Comparative Analysis: What has changed in the 2019 Heath Food Excipients Directory?

On 6 November 2019, State Administration for Market Regulation (SAMR) issued the Available Excipients for Heath Food Filing and Their Usage Rules (2019) (referred to 2019 Excipients Directory), and it will be officially implemented on 1 December 2019. CIRS made a comparative analysis between the 2019 Excipients Directory and Available Excipients for Heath Food Filing and Their Usage Rules (2017) (referred to 2017 Excipients Directory) from multiple aspects, including the list of available excipients, related standards for excipients, version of related standards for excipients, etc.

1. 17 new available excipients

Compared with the 2017 Excipients Directory, the available excipients in the 2019 Excipients Directory have increased from 179 to 196, including phospholipid, curcumin, octyl and decyl glycerate, fruit and vegetable powder, etc.

The 17 new excipients are as follows:

S.N.	Excipient name	Related standards	Maximum dosage
S.N.	Excipient name	Related standards	Solid preparation	Liquid preparation
1	Menthol	GB 1886.199 Natural Menthol; The current Pharmacopoeia of the People's Republic of China (referred to Chinese Pharmacopoeia) - Menthol	Appropriate level as required for flavoring
2	Galacto-oligosaccharide	NHC Notice of No.20, 2008; NHC Notice of No.8, 2016; NHC Notice of No.8, 2017	Appropriate level as required for condiment
3	Fructooligosaccharide	GB/T 23528 Fructooligosaccharide	Appropriate level as required for condiment
4	Isomaltooligosaccharide	GB/T 20881 Isomaltooligosaccharide	Appropriate level as required for condiment
5	Edible sweet potato starch	GB/T 34321 Edible sweet potato starch; GB 31637 Edible starch	Appropriate level	Appropriate level
6	Magnesium carbonate	GB 25587 Magnesium carbonate; The current Chinese Pharmacopoeia - Heavy Magnesium Carbonate	It is unavailable for products supplementing Mg or products targeted for 1-3 years old; Other products: ≤0.8g per day (count as Mg).
7	Citric acid	The current Chinese Pharmacopoeia - Citric Acid	Appropriate level	Appropriate level
8	Anhydrous citric acid	The current Chinese Pharmacopoeia - Anhydrous citric acid	Appropriate level	Appropriate level
9	Phospholipid	GB 28401 Phospholipid	Appropriate level as required for emulsifier, solubilizer
10	Concentrated soybean lecithin	LS/T 3219 Soybean lecithin	Appropriate level as required for emulsifier, solubilizer
11	Soybean lecithin powder	LS/T 3219 Soybean lecithin	Appropriate level as required for emulsifier, solubilizer
12	Fractionated soybean lecithin	LS/T 3219 Soybean lecithin	Appropriate level as required for emulsifier, solubilizer
13	Transparent soybean lecithin	LS/T 3219 Soybean lecithin	Appropriate level as required for emulsifier, solubilizer
14	Soybean lecithin	The current Chinese Pharmacopoeia	Appropriate level as required for emulsifier, solubilizer
15	Octyl and decyl glycerate	GB28302 Octyl and decyl glycerate	Appropriate level as required for emulsifier
16	Curcumin	GB 1886.76 Curcumin	Appropriate level as required for coloring, ≤0.7g/kg
17	Fruit and vegetable powder (the specific name shall be clearly defined)	NY/T1884 Green food - Fruit and vegetable powder - fruit and vegetable powder of raw material type	Appropriate level as required for condiment

* CIRS interpretation: fruit and vegetable powder

1). According to the 2019 Excipients Directory, the specific name of the fruit and vegetable powder shall be clearly defined. But will the government list all available specific fruit and vegetable powder into the filing system where companies only can choose from? Or can companies fill in the names of the available fruit and vegetable powder in the system? It hasn’t been not clear yet, and the relevant authorities will give the further explanation in the near future.

2). The fruit and vegetable powder of raw material type described in NY/T1884 refer to the products that are manufactured by single fruit, vegetable or nut through screening (shelling), washing, beating, homogenization, sterilization and drying. Companies should not use the fruit and vegetable powder that does not meet the requirements or has other food additives.

2. Supplement the standard of 28 existing excipients

Compared with the 2017 Excipients Directory, related standards have been made for 28 excipients in the 2019 Excipients Directory. The specific comparisons are as follows:

S.N.	Excipient name	2017 Excipients Directory	2019 Excipients Directory
1	Acacia	GB 29949 Acacia	GB 29949 Acacia; The current Chinese Pharmacopoeia - Acacia
2	β-Cyclodextrin	GB 1886.180 β-Cyclodextrin	GB 1886.180 β-Cyclodextrin; The current Chinese Pharmacopoeia - β-Cyclodextrin
3	D-Mannitol	GB 1886.177 D-Mannitol	GB 1886.177 D-Mannitol; The current Chinese Pharmacopoeia - D-Mannitol
4	Silicon dioxide	GB 25576 Silicon dioxide	GB 25576 Silicon dioxide; The current Chinese Pharmacopoeia - Silicon dioxide
5	Titanium oxide	GB 25577 Titanium oxide	GB 25577 Titanium oxide; The current Chinese Pharmacopoeia - Titanium oxide
6	Bees wax	GB 1886.87-2015 Bees wax	GB 1886.87-2015 bees wax; The current Chinese Pharmacopoeia - Bees wax
7	Glycerol	GB 29950 Glycerol	GB 29950 Glycerol; The current Chinese Pharmacopoeia - Glycerol
8	Talc	GB 1886.246 Talc	GB 1886.246 Talc; The current Chinese Pharmacopoeia - Talc
9	Methyl cellulose	GB 1886.256 Methyl cellulose	GB 1886.256 Methyl cellulose; The current Chinese Pharmacopoeia - Methyl cellulose
10	Gelatin	GB 6783 Gelatin	GB 6783 Gelatin; The current Chinese Pharmacopoeia – Gelatin for Capsules
11	Xylitol	GB 1886.234 Xylitol	GB 1886.234 Xylitol; The current Chinese Pharmacopoeia - Xylitol
12	Citric acid	GB 1886.235 Citric acid	GB 1886.235 Citric acid; GB/T 8269 Citric acid
13	Hydroxypropylmethylcellulose	GB 1886.109 Hydroxypropylmethylcellulose (HPMC)	GB 1886.109 Hydroxypropylmethylcellulose (HPMC); The current Chinese Pharmacopoeia - Hydroxypropylmethylcellulose
14	Sucralose	GB 25531 Sucralose	GB 25531 Sucralose; The current Chinese Pharmacopoeia - Sucralose
15	Sorbic acid and potassium sorbate (count as sorbic acid)	GB 1886.186 Sorbic acid GB 1886.39 Potassium sorbate	GB 1886.186 Sorbic acid; GB 1886.39 Potassium sorbate; The current Chinese Pharmacopoeia - Sorbic acid, potassium sorbate
16	Sorbitol and sorbitol solution	GB 1886.187 Sorbitol and sorbitol solution	GB 1886.187 Sorbitol and sorbitol solution; The current Chinese Pharmacopoeia - Sorbitol
17	Carboxy methyl starch sodium	GB 29937 Carboxy methyl starch sodium	GB 29937 Carboxy methyl starch sodium; The current Chinese Pharmacopoeia - Carboxy methyl starch sodium
18	Carboxymethyl cellulose sodium	GB 1886.232 Carboxymethyl cellulose sodium	GB 1886.232 Carboxymethyl cellulose sodium; The current Chinese Pharmacopoeia - Carboxymethyl cellulose sodium
19	Aspartame	GB 1886.47 Aspartame	GB 1886.47 Aspartame; The current Chinese Pharmacopoeia - Aspartame
20	Microcrystalline cellulose	GB 1886.103 Microcrystalline cellulose	GB 1886.103 Microcrystalline cellulose; The current Chinese Pharmacopoeia - Microcrystalline cellulose
21	Magnesium stearate	GB 1886.91 Magnesium stearate	GB 1886.91 Magnesium stearate; The current Chinese Pharmacopoeia - Magnesium stearate
22	Potato starch	GB/T 8884 Potato starch	GB/T 8884 Potato starch; The current Chinese Pharmacopoeia - Potato starch; GB 31637 Edible starch
23	Maltodextrin	GB/T 20884 Maltodextrin	GB/T 20884 Maltodextrin; The current Chinese Pharmacopoeia –Maltodextrin; GB 15203 starch sugar
24	Cassava starch	GB/T 29343 Cassava starch	GB/T 29343 Cassava starch; The current Chinese Pharmacopoeia - Cassava starch; GB 31637 Edible starch
25	Lactose	GB25595 Lactose	GB25595 Lactose; The current Chinese Pharmacopoeia - Lactose
26	Edible dextrose	GB 15203 Starch sugar GB/T 20880 Edible dextrose	GB 15203 Starch sugar; GB/T 20880 Edible dextrose; The current Chinese Pharmacopoeia – Glucose; The current Chinese Pharmacopoeia – Anhydrous glucose
27	Edible wheat starch	GB/T 8883 Edible wheat starch	GB/T 8883 Edible wheat starch; The current Chinese Pharmacopoeia - Wheat starch; GB 31637 Edible starch
28	Edible corn starch	GB/T 8885 Edible corn starch	GB/T 8885 Edible corn starch; The current Chinese Pharmacopoeia - Maize starch; GB 31637 Edible starch

3. Update the version of Pharmacopoeia of the People's Republic of China

In the 2017 Excipients Directory, the related standard for 20 excipients such as purified water is the 2015 Chinese Pharmacopoeia (Part Ⅳ), and in the 2019 Excipients Directory, it is the current Chinese Pharmacopoeia. The 20 excipients are as follows:

Purified water, Simple syrup, Low-substituted hydroxypropyl cellulose, Black ferric oxide, Red ferric oxide, Dextrin, Yellow ferric oxide, Crospovidone, Croscarmellose sodium, Povidone K30, Macrogol, Soluble starch, Hydroxypropyl cellulose, Triacetin, Anhydrous calcium hydrogen phosphate, Ethylcellulose, Pregelatinized starch, Sucrose, Brown ferric oxide, Vacant capsules

4. Update the name of one excipient

The name “glyceryl triacetate” in the 2017 Excipients Directory was renamed “triacetin” in the 2019 Excipients Directory.

CIRS Comments

The implementation of the health food filing has simplified the procedures of administrative approval and reduced the reporting period and costs, so it is favoured by health food companies. However, the filing system may lead manufacturers to produce similar products due to the restrictive raw materials and excipients, and the competition will be getting tougher. The release of the 2019 Excipients Directory has brought new hopes to health food companies. Compared with the 2017 Excipients Directory, the 2019 Excipients Directory added 17 available excipients, including common food additives such as phospholipids, Octyl and decyl glycerate, and common food materials such as fruit and vegetable powders. These new excipients provide a more favourable guarantee for enriching the taste of the products and enhancing the market competitiveness of the products. Besides, the new standards of 28 excipients also provide more space for companies to choose suppliers.

Up to now, according to the query of CIRS in the filing system, new excipients have not been entered into the system. It is believed that the SAMR will complete the update of the filing system before 1 December, and companies need to wait patiently.

Reference:

SAMR Notice: http://gkml.samr.gov.cn/nsjg/tssps/201911/t20191106_308220.html

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