Analysis of Application Approval of New Food-Related Products (Food Contact Additives and Resins) in 2019 - Regulatory News - Food & Food Contact Materials

In 2019, the National Health Commission of the People's Republic of China (NHC) issued a total of 3 announcements in the form of "Three New Foods” (No. 2, 2019 ,No. 4, 2019, and No. 6, 2019). “Three New Foods” are new food raw materials, new food additives, and new food-related products (herein "new food contact additives and resins"). There were 71 “Three New Foods” products approved this year. Among them, there were a total of 40 new food contact additives and resins (including expanded use) approved.

Besides, from the website of NHC and China National Center for Food Safety Risk Assessment (CFSA), a total of 48 new food contact additives and resins application were officially accepted and 52 of public comments on food contact additives and resins (including expanded use) were issued for public comments.

CIRS Group will take you to detailed information about the acceptance and approval of new food contact additives and resins in China in 2019.

1. List of new food contact additives and resins application acceptance in 2019

In 2019, NHC accepted the applications of 48 new food contact additives and resins, which include 22 of domestic products and 26 of overseas products. According to the requirements of the normal application process, it will take at least one year for a new product to get the certificate. Therefore, none of the 48 products have been formally approved. However, many of them have passed the technical review of the Expert Review Committee from CFSA and have been open for public comments.

S.N.	Acceptance date	Acceptance code	Name of the new food contact additive or resin	Approval status (by the end of 2019)
1	2019-01-02	衛食相申字(2019)第0001號	3-Aminopropyltriethoxysilane	Passed the technical review, and issued for public comments on August 21, 2019
2	2019-01-08	衛食相申字(2019)第0002號	1,3-Benzenedicarboxylic acid, polymer with 1,4-butanediol, terephthalic acid, dimethyl ester and hexanedioic acid	Passed the technical review, and issued for public comments on October 15, 2019
3	2019-01-10	衛食相進申字(2019)第0001號	Zinc caprylate	Passed the technical review, and issued for public comments on August 21, 2019
4	2019-01-10	衛食相進申字(2019)第0002號	2,5-Furandione, dihydro-, mono-C_15-20-alkenyl derivs	Has not passed the technical review yet
5	2019-02-11	衛食相進申字(2019)第0003號	Polybutylene succinate adipate	Has not passed the technical review yet
6	2019-02-11	衛食相進申字(2019)第0004號	C.I. Disperse Violet 26; Disperse Violet H-FRL; 1,4-diamino-2,3-diphenoxyanthraquinone	Passed the technical review, and issued for public comments on June 18, 2019
7	2019-02-26	衛食相申字(2019)第0003號	Erucamide	Passed the technical review, and issued for public comments on August 21, 2019
8	2019-03-04	衛食相申字(2019)第0004號	Wollastonite	Passed the technical review, and issued for public comments on August 21, 2019
9	2019-03-15	衛食相進申字(2019)第0005號	C.I. Solvent Violet 36; 1,8-bis[(4-Methylphenyl)amino] -9,10-anthracenedione	Passed the technical review, and issued for public comments on December 2, 2019
10	2019-03-26	衛食相進申字(2019)第0006號	Reaction product of titanium dioxide with bis(2,4,4-trimethylpentyl)-phosphonic acid	Has not passed the technical review yet
11	2019-04-09	衛食相進申字(2019)第0007號	1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,4-butanediol and α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl)	Passed the technical review, and issued for public comments on August 21, 2019
12	2019-04-12	衛食相申字(2019)第0005號	2-(4,6-Bis-(2,4-dimethylphenyl)- 1,3,5-triazin-2-yl)-5-(octyloxy)-phenol	Has not passed the technical review yet
13	2019-04-15	衛食相進申字(2019)第0009號	Reaction product of titanium dioxide with hexyltrichlorosilane	Has not passed the technical review yet
14	2019-04-28	衛食相申字(2019)第0006號	Vitamin E (DL-vitamin acetate)	Has not passed the technical review yet
15	2019-05-10	衛食相進申字(2019)第0010號	Dimethyl 1,4-benzenedicarboxylate, polymer with 1,4-butanediol and tricyclodecane dimethanol	Has not passed the technical review yet
16	2019-05-10	衛食相進申字(2019)第0011號	Hydrogenated debenzenized light steam-cracked naphtha polymers	Has not passed the technical review yet
17	2019-05-10	衛食相進申字(2019)第0012號	Hydrogenated C_6-20 polyolefin	Has not passed the technical review yet
18	2019-05-17	衛食相進申字(2019)第0013號	Microfibrillated cellulose pulp	Has not passed the technical review yet
19	2019-06-27	衛食相進申字(2019)第0014號	Dibutyl fumarate homopolymer	Has not passed the technical review yet
20	2019-06-27	衛食相進申字(2019)第0015號	1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid and 1,2-ethanediol	Passed the technical review, and issued for public comments on December 2, 2019
21	2019-06-27	衛食相進申字(2019)第0016號	1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol, 1,8-octanedicarboxylic acid and 1,2-ethanediol	Passed the technical review, and issued for public comments on December 2, 2019
22	2019-06-27	衛食相進申字(2019)第0017號	1,3-Benzenedicarboxylic acid, polymer with terephthalic acid, dimethyl ester, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol	Has not passed the technical review yet
23	2019-06-27	衛食相進申字(2019)第0018號	Terephthalic acid, dimethyl ester, polymer with decanedioic acid, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol	Has not passed the technical review yet
24	2019-06-27	衛食相進申字(2019)第0019號	2-Propenoic acid, 2-methyl-, polymer with butyl 2-methyl-2-propenoate, 2-(chloromenthyl)oxirane, ethenylbenzene, ethyl 2-propenoate, 4,4'-(1-methylethylidene)bis[phenol] and 2-propenoic acid, reaction products with 2-(dimethylamino)ethanol	Passed the technical review, and issued for public comments on December 2, 2019
25	2019-06-28	衛食相進申字(2019)第0020號	Poly((R)-3-hydroxybutyrate-co-(R) -3-hydroxycaproic acid)	Has not passed the technical review yet
26	2019-07-05	衛食相申字(2019)第0007號	Glass fiber	Passed the technical review, and issued for public comments on October 15, 2019
27	2019-07-05	衛食相申字(2019)第0008號	Polyethylene	Passed the technical review, and issued for public comments on December 2, 2019
28	2019-07-11	衛食相進申字(2019)第0021號	1,3,5-tris(2,2-Dimethylpropanamide)benzene	Has not passed the technical review yet
29	2019-07-15	衛食相申字(2019)第0009號	2-(4,6-Bis-(2,4-dimethylphenyl)- 1,3,5-triazin-2-yl)-5-(octyloxy)-phenol	Has not passed the technical review yet
30	2019-07-31	衛食相進申字(2019)第0022號	1,4-Cyclohexanedimethanol, polymer with 2-methyl-1,3-propanediol, Tricyclo(5.2.1.O2,7)decan-4,8-dimethanol, Terephthalic acid, Isophthalic acid, Maleic acid and 5-isocyanato-1-(isocyanatomethyl) -1,3,3-trimethylcyclohexane	Has not passed the technical review yet
31	2019-08-13	衛食相進申字(2019)第0023號	1,4-butanediol, polymer with ethylene glycol, 1,2-Propanediol, trimethylolpropane, dimethyl 1,4-benzenedicarboxylate, isophthalic acid and decanedioic acid	Has not passed the technical review yet
32	2019-09-16	衛食相進申字(2019)第0024號	2-Methyl-2-propenoic acid, polymer with N-(butoxymethyl)-2-acrylamide, styrene and ethyl acrylate	Has not passed the technical review yet
33	2019-09-16	衛食相進申字(2019)第0025號	Paraffin wax and hydrocarbon wax	Has not passed the technical review yet
34	2019-09-16	衛食相進申字(2019)第0026號	hydrogenated styrene, polymer with 2-methyl-1,3-butadiene and 1,3-butadiene block	Has not passed the technical review yet
35	2019-09-16	衛食相申字(2019)第0010號	C.I. Pigment Violet 15; Sodium aluminosilicate violet	Has not passed the technical review yet
36	2019-10-23	衛食相申字(2019)第0011號	Calcium stearate	Has not passed the technical review yet
37	2019-10-23	衛食相申字(2019)第0012號	2-Propenioc acid, 2-methyl-2-ethyl-2- [[(2-methyl-1-oxo-2-propeny)oxy]methyl] -1,3-propanediyl ester	Has not passed the technical review yet
38	2019-10-28	衛食相申字(2019)第0013號	Octadecyl 3-(3,5-di-tert-butyl-4- hydroxyphenyl)propionate	Passed the technical review, and issued for public comments on December 2, 2019
39	2019-10-28	衛食相申字(2019)第0014號	C.I. Solvent Red 135; 8,9,10,11-Tetrachloro-12H -isoindolo[2,1-a]periMidin-12-one	Has not passed the technical review yet
40	2019-10-28	衛食相申字(2019)第0015號	C.I. Solvent Red 52; 3-methyl-6-[(4-methylphenyl)amino]- 3H-Dibenz[f,ij]isoquinoline-2,7-dione	Has not passed the technical review yet
41	2019-10-28	衛食相申字(2019)第0016號	C.I. Pigment Red 101; Ferric oxide	Has not passed the technical review yet
42	2019-10-28	衛食相申字(2019)第0017號	2-Propenoic acid, polymer with 2-ethylhexyl 2-propenoate	Has not passed the technical review yet
43	2019-12-02	衛食相進申字(2019)第0027號	Guanidine, dodecyl, monohydro chloride	Has not passed the technical review yet
44	2019-12-13	衛食相申字(2019)第0018號	Formaldehyde, polymer with 2-methylphenol and phenol	Has not passed the technical review yet
45	2019-12-13	衛食相申字(2019)第0019號	Formaldehyde, polymer with 2-methylphenol and phenol, butyl ether	Has not passed the technical review yet
46	2019-12-18	衛食相申字(2019)第0020號	Silicon oxide coating	Has not passed the technical review yet
47	2019-12-24	衛食相申字(2019)第0021號	Isophthalic acid, polymer with azacyclotridecan-2-one, terephthalic acid, dodecanedioic acid and 3,3'-Dimethyl-4,4'- diaminodicyclohexylmethane	Has not passed the technical review yet
48	2019-12-26	衛食相申字(2019)第0022號	C.I. Pigment Blue 15	Has not passed the technical review yet

2. List of drafted approved new food contact additives and resins in 2019

In 2019, 52 of new food contact additives and resins have passed the technical review of the CFSA Expert Review Committee and have been open for public comments, including 15 of new food contact additives, 13 of expanded use of current food contact additives, 21 of new food contact resins, and 3 of expanded use of current food contact resins. Among them, all of the products issued on 21st March and 22nd May were officially approved on 13th December.

2.1 List of drafted approved new food contact additives (15 types)

S.N.	Name of the new food contact additive	CAS No.	Application scope	Maximum Level (%)	Approval status (by the end of 2019)
1	Formaldehyde, polymer with 3-methylphenol, Bu ether	61991-38-6	Coating and coating film	12 (count as the dry weight of coating)	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
2	Copolymers of acrylamide, diallyldimethylammonium chloride, itaconic acid and propenoic acid	1802295-96-0	Paper and paperboard	1.5 (count as the dry weight of finished paper)	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
3	Polycyclooctene	25267-51-0	Plastic: EVOH	8	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
4	Propenoic acid, polymer with butyl propenoate, compd. with N,N-diethylethanamine	27306-98-5	Coating and coating film	1	Issued for public comments on May 22, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
5	Melamine, polymer with formaldehyde, isobutylated	68002-21-1	Coating and coating film	6	Issued for public comments on May 22, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
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	Coating and coating film	Appropriate level	Issued for public comments on May 22, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
7	Benzoic acid, 2-hydroxy-, polymer with formaldehyde and 6-phenyl-1,3,5-triazine-2,4-diamine, ethylated methylated	196823-49-1	Coating and coating film	Appropriate level	Issued for public comments on May 22, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
8	Siloxanes and silicones, dimethyl, 3-hydroxypropyl group-terminated, diesters with poly(2-oxepanone), diacetates	116810-47-0	Coating and coating film	0.025 (count as the dry weight of coating)	Issued for public comments on August 21, 2019, but has not officially approved.
9	Polymer of 2,2-dimethyl-1,3-propandiol, ethylene glycol, isophthalic acid, dimethyl terephthalate, dimer acid and trimellitic anhydride	157479-47-5	Coating and coating film	2.5 (count as the coating formula)	Issued for public comments on August 21, 2019, but has not officially approved.
10	Nepheline syenite	37244-96-5	Plastic	50	Issued for public comments on August 21, 2019, but has not officially approved.
11	Copolymer of 1,2,4-benzenetricarboxylic anhydride, 4,4’-diphenylmethane diisocyanate, and 3,3’-dimethyl-4,4’-biphenylene diisocyanate	133078-67-8	Coating and coating film	50 (count as the dry weight of coating)	Issued for public comments on August 21, 2019, but has not officially approved.
12	Zinc caprylate	557-09-5	Plastic: EVOH	0.06	Issued for public comments on August 21, 2019, but has not officially approved.
13	Siloxanes and silicones, di-me, me hydrogen, reaction products with vinyl group terminated di-me siloxanes	156065-02-0	Paper and paperboard	0.0022 (count as the pulp)	Issued for public comments on October 15, 2019, but has not officially approved.
14	Polymer of 2,2-dimethyl-1,3-propandiol, ethylene glycol, isophthalic acid, sebacic acid, terephthalic acid and trimellitic anhydride	-一	Coating and coating film	1.8 (count as the coating formula)	Issued for public comments on October 15, 2019, but has not officially approved.
15	2-Propenoic acid, ethyl ester, polymer with 2-methyl-2-propenamide	25085-36-3	Plastic: ABS	1	Issued for public comments on December 2, 2019, but has not officially approved.

2.2 List of drafted approvals of expanded use of current food contact additives (13 types)

S.N.	Name of the new food contact additive	CAS No.	Application scope	Maximum Level (%)	Approval status (by the end of 2019)
1	Microcrystalline wax and hydrocarbon wax	63231-60-7	Plastic: PS	0.5	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
2	Fatty acids, C₁₄-C₁₈ and C₁₆-C₁₈-unsatd	67701-06-8	Plastic: ABS	Appropriate level	Issued for public comments on May 22, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
3	C.I. Disperse Violet 26; Disperse Violet H-FRL; 1,4-diamino-2,3-diphenoxyanthraquinone	6408-72-6	Plastic: AS	0.0003	Issued for public comments on June 18, 2019, but has not officially approved.
4	Wollastonite	13983-17-0	Rubber	15	Issued for public comments on August 21, 2019, but has not officially approved.
5	Erucamide	112-84-5	Plastic: PVC	1	Issued for public comments on August 21, 2019, but has not officially approved.
6	3-Aminopropyltriethoxysilane	919-30-2	Plastic: PPS	0.35	Issued for public comments on August 21, 2019, but has not officially approved.
7	1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,4-butanediol and α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl)	9078-71-1	Plastic: PET	18	Issued for public comments on August 21, 2019, but has not officially approved.
8	Polymer sodium salts of 2-acrylic acid and 2-acrylamide	25987-30-8	Paper and paperboard	0.5 (count as dry basis)	Issued for public comments on August 21, 2019, but has not officially approved.
9	2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 2-propenoic acid	30351-73-6	Adhesive	Appropriate level	Issued for public comments on August 21, 2019, but has not officially approved.
10	Glass fiber	65997-17-3	Plastic: PTFE	25	Issued for public comments on October 15, 2019, but has not officially approved.
11	Polyethylene	9002-88-4	Rubber	2	Issued for public comments on December 2, 2019, but has not officially approved.
12	C.I. Solvent Violet 36; 1,8-bis[(4-Methylphenyl)amino] -9,10-anthracenedione	82-16-6	Plastic: AS	0.0005	Issued for public comments on December 2, 2019, but has not officially approved.
13	Octadecyl 3-(3,5-di-tert-butyl-4- hydroxyphenyl)propionate	2082-79-3	Plastic: PB-1	0.045	Issued for public comments on December 2, 2019, but has not officially approved.

2.3 List of drafted approved new food contact resins (21 types)

S.N.	Name of the new food contact additive	CAS No.	Application scope	Maximum Level (%)	Approval status (by the end of 2019)
1	Formaldehyde, phenol and p-tert-butylphenol, polymer with n-butanol	947534-60-3	Coating and coating film	9.5	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019. (Note: the CAS No. in approval Notice is 2215936-67-5)
2	Formaldehyde, reaction products with Bu alcohol and phenol	96446-41-2	Coating and coating film	10.8	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
3	1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol, propane-1,2-diol and hexanedioic acid	95505-95-6	Coating and coating film	60	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
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	Coating and coating film	85 (count as the dry weight of coating)	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
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	Coating and coating film	35 (count as the dry weight of coating)	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
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	Coating and coating film	85 (count as the dry weight of coating)	Issued for public comments on March 21, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
7	Formaldehyde, polymer with methylphenol	9016-83-5	Coating and coating film	19	Issued for public comments on May 22, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
8	Formaldehyde, polymer with 4,4'-(1-methylethylidene)bis[phenol], 3-methylphenol and 4-methylphenol, butylated	335637-88-2	Coating and coating film	—	Issued for public comments on May 22, 2019, and officially approved on December 13, 2019 according to Notice No. 6, 2019.
9	Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol and bisphenol A	54579-44-1	Coating and coating film	15	Issued for public comments on June 18, 2019, but has not officially approved.
10	2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate and methyl 2-propenoate	74082-28-3	Adhesive	—	Issued for public comments on August 21, 2019, but has not officially approved.
11	2-Propenoic acid, 2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethenyl acetate and 2-ethylhexyl 2-propenoate	193542-91-5	Adhesive	—	Issued for public comments on August 21, 2019, but has not officially approved.
12	2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenyl acetate and 2-ethylhexyl 2-propenoate	26794-25-2	Adhesive	—	Issued for public comments on August 21, 2019, but has not officially approved.
13	2-Propenoic acid, 2-ethylhexyl ester, polymer with ethenyl acetate	25067-02-1	Adhesive	—	Issued for public comments on August 21, 2019, but has not officially approved.
14	1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-cyclohexanedimethanol and 2-methyl-1,3-propanediol	164002-50-0	Coating and coating film	85 (count as the dry weight of coating)	Issued for public comments on August 21, 2019, but has not officially approved.
15	2,4-Hexadienoic acid, (2E,4E)-, polymer with 1,4-benzenediol, 2-(chloromethyl)oxirane, ethyl 2-propenoate, 4,4’-methylenebis[2,6-dimethylphenol], methyl 2-methyl-2-propenoate, 2-methyl-2-propenoic acid and 2-propenoic acid, reaction products with 2-(dimethylamino)ethanol	—	Coating and coating film	—	Issued for public comments on August 21, 2019, but has not officially approved.
16	5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, polymer with 1,2-ethanediol	43011-20-7	Coating and coating film	5 (count as the dry weight of coating)	Issued for public comments on August 21, 2019, but has not officially approved.
17	Polymer of ethylene glycol, isophthalic acid, terephthalic acid, dimethyl ester and adipic acid	82076-71-9	Coating and coating film	30 (count as the coating formula)	Issued for public comments on October 15, 2019, but has not officially approved.
18	1,3-Benzenedicarboxylic acid, polymer with 1,4-butanediol, terephthalic acid, dimethyl ester and hexanedioic acid	-82076-69-5	Coating and coating film	80 (count as the dry weight of coating)	Issued for public comments on October 15, 2019, but has not officially approved.
19	1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid and 1,2-ethanediol	24938-04-3	Coating and coating film	20	Issued for public comments on December 2, 2019, but has not officially approved.
20	2-Propenoic acid, 2-methyl-, polymer with butyl 2-methyl-2-propenoate, 2-(chloromenthyl)oxirane, ethenylbenzene, ethyl 2-propenoate, 4,4’-(1-methylethylidene)bis[phenol] and 2-propenoic acid, reaction products with 2-(dimethylamino)ethanol	—	Coating and coating film	85	Issued for public comments on December 2, 2019, but has not officially approved.
21	1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol, 1,8-octanedicarboxylic acid and 1,2-ethanediol	61039-00-7	Coating and coating film	50	Issued for public comments on December 2, 2019, but has not officially approved.

2.4 List of drafted approvals of expanded use of current new food contact resins (3 types)

S.N.	Name of the new food contact additive	CAS No.	Application scope	Maximum Level (%)	Approval status (by the end of 2019)
1	Styrene block polymer with 1,3-butadiene, hydrogenated	66070-58-4	Plastic, Rubber	—	Issued for public comments on August 21, 2019, but has not officially approved.
2	Vinyl acetate, polymer with vinyl chloride, fumaric acid and glycidyl methacrylate	—	Adhesive, Coating and coating film, Ink	Appropriate level	Issued for public comments on August 21, 2019, but has not officially approved.
3	2-Propenoic acid, 2-methyl-, oxiranylmethyl ester, polymer with chloroethene and ethenyl acetate	26781-49-7	Adhesive, Coating and coating film, Ink	Appropriate level	Issued for public comments on August 21, 2019, but has not officially approved.

3. List of officially approved new food contact additives and resins in 2019

In 2019, there were totally 40 of new food contact additives and resins officially approved by NHC, including 9 new food contact additives, 13 of expanded use of current food contact additives, and 18 of new food contact resins. The detailed information of those 40 products are listed as follows:

3.1 List of approvals of new food contact additives (9 types)

S.N.	Basic information	Acceptance date	Date for comments	Approval date
1	Name: Octadecanamide, N,N'-1,2-ethanediylbis-, reaction products with azacyclotridecan-2-one homopolymer and 1-isocyanatooctadecane CAS No.: 338462-62-7 Scope: Coating and coating film Maximum level of use: 2%	Accepted on January 9, 2018. The Acceptance code is衛食相進申字(2018)第0004號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
2	Name: Oxirane, (chloromethyl)-, polymer with 4,4'-methylenebis[2,6- dimethylphenol] CAS No.: 113693-69-9 Scope: Coating and coating film Maximum level of use: Appropriate level	Accepted on November 25, 2016. The Acceptance code is衛食相進申字(2016)第0019號. Or accepted on January 11, 2017. The Acceptance code is衛食相進申字(2017)第0002號.	Issued for public comments on December 6, 2018.	Approved on July 22, 2019 according to Notice No. 4, 2019.
3	Name: Polycyclooctene CAS No.: 25267-51-0 Scope: Plastic: EVOH Maximum level of use: 8%	Accepted on August 10, 2015. The Acceptance code is 衛食相進申字(2015)第0005號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
4	Name: Formaldehyde, polymer with 3-methylphenol, butyl ether CAS No.: 61991-38-6 Scope: Coating and coating film Maximum level of use: 12% (count as the dry weight of coating)	Accepted on September 25, 2018. The Acceptance code is衛食相進申字(2018)第0038號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
5	Name: Copolymers of acrylamide, diallyldimethylammonium chloride, itaconic acid and propenoic acid CAS No.: 1802295-96-0 Scope: Paper and paperboard Maximum level of use: 1.5% (count as the dry weight of finished paper)	Accepted on January 10, 2017. The Acceptance code is衛食相申字(2017)第0001號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
6	Name: Propenoic acid, polymer with butyl propenoate, compd. with N,N-diethylethanamine CAS No.: 27306-98-5 Scope: Coating and coating film Maximum level of use: 1% (count as the coating formula)	Accepted on May 8, 2018. The Acceptance code is衛食相進申字(2018)第0023號.	Issued for public comments on May 22, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
7	Name: Melamine, polymer with formaldehyde, isobutylated CAS No.: 68002-21-1 Scope: Coating and coating film Maximum level of use: 6% (count as the coating formula)	/ (Note: The acceptance information cannot be found)	Issued for public comments on May 22, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
8	Name: 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 CAS No.: 384330-10-3 Scope: Coating and coating film Maximum level of use: Appropriate level	Accepted on May 8, 2018. The Acceptance code is衛食相進申字(2018)第0020號.	Issued for public comments on May 22, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
9	Name: Benzoic acid, 2-hydroxy-, polymer with formaldehyde and 2,4-diamino-6-phenyl-1,3,5-triazine, ethylated methylated CAS No.: 196823-49-1 Scope: Coating and coating film Maximum level of use: Appropriate level	Accepted on May 8, 2018. The Acceptance code is衛食相進申字(2018)第0019號.	Issued for public comments on May 22, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.

3.2 List of approvals of expanded use of current food contact additives (13 types)

S.N.	Basic information	Acceptance date	Date for comments	Approval date
1	Name: Magnesium sulfate CAS No.: 7487-88-9 Scope: Plastic: ABS Maximum level of use: Appropriate level	Accepted on July 10, 2018. The Acceptance code is衛食相申字(2018)第0011號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
2	Name: Bis(3,4-dimethylbenzylidene) sorbitol CAS No.: 135861-56-2 Scope: Plastic: PB-1 Maximum level of use: 0.3%	Accepted on September 7, 2018. The Acceptance code is衛食相申字(2018)第0019號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
3	Name: Erucamide CAS No.: 112-84-5 Scope: Plastic: PB-1 Maximum level of use: 0.3%	Accepted on May 6, 2016. The Acceptance code is衛食相進申字(2016)第0002號. Or accepted on September 7, 2018. The Acceptance code is衛食相申字(2018)第0018號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
4	Name: Calcium stearate CAS No.: 1592-23-0 Scope: Plastic: PB-1 Maximum level of use: 0.2%	Accepted on September 7, 2018. The Acceptance code is衛食相申字(2018)第0017號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
5	Name: Zinc stearate CAS No.: 557-05-1 Scope: Plastic: PMP Maximum level of use: 0.04%	Accepted on September 5, 2018. The Acceptance code is衛食相進申字(2018)第0031號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
6	Name: Pentaerythritol tetra [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate] CAS No.: 6683-19-8 Scope: Plastic: PMP Maximum level of use: 0.13%	Accepted on September 5, 2018. The Acceptance code is衛食相進申字(2018)第0032號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
7	Name: Tri(2,4-ditertrabutyl phenyl) phosphite ester CAS No.: 31570-04-4 Scope: Plastic: PMP Maximum level of use: 0.08%	Accepted on September 5, 2018. The Acceptance code is衛食相進申字(2018)第0033號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
8	Name: 2-Propenoic acid, butyl ester, polymer with 2-ethylhexyl 2-propenoate CAS No.: 171885-12-4 Scope: Coating and coating film Maximum level of use: Appropriate level	Accepted on February 5, 2018. The Acceptance code is衛食相進申字(2018)第0005號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
9	Name: Sodium acetate CAS No.: 127-09-3 Scope: Plastic: EVOH Maximum level of use: Appropriate level	Accepted on July 10, 2018. The Acceptance code is衛食相進申字(2018)第0026號.	Issued for public comments on December 6, 2018.	Approved on July 22, 2019 according to Notice No. 4, 2019.
10	Name: Phosphoric acid CAS No.: 7664-38-2 Scope: Plastic: EVOH Maximum level of use: Appropriate level	Accepted on July 10, 2018. The Acceptance code is衛食相進申字(2018)第0028號.	Issued for public comments on December 6, 2018.	Approved on July 22, 2019 according to Notice No. 4, 2019.
11	Name: Potassium dihydrogen phosphate CAS No.: 7778-77-0 Scope: Plastic: EVOH Maximum level of use: Appropriate level	Accepted on July 10, 2018. The Acceptance code is衛食相進申字(2018)第0027號.	Issued for public comments on December 6, 2018.	Approved on July 22, 2019 according to Notice No. 4, 2019.
12	Name: Microcrystalline wax and hydrocarbon wax CAS No.: 63231-60-7 Scope: Plastic: PS Maximum level of use: 0.5%	Accepted on December 5, 2017. The Acceptance code is衛食相申字(2017)第0007號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
13	Name: Fatty acids, C₁₄-C₁₈ and C₁₆-C₁₈-unsatd CAS No.: 67701-06-8 Scope: Plastic: ABS Maximum level of use: Appropriate level	Accepted on November 12, 2018. The Acceptance code is衛食相申字(2018)第0022號.	Issued for public comments on May 22, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.

3.3 List of approvals of new food contact resins (18 types)

S.N.	Basic information	Acceptance date	Date for comments	Approval date
1	Name: 1,4-Benzenedicarboxylic acid, polymer with hexanedioic acid, 1,4-butanediol and 1,2,4-benzenetricarboxylic acid 1,2-anhydride CAS No.: / Scope: Coating and coating film Maximum level of use: 30%	/ (Note: The acceptance information cannot be found)	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
2	Name: Polymer with 2-(chloromethyl)oxirane, 4-4'-methylenebis[2,6-dimethylphenol] and 1,4-benzenediol CAS No.: / Scope: Coating and coating film Maximum level of use: 90%	Accepted on Januery 11, 2017. The Acceptance code is衛食相進申字(2017)第0003號. Or accepted on January 9, 2018. The Acceptance code is衛食相進申字(2018)第0002號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
3	Name: Poly(bisphenol A-co-epichlorohydrine) glycidyl end-capped, reaction products with styrene, methyl methacrylate, 2-ethylhexyl acrylate, acrylic acid, and methacrylic acid, partially neutralized with dimethyl ethanol amine CAS No.: / Scope: Coating and coating film Maximum level of use: /	/ (Note: The acceptance information cannot be found)	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
4	Name: 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol, 1,2-ethanediol and hexanedioic acid CAS No.: 72229-82-4 Scope: Coating and coating film Maximum level of use: 50%	Accepted on December 7, 2017. The Acceptance code is衛食相進申字(2017)第0016號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
5	Name: Poly(isophorone diisocyanate) reaction products with 2,2-dimethyl-1,3-propanediol, diethylene glycol, 1,4-cyclohexanedimethanol, isophthalic acid, fatty acids, C₁₈-unsturated, dimers, hydrogenated and caprolactam CAS No.: / Scope: Coating and coating film Maximum level of use: 70%	Accepted on January 9, 2018. The Acceptance code is衛食相進申字(2018)第0001號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
6	Name: 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,3-dihydro-1,3- dioxo-5-isobenzofurancarboxylic acid, hexanedioic acid, 2-methyl-1,3-propanediol and 2,2'-oxybis[ethanol] CAS No.: 1013326-79-8 Scope: Coating and coating film Maximum level of use: 18.5%	Accepted on February 5, 2018. The Acceptance code is衛食相進申字(2018)第0007號.	Issued for public comments on October 8, 2018.	Approved on May 29, 2019 according to Notice No. 2, 2019.
7	Name: Formaldehyde, polymer with 2-methylphenol, 3-methylphenol, 4-methylphenol, butyl ether CAS No.: 298689-79-9 Scope: Coating and coating film Maximum level of use: 5%	Accepted on February 5, 2018. The Acceptance code is衛食相進申字(2018)第0009號.	Issued for public comments on December 6, 2018.	Approved on July 22, 2019 according to Notice No. 4, 2019.
8	Name: Vinyl chloride- vinyl acetate- maleic acid terpolymer CAS No.: 9005-09-8 Scope: Coating and coating film Maximum level of use: 4.5%	Accepted on April 24, 2018. The Acceptance code is衛食相申字(2018)第0005號.	Issued for public comments on December 6, 2018.	Approved on July 22, 2019 according to Notice No. 4, 2019.
9	Name: 1,4-cyclohexamedimethanol polymer with trimethylol propane, neopentyl glycol, adipic acid, isophthalic acid and maleic anhydride CAS No.: / Scope: Coating and coating film Maximum level of use: 65%	Accepted on April 24, 2018. The Acceptance code is衛食相進申字(2018)第0014號.	Issued for public comments on December 6, 2018.	Approved on July 22, 2019 according to Notice No. 4, 2019.
10	Name: Formaldehyde, polymer with 4,4'-(1-methylethylidene)bis[phenol] CAS No.: 25085-75-0 Scope: Coating and coating film Maximum level of use: 10%	Accepted on April 24, 2018. The Acceptance code is衛食相申字(2018)第0004號.	Issued for public comments on December 6, 2018.	Approved on July 22, 2019 according to Notice No. 4, 2019.
11	Name: Formaldehyde, phenol and p-tert-butylphenol polymer with n-butanol CAS No.: 2215936-67-5 Scope: Coating and coating film Maximum level of use: 9.5% (count as the coating formula)	Accepted on April 24, 2018. The Acceptance code is衛食相進申字(2018)第0012號.	Issued for public comments on March 21, 2019. (Note: the CAS No. in comments is 947534-60-3)	Approved on December 13, 2019 according to Notice No. 6, 2019.
12	Name: Formaldehyde, reaction products with butyl alcohol and phenol CAS No.: 96446-41-2 Scope: Coating and coating film Maximum level of use: 10.8% (count as the coating formula)	Accepted on April 24, 2018. The Acceptance code is衛食相進申字(2018)第0013號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
13	Name: 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol, propane-1,2-diol and hexanedioic acid CAS No.: 95505-95-6 Scope: Coating and coating film Maximum level of use: 60% (count as the dry weight of coating)	Accepted on April 24, 2018. The Acceptance code is衛食相進申字(2018)第0015號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
14	Name: 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, decanedioic acid, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol CAS No.: 26353-05-9 Scope: Coating and coating film Maximum level of use: 85% (count as the dry weight of coating)	Accepted on July 5, 2018. The Acceptance code is衛食相申字(2018)第0010號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
15	Name: 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-cyclohexanedimethanol, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol CAS No.: 61960-52-9 Scope: Coating and coating film Maximum level of use: 35% (count as the dry weight of coating)	Accepted on July 4, 2018. The Acceptance code is衛食相申字(2018)第0008號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
16	Name: 1,3-Benzenedicarboxylic acid, polymer with decanedioic acid, 1,4-dimethyl-1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol CAS No.: 61412-73-5 Scope: Coating and coating film Maximum level of use: 85% (count as the dry weight of coating)	Accepted on July 5, 2018. The Acceptance code is衛食相申字(2018)第0009號.	Issued for public comments on March 21, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
17	Name: Formaldehyde, polymer with methylphenol CAS No.: 9016-83-5 Scope: Coating and coating film Maximum level of use: 19% (count as the coating formula)	Accepted on April 24, 2018. The Acceptance code is衛食相申字(2018)第0006號.	Issued for public comments on May 22, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.
18	Name: Formaldehyde, polymer with 4,4'-(1-methylethylidene)bis[phenol], 3-methylphenol and 4-methylphenol, butylated CAS No.: 335637-88-2 Scope: Coating and coating film Maximum level of use: Appropriate level	Accepted on May 8, 2018. The Acceptance code is衛食相進申字(2018)第0022號.	Issued for public comments on May 22, 2019.	Approved on December 13, 2019 according to Notice No. 6, 2019.

Summary:

The application process of new food contact additives and resins must go through three important stages. Stage 1, NHC accepts the application. Stage 2, CFSA issues the public comments of the application. Stage 3, NHC approves the application. Generally, the application timeline is at least one year. Thus, if the application is accepted this year, the published comment will be issued at the end of this year or in the next year, and the application may be approved in the next year or the year after next year.

It can be speculated that the supplement materials should be provided at least one time during the first stage and the second stage, and it will take several months. While it will also take about a half year from stage 2 to stage 3, the period is mainly used to collect and summary of the public comments, and communicate with other Chinese governments.

Note: there may be omissions and errors in the data statistics process because of the change of official websites. The data in this article is for reference only, please refer to the official information published by government departments.

PS. If you want to get the completed list of newly approved food contact additives and resins since 2016, please refer to the Guideline on New Food Contact Substance Chinese Market Access

If you have any question, please contact us at service@cirs-group.com