Key FAQs on New Food Raw Materials in China

Food raw materials have complex compositions with varied extraction methods. The management of food extracts is typically handled on a case-by-case basis. 

Substances listed in the Catalogue of Substances Traditionally Considered as Both Food and Chinese Medicine may undergo simple water extraction during food production, provided this process does not alter the fundamental properties of the substance. The concentrated liquids, extracts, and powders obtained through methods like freeze-drying, spray drying, vacuum drying, or hot-air drying can then be used as raw materials in food products. However, the quantity used must align with the traditional usage levels of the corresponding substance, after conversion.

For specific guidance on whether a particular item can be used as a food raw material, please refer to the Explanation on New Food Raw Materials, Common Food, and Health Foods issued by the National Health and Family Planning Commission (NHFPC), now replaced by the NHC.

The production and use of new food raw materials should be consistent with the details in the announcement.

Currently, when reviewing applications for new food raw materials with different appearances, the safety review process has been expanded to include a more inclusive review of these varying appearances. As long as safety is ensured, the announcement should cover these differences as comprehensively as possible.

For example, certain appearance requirements, such as for Lepidium meyenii Walp, are accepted even if the product has undergone simple physical processing (e.g., slicing, drying, or grinding) that did not alter the basic substance. As long as the safety of the product is guaranteed, these variants are considered within the scope of the announcement.

Yes, companies should strictly adhere to the recommended consumption amounts, usage ranges, and maximum usage limits for new food raw materials as outlined in the announcement. Regulatory authorities are responsible for ensuring company’s compliance with these requirements. Consumers are also advised to follow the recommended consumption levels provided in the announcement.

The recommended consumption amounts, usage scopes, and maximum usage limits are based on available data, including population consumption patterns, toxicological studies, nutritional and physiological research, as well as international approval standards. These requirements are determined through safety assessments and technical reviews. Under these established requirements, public health can be adequately protected.

There are two main scenarios for converting the recommended consumption amount of new food raw materials:

Scenario 1: No Specific Component

If the new food raw material contains no specific component, the recommended consumption amount does not need conversion; if contains multiple components or mixtures without a clearly defined characteristic component, the recommended consumption is simply the approved amount for the product where no concentration conversion is necessary. Examples include tomato seed oil, acer truncatum bunge seed oil, peony seed oil, elaeagnus mollis diels oil, and chlorella pyrenoidesa.

Scenario 2: Specific Component Presents

When there is a specific component, the recommended consumption must be converted. This can be broken down into two cases:

Recommended Consumption Calculated Based on a Particular Component: If the announcement specifies the recommended consumption based on a particular component, the consumption amount refers to that specific component. When using a new food raw material that meets the quality specifications in the announcement, the recommended consumption should be converted based on the actual concentration of that component.

The following table showcases an example regarding DHA algae oil:

Recommended Consumption Calculated Not Based on a Particular Component: If the announcement does not specify the recommended consumption based on a particular component, and the product's name or naming is based on a specific component with quality specifications for that component, but the recommended consumption is not based on the component, then the announced recommended consumption is for the minimum quality requirement. Anything above this should be converted based on the actual content of that component. Examples include theanine, lutein esters, gamma aminobutyric, hyriopsis cumingii polysacchride, etc.

The following table showcases an example regarding tea with 40% theanine content.

According to the GB 13432-2013 Labeling of Prepackaged Foods for Special Dietary Uses, foods for special dietary uses refer to foods that are specially processed or formulated to meet special physical or physiological conditions and (or) meet special dietary needs of people with diseases and/or disorders. These include formula for infants and young children, complementary foods for infants and young children, foods for special medical purposes, and other foods for special dietary uses, such as sports nutrition foods.

New food raw materials approved for use in foods for special dietary uses can be used as raw materials for these products, provided they meet the relevant standards and regulations. If the approved scope of a new food raw material does not explicitly cover foods for special dietary uses, it must still be in line with the applicable standards and requirements governing such foods.

For new food raw materials approved for use in beverages, the recommended maximum usage in concentrated beverages can be converted to liquid volume equivalents. For example, the maximum usage amount of dihydroquercetin in beverages is 20 mg/L. If used in solid beverages, the dosage should be adjusted based on the reconstituted liquid volume.

For new food raw materials approved for use in dairy products, if added to milk powder, the milk powder should be converted to liquid milk at a ratio of 1:8 (w:w) to calculate the daily intake. For instance, sodium hyaluronate is approved as a new food raw material for use in dairy products, with a maximum usage limit of 0.2 g/kg in these products. Milk powder should be converted to liquid milk at a 1:8 ratio (w:w).

Infants and young children (婴幼儿) are defined as individuals aged 0 to 36 months (inclusive of 36 months). The terms "children"(儿童), "juvenile children"(少年儿童), and "children under 14 years old" all refer to the same group, generally encompassing those aged 3 to 14 years (excluding 3 years old but including 14 years old).

Currently, both international and national standards do not provide a precise definition of "food for infants and young children"(婴幼儿食品). In China's GB standards, it refers to formula for infant and young children and complementary foods for infants and young children.

In the context of the new food raw material announcement, "not allowed for use in foods for infants and young children" means the food raw material cannot be used in formula for infant and young children and complementary foods for infants and young children. "Not suitable for infants and young children" indicates the product must be labeled as inappropriate for this age group. The two situations are different.

Currently, there are no internationally or domestically standardized methods or criteria for assessing strain consistency. Strain identification typically involves a comprehensive evaluation of phenotypic characteristics, genetic data, and the strain’s origin. Several genetic identification techniques, such as average nucleotide identity (ANI) from whole-genome sequencing, single nucleotide polymorphisms (SNPs), and multi-locus sequence typing (MLST) of core genes, are widely accepted in the scientific community for determining strain consistency.

The bacterial cultures in the List of Bacterial Cultures Permitted in Food are generally permitted for use in common foods, except foods for infants and young children. For those with specific usage restrictions, the corresponding announcements should be followed, and the usage scope must be clearly stated on the labels and instructions. The bacterial cultures in the List of Bacterial Cultures Permitted in Baby foods are allowed for use in foods for infants and young children unless otherwise noted.

According to NHFPC's No. 3 Announcement in 2013, substances derived from edible animal or plant proteins and hydrolyzed through food-grade enzymes permitted by GB 2760 Standard for Uses of Food Additives, are considered as common food. Since the release of this announcement, the authority will no longer accept applications for the approval of the above substances as new food raw materials.

Edible animals or plants refer to those managed as common food. For protein produced from the hydrolyzation of new food raw materials using allowed food-grade enzymes, any unsuitable population should align with that of the new food raw material. The recommended intake should be calculated based on the protein content of the new food raw material. Both the unsuitable population and recommended intake must be labeled as required by the original announcement.

Examples of food raw materials that were approved prior to this include bonepep, corn oligopeptides powder, wheat oligopeptides, etc., which are derived from edible animal or plant proteins and hydrolyzed using food-grade enzymes permitted by GB2760. They are classified as common food according to NHFPC's No. 3 Announcement in 2013.

Ginseng (manually planted for 5 years or less) has been approved as a new food raw material in 2012, with specific requirements regarding its Latin name Panax Ginseng C.A. Meyer, recommended intake, and unsuitable populations. According to the Pharmacopoeia of the People's Republic of China (2020 edition), red ginseng is a processed form of ginseng that has been steamed and dried. Red ginseng made from ginseng compliant to its requirements, can be used as a food raw material, subject to the same usage and safety requirements as ginseng.

Yellowhorn seed kernel was approved as a new food raw material in 2023, with specific requirements regarding unsuitable populations. Since shiny-leaved yellowhorn oil has a long history of consumption and the National Food and Strategic Reserves Administration has issued an industry standard for it (LS/T3265-2019), shiny-leaved yellowhorn oil is no longer subject to review and is managed as a common food.

Galacto-oligosaccharides (GOS) were approved as a new food raw material in 2008, with clear requirements on its basic characteristics, production process, usage, recommended intake, and quality standards.

GB 14880-2012 Standard for the Use of Nutritional Fortification Substances in Foods sets specific limits on the usage and recommended amounts of GOS as a nutritional fortification substance. 

In 2017, the NHC approved GOS (sourced from whey permeate) for use as a nutritional fortification substance, with the same usage range and quantity limits as GOS derived from lactose, as outlined in GB 14880.

In 2019, the NHC approved the use of GOS (sourced from whey permeate) as a nutritional fortification substance in modified milk powder (only for the milk powder for children), with a maximum usage of 64.5 g/kg.

When used as a nutritional fortification substance, GOS must comply with the requirements of GB 14880. When used as a new food raw material, it must be in line with the relevant regulations outlined in the approval announcement of the new food raw material.