On 1st July, 2022, China National Center for Food Safety Risk Assessment (CFSA) issued 8 new food additives passing the technical review of the CFSA Expert Review Committee and now opens for public comments. These eight substances include 4 new food enzymes, 2 new food nutrition enhancers (amino acids) and 2 food processing aids with expanded scope. Deadline for public comments is 29th July, 2022.
Related information is as follows:
1. List of food additives
New food enzymes (4 types)
No. | Name | Source | Donor |
1 | Aminopeptidase | Aspergillus oryzae | Aspergillus oryzae |
2 | Xylanase | Bacillus licheniformis | Bacillus licheniformis |
3 | Carboxypeptidase | Aspergillus oryzae | Aspergillus oryzae |
4 | Deaminase | Aspergillus oryzae | — |
Note: The quality specification of enzymes should meet the requirements of the ‘National Food Safety Standard, Food Additives and Enzyme’ (GB 1886.174).
Processing aids with expanded scope (2 types)
No. | Name | Function | Usage scope |
1 | Polydimethyl siloxane and emulsion | Antifoaming agents | Collagen casing processing technology |
2 | Magnesium stearate | Lubricating agent, release agent, anti-stick agent | Effervescent tablet compression processing technology |
New food nutrition enhancers (2 types)
No. | Name | Category number | Food Name/ category | Maximum level (g/kg) |
1 | L-Alanine | 13.01.03 | Infant formula food for special medical purpose | Execute with reference to the relevant standards for foods for special dietary use |
13.03 | Formula foods for special medical purposes (except for the varieties involved in 13.01) | |||
2 | L-Arginine Hydrochloride | 13.01.03 | Infant formula food for special medical purpose | Execute with reference to the relevant standards for foods for special dietary use |
13.03 | Formula foods for special medical purposes (except for the varieties involved in 13.01) |
Please refer to the reference website at the end of the article for details on quality specification requirements and inspection methods.
2. The significance of new amino acids to FSMP
According to the Appendix B of GB 25596 General Rules for Infant Formula for Special Medical Purposes, 19 amino acids are allowed to be used in FSMP for infants under the age of 12 months. According to the Appendix B of GB 29922 General Rules for Formula Food for Special Medical Purposes, 21 amino acids are allowed to be used in FSMP for people over the age of 12 months.
In fact, L-Alanine and L-Arginine Hydrochloride are listed in the appendixes of above two standards. Why does the company apply them as new nutrition enhancers again?
CIRS group estimated that it may due to the quality standards of amino acid in China. Although these amino acids are allowed to be used in FSMP, they cannot be really used because of the lack of national food safety standards for most amino acids in China. After being officially approved as a new nutrition enhancer, NHC will attach the quality standard of the amino acid in the approval announcement. Therefore, when L-Alanine and L-Arginine Hydrochloride are officially approved, they can be really used in FSMP.
A series of amino acids are in registration
More than 15 amino acids are applying for new food additives in China since the end of last year (see below table), according to information released by the NHC government Affairs Office. At present, amino acids other than L-Alanine and L-Arginine Hydrochloride excepted are still in the process of technical evaluation, and the application scopes are unknown. But it is certain that when a new amino acid is approved, its quality specifications will be published at the same time, which is undoubtedly good news for the manufacturers of FSMP who want to use amino acids as ingredients in their products (such as PKU products).
CIRS Group will continue to pay attention to the approval progress of these amino acids.
Summary of the new food additive application of amino acids
Date of acceptance | Number of acceptance | Substance |
---|---|---|
2021.11.16 | 衛食添新申字(2021)第0055號 | L-Arginine Hydrochloride |
2021.11.16 | 衛食添新申字(2021)第0056號 | L-Arginine - Aspartic acid |
2021.11.16 | 衛食添新申字(2021)第0057號 | L-Arginine |
2021.11.18 | 衛食添新申字(2021)第0059號 | L-Alanine |
2022.03.03 | 衛食添新申字(2022)第0008號 | L-Alanine |
2022.03.08 | 衛食添新申字(2022)第0011號 | L-Leucine |
2022.03.08 | 衛食添新申字(2022)第0012號 | L-Isoleucine |
2022.03.08 | 衛食添新申字(2022)第0013號 | L-Valine |
2022.05.26 | 衛食添新申字(2022)第0022號 | L-Cystine |
2022.05.26 | 衛食添新申字(2022)第0023號 | L-Cysteine hydrochloride monohydrate |
2022.05.26 | 衛食添新申字(2022)第0024號 | L-Lysine acetate |
2022.05.26 | 衛食添新申字(2022)第0025號 | L-Histidine |
2022.05.26 | 衛食添新申字(2022)第0026號 | L-Threonine |
2022.05.26 | 衛食添新申字(2022)第0027號 | L-Cysteine hydrochloride |
2022.05.26 | 衛食添新申字(2022)第0028號 | L-Cysteine |
2022.05.26 | 衛食添新申字(2022)第0029號 | L-Phenylalanine |
2022.05.26 | 衛食添新申字(2022)第0030號 | L-lysine hydrochloride |
2022.05.26 | 衛食添新申字(2022)第0031號 | Histidine hydrochloride monohydrate |
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