Pepsin
9001-75-6 · PepsinCAS 9001-75-6
Listed as an enzyme by the US.
Listed as enzymes (US)
- United States: Enzyme — FDA, Substances Added to Food: PEPSIN
- United States: Enzymes — 21 CFR 184.1595, citing 21 CFR 170.3(o)(9)
Pepsin is a protein-digesting enzyme used in cheesemaking, often blended with rennet, and in producing protein hydrolysates. It is obtained from the stomachs of pigs and cattle.
Where it is and isn’t permitted
| Jurisdiction | Status | Scope and limits | Citation |
|---|---|---|---|
| Australia and New Zealand | No listed food uses foundThis site has not matched this substance to any food use on this jurisdiction’s list of authorised food additives. A food additive may be used only in foods that list names. Flavourings, enzymes, processing aids and added nutrients are regulated separately and do not appear on it. | ||
| Canada | No listing matchedHealth Canada’s lists name additives without E or INS numbers, so this site matches them by exact name. A substance listed there under a name this site does not recognise has no row here. | ||
| European Union | No listed food uses foundThis site has not matched this substance to any food use on this jurisdiction’s list of authorised food additives. A food additive may be used only in foods that list names. Flavourings, enzymes, processing aids and added nutrients are regulated separately and do not appear on it. | ||
| Great Britain | No listed food uses foundThis site has not matched this substance to any food use on this jurisdiction’s list of authorised food additives. A food additive may be used only in foods that list names. Flavourings, enzymes, processing aids and added nutrients are regulated separately and do not appear on it. | ||
| Japan | No listing matchedThis site imports only Japan’s list of designated additives (Appended Table 1 to the Regulations for Enforcement of the Food Sanitation Act), matched by English name. Existing additives, natural flavouring agents and ordinary foods used as additives are permitted outside that list and are not imported, so an empty row does not show that Japan does not permit the substance. | ||
| South Korea | Permitted, with conditions | Designated food additive: Standards and Specifications for Food Additives, Part III, 2. …Designated food additive: Standards and Specifications for Food Additives, Part III, 2. 가공보조제 (processing aids), 펩신 (“Pepsin”, the English the Code prints beside it). Main use (주용도) of 펩신: 효소제. Standard for use (사용기준) of 펩신: (1) [to be used under the general standard for use in II. 2. 1), the minimum amount that achieves the technical effect, with no limit set for this additive in particular] “II. 2. 1)의 규정에 따라 사용하여야 한다.” The Korean is the standard as published. There is no official English translation of the current Code (the English version on MFDS’s website is the 2020 edition and has no legal effect); the English in square brackets is this site’s description of what each sentence does, not a translation of the foods or the levels. Compositional specifications (Part IV) are not imported, nor are the general standards in Part II, which apply to every additive. | Standards and Specifications for Food Additives (식품첨가물의 기준 및 규격), MFDS Notification, Part III (Standards for use, by item)retrieved 2026-10-18 |
| United States | Permitted | 21 CFR 184.1595retrieved 2026-10-17 | |
| Codex Alimentarius | Not listedDoes not appear on this jurisdiction’s permitted list. That is not the same as being prohibited. |
How much is permitted
A listing usually limits the quantity as well as the food. Only one of the forms that takes is a figure: quantum satis and good manufacturing practice permit the amount the technological effect requires and no more, which is a limit rather than the absence of one. Figures below are the range across every food category this page is listed in, and categories differ between regulators — see how much is permitted.
| South Korea | — | 1 no quantity stated |
|---|---|---|
| United States | — | 1 no quantity stated |
No regulator sets a figure for Pepsin. That is not an absence of control: where the listing says quantum satis or good manufacturing practice, the quantity is limited to what the effect requires.
What it is made from
Extracted from the glandular layer of porcine or bovine stomachs. The porcine source is why pepsin raises a specific concern under halal and kosher rules beyond the general question of animal derivation.
- Not vegan
- Not vegetarian
- May raise a halal question
- May raise a kosher question
Compare other additives on the dietary indexes.
- CAS registry number
- 9001-75-6
How JECFA defines it
The international specification for identity and purity, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by FAO. It is a different document from any above, written by a different body and revised on its own cycle; it is advisory, and a country adopts it or does not.
Pepsin from Hog Stomach
Synonyms: Pepsin
Assay, identification and purity criteria
Description and assay
- Specification history
- Prepared at the 15th JECFA (1971), published in NMRS 50B (1972) and in FNP 52 (1992). An ADI 'not limited' was established at the 15th JECFA (1971)
- SOURCES
- Commercial preparations of Pepsin contain proteolytic enzymes obtained from the glandular layer of hog stomach.
- Active principles
- Pepsin (acid proteinase), composed of Pepsin A (major component), Pepsin B and Pepsin C
- Systematic names and numbers
- None (EC 3.4.23.1) None (EC 3.4.23.2) None (EC 3.4.23.3)
- Reactions catalyzed
- The enzyme preparations hydrolyze polypeptides, including those with linkages adjacent to aromatic or L-leucine residues yielding peptides of lower molecular weight. Pepsin B and Pepsin C which are minor components have more restricted specificity.
- DESCRIPTION
- White to light tan, water soluble powders, amber pastes or clear amber to brown aqueous liquids
- FUNCTIONAL USES
- Enzyme preparation Used in the preparation of fish meal and other protein hydrolysates, and the clotting of milk in cheese making in combination with one of the rennet.
- GENERAL SPECIFICATIONS
- Must conform to the General Specifications for Enzyme Preparations use d in Food Processing (See Volume Introduction)
Identification
- Pepsin activity
- The sample shows proteolytic activity See description under TESTS
- Test: Proteolytic activity
- Principle: Coagulated egg albumin is digested with a pepsin solution and the residue of the undissolved albumen is compared with that from a test with a reference standard. Definition of Activity: The activity of pepsin is expressed as the multiple of its own weight with that of coagulated egg albumen which it can digest. The Food Chemicals Codex defines, that one pepsin unit digests 3,000 times its weight of coagulated egg albumen under the condition of the assay. Procedure: Mix 35 ml of 1.0N hydrochloric acid with 385 ml of water. Dissolve 100 mg of pepsin, accurately weighed, in 150 ml of this solution. Prepare a similar solution of N.F. Pepsin Reference Standard, accurately weighed. Boil one or more hen eggs for 15 min to provide coagulated albumen for the assay. Cool them rapidly to room temperature by immersion in cold water; remove the shell and pellicle and all of the yolk and at once rub the albumen through a clean, dry No. 40 sieve rejecting the first portion that passes through the sieve. Place 10 g of the succeeding well mixed portion in each of 3 wide-mouth bottles of about 100 ml capacity. Immediately add 35 ml of the dilute acid at one time or in portions and, by suitable means, thoroughly disintegrate the particles of albumen. Place the bottles in a water bath at 52 o . After the contents of the bottles have reached that temperature, add 5.0 ml of the acidified solution of pepsin to one bottle, 4.30 ml of the same solution and 0.7 ml of the dilute acid to another bottle, and 5.0 ml of the Reference Standard solution to the third bottle. At once stopper the bottles securely, invert them 3 times, and maintain them at 52 o for 2 h and 30 min, agitating the contents equally every 10 min by inverting the bottles once. Remove the bottles from the bath, pour the contents into 100 ml conically shaped measuring vessels, having diameters not exceeding 1 cm at the bottom and complying in other respects with the water and sediment tube ASTM Standard Methods D 96-68, graduated from 0 to 0.5 ml in 0.05 ml graduations; from 0.5 to 2 ml in 0.1 ml graduations; from 2 to 3 in 0.2 ml graduations; from 3 to 5 ml in 0.5 ml graduations; from 5 to 10 ml in 1 ml graduations; from 10 to 25 ml in 5 ml graduations; and with graduation marks at 50, 75, and 100 ml points. Transfer the undigested egg albumen which adheres to the sides of the bottles to the respective measuring vessels with the aid of small portions of water until 50 ml has been used for each. Mix the contents of each measuring vessel, and allow them to stand for 30 min. The volume of the undissolved albumen in the measuring vessel corresponding to 5.0 ml of the solution of pepsin being assayed does not exceed the volume of the undissolved albumen in the measuring vessel corresponding to 5.0 ml of the Reference Standard solution, and the volume of the undissolved albumen in the measuring vessel corresponding to 4.30 ml of the solution of pepsin being assayed is not less than the volume of the undissolved albumen in the measuring vessel corresponding to 5.0 ml of the Reference Standard solution. Note: Other measuring vessels than the type described in this monograph may be used if they are of such design and graduation as to measure the residue accurately.
Every name it appears under
2 recorded names. A label may use any of them.
CAS registry number
- 9001-75-6
As it appears in regulation
- Pepsin
Hazard reference values
No reference value for this substance in the sources we hold.
Evidence and how bodies read it
Studies, and the differing conclusions regulators drew from them, are curated rather than machine-read, and none has been written for this substance yet.
Common questions
Assembled from what is above, in the words the questions are usually asked in. Each answer is the same statement the relevant section makes, with the same citations behind it.
- What is Pepsin?
- Pepsin is a protein-digesting enzyme used in cheesemaking, often blended with rennet, and in producing protein hydrolysates. It is obtained from the stomachs of pigs and cattle.
- What is Pepsin used for in food?
- It is listed as an enzyme — the role the US assigns it. This page shows every function each regulator records, with the citation for each.
- Is Pepsin banned in Europe?
- No. Pepsin is not on the EU's list of authorised food additives, but it would not be expected to be: every role regulators give it — enzyme — the EU regulates under separate law. Its absence from the additives list says nothing about whether it is permitted in Europe.
- Where is Pepsin permitted?
- Of the seven regulators this site reads, South Korea and the US permit it. Each permission is for named foods at named levels, not a blanket one; the table on this page gives them with citations.
- Is Pepsin vegan?
- No. Pepsin is animal-derived, and is not vegetarian either. This page says what it is made from.
Sources for this page
- kr retrieved 2026-10-18
- ecfr retrieved 2026-10-17
- jecfaspecs retrieved 2026-09-23
Full licence terms and publisher details on Sources. How this page is built and updated: Method.
Machine-readable: a JSON record of this additive is given on request —how to ask for access.
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