Updates on China’s Regulation of Food Ingredients and Additives
China has recently announced various developments regarding food ingredients and additives, as well as health food ingredients. For example, the authority proposed an amendment to the standard on nutrition fortification substances, which are regulated as food additives in China. In addition, to help the industry better understand the status of approved food ingredients and food additives, China National Health Commission (NHC) introduced a catalogue of “Three New Foods” which compiles the approvals of 98 new food ingredients and 215 new food additives that were published during 2009 to 2021. Further, given the nation’s commitment to promoting its management of health foods, China also updated its regulation of health food ingredients.
The following is a summary of the recent regulatory developments in China on food ingredients and additives in the past few months.
- Draft Standard on Nutrition Fortifiers Re-open for Consultation
On July 31, 2023, China National Center for Food Risk Assessment (CFSA), for the second time, solicited public comments on GB 14880-202x National Food Safety Standard for Use of Nutrition Fortification Substances (“GB 14880”). This follows on CFSA’s first draft release of GB 14880 for public consultation this past January. More details of the January draft can be found in our CRM – China Announces Draft Standard on Nutritional Fortification Substances: What Will its Impact Be on Alternative Protein Foods?
By way of background, China regulates nutrition fortification substances as food additives. The revision of GB 14880 will impact both domestic and overseas producers of foods and food additives, as the use of all nutrition fortification substances in food products distributed in China must comply with this Standard.
As a follow-up to the introduction of “mass food fortification” and “voluntary food fortification” in the first draft of GB 14880, the second draft updates the fortification requirements per these two food categories. For example, “fermented milk” and “flavored fermented milk” are now removed from food categories involved in mass food fortification. L-Lysine, γ-linolenic acid, casein calcium peptide, and casein phosphopeptides are added as four optional nutrition substances for mass food fortification. With respect to voluntary food fortification, the second draft of GB 14880 encourages the selection of food carriers in line with the Dietary Guidelines for Chinese Residents and other nutrition policy documents. For instance, the fortification levels of Vitamin D, Vitamin E, and Vitamin K in modified milk powder (milk powder for children), biscuits, and vegetable protein beverages have been adjusted in order to better align with the levels recommended in the dietary guidelines.
Compared with the first draft in which a food category of “04.04.01.05 – novel bean products (soybean protein puffed food, soybean vegetarian meat, etc.)” is newly proposed, the second draft further specifies nutrition fortification substances permitted therein, e.g., Vitamin A, Vitamin D, Vitamin E, Vitamin K, Vitamin B1, Folic Acid, Iron, Calcium, Zinc etc.
To achieve the goal of “Three Reduction Three Healthy,” confectionaries in the draft GB 14880 refer to three sub-categories which are “sugar free confectionaries,” “chewing gum,” and “other confectionaries.” While more nutrients are allowed to be fortified in confectionaries in general, some of the more water-soluble vitamins are allowed in “sugar free confectionaries.” Sources of fructo-oligosaccharides are now expressly prescribed as “including chicory, Jerusalem artichoke, and sucrose.” Further, the use of nutrition fortification substances in beverages and jelly have been revised for safety risk assessment, their approval status in other standards, as well as their base values in food and international practice.
Annex E is newly incorporated in GB 14880 to prescribe allowed amino acids in food for special dietary purposes (e.g., infant formula food, supplementary food for pregnant and lactating women, sports nutrition food) and their corresponding compound sources.
- Approvals of “Three New Foods” Compiled in Catalogue
In May 2023, NHC, via Announcement No. 4 of 2023, published a catalogue of “Three New Foods” (“Catalogue”), which compiles the approvals of 98 new food ingredients and 215 new food additives that were published during 2009 to 2021. This comprehensive catalogue can be a useful tool to identify applicable safety standards for separately approved food ingredients and food additives. By releasing this Catalogue, the Chinese government aims to provide more clarity on “Three New Foods” in terms of their specification requirements as well as the corresponding inspection methods.
Compared with the original government approvals, the newly released Catalogue sets forth additional safety indicators for some of the new food ingredients, including lead (Pb), total arsenic (As), peroxide value, fungal toxins, contaminants, and microbial limits.
Notably, if a new food ingredient is designated as being governed by an existing national food safety standard, such as edible fungi, edible algae, seasonings, etc., it is required to comply with the food safety indicators specified in the standard. As an example, Nannochloropsis gaditana, which was approved as a new food ingredient through NHC Announcement No.5/2021, must comply with the safety indicators outlined in the national food safety standards for algae and its products in China. Also, ingredient specifications stated in the original government announcements, such as those on the origin species, edible amount, methods of consumption, production processes, fermentation strains, etc., remain effective. China grants an 18-month transitional period for new food ingredients listed in this Catalogue to comply with prescribed requirements.
Furthermore, the Catalogue provides a list of new food additives approved since 2009 and clarifies corresponding standards. Specifically, for food additives subject to established national food safety standards, they must adhere to requirements specified in pertinent standards. For those not subject to any existing national food safety standard, they will continue to be governed by specifications prescribed in the original announcements until corresponding food safety standards are developed.
- Catalogues of Health Food Ingredients Expanded
Health food is governed by a set of rules separate from those applying to conventional food in China. This summer, the Chinese food agencies made progress to update China’s regulation of health food ingredients.
More specifically, four catalogues of health food ingredients were published at the end of June 2023 by the Chinese State Administration Market Regulation (SAMR), jointly with the NHC and the National Administration of Traditional Chinese Medicine. These catalogues expand the list of cleared ingredients in nutrition supplements, and prescribe the use conditions and specifications for various substances used in health foods.
Of particular note, the Catalogue of Health Food Ingredients – Nutrition Supplements (2023 Edition) has been updated to include docosahexaenoic acid (DHA), “casein phosphopeptide + calcium,” and hemin chloride. It also updates the standard basis for some health food ingredients and compounds. The Catalogue of Allowed Health Function Claims of Health Food – Nutrient Supplements (2023 Edition) is added with the health function of supplementing n-3 polyunsaturated fatty acids with corresponding function interpretation. The Catalogue of Health Food Ingredient Soybean Protein Isolate and Catalogue of Health Food Ingredient Whey Protein stipulate the ingredient name, daily dosage, suitable and unsuitable consumer groups, corresponding efficacy, and technical requirements, etc. for these two ingredients. In addition, on August 31, 2023, SAMR published a range of long-awaited new regulations for health foods. We will report on these new regulations, as they will benefit industry in various ways, e.g., industry can apply for new health claims other than the ones on the positive list.
If you have any questions or need further information on the regulatory requirements for food ingredients and food additives in China or would like to submit approvals for new food ingredients or additives, please do not hesitate to contact David Ettinger (firstname.lastname@example.org), Jenny Li (email@example.com), Yin Dai (firstname.lastname@example.org), or your existing contact at Keller and Heckman LLP.
 “Three New Foods” in China refer to new food additives, new food ingredients, and new food contact materials.
 “Mass food fortification” is the action of adding one or more micronutrients to specific foods that are widely consumed by the public (e.g., pasteurized milk, sterilized milk, vegetable oil, rice, wheat flour, and soy sauce) which is usually organized and implemented by the government.
 “Voluntary food fortification” refers to the action of adding micronutrients and (or) other nutritional components to foods other than mass food fortification, which is usually at the discretion of the food producer.
 “Three Reduction Three Healthy” is a concept raised in the National Nutrition Plan (2017-2030) of China, which refers to “reduction of fat, salt and sugar,” and “healthy oral cavity, weight, and bones,” respectively.
 Industry can apply for approvals of new food ingredients and food additives through filing applications with the National Health Commission in China (NHC). NHC will issue announcements upon their approvals of the new ingredients/additives in which product specifications will be provided.