On September 8, 2022, China’s National Health Commission (NHC) published on its website 18 draft National Food Safety Standards (GB standards) in relation to food additives for public comment.[1] These include the following Standards:

Food Additive N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-L-α-aspartyl]-L-phenylalanine 1-methyl ester

Food Additive 5-Phenyl-3H-furan-2-one

General rules for the use of food additives (GB2760)

Food Additive Enzyme preparation for food industrial use

Food Additive Pentaerythritol ester of wood rosin

Food Additive Morpholine fatty acid salt (fruit wax)

Amendment No. 1 of GB 1886.100-2015 Food Additive Disodium ethylene-diamine-tetra-acetate 

Amendment No. 1 of GB 29209-2012 Food Additive Sodium sulfate

Amendment No. 1 of GB 1886.43-2015 Food Additive Calcium ascorbate

Other than GB2760, which is a national standard in China to provide the requirements for the use of food additives, the remaining standards are the ones that address the technical specifications of the food additives. Specifically, NHC proposes to create mandatory standards for food additives, including N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-L-α-aspartyl]-L-phenylalanine 1-methyl ester, 5-Phenyl-3H-furan-2-one, quillaia extract, iron tartrate, sodium formate, and theaflavins, which detail requirements on raw materials, sensory test, as well as physiochemical specifications. Accordingly, food additives sold in China must comply with such requirements once these standards are finalized.

Moreover, the draft standard, i.e., Food Additive Enzyme Preparation for Food Industrial Use, will replace existing GB standards on food enzymes (GB 1886.174-2016).[2] Compared with GB 1886.174-2016, the draft includes terms and definitions of “excipients for food enzyme use” and “enzyme immobilization,” and establishes a list of excipients permitted for use in food enzymes, under which 97 substances (e.g., citric acid, lactic acid) can be used as excipients for enzyme preparations.

For the national standard for food additives -- GB2760, the following major changes are proposed in the draft amendment:

β-carotene and diacetyl tartaric acid mono- and di-glycerides as permitted food additives in distilled spirits; and 

Azocarboxamide for use in wheat flour.

It also adds a new warning requirement for food using excessive polyol(s) in its production that may cause diarrhea. However, the specific use level of polyol(s) that could trigger the additional labeling obligation is not yet specified in the draft standard. That is to say, if the use level of polyols in the finished food remains low, special on-pack warnings may not be required. As of now, NHC has not revealed the language that shall be used for the warning. It is expected that further details will be made available in subsequent guidance documents. 

All stakeholders that wish to comment on the draft food additive standards shall submit their suggestions to NHC by October 10, 2022.

David Ettinger joined Keller and Heckman in 1999. Mr. Ettinger represents domestic and foreign corporations in the area of food and drug law.

Mr. Ettinger relocated to Keller and Heckman's Shanghai office in November 2012 to focus on the Asian market and counsel companies in the Far East on food, drug, and chemical regulatory matters. He has extensive experience counseling clients on product development and product protection of food and drug packaging in the United States, Europe, Asia, Canada, and South America. From 2006-2007, Mr. Ettinger...

Jenny Li joined Keller and Heckman in October 2007.

Ms. Li counsels clients on regulatory issues focusing on food and drug, with an emphasis on regulatory regimes in the Asia-Pacific region. She also counsels clients on food labeling, food claims, food additives, as well as, important issues regarding food imports in Asian countries.

Yin Dai joined Keller and Heckman in 2013.  She is a paralegal in the food and drug practice area. She monitors developments impacting the regulations of food, food packaging, drugs and medical devices throughout Asia.  Ms. Dai assists multi-national food and chemical companies in product stewardship and compliance matters, especially in China, Japan, Korea, Thailand, and other ASEAN countries.  She also participates in the clearance for new food related materials in China and other Asian countries.

Prior to joining Keller and Heckman, Ms. Dai...

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