On February 18th and 20th, 2020, CFSA opened ten new FCM additives and four new food additives to public feedback. The new food additives and FCM additives have already passed a technical evaluation by the expert review committee. Here are the details.
Ten New FCM Additives (CFSA Notice, February 18, 2020)
Two New Varieties of FCM additives
No. | Name | CAS No. | Usage scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
1 | Microfibrillated cellulose pulp | 65996-61-4 | Paper and paperboard | 5 (calculated as dry weight of fiber) | — | — | — |
2 | 2-Butenedioic acid (2E)-, dibutyl ester, homopolymer | — | Painting and coatings | 2 | — | — | Paintings and coatings added with this substance shall not contact infant formula and breast milk. The maximum using temperature is 121 ℃. |
Two Varieties of FCM additives Expanded with Application Scope
No. | Name | CAS No. | Usage scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
1 | Calcium stearate | 1592-23-0 | Plastic: polyether ether ketone, PEEK | 0.03 | — | — | — |
2 | 2,5-Furandione, dihydro-, mono-C15~20- alkenyl derivs | 68784-12-3 | Plastic: PE, PP | 0.48 | 30 (calculated as maleic acid) | — | Plastic material and products added with this substance shall not contact infant formula and breast milk. The maximum using temperature is 100 ℃. |
Six New Varieties of Resins
1. Fatty acid, C18- unsaturated, dimers, polymers with caprolactam and hexamethylenediamine (CAS No. 2068097-08-3)
Usage scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
Plastic | — | 15 (calculated as caprolactam);
2.4 (Hexamethylenediamine);
0.05 (calculated as the total amount of unhydrogenated unsaturated fatty acid C18 dimer and hydrogenated C18-unsaturated fatty acid dimers) | — | Plastic material and products manufactured with this substance as the raw material shall not contact infant formula and breast milk; and shall be filled and stored under room temperature (including the hot filling and pasteurization under T≤70℃, t≤2h or T≤100℃, t≤15min) |
2. 2-Propenoic acid, 2-methyl-, polymer with N- (butoxymethyl)-2-propenamide, ethenylbenzene and ethyl 2-propenoate (CAS No. 26589-46-8)
Usage scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
Paintings and coatings | — | 6 (calculated as methacrylic acid);
6 (calculated as acrylic acid);
ND (N-(butoxymethyl)prop-2-enamide, DL=0.01 mg/kg) | — | Food contact paintings and coatings manufactured with this substance as raw material shall not contact acid-forming food with PH value lower than 3.64, oils and fats, food with fatty surface, infant formula and breast milk. The maximum using temperature is 121 ℃. |
3. Styrene block polymers with 2-methyl-1,3- butadiene and 1,3-butadiene, hydrogenated (CAS No. 132778-07-5)
Usage scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
Plastic | — | ND (1,3-Butadiene: SML, DL=0.01);
ND (2-methyl-1,3-butadiene: SML, DL=0.01) | 0.5% (styrene);
1mg/kg (1,3-Butadiene);
1mg/kg (2-methyl-1,3-butadiene) | — |
4. Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, benzoate (CAS No. 52907-82-1)
Usage scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
Paintings and coatings | 19.7 (calculated as the painting formula) | 0.6 (bisphenol A) | 1 (epichlorohydrin) | Food contact paintings and coatings manufactured with this substance as raw material shall not contact infant formula and breast milk. |
5. Polymer of 1,4-bis(hydroxymethyl)cyclohexane,2- methylpropane-1,3-diol, tricyclo(5.2.1.02,7)decan4,8-dimethanol,benzene-1,4-dicarboxylic acid, benzene-1,3-dicarboxylic acid, cis-butenedioic acid, 5-isocyanato-1-isocyanatomethyl-1,3,3- trimethylcyclohexane (CAS No. —)
Usage scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | QM (mg/kg) | Note |
Paintings and coatings | 30 (calculate as the painting formula) | 5 (2-Methyl- 1,3-Propanediol);
0.05 (4,8-bis(hydroxymethyl)tricyclo[5.2.1.0(2,6)]decane);
7.5 (calculated as 1,4-dicarboxybenzene);
5 (calculated as iso-phthalic acid);
30 (maleic acid) | 1 (calculated as isocyanic acid) | Paintings and coatings manufactured with this substance as raw material shall not contact infant formula and breast milk. |
6. Polymer of butanediol-1,4,ethylene glycol,propylene glycol-1,2,trimethylolpropane,dimethyl terephthalate,isophthalic acid and sebacic acid (CAS No. —)
Usage scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | QM (mg/kg) | Note |
Paintings and coatings | 30 (calculate as the painting formula) | 5 (calculated as 1,4-butanediol);
30 (calculated as ethylene glycol);
6 (trimethylolpropane);
5 (calculated as iso-phthalic acid) | — | Paintings and coatings manufactured with this substance as raw material shall not contact infant formula and breast milk. |
Opinion Feedback
Any comments should be sent to biaozhun@cfsa.net.cn prior to March 11, 2020.
Four New Food Additives (CFSA Notice, February 20, 2020)
New Variety of Enzyme
No. | Name | Source | Donor | Note |
1 | Protein glutaminase, PG | Chryseobacterium proteolyticum | - | The quality specification shall conform to GB 1886.174 Enzyme Preparations for Food Industry. |
Food Additive with Expanded Application Scope
No. | Name | Function | Food Classification No. | Food Category | Maximum Using Amount (g/kg) | Note |
1 | DL-Tartaric acid | Acidity regulator | 04.02.02.03 | Pickled vegetables | 3.0 | Calculated as tartaric acid |
06.05.02.01 | Vermicelli | 2.0 |
Food Processing Aid with Expanded Application Scope
No. | Name | Function | Application Scope | Note |
1 | Manganese sulfate | Nutrient used in fermentation process | Fermentation technique | Can be used in the fermentation technique of edible fungus, dairy products, meat, etc. The specification of manganese sulfate shall refer to GB 29208-2012. |
Nutritional Fortifier with Expanded Application Scope
No. | Name | Function | Food Classification No. | Food Category | Usage Amount (g/kg) | Note |
1 | 6S-5-methyltetrahydrofolate calcium, magnafolate | Nutritional fortifier | 01.01.03 | Only limited to the modified dairy for the pregnant and lactating | Conform to the standard related to folic acid in GB 14880. | Used as the compound source of folic acid.
The quality and specification shall refer to the No. 13 notice of the former NHFPC, 2017. |
01.03.02 | Only limited to the modified dairy powder for children | |||||
Only limited to the modified dairy powder for the pregnant and lactating | ||||||
06.06 | Instant cereal, including rolled oats (oatmeal) | |||||
14.02.03 | Fruit and vegetable juice (pulp) beverage (including fermented products) | |||||
13.03 | Foods for special medical purpose (except for the categories listed in 13.01) | Can be used as the source of folic acid. The usage amount goes with the standard related to folic acid in GB 29922. |
Opinion Feedback
Any comments should be sent to zqyj@cfsa.net.cn prior to March 19, 2020.