Milk-clotting enzyme from recombinant Aspergillus oryzae

Listed as an enzyme by the US.

Listed as enzymes (US)

Milk-clotting enzyme from recombinant Aspergillus oryzae is a milk-clotting enzyme made by pure-culture fermentation and used in cheesemaking in place of animal rennet. 21 CFR 173.150 names this organism among those the enzyme may be derived from. Its gene is the aspartic proteinase gene of Rhizomucor miehei.

Where it is and isn’t permitted

Status of Milk-clotting enzyme from recombinant Aspergillus oryzae by jurisdiction. Every jurisdiction this site covers is listed, including those where the substance does not appear.
JurisdictionStatusScope and limitsCitation
Australia and New ZealandFood Standards Australia New ZealandNo 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.
CanadaHealth CanadaNo 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 UnionEuropean Commission / EFSANo 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 BritainFood Standards Agency / Food Standards ScotlandNo 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.
JapanConsumer Affairs AgencyNo 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 KoreaMinistry of Food and Drug SafetyNo listing matchedThis site imports Part III of South Korea’s Standards and Specifications for Food Additives, matched by CAS number, then INS number, then exact name. Mixed preparations and sanitisers are not imported, and an entry whose identifiers disagreed with a page’s is held for review, so an empty row does not show that South Korea does not permit the substance.
United StatesFood and Drug AdministrationPermitted, with conditions
Named in 21 CFR 173.150(a)(5): milk-clotting enzyme derived by a pure-culture fermentation process from Aspergillus oryzae modified by recombinant DNA techniques may be safely used …

Named in 21 CFR 173.150(a)(5): milk-clotting enzyme derived by a pure-culture fermentation process from Aspergillus oryzae modified by recombinant DNA techniques may be safely used in the production of cheese, in an amount not in excess of the minimum required, for the cheeses that standards of identity permit it in. The section is held on this site as the page milk-clotting-enzymes-microbial; read it for the conditions.

21 CFR 173.150retrieved 2026-10-18
Codex AlimentariusCodex Alimentarius Commission / JECFANot 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.

United States—1 no quantity stated

No regulator sets a figure for Milk-clotting enzyme from recombinant Aspergillus oryzae. 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

Produced by pure-culture fermentation of the organism the page names, and removed from the cheese-making process as 21 CFR 173.150(c) requires of the generating organism.

Every name it appears under

2 recorded names. A label may use any of them.

Other names

  • Milk Clotting Enzyme, Aspergillus Oryzae Recombinant
  • Milk-clotting enzyme from recombinant Aspergillus oryzae

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 Milk-clotting enzyme from recombinant Aspergillus oryzae?
Milk-clotting enzyme from recombinant Aspergillus oryzae is a milk-clotting enzyme made by pure-culture fermentation and used in cheesemaking in place of animal rennet. 21 CFR 173.150 names this organism among those the enzyme may be derived from. Its gene is the aspartic proteinase gene of Rhizomucor miehei.
What is Milk-clotting enzyme from recombinant Aspergillus oryzae 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 Milk-clotting enzyme from recombinant Aspergillus oryzae banned in Europe?
No. Milk-clotting enzyme from recombinant Aspergillus oryzae 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 Milk-clotting enzyme from recombinant Aspergillus oryzae permitted?
Of the seven regulators this site reads, the US permits it. Each permission is for named foods at named levels, not a blanket one; the table on this page gives them with citations.

Sources for this page

  • us-listings retrieved 2026-10-18

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.

Follow changes to Milk-clotting enzyme from recombinant Aspergillus oryzae:Atom feed — regulatory events, and any change the weekly refresh detects in its provisions.