Food Safety Substance
NisinE234
Nisin (E234) is a food additive with PUBLISHED in the EU, FDA has no questions in the US, and data from 9 regulatory sources.
Substance Identity
Resolved identifiers used to render this food-safety record.
Multi-Jurisdiction Comparison
Side-by-side status rows for the same resolved substance across public food regulators.
| Jurisdiction | Authority | Status | Evidence |
|---|---|---|---|
| European Union | EU Commission | PUBLISHED | EU additive listing; Annex II entry |
| United States | FDA | FDA has no questions | GRAS notice |
| Canada | Health Canada | Listed | Preservative |
| Codex | Codex Alimentarius | Listed | Preservative |
EU Food Additive Status
EU Commission food-additive listing rows from eu_food_additives.
| Jurisdiction | E-number | Status | Type | Name | Note |
|---|---|---|---|---|---|
| European Union | E234 | PUBLISHED | substanceFAD | Nisin | - |
EU Annex II Authorised Uses
Authorised additive rows and use conditions from EU Annex II tables.
| Jurisdiction | E-number | Name | INS | Policy item | Note |
|---|---|---|---|---|---|
| European Union | E234 | Nisin | - | POL-FAD-IMPORT-3052 | - |
Conditions and restrictions
| Jurisdiction | Food category | Restriction | Comment | Source |
|---|---|---|---|---|
| European Union | 10.2 processed eggs and egg products | ML 6.25 mg/kg | only pasteurised liquid egg (white, yolk or whole egg) | EU Annex II Union List |
| European Union | 16 Desserts excluding products covered in category 1 3 and 4 | ML 3 mg/kg | only semolina and tapioca puddings and similar products | EU Annex II Union List |
| European Union | 1.6.3 other creams | ML 10 mg/kg | only clotted cream | EU Food Additives Database |
| European Union | 1.7.1 unripened cheese excluding products falling in category 16 | ML 10 mg/kg | only mascarpone | EU Food Additives Database |
| European Union | 1.7.2 ripened cheese | ML 12.5 mg/kg | This substance may be present naturally in certain cheeses as a result of fermentation processes | EU Food Additives Database |
| European Union | 1.7.5 processed cheese | ML 12.5 mg/kg | This substance may be present naturally in certain cheeses as a result of fermentation processes | EU Food Additives Database |
| European Union | 10.2 processed eggs and egg products | ML 6.25 mg/kg | only pasteurised liquid egg (white, yolk or whole egg) | EU Food Additives Database |
| European Union | 16 Desserts excluding products covered in category 1 3 and 4 | ML 3 mg/kg | only semolina and tapioca puddings and similar products | EU Food Additives Database |
| European Union | 1.7.6 cheese products (excluding products falling in category 16) | ML 12.5 mg/kg | only ripened and processed products | EU Food Additives Database |
Codex GSFA Status
Codex Alimentarius GSFA permissions and maximum-use rows.
| Jurisdiction | INS / E-number | Function | Food category | Max level | Notes |
|---|---|---|---|---|---|
| Codex | 234 | Preservative | 01.1.4 Flavoured fluid milk drinks | 12 mg/kg | As nisin.; For use in flavoured products heat treated after fermentation only. |
| Codex | 234 | Preservative | 01.4.3 Clotted cream (plain) | 10 mg/kg | Excluding products conforming to the Standard for Cream and Prepared Creams (CXS 288-1976) |
| Codex | 234 | Preservative | 01.6.1 Unripened cheese | 12 mg/kg | Includes use in products conforming to the Standard for Mozzarella (CXS 262-2006) except for the surface treatment of high moisture products packaged in liquid, noting the... |
| Codex | 234 | Preservative | 01.6.2 Ripened cheese | 12 mg/kg | Excluding products conforming to the Standard for Coulommiers (CXS 274-1969).; As nisin.; Excluding products conforming to the Standard for Brie (CXS 277-1973).; Excluding... |
| Codex | 234 | Preservative | 01.6.4 Processed cheese | 12 mg/kg | As nisin. |
| Codex | 234 | Preservative | 01.6.5 Cheese analogues | 12 mg/kg | - |
| Codex | 234 | Preservative | 01.6.6 Whey protein cheese | 12 mg/kg | - |
| Codex | 234 | Preservative | 01.7 Dairy-based desserts (e.g. pudding, fruit or flavoured yoghurt) | 12 mg/kg | As nisin.; Except for use in products conforming to the Standard for Fermented Milks (CXS243-2003): for use in flavoured fermented products, heat treated after fermentation. |
| Codex | 234 | Preservative | 06.5 Cereal and starch based desserts (e.g. rice pudding, tapioca pudding) | 3 mg/kg | - |
| Codex | 234 | Preservative | 07.2 Fine bakery wares (sweet, salty, savoury) and mixes | 6 mg/kg | As nisin. |
| Codex | 234 | Preservative | 08.2.2 Heat-treated processed meat, poultry, and game products in whole pieces or cuts | 25 mg/kg | Excluding products conforming to the Standard for Cooked Cured Pork Shoulder (CODEX STAN 97-1981).; Excluding products conforming to the Standard for Cooked Cured Ham (CODEX STAN... |
| Codex | 234 | Preservative | 08.3.2 Heat-treated processed comminuted meat, poultry, and game products | 25 mg/kg | For products conforming to the Standard for Luncheon Meat (CODEX STAN 89-1981), Standard for Cooked Cured Chopped Meat (CODEX STAN 98-1981), and Standard for Corned Beef (CODEX... |
| Codex | 234 | Preservative | 08.4 Edible casings (e.g. sausage casings) | 7 mg/kg | As nisin. |
| Codex | 234 | Preservative | 10.2.1 Liquid egg products | 6 mg/kg | As nisin. |
| Codex | 234 | Preservative | 12.5.1 Ready-to-eat soups and broths, including canned, bottled, and frozen | 5 mg/kg | As nisin.; Excluding use for canned bouillons and consommés. |
| Codex | 234 | Preservative | 12.6.1 Emulsified sauces and dips (e.g. mayonnaise, salad dressing, onion dip) | 5 mg/kg | For use in low oil content or refrigerated products only.; As nisin. |
| Codex | 234 | Preservative | 12.6.2 Non-emulsified sauces (e.g. ketchup, cheese sauce, cream sauce, brown gravy) | 5 mg/kg | Excluding products conforming to the Standard for Chilli Sauce (CXS 306-2011).; For use in low oil content or refrigerated products only.; As nisin. |
| Codex | 234 | Preservative | 12.6.4 Clear sauces (e.g. fish sauce) | 5 mg/kg | Excluding products conforming to the Standard for Fish Sauce (CODEX STAN 302-2011).; For use in low oil content or refrigerated products only.; As nisin. |
| Codex | 234 | Preservative | 12.7 Salads (e.g. macaroni salad, potato salad) and sandwich spreads excluding cocoa- and nut-based spreads of food categories 04.2.2.5 and 05.1.3 | 5 mg/kg | For use in low oil content or refrigerated products only.; As nisin. |
FDA GRAS Status
US FDA GRAS notice evidence from enriched and notice tables.
| Jurisdiction | GRN | Substance | FDA response | Intended use | Basis | Notifier |
|---|---|---|---|---|---|---|
| United States | 65 | Nisin | FDA has no questions | Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent | Scientific procedures | Rhodia, Inc. |
| United States | 65 | Nisin | FDA has no questions | Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent | Scientific procedures | Rhodia, Inc. |
Health Canada Status
Health Canada food-additive permissions by functional class and food scope.
| Jurisdiction | Class | Permitted foods | Maximum level | List |
|---|---|---|---|---|
| Canada | Preservative | (a)Baking mixes containing egg; Brine for hard-boiled egg; Liquid whole egg; Liquid whole egg mix | (a)15 ppm | List of Permitted Preservatives |
| Canada | Preservative | (b)Concentrated (naming the fruit) juice; (Naming the fruit) juice; (Naming the fruits) juice; Unstandardized beverage concentrates containing fruit juice; Unstandardized beverages containing fruit juice | (b)2.5 ppm in the beverage as consumed | List of Permitted Preservatives |
| Canada | Preservative | (c) Egg-white wraps | (c) 20 ppm | List of Permitted Preservatives |
| Canada | Preservative | (d) Liquid plant protein isolate-based products that resemble egg products | (d) 25 ppm | List of Permitted Preservatives |
| Canada | Preservative | (e)Meat and meat by-product loaf; Meat by-product loaf; Meat loaf; Meat lunch; Meat roll; Ready-to-eat prepared meat or ready-to-eat prepared meat by-product; Ready-to-eat prepared poultry meat or ready-to-eat prepared... | (e)25 ppm | List of Permitted Preservatives |
| Canada | Preservative | (f)Refrigerated cooked potato-based products | (f)12.5 ppm | List of Permitted Preservatives |
| Canada | Preservative | (g)Unstandardized heat-treated low-acid sauces | (g)6.25 ppm | List of Permitted Preservatives |
| Canada | Preservative | (h)Unstandardized processed cheese products | (h)30 ppm | List of Permitted Preservatives |
JECFA ADI Values
JECFA ADI records and evaluation years.
| Jurisdiction | Chemical name | JECFA no. | CAS | ADI | ADI upper | Function | Evaluation year |
|---|---|---|---|---|---|---|---|
| JECFA | NISIN A | - | 1414-45-5 | 0-33000 units/kg bw | 33000 | PRESERVATIVE | 2024 |
| JECFA | FUMONISIN B1 | - | - | no_data | - | - | 2016 |
| JECFA | FUMONISIN B2 | - | - | no_data | - | - | 2016 |
| JECFA | FUMONISIN B3 | - | - | no_data | - | - | 2016 |
| JECFA | FUMONISINS | - | - | no_data | - | MYCOTOXIN | 2016 |
Cross-Reference to Cosmetics / Chemicals / Pharma
Same-CAS public rows from adjacent Roots verticals where available.
Cross-Vertical Regulatory Divergence
This substance has different regulatory treatment across food, cosmetics, and industrial use.
Frequently Asked Questions
Food-use, safety, ADI, and cross-vertical answers mirrored into FAQPage JSON-LD.
What is Nisin used for in food?
Nisin appears in food-use rows as: Preservative; Preservative; Preservative.
Is Nisin / E234 safe?
This page does not assign a standalone safety verdict; it renders public regulatory evidence. ADI/reference value: EFSA ADI = 0.13 mg/kg bw/day. EU status evidence: PUBLISHED. US/FDA evidence: FDA has no questions.
What is the ADI for Nisin?
Nisin has this ADI/reference value in the food-safety tables: EFSA ADI = 0.13 mg/kg bw/day. Source: EFSA AFC 2006.
Is Nisin also used in cosmetics?
Nisin has a same-CAS cosmetics cross-reference: Lactococcus Ferment Lysate, EU status permitted.