under 14 years old" refer to the same group, typically those aged 3-14 years (excluding 3 years, but including 14 years).

Q7: Can Protein Hydrolysates be Used as Food Iingredients?

A: According to Announcement No. 3 (2013) from the former National Health and Family Planning Commission in China, substances made from edible animal or plant proteins, hydrolyzed using food enzymes permitted by National Food Safety Standard Standard for Uses of Food Additives(GB 2760), are classified as regular food. If the protein comes from a new food ingredient, the restrictions for unsuitable consumers should align with the original ingredient, and the recommended intake should be calculated based on its protein content, labeled accordingly.

Examples include hydrolyzed egg yolk powder, corn oligopeptide powder, and wheat oligopeptide, all compliant with these regulations and managed as regular food.

Q8: Determination of Strain Consistency

A: Currently, no standard methods or criteria for determining strain consistency have been established by relevant institutions, either domestically or internationally. Strain identification requires a comprehensive assessment based on phenotype, genetic data, and strain origin. Various genetic identification methods are available, such as Average Nucleotide Identity (ANI), Single Nucleotide Polymorphism (SNP), and core gene Multilocus Sequence Typing (MLST), all of which are widely recognized in the scientific community for strain-level identification.

Food compliance is crucial but can also be quite challenging. To address these complexities, ZMUni Compliance Centre offers one-stop solutions, covering new food ingredient application, new food additives application, pet food compliance, food clearance services and etc. If you require any assistance with these services, feel free to contact us at info@zmuni.com.