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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

          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

          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

            

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