China Publishes Draft Standards for Food Additives
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:
| No. | Standard Name |
| 1. | Food Additive N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-L-α-aspartyl]-L-phenylalanine 1-methyl ester |
| 2. | Food Additive 5-Phenyl-3H-furan-2-one |
| 3. | Food Additive Quillaia extract |
| 4. | Food Additive Iron tartrate |
| 5. | Food Additive Sodium formate |
| 6. | Food Additive Theaflavins |
| 7. | General rules for the use of food additives (GB2760) |
| 8. | Food Additive Enzyme preparation for food industrial use |
| 9. | Food Additive Methyl cellulose |
| 10. | Food Additive Lactitol |
| 11. | Food Additive Pentaerythritol ester of wood rosin |
| 12. | Food Additive Morpholine fatty acid salt (fruit wax) |
| 13. | Food Additive Quinoline yellow |
| 14. | Food Additive Calcium hydroxide |
| 15. | Food Additive Cellulose |
| 16. | Amendment No. 1 of GB 1886.100-2015 Food Additive Disodium ethylene-diamine-tetra-acetate |
| 17. | Amendment No. 1 of GB 29209-2012 Food Additive Sodium sulfate |
| 18. | 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 tests, 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:
- It removes:
- 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.
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If you have any questions or need further information on the above draft standards or compliance with the Chinese food regulations in general, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Li (li@khlaw.com), Yin Dai (dai@khlaw.com), or your existing contact at Keller and Heckman LLP.
[1] http://www.nhc.gov.cn/sps/s7891/202209/f31c2c9f139e43fda9dade1320b8897e.shtml
[2] https://sppt.cfsa.net.cn:8086/db?type=2&guid=97989B2C-544C-404E-8428-EE9B59ACE891