In accordance with the provisions of the Food Safety Law of the People’s Republic of China, the reviewing authority organized experts to review and adopt the safety assessment materials of three substances, including Paraguayan holly leaves (Maté tea leaves), two substances, including edible tannins, applying for new varieties of food additives, and four substances, including N,N’-hexyl-1,6-bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide], applying for new varieties of food-related products. and 4 other substances applying for new varieties of food-related products were examined and approved.
The announcement is hereby made.
National Health and Wellness Commission
November 23, 2023
The following is the text of the Announcement on “Three New Foods” (No. 10 of 2023), including 9 kinds of Paraguayan Holly Leaf (Matei Tea Leaf), and its interpretation.

Interpretation of New Food Ingredients

1. Paraguay Holly Leaf (Matei Tea Leaf)
Paraguayan Holly Leaves (Matei Tea Leaves) is made from the leaves of Paraguayan Holly ( Ilex paraguariensis A.St.-Hil.), a plant of the genus Ilex, in the family of Holly, through the process of picking, roasting, chopping and drying. The main nutrients are carbohydrates, crude fiber, protein, fat, vitamins, minerals and amino acids, and contains a small amount of polyphenols, flavonoids and saponins and other substances.

Paraguayan holly leaves (mate leaves) are regulated as “Generally Recognized As Safe (GRAS)” in the United States, approved for use as a new food ingredient in the European Union, approved for use as a natural health food in Canada, and approved for use in tea production in Brazil.

According to the provisions of the Food Safety Law of the People’s Republic of China and the Administrative Measures for the Review of the Safety of New Food Ingredients, the National Health and Wellness Commission entrusted the review body to organize experts to review and pass the safety assessment materials of Paraguayan holly leaves (mate tea leaves) in accordance with the statutory procedures.

The production and use of new food ingredients should be in line with the content of the announcement and the requirements of food safety-related regulations. In view of the insufficient information on the safety of consumption of Paraguayan wintergreen leaves (Matei Tea Leaves) in infants and young children, pregnant women and lactating women, from the principle of risk prevention, the above groups should not be consumed, and labels and instructions should be labeled with inappropriate groups.

The food safety index of this raw material is implemented in accordance with the announcement. When the national food safety standard of substitute tea is released, it will be implemented according to the standard of substitute tea.

2. Yeast protein
Yeast protein is brewer’s yeast ( Saccharomyces Cerevisiae ) as a strain, after culture, fermentation, centrifugation, collection of raw materials to obtain the bacterium, by removing nucleic acids, centrifugation, enzymatic, extraction, purification, separation, sterilization, drying and other processes. The main nutrients are protein (≥70.0g/100g), fat, dietary fiber and water.

At present, the United States has approved brewer’s yeast protein as a nutritional supplement added to food, and the European Union has approved brewer’s yeast protein as a new food ingredient, both of which have not been limited to the amount of consumption.

According to the “Food Safety Law of the People’s Republic of China” and “Management Measures for the Review of the Safety of New Food Ingredients”, the National Health and Health Commission commissioned the review body in accordance with the statutory procedures, the organization of experts on the safety assessment of yeast protein material review and adoption.

The production and use of new food ingredients should be in line with the contents of the announcement and the requirements of food safety-related regulations. In view of the lack of information on the safety of yeast protein in infants and young children, pregnant women and lactating women, from the principle of risk prevention, the above groups should not be consumed, labeling and instructions should be marked inappropriate for the population. The food safety indicators of this raw material in accordance with the provisions of the announcement.

3. Catechin
Catechin is tea as raw materials, alcohol extraction, concentration, separation, extraction, enzymatic, concentration, drying and other processes. The main components are catechins, including epigallocatechin (EC), epigallocatechin (EGC), hydrated epigallocatechin gallate ( _ECG-H2O ), hydrated epigallocatechin gallate ( _EGCG-H2O ), gallocatechin gallate (GCG), catechin ( dl-C ), the total content of catechins (dry basis) ≥ 90 g/100g, of which EGCG content of EGCG ≥ 90 g/100g. 100g, of which EGCG content ≥50 g/100g.

The former Ministry of Health approved epigallocatechin gallate (EGCG) as a new resource food in Announcement No. 17 of 2010, with a recommended daily consumption of ≤300 mg/day (in terms of EGCG). Green tea catechin has been approved by Japan as a functional ingredient for specific health food. The recommended daily intake of this product is ≤300 mg/day (in terms of total catechins) (i.e. the recommended daily intake of raw materials with total catechin content of 100 g/100g is ≤300 mg/day, and the content of 90-100 g/100g is converted according to the actual content).

According to the “Food Safety Law of the People’s Republic of China” and “Administrative Measures for the Review of the Safety of New Food Ingredients”, the National Health and Health Commission commissioned the review body in accordance with the statutory procedures, the organization of experts on the safety assessment of catechins material review and adoption.

The production and use of new food ingredients should be in line with the content of the announcement and the requirements of food safety-related regulations. In view of the lack of information on the safety of catechins in infants and young children, pregnant women and lactating women in the population, from the principle of risk prevention, the above groups should not be consumed, labeling and instructions should be marked unsuitable for the population and consumption limits. The food safety index of this raw material is implemented according to the announcement.

Interpretation materials of new varieties of food additives
1. Edible Tannins
1) Background information. Edible tannin as a food industry processing aids have been included in the “Food Safety National Standard for Food Additives” (GB 2760), allowed to be used in the processing of yellow wine, beer, wine and prepared wine, oil and fat decolorization process.

This application expands the scope of use for sugar manufacturing process. The Ministry of Health, Labor and Welfare of Japan allows it to be used as a processing aid for all kinds of food.

(2) Process Necessity. The substance is used as a processing aid for the food industry in the sugar manufacturing process to improve the clarification effect. Its quality specifications implement the National Food Safety Standard for Food Additives Edible Tannins (GB 1886.303).

2. Ethyl Acetate
1) Background information. Ethyl acetate as a food industry processing aids have been included in the “National Food Safety Standards for Food Additives” (GB 2760), allowing for the processing of prepared wine, yeast extract processing.

This application expands the scope of use for the processing of tea extracts. It is permitted to be used as extraction solvent for all kinds of food by the European Commission, Australia and New Zealand Food Standards Agency. According to the evaluation results of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the Acceptable Daily Intake (ADI) for this substance is 0-25mg/kgbw.

2) Process Necessity. The substance is used as a processing aid for the food industry in the processing of tea extracts for the extraction of tea polyphenols and theanine. Its quality specification implements the National Food Safety Standard for Food Additives Ethyl Acetate (GB 1886.190).

Interpretation materials of new varieties of food-related products

1.N,N’-hexyl-1,6-bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanamide]

1) Background. The substance is a white solid powder at room temperature and pressure. It has been approved for use as an additive in rubber and a variety of plastic materials and products such as polyethylene (PE) and polypropylene (PP) in the National Standard for the Use of Additives for Food Contact Materials and Products for Food Safety (GB 9685).

This application extends its use to polyurethane (PU) conveyor belts. Both the U.S. Food and Drug Administration and the European Commission allow the substance to be used in plastic materials and products for food contact.

2) Process Necessity. The substance acts as an antioxidant to slow down the thermo-oxidative degradation of polyurethane.

2.2,2-Bis[[3[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]-1-oxopropoxy]methyl]-1,3-propanediyl-3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; Tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionic acid] pentaerythritol ester
1) Background. This substance is a white solid powder at room temperature and pressure. GB 9685 approves its use as an additive in rubber, paints and coatings, adhesives, and a variety of plastic materials and products such as PE and PP.

This application extends its use to PU conveyor belts. The U.S. Food and Drug Administration and the European Commission both allow the substance to be used in plastic materials and products for food contact.

2) Process necessity. The substance acts as an antioxidant to slow down the thermo-oxidative degradation of polyurethane.
3. Coffee grounds
1) Background information. This substance is the residual material after coffee is extracted from roasted coffee beans by water. It is a brown (brown) to dark coffee-colored powdery fine particle at room temperature, and is insoluble in water.

Similar materials such as sunflower seed hulls and wood fibers have been permitted by the U.S. Food and Drug Administration and the European Commission for use in plastic materials and products for food contact.

2) Process necessity. The substance is used as a filler in poly(lactic acid) (PLA) and polybutylene succinate (PBS) plastic materials and products to improve the comprehensive mechanical properties of the materials, molding and processing properties, and the use of the products.

4. polymers of butyl methacrylate with methyl methacrylate, n-butyl acrylate and 1,4-butanediol dimethacrylate
1) Background. The substance is insoluble in water and practically insoluble in organic solvents such as n-octanol. Both the U.S. Food and Drug Administration and the European Commission allow the substance to be used in paints and coatings for food contact.

2) Process Necessity. The substance is the main film-forming substance for coatings and can be used in water-based coatings with strong film adhesion and good corrosion resistance.