As revealed by a notice1 released on July 26, 2021, 9 new varieties of food additives and 19 new food-related products were approved by China’s National Health Commission (NHC).
Nine New Food Additives
Nine new types of enzyme preparations were granted approval. Their quality specifications shall conform to GB 1886.174 National Food Safety Standard Food Additive Enzymes for Food Industry.
S/N | Name | Source | Donor |
1 | 4-α-glucanotransferase | Aeribacillus pallidus | / |
2 | Alpha-amylase | Aspergillus niger | Rhizomucor pusillus |
3 | Polygalacturonase | Trichoderma reesei | Aspergillus tubingensis |
4 | Pectin esterase | Trichoderma reesei | Aspergillus tubingensis |
5 | Phosphoinositide Phospholipase C | Bacillus licheniformis | Pseudomonas sp. |
6 | Phospholipase C | Bacillus licheniformis | Bacillus thuringiensis |
7 | Xylanase | Trichoderma reesei | Thermopolyspora flexuosa |
8 | Glucoamylase | Aspergillus niger | Gloeophyllum trabeum |
9 | Lipase | Trichoderma reesei | Fusarium oxysporum |
19 New Food-related Products
19 new varieties of food-related products were approved, including 3 food contact materials (FCM) additives, 9 FCM additives with extended application scope, and 7 resins for FCM.
3 New FCM Additives | |||||
Name | CAS No. | Application Scope | Maximum Level/% | SML/ (mg/kg) | Note |
Silicic acid, sodium salt, reaction product with chlorotrimethylsilane and isopropyl alcohol | 68988-56-7 | Paper and paperboard | 0.00585 (by dry weight) | / | Paper and paperboard added with this substance cannot be used in contact with infant and young children food or breast milk. |
Dodecylguanidine hydrochloride | 13590-97-1 | Paper and paperboard | 0.02 (by dry weight) | / | / |
Poly(1,4-butylene adipate) | 25103-87-1 | Plastic | 0.09 | 5(1,4-butanediol) | Food contact plastic material and articles added with this substance should not be used in contact with infant and young children food or breast milk. |
9 FCM Additives with Extended Application Scope | |||||
Name | CAS No. | Application Scope | Maximum Level/% | SML/ (mg/kg) | Note |
Talc | 14807-96-6 | Plastic: PLA | 30 | / | It should not contain asbestos. PLA plastic material and articles added with this substance cannot be used in contact with infant and young children food or breast milk. |
Phosphorous trichloride, reaction products with 1,1’-biphenyl and 2,4-bis(1,1-dimethylethyl)phenol | 119345-01-6 | Plastic: PPSU; PESU | PPSU: 0.15; PES：0.115 | 18 | / |
C.I. solvent red 135; C.I. oil solvent red 135; 8,9,10,11-Tetrachloro-12-phthaloperinone | 20749-68-2 | Plastic: PCT | 0.03 | / | PCT plastic material and articles cannot be used in contact with food containing over 10% of ethanol or fatty food, and can only be used for room-temperature filling and long-term storage (including hot filling in the condition of T≤70℃, t≤2h or T≤100℃，t≤15min and pasteurization). This substance should comply with requirements of colorant purity specified in GB 9685-2016 Appendix A. |
C.I. pigment violet 15；Sodium aluminosilicate violet | 12769-96-9 | Plastic: PS | 3 | / | This substance should meet the colorant purity requirements listed in GB 9685-2016 Appendix A. |
Zinc phosphate | 7779-90-0 | Paints and coatings | 12 (by dry weight of coating) | 25 (by zinc) | / |
Ethanol, 2-amino- | 141-43-5 | Paper and paperboard | 0.041 (for paper and paperboard, by dry weight); 0.01 (for paper coating, by dry weight) | 0.05 | Paper and paperboard added with this substance can be used in contact oils and fats only at room temperature or below. It cannot be used in contact with infant and young children food or breast milk. |
2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine | 2725-22-6 | Plastic: PP and PE | 0.03 (except in contact with water-based food) | 5 | Food contact PP and PE plastic and articles added with this substance should not be used in contact with infant and young children food or breast milk. |
2-Methyl-2-propenoic acid 2-ethyl-2-[[(2-methyl-1-oxo-2-propenyl) oxy] methyl]-1,3-propanediyl ester | 3290-92-4 | Rubber | 1.2 | 0.05 | Rubber added with this substance can only be used if the temperature does not exceed 150°C. |
2-Propenoic acid, polymer with 2-ethylhexyl 2-propenoate | 25134-51-4 | Plastic: ABS | 0.036 | 6 (by propenoic acid); 0.05(2-ethylhexyl 2-propenoate) | / |
7 New Resins for FCM | |||||
Name | CAS No. | Application Scope | Maximum Level/% | SML/ (mg/kg) | Note |
2-Butenedioic acid (E)-, polymer with 1,3-isobenzofurandione and tricyclodecanedimethanol | 68784-89-4 | Paints and coatings | 15 (by dry weight of coating) | 0.05 (tricyclodecanedimethanol) | Operation temperature of paints and coatings produced with this substance should not exceed 121℃. |
1,4-Benzenedicarboxylic acid, polymer with 1,3-benzenedicarboxylic acid, 2,2,4,4-tetramethyl-1,3-cyclobutanediol,1,4-cyclohexanedimethanol, and 1,6-hexanediol | / | Paints and coatings | 80 (by dry weight of coating) | 7.5 (by 1,4-benzenedicarboxylic acid); 5 (by 1,3-benzenedicarboxylic acid); 5 (by 2,2,4,4-tetramethyl-1,3-cyclobutanediol); 0.05 (1,6-hexanediol) | Paints and coatings produced with this substance cannot be operated at the temperature over 130℃, and cannot be used in contact with infant and young children food or breast milk. |
2-Propenoic acid, 2-methyl-, polymer with N-(butoxymethyl)-2-propenamide, ethenylbenzene and ethyl 2-propenoate | 26589-46-8 | Paints and coatings | As necessary for production | 6 (by methacrylic acid); 6 (by acrylicacid); ND [N-(butoxymethyl)-2--propenamide, DL=0.01mg/kg] | Paints and coatings produced with this substance cannot be operated at the temperature over 121℃, and cannot be used in contact with fatty food, infant and young children food or breast milk. |
2,6-Naphthalenedicarboxylic acid, 2,6-dimethyl ester, polymer with 1,4-cyclohexanedimethanol,1,2-ethanediol,2,2’-oxybis[ethanol] and β3,β3,β9,β9-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol | 2146168-28-5 | Plastic (Generic class name: PCN) | As necessary for production | 0.05 (2,6-Naphthalenedicarboxylic acid, 2,6-dimethylester); 30 (by ethanediol); 5 (β3,β3,β9,β9 -tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol) | Plastic material and articles produced with this substance can only be used in contact with liquid milk, and limited to be used in the condition of 70℃≤T≤100℃, t≤1h and T＜70℃, t≤2h. |
Poly[imino-1,4-butanediylimino(1,10-dioxo-1,10-decanediyl)] | 26247-06-3 | Plastic (Generic class name: PA) | As necessary for production | / | Plastic film made of this substance should not be thicker than 50μm and should not be used in contact with infant and young children food or breast milk. |
2-Propenoic acid, polymer with butyl 2-propenoate, ethenyl acetate, 2-ethylhexyl 2-propenoate and ethyl 2-propenoate | 68698-72-6
| Bonding agent (indirectly contact food) | 20 g/m2 (by dry substance) | 6 (by propenoic acid); 12 (by etheny lacetate); 0.05(2-ethylhexyl 2-propenoate) | Bonding agent using this substance as raw material should be used in the condition of room temperature filling, and should be long-term stored at room temperature (including hot filling in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and pasteurization.) |
2,5-Furandione, polymer with ethene, ester with ethenol homopolymer；Maleic anhydride, polymer with ethene, ester with ethenol homopolymer | 76930-37-5 | Paints and coatings | As necessary for production | 12 (vinyl acetate); 30 (by maleic acid) | Paints and coatings with this substance can only be used for nylon 6. It should be used at room temperature or below (including high temperature sterilization in the condition of T≤121°C, t≤0.5h). It should not be used in contact with infant and young children food or breast milk. |
Check ChemLinked FCM food-list and food additives database for more information about approved food additives and food-related products in China.
