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

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