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8 New Food Additives (including two amino acids) Open for Public Consultation

from CIRS by

China,Food,Additive,Consultation,New,Public

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

卫食添新申字(2021)第0055号

L-Arginine Hydrochloride

2021.11.16

卫食添新申字(2021)第0056号

L-Arginine - Aspartic acid

2021.11.16

卫食添新申字(2021)第0057号

L-Arginine

2021.11.18

卫食添新申字(2021)第0059号

L-Alanine

2022.03.03

卫食添新申字(2022)第0008号

L-Alanine

2022.03.08

卫食添新申字(2022)第0011号

L-Leucine

2022.03.08

卫食添新申字(2022)第0012号

L-Isoleucine

2022.03.08

卫食添新申字(2022)第0013号

L-Valine

2022.05.26

卫食添新申字(2022)第0022号

L-Cystine

2022.05.26

卫食添新申字(2022)第0023号

L-Cysteine hydrochloride monohydrate

2022.05.26

卫食添新申字(2022)第0024号

L-Lysine acetate

2022.05.26

卫食添新申字(2022)第0025号

L-Histidine

2022.05.26

卫食添新申字(2022)第0026号

L-Threonine

2022.05.26

卫食添新申字(2022)第0027号

L-Cysteine hydrochloride

2022.05.26

卫食添新申字(2022)第0028号

L-Cysteine

2022.05.26

卫食添新申字(2022)第0029号

L-Phenylalanine

2022.05.26

卫食添新申字(2022)第0030号

L-lysine hydrochloride

2022.05.26

卫食添新申字(2022)第0031号

Histidine hydrochloride monohydrate

If you have any needs or questions, please contact us at service@cirs-group.com.

For official info please click:

CFSA Opened Public Comments for 8 New Food Additives