In 2022, 5 New Food Ingredients were approved, 3 ingredients were terminated for review, and 3 ingredients were rejected for approval according to the data released by the China National Health Commission (NHC) and the China National Center for Food Safety Risk Assessment (CFSA).
ZMUni Analyzes Each Case to Provide You Deep Insights!
I. New Food Ingredients Approved (5 types)
5 New Food Ingredients were approved by the NHC in 2022, including one strain that can be used in infant foods - Bifidobacterium longum subsp. longum BB536.
Table 1: New Food Ingredients Approved in 2022 | |||
Name | Approval Announcement (Date) | Acceptance No. (Date) | Date of consultation |
Kanzan flower | NHC Announcement | NHC New Food Ingredient Application | August 17, 2021 |
Pyrroloquinoline quinone disodium (PQQ) salt | NHC New Food Ingredient Application (2021) No. 0004 | August 17, 2021 | |
Chlamydomonas reinhardtii | NHC Announcement | NHC New Food Ingredient Application | December 8, 2021 |
Sugarcane Polyphenols | NHC New Food Ingredient Application | November 1, 2021 | |
The following New Food Ingredients are strains that can be used in baby food | |||
Bifidobacterium longum subsp. longum BB536 | NHC Announcement | NHC Imported New Food Ingredient Application | November 1, 2021 |
The approved information for each new food ingredient is as follows.
1. Kanzan flower
Name | Kanzan flower |
Basic Information | Species: Cerasus serrulate ‘Sekiyama’ Edible parts: flower The flowering period of collection is from more than 3/4 of the buds to full bloom. |
Other information | 1. The substance shall not be consumed by infants, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions. 2. Food safety indexes are implemented in accordance with the relevant national regulations of other vegetables products. |
2. Pyrroloquinoline quinone disodium (PQQ) salt
Name | Pyrroloquinoline quinone disodium (PQQ) salt | ||
Basic Information | CAS：122628-50-6 Molecular formula: C14H4N2Na2O8 Molecular weight: 374.17 Structural formula：
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Production process | Using 6-amino-5-methoxyindole-1H-2-carboxylic acid ethyl ester and dimethyl 2-oxoglutaconate as raw materials, after coupling reaction, formation of quinoline ring, oxidation reaction and hydrolysis reaction of ester and refining. | ||
Recommended intake | ≤20 mg/d | ||
Quality requirements | Property | Reddish brown powder | |
Pyrroloquinoline quinone disodium (PQQ) salt (on a dry basis), g/100 g | ≥98.0 | ||
Moisture (Water content), g/100 g | ≤12.0 | ||
Other information | 1. Application scope and maximum usage: beverages (40 mg/ kg, solid beverages are converted according to the mass of liquid after preparation). 2. The substance shall not be consumed by infants, young children, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions. 3. Pyrroloquinoline quinone disodium (PQQ)salt and the other two impurities’ test method is described in the announcement. 4. Food safety indicators must meet the following requirements: | ||
Pb/(mg/kg) | ≤0.5 | ||
As/(mg/kg) | ≤1.0 | ||
Cd/(mg/kg) | ≤0.1 | ||
Hg/(mg/kg) | ≤0.1 | ||
3-chloro-4,5-dioxo-4,5-dihydro-1H-pyrrole [2,3-f] quinoline-2,7,9-tricarboxylic acid，g/100g | ≤0.8 | ||
4-nitro-5-methoxy-1H -pyrrole [2,3-f] quinoline-2,7, 9-tricarboxylic acid，g/100g | ≤0.5 | ||
3. Chlamydomonas reinhardtii
Latin Name | Chlamydomonas reinhardtii | |
Basic Information | Species: Chlamydomonas family, Chlamydomonas | |
Brief description of the production process | Made by algal species cultivation, fermentation tank heterotrophic expansion cultivation, drying, and other processes. | |
Quality requirements | Shape and properties | Green powder |
Protein content | ≥30.0% | |
Crude polysaccharide content | ≥10.0% | |
Other information | 1. The scope of use does not include infant and young children food. 2. Food safety indicators are implemented in accordance with the relevant regulations of algae and algae products. | |
4. Sugarcane Polyphenols
Name | Sugarcane Polyphenols |
Brief description of the production process | Using sugarcane as raw material through crushing, filtration, extraction, removing excess sugar and salt, using water and ethanol as an extraction solvent to be transferred into powder by filtration, vacuum concentration, ion exchange, spray drying, and other processes; or to be transferred into liquid by filtration, vacuum distillation, and other processes. |
Recommended intake | ≤1 g/d(powder), or≤10 g/d(liquid) The recommended daily intake of powder with total polyphenol content of 200 g/kg is 1 g/d, and liquid with total polyphenol content of 14.8 g/kg is 10g/d. If the above content is exceeded, it shall be converted according to the actual content. |
Other information | 1. Not suitable for consumption by infants, pregnant women, and breastfeeding women. This should be indicated on the labels and instructions. 2. Quality specifications and food safety indicators are described in the announcement. |
5. Bifidobacterium longum subsp. longum BB536
Name | Bifidobacterium longum subsp. longum BB536 |
Other information | 1. 1. Can be used in infant food 2. 2. Food safety indicators should conform to relevant Chinese standards |
II. New Food Ingredients on the Termination Review List (3 types)
In 2022, 3 New Food Ingredients were terminated for review. Among them, N-Acetylneuraminic (fermentation strain of Escherichia coli CASOV-O9) and the approved-product N-Acetylneuraminic (fermentation strain of Escherichia coli SA-8, National Health and Family Planning Commission of the People's Republic of China (NHFPC): Announcement No. 7 of 2017) are ‘substantially equivalent’. Therefore, the review was terminated. Penthorum chinense Pursh belongs to the consent to expand the scope of use. Trichosanthes kirilowii is terminated because it has already been a general food ingredient.
Table 2: New Food Ingredients Terminated for Review in 2022 | ||
Name | Acceptance Date | Acceptance Number |
N-Acetylneuraminic | April 6, 2021 | NHC New Food Ingredient Application |
Penthorum chinense Pursh | January 17, 2022 | NHC New Food Ingredient Application |
Trichosanthes kirilowii | April 24, 2022 | NHC New Food Ingredient Application |
The comments of the termination are as follows.
1. N-Acetylneuraminic acid (sialic acid)
This product is made from Escherichia coli (strain number CASOV-O9) as the fermenting strain, using food-grade glucose, corn pulp and other nutrients as fermentation raw materials, through the process of bacterial fermentation, filtration, sterilization, hydrolysis, ultrafiltration, decolorization, de-hybridization, nanofiltration, concentration, purification, drying, crushing, sieving, etc. Its production process is basically the same as that of the approved N-Acetylneuraminic (NHFPC Announcement No. 7 of 2017). Therefore, it has substantial equivalence.
In accordance with the approved N-Acetylneuraminic, the following requirements for food safety indicators shall be met: aflatoxin B1 ≤ 5μg/kg, lead (Pb) ≤ 0.8mg/kg, mercury (Hg) ≤ 0.2mg/kg, arsenic (As) ≤ 0.4mg/kg, total bacterial colony ≤ 1000CFU/g Coliform ≤ 0.6MPN/g, mold ≤ 100CFU/g, yeast ≤ 100CFU/g, Salmonella and Staphylococcus aureus shall not be detected in 25g samples.
2. Penthorum chinense Pursh
The NHC has approved Penthorum chinense Pursh as a new food ingredient to be used as brewing in Announcement No. 4 of 2020, and this application was extended to beverages. Based on the safety assessment information provided, it was approved to expand the scope of use to beverages and thus, recommended to terminate the review.
Penthorum chinese Pursh, except for the way of consumption, is implemented in accordance with NHC Announcement No.4 of 2020
3. Trichosanthes kirilowii
Trichosanthes kirilowii has been listed in China's National Food Safety Standard for Nuts and Seeds (GB 19300) and is managed in accordance with nuts and seeds when used as a food ingredient. Thus, it is recommended to terminate the review.
III. Disapproval of New Food Ingredients (3 types)
In total, 3 Ingredients were disapproved in 2022 as follows:
Table 3: Disapproval of New Food Ingredients | |||
Name | Date of Disapproval | Acceptance Date | Acceptance Number |
Antrodia Cinnamomea mycelium powder | February 18, 2022 | Not available* | NHC New Food Ingredient Application |
Isomaltodextrin | April 22, 2022 | April 12, 2021 | NHC New Food Ingredient Application |
Corn-fermented material | April 26, 2022 | July 19, 2021 | NHC New Food Ingredient Application (2021) No. 0004 |
*Note: The date is not officially announced. | |||
If companies intend to apply New Food Ingredients, ZMUni recommends that it is essential to strengthen the understanding and implementation of regulations and policies. This is conducive to making reasonable plans for your ingredient launching, depending on the nature and condition of your ingredient. Comprehensive assessment and preparation will be contributive tor the success of your application.
ZMUni Provides Related Services:
1. Pre-evaluation of New Food Ingredients Application
2. Submission for New Food Ingredients
3. Other Customized Consulting Services
*The data is obtained from the China National Health Commission (NHC) and the China National Center for Food Safety Risk Assessment (CFSA) website inquiries.In case of discrepancies, please refer to the official data of NHC and CFSA.
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