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As revealed by the NHC Notice [1] released on Dec 13th, 2019, 28 new ingredients have passed the safety evaluation and were granted approval, which includes 11 new food additives and 17 new FCM additives.
11 New Food Additives
1 New Variety of Enzyme
| No. | Name | Source | Donor | Note |
| 1 | Glucoamylase | Trichoderma reesei | Trichoderma reesei | The quality specification shall conform to GB 1886.174 Enzyme Preparations for Food Industry [2] |
2 New Varieties of Food Flavors
| No. | Name | Usage Scope | Amount | Note |
| 1 | (1R,2S,5R)-N-(4-Methoxyphenyl)-5-methyl-2-(1- methylethyl) cyclohexanecarboxamide | All kinds of food, except for the food listed in B.1 of GB 2760-2014 [3], which is the list of foods not allowed to be added with flavorings and essences | As appropriate | Details about its quality specification, determination method, gas chromatography as well as its operation condition are attached in this NHC notice. |
| 2 | 2-(4-Methylphenoxy)-N-(1H-pyrazol-3-yl)-N- (thiophen-2-ylmethyl) acetamide | All kinds of food, except for the food listed in B.1 of GB 2760-2014, which is the list of foods not allowed to be added with flavorings and essences | As appropriate | Details about its quality specification, determination method, gas chromatography as well as its operation condition are attached in this NHC notice. |
1 New Variety of Nutrition Supplement
| No. | Name | Food Classification No. | Food Category | Usage Amount | Note |
| 1 | Vitamin K2 (Synthesis method) | 01.03.02 | Modified dairy powder (only limited for children) | 420 μg/kg~750 μg/kg | Details about its quality specification and examination method are attached in this NHC notice. |
| Modified dairy powder (only limited for the pregnant and lactating women) | 340 μg/kg~680 μg/kg |
7 Food Additives with Expanded Application Scope
| No. | Name | Function | Food Classification No. | Food Category | Maximum Usage Amount (g/kg) | Note |
| 1 | Calcium propionate | Preservative | 08.02.01 | Prepared meat products (raw meat are added with seasoning) | 3.0 | Calculated as propanoic acid |
| 08.03.02 | Smoked, roasted and baked meat | |||||
| 2 | Monascus yellow pigment | Colorant | 12.10.01.02 | Chicken essence, chicken powder | As appropriate | — |
| 3 | Caramel colour Class IV-ammonia sulphite process | Colorant | 15.01.07 | Other distilled liquors (only limited to tequila) | 1.0 g/L | — |
| 4 | ε-polylysine hydrochloride | Preservative | 10.02.01 | Spiced eggs | 0.5 | — |
| 5 | Paprika red | Colorant | 04.04.01.03 | Dried bean curd products | As appropriate | — |
| 09.04 | Cooked aquatic products (directly edible) | |||||
| 6 | Sodium stearoyl lactylate | Emulsifier, stabilizer | 02.05 | Other fat and fat products (only limited to powdered oil) | 2.0 | — |
| 7 | Vegetable carbon, carbon black | Colorant | 04.04.01.02 | Dried bean curds | As appropriate | — |
| 04.05.02 | Processed nuts and seeds |
17 FCM Additives
7 New Additives for Food Contact Materials and Products
| No. | Name | CAS No. | Application Scope | Maximum Usage Amount/% | Specific Migration Limit (SML)/(mg/kg) | Maximum Permitted Quantity (QM)/(mg/kg) | Note |
| 1 | Polycyclooctene | 25267-51-0 | Plastic: EVOH (Ethylene vinyl alcohol) | 8 | 0.05 (cyclooctene) | — | EVOH added with this substance can be used as the non-food contact layer of food contact materials and products that possess multiple layers. The thickness shall be less than 100µm. The maximum usage temperature is 100 ℃. EVOH added with this substance shall not contact infant food and breast milk. |
| 2 | Formaldehyde, polymer with 3-methylphenol, butyl ether | 61991-38-6 | Paints and coatings | 12 (calculated as the dry weight of film) | 15 (calculated as formaldehyde) | — | Food contact paints and coatings added with this substance shall not contact food whose ethanol content is higher than 50%. The maximum usage temperature is 127 ℃. |
| 3 | Copolymers of acrylamide, diallyldimethylammonium chloride, itaconic acid and propenoic acid | 1802295-96-0 | Paper and paperboard | 1.5 (calculated as the dry weight of finished paper) | ND (acrylamide, DL=0.01 mg/kg); 6 (calculated as propenoic acid) | — | Food contact paper, paperboard and its product added with this substance shall not contact infant food and breast milk. |
| 4 | Propenoic acid, polymer with butyl propenoate, compd. with N,N-diethylethanamine | 27306-98-5 | Paints and coatings | 1 (calculated as the paint formula) | 6 (calculated as propenoic acid) | — | — |
| 5 | Melamine, polymer with formaldehyde, isobutylated | 68002-21-1 | Paints and coatings | 6 (calculated as the paint formula) | 15 (calculated as formaldehyde); 2.5 (melamine) | — | To food contact materials and products manufactured especially for infants, the SML of melamine is 1 mg/kg. |
| 6 | 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,2-propanediol and 1,2,3-propanetriol | 384330-10-3 | Paints and coatings | As appropriate | 5 (calculated as 1,2,4-benzenetricarboxylic acid ); 6 (1,1,1-trimethylolpropane) | — | Paints and coatings added with this substance shall not contact food whose ethanol content is higher than 8%. |
| 7 | Benzoic acid, 2-hydroxy-, polymer with formaldehyde and 2,4-diamino-6-phenyl-1,3,5-triazine, ethylated methylated | 196823-49-1 | Paints and coatings | As appropriate | 15 (calculated as formaldehyde); 5 (2,4-diamino-6-nonyl-1,3,5-triazine) | — | Paints and coatings added with this substance shall not contact food whose ethanol content is higher than 8%. |
2 FCM Additives with Expanded Application Scope
| No. | Name | CAS No. | Application Scope | Maximum Usage Amount/% | Specific Migration Limit (SML)/(mg/kg) | Maximum Permitted Quantity (QM)/(mg/kg) | Note |
| 1 | Microcrystalline wax and hydrocarbon wax | 63231-60-7 | Plastics: PS | 0.5 | — | — | Food contact plastic materials and products added with this substance shall not contact food whose ethanol content is higher than 50%; only applies to the filling and the long-term storage under room temperature (during the hot filling and pasteurization process, the temperature shall be under 70℃ and all the process shall be finished within 2 hours, or the temperature shall be under 100 ℃ and the process shall be finished within 15 minutes). The average molecular weight of this substance is more than 500 Dw. The viscosity of it is no less than 11mm2/s at 100℃; The content of mineral hydrocarbons whose carbon number is lower than 25 shall be no more than 5% (calculated as the mass fraction). |
| 2 | Fatty acids, C14-C18 and C16-C18-unsatd | 67701-06-8 | Plastics: ABS | As appropriate | — | — | — |
8 New Varieties of Resins
| No. | Name | CAS No. | Application Scope | Maximum Usage Amount/% | Specific Migration Limit (SML)/(mg/kg) | Maximum Permitted Quantity (QM)/(mg/kg) | Note |
| 1 | Formaldehyde, phenol and p-tert-butylphenol polymer with n-butanol | 2215936-67-5 | Paints and coatings | 9.5 (calculated as the paint formula) | 15 (calculated as formaldehyde); 3.0 (free phenol, calculated as phenol); 0.05 (p-tert-Butylphenol) | — | — |
| 2 | Formaldehyde, reaction products with butyl alcohol and phenol | 96446-41-2 | Paints and coatings | 10.8 (calculated as the paint formula) | 15 (calculated as formaldehyde); 3.0 (free phenol, calculated as phenol) | — | To food contact paints and coatings produced by this material as the ingredient, the maximum usage temperature is 121 ℃. |
| 3 | 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol, propane-1,2-diol and hexanedioic acid | 95505-95-6 | Paints and coatings | 60 (calculated as the dry weight of film) | 5 (calculated as isophthalic acid); 7.5 (calculated as 1,4-dicarboxybenzene); 5 (calculated as 1,4-butanediol) | — | Food contact paints and coatings produced by this substance as the ingredient shall not contact food whose ethanol content is higher than 20%. The maximum usage temperature is 121℃. |
| 4 | 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, decanedioic acid, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol | 26353-05-9 | Paints and coatings | 85 (calculated as the dry weight of film) | 5 (calculated as isophthalic acid); 7.5 (calculated as 1,4-dicarboxybenzene); 0.05 (2,2-Bis(hydroxymethyl)propane); 30 (calculated as ethylene glycol) | — | The maximum usage temperature of FCM paints and coatings produced by this substance as the ingredient is 127 ℃. The content of 2,2-Bis(hydroxymethyl)propane in this substance shall be no more than 30% (calculated as mass fractions). |
| 5 | 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-cyclohexanedimethanol, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol | 61960-52-9 | Paints and coatings | 35 (calculated as the dry weight of flim) | 5 (calculated as isophthalic acid); 7.5 (calculated as 1,4-dicarboxybenzene); 0.05 (2,2-Bis(hydroxymethyl)propane); 30 (calculated as ethylene glycol) | — | The maximum usage temperature of FCM paints and coatings produced by this substance as the ingredient is 130 ℃. The content of 2,2-Bis(hydroxymethyl)propane in this substance shall be no more than 30% (calculated as mass fractions). |
| 6 | 1,3-Benzenedicarboxylic acid, polymer with decanedioic acid, 1,4-dimethyl-1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol | 61412-73-5 | Paints and coatings | 85 (calculated as the dry weight of film) | 5 (calculated as isophthalic acid); 7.5 (calculated as 1,4-dicarboxybenzene); 0.05 (2,2-Bis(hydroxymethyl)propane); 30 (calculated as ethylene glycol) | — | The maximum usage temperature of FCM paints and coatings produced by this substance as the ingredient is 127 ℃. The content of 2,2-Bis(hydroxymethyl)propane in this substance shall be no more than 30% (calculated as mass fractions). |
| 7 | Formaldehyde, polymer with methylphenol | 9016-83-5 | Paints and coatings | 19 (calculated as paint formula) | 15 (calculated as formaldehyde); 3.0 (free phenol, calculated as phenol) | — | — |
| 8 | Formaldehyde, polymer with 4,4'-(1-methylethylidene)bis[phenol], 3-methylphenol and 4-methylphenol, butylated | 335637-88-2 | Paints and coatings | As appropriate | 15 (calculated as formaldehyde); 0.6 (bisphenol A) | — | FCM paints and coatings manufactured by this substance shall not contact infant food and breast milk. |
View ChemLinked’s Flist for more info about the approved food additives [4], FCM food additives [5] and resins [6].
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