Food Safety Substance
Annatto
Annatto is a food additive with PUBLISHED in the EU, FDA has no questions; some uses may require a color additive listing in the US, and data from 9 regulatory sources.
CAS 1393-63-1
Indexable evidence set
FDA
FDA has no questions; some uses may require a color additive listing
ADI / TDI
EFSA ADI = 0.3 mg/kg bw/day
Codex
60 row(s)
SOURCE
D1 identity resolution
e number aliases | Food Additives | dsstox identifiers | 9 matched regulatory source group(s)
Substance Identity
Resolved identifiers used to render this food-safety record.
Substance name
Annatto
CAS
1393-63-1
DTXSID
DTXSID7024534
Evidence tier
Indexable evidence set (14)
SOURCE
EU Commission
FDA | Health Canada | Codex Alimentarius
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; some uses may require a color additive listing | GRAS notice |
| Canada | Health Canada | Listed | Food Colours |
| Codex | Codex Alimentarius | Listed | Colour |
SOURCE
EU Commission
EU Food Additives | EU Food Additives Database
EU Food Additive Status
EU Commission food-additive listing rows from eu_food_additives.
| Jurisdiction | E-number | Status | Type | Name | Note |
|---|---|---|---|---|---|
| European Union | E160B | PUBLISHED | substanceFAD | Annatto, Bixin, Norbixin/Deleted from the Union List of authorised additives | According to the Regulation (EU) No 2020/0771, Annatto, Bixin, Norbixin is deleted from the Union List and is replaced by two separate Food Additives namely Annatto bixin (E... |
| European Union | - | PUBLISHED | substanceFAD | Annatto bixin | According to the Regulation (EU) No 2020/0771, Annatto, Bixin, Norbixin (E 160b) is deleted from the Union List and is replaced by two separate Food Additives namely Annatto bixin... |
| European Union | - | PUBLISHED | substanceFAD | Annatto norbixin | According to the Regulation (EU) No 2020/0771, Annatto, Bixin, Norbixin (E 160b) is deleted from the Union List and is replaced by two separate Food Additives namely Annatto bixin... |
SOURCE
EU Commission
EU Annex II Authorised | EU Food Additives Database
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 | E160B | Annatto, Bixin, Norbixin/Deleted from the Union List of authorised additives | - | POL-FAD-IMPORT-3011 | According to the Regulation (EU) No 2020/0771, Annatto, Bixin, Norbixin is deleted from the Union List and is replaced by two separate Food Additives namely Annatto bixin (E... |
| European Union | - | Annatto bixin | - | POL-FAD-IMPORT-3379 | According to the Regulation (EU) No 2020/0771, Annatto, Bixin, Norbixin (E 160b) is deleted from the Union List and is replaced by two separate Food Additives namely Annatto bixin... |
| European Union | - | Annatto norbixin | - | POL-FAD-IMPORT-3380 | According to the Regulation (EU) No 2020/0771, Annatto, Bixin, Norbixin (E 160b) is deleted from the Union List and is replaced by two separate Food Additives namely Annatto bixin... |
SOURCE
Codex Alimentarius
Codex GSFA
Codex GSFA Status
Codex Alimentarius GSFA permissions and maximum-use rows.
| Jurisdiction | INS / E-number | Function | Food category | Max level | Notes |
|---|---|---|---|---|---|
| Codex | 160b(i) | Colour | 01.1.4 Flavoured fluid milk drinks | 20 mg/kg | As bixin.; Excluding chocolate milk. |
| Codex | 160b(i) | Colour | 01.3.2 Beverage whiteners | 50 mg/kg | Excluding products conforming to the Standard for a Blend of Evaporated Skimmed Milk and Vegetable Fat (CODEX STAN 250-2006).; As bixin.; Excluding products conforming to the... |
| Codex | 160b(i) | Colour | 01.4.4 Cream analogues | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 01.5.2 Milk and cream powder analogues | 100 mg/kg | As bixin.; Excluding products conforming to the Standard for a Blend of Skimmed Milk and Vegetable Fat in Powdered Form (CODEX STAN 251-2006). |
| Codex | 160b(i) | Colour | 01.6.2.2 Rind of ripened cheese | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 01.6.2.3 Cheese powder (for reconstitution; e.g. for cheese sauces) | 50 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 01.6.4.1 Plain processed cheese | 60 mg/kg | As bixin.; Except for use at 100 mg/kg in sliced processed cheeses. |
| Codex | 160b(i) | Colour | 01.6.4.2 Flavoured processed cheese, including containing fruit, vegetables, meat, etc. | 15 mg/kg | As bixin.; Except for use at 100 mg/kg in sliced processed cheese. |
| Codex | 160b(i) | Colour | 01.6.5 Cheese analogues | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 01.7 Dairy-based desserts (e.g. pudding, fruit or flavoured yoghurt) | 100 mg/kg | As bixin.; Except for use in non-plain products conforming to the Standard for Fermented Milks (CXS 243- 2003) at 20 mg/kg. |
| Codex | 160b(i) | Colour | 02.1.1 Butter oil, anhydrous milkfat, ghee | 100 mg/kg | As bixin.; Except for use in products conforming to the Standard for Edible Fats and Oils not covered by Individual Standards (CXS 19-1981) for the purposes of natural colour lost... |
| Codex | 160b(i) | Colour | 02.1.2 Vegetable oils and fats | 10 mg/kg | For use in products, excluding virgin or cold pressed oils and vegetable oils, conforming to the Standard for Edible Fats and Oils not Covered by Individual Standards (CXS... |
| Codex | 160b(i) | Colour | 02.1.3 Lard, tallow, fish oil, and other animal fats | 10 mg/kg | As bixin.; For use in products conforming to the Standard for Edible fats and oils not Covered by Individual Standards (CXS 19-1981) and the Standard for Named Animal Fats (CXS... |
| Codex | 160b(i) | Colour | 02.2.1 Butter | 20 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 02.2.2 Fat spreads, dairy fat spreads and blended spreads | 100 mg/kg | As bixin.; Except for use in products conforming to the Standard for Dairy Fat Spreads (CODEX STAN 253-2006) at 20 mg/kg. |
| Codex | 160b(i) | Colour | 02.3 Fat emulsions mainly of type oil-in-water, including mixed and/or flavoured products based on fat emulsions | 25 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 02.4 Fat-based desserts excluding dairy-based dessert products of food category 01.7 | 15 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 03.0 Edible ices, including sherbet and sorbet | 20 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 04.1.2.11 Fruit fillings for pastries | 50 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 04.1.2.5 Jams, jellies, marmelades | 20 mg/kg | As bixin.; Excluding products conforming to the Standard for Jams, Jellies and Marmalades (CODEX STAN 296-2009). |
| Codex | 160b(i) | Colour | 04.1.2.6 Fruit-based spreads (e.g. chutney) excluding products of food category 04.1.2.5 | 20 mg/kg | As bixin.; Excluding products conforming to the Standard for Mango Chutney (CODEX STAN 160-1987). |
| Codex | 160b(i) | Colour | 04.1.2.7 Candied fruit | 20 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 04.1.2.8 Fruit preparations, including pulp, purees, fruit toppings and coconut milk | 100 mg/kg | Excluding products conforming to the Standard for Aqueous Coconut Products (CODEX STAN 240-2003).; As bixin.; Excluding products conforming to the Standard for Date Paste (CODEX... |
| Codex | 160b(i) | Colour | 04.1.2.9 Fruit-based desserts, including fruit-flavoured water-based desserts | 30 mg/kg | As bixin.; Except for use at 100 mg/kg in jelly desserts and fruit-flavoured jelly. |
| Codex | 160b(i) | Colour | 04.2.2.3 Vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds in vinegar, oil, brine, or soybean sauce | 10 mg/kg | Excluding products conforming to the General Standard for Edible Fungi and Fungus Products (CODEX STAN 38-1981).; As bixin.; Except for use at 300 mg/kg in products conforming to... |
| Codex | 160b(i) | Colour | 04.2.2.5 Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed purees and spreads (e.g., peanut butter) | 20 mg/kg | As bixin.; Excluding products conforming to the Standard for Processed Tomato Concentrates (CODEX STAN 57-1981). |
| Codex | 160b(i) | Colour | 04.2.2.6 Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed pulps and preparations (e.g. vegetable desserts and sauces, candied vegetables) other than food category 04.2.2.5 | 10 mg/kg | Excluding products conforming to the General Standard for Edible Fungi and Fungus Products (CODEX STAN 38-1981).; As bixin.; Excluding tomato-based sauces.; Excluding products... |
| Codex | 160b(i) | Colour | 04.2.2.7 Fermented vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera) and seaweed products, excluding fermented soybean products of food categories 06.8.6, 06.8.7, 12.9.1, 12.9.2.1 and 12.9.2.3 | 10 mg/kg | Excluding products conforming to the Standard for Kimchi (CXS 223-2001).; Excluding products conforming to the General Standard for Edible Fungi and Fungus Products (CODEX STAN... |
| Codex | 160b(i) | Colour | 05.1.3 Cocoa-based spreads, including fillings | 50 mg/kg | As bixin.; Excluding products conforming to the Standard for Cocoa Butter (CODEX STAN 86-1981). |
| Codex | 160b(i) | Colour | 05.1.4 Cocoa and chocolate products | 50 mg/kg | As bixin.; For use in surface decoration only. |
| Codex | 160b(i) | Colour | 05.1.5 Imitation chocolate, chocolate substitute products | 50 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 05.2 Confectionery including hard and soft candy, nougats, etc. other than food categories 05.1, 05.3 and 05.4 | 200 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 05.3 Chewing gum | 300 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 05.4 Decorations (e.g. for fine bakery wares), toppings (non-fruit) and sweet sauces | 80 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 06.3 Breakfast cereals, including rolled oats | 75 mg/kg | As bixin.; Except for use at 100 mg/kg in extruded and/or puffed cereal products. |
| Codex | 160b(i) | Colour | 06.4.2 Dried pastas and noodles and like products | 10 mg/kg | As bixin.; Some Codex Members allow the use of additives with colour function in this food category while others limit these additives to certain products. |
| Codex | 160b(i) | Colour | 06.4.3 Pre-cooked pastas and noodles and like products | 20 mg/kg | As bixin.; Some Codex Members allow the use of additives with colour function in this food category while others limit these additives to certain products. |
| Codex | 160b(i) | Colour | 06.5 Cereal and starch based desserts (e.g. rice pudding, tapioca pudding) | 10 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 06.6 Batters (e.g. for breading or batters for fish or poultry) | 80 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 06.8.1 Soybean-based beverages | 10 mg/kg | As bixin.; Except for use in composite/flavoured soybean beverages and soybean-based beverages conforming to the Regional Standard for Non-Fermented Soybean Products (Asia) (CXS... |
| Codex | 160b(i) | Colour | 07.1.2 Crackers, excluding sweet crackers | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 07.1.4 Bread-type products, including bread stuffing and bread crumbs | 200 mg/kg | Some Codex Members allow the use of additives with sweetener and colour functions in this food category while others limit this food category to products without these additives.;... |
| Codex | 160b(i) | Colour | 07.1.5 Steamed breads and buns | 200 mg/kg | Some Codex Members allow the use of additives with sweetener and colour functions in this food category while others limit this food category to products without these additives.;... |
| Codex | 160b(i) | Colour | 07.1.6 Mixes for bread and ordinary bakery wares | 200 mg/kg | Some Codex Members allow the use of additives with sweetener and colour functions in this food category while others limit this food category to products without these additives.;... |
| Codex | 160b(i) | Colour | 07.2 Fine bakery wares (sweet, salty, savoury) and mixes | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 08.1.2 Fresh meat, poultry, and game, comminuted | 20 mg/kg | As bixin.; For use only in breakfast sausages, merguez type products, salsicha fresca, butifarra fresca, longaniza fresca and chorizo fresco and mici. |
| Codex | 160b(i) | Colour | 08.2.2 Heat-treated processed meat, poultry, and game products in whole pieces or cuts | 20 mg/kg | Except for use in cooked ham and cooked chicken at 100 mg/kg to restore faded colour and improve the frying colour.; As bixin.; Excluding products conforming to the Standard for... |
| Codex | 160b(i) | Colour | 08.3.1.1 Cured (including salted) non-heat treated processed comminuted meat, poultry, and game products | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 08.3.1.2 Cured (including salted) and dried non-heat treated processed comminuted meat, poultry, and game products | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 08.3.1.3 Fermented non-heat treated processed comminuted meat, poultry, and game products | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 08.3.2 Heat-treated processed comminuted meat, poultry, and game products | 100 mg/kg | Excluding products conforming to the Standard for Cooked Cured Chopped Meat (CODEX STAN 98-1981).; As bixin.; Excluding products conforming to Standard for Luncheon Meat (CODEX... |
| Codex | 160b(i) | Colour | 08.3.3 Frozen processed comminuted meat, poultry, and game products | 20 mg/kg | For use in glaze, coatings or decorations for fruit, vegetables, meat or fish only.; As bixin. |
| Codex | 160b(i) | Colour | 09.2.5 Smoked, dried, fermented, and/or salted fish and fish products, including mollusks, crustaceans, and echinoderms | 10 mg/kg | As bixin.; Excluding products conforming to the Standard for Dried Shark Fins (CODEX STAN 189-1993).; Excluding products conforming to the Standard for Boiled Dried Salted... |
| Codex | 160b(i) | Colour | 12.2.2 Seasonings and condiments | 600 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 12.4 Mustards | 100 mg/kg | As bixin. |
| Codex | 160b(i) | Colour | 12.5 Soups and broths | 50 mg/kg | As bixin.; Except for use at 300 mg/kg in carrot and pumpkin flavoured soup. |
| Codex | 160b(i) | Colour | 12.6.1 Emulsified sauces and dips (e.g. mayonnaise, salad dressing, onion dip) | 30 mg/kg | As bixin.; Except for use at 100 mg/kg in cheese dips and flavoured mayonnaise. |
| Codex | 160b(i) | Colour | 12.6.2 Non-emulsified sauces (e.g. ketchup, cheese sauce, cream sauce, brown gravy) | 100 mg/kg | As bixin.; Except for use at 50 mg/kg in products conforming to the Standard for Chili Sauce (CXS 306-2011). |
| Codex | 160b(i) | Colour | 12.6.3 Mixes for sauces and gravies | 100 mg/kg | As bixin.; On the served to the consumer basis. |
| Codex | 160b(i) | Colour | 12.6.4 Clear sauces (e.g. fish sauce) | 400 mg/kg | As bixin.; Excluding products conforming to the Standard for Fish Sauce (CODEX STAN 302-2011). |
SOURCE
FDA
FDA GRAS
FDA GRAS Status
US FDA GRAS notice evidence from enriched and notice tables.
| Jurisdiction | GRN | Substance | FDA response | Intended use | Basis | Notifier |
|---|---|---|---|---|---|---|
| United States | 471 | Annatto seed extract | FDA has no questions; some uses may require a color additive listing | As a source of vitamin E in food at a level of up to 100 milligrams of tocotrienols per serving | Scientific procedures | American River Nutrition, Inc. |
| United States | 471 | Annatto seed extract | FDA has no questions; some uses may require a color additive listing | As a source of vitamin E in food at a level of up to 100 milligrams of tocotrienols per serving | Scientific procedures | American River Nutrition, Inc. |
SOURCE
Health Canada
Health Canada Status
Health Canada food-additive permissions by functional class and food scope.
| Jurisdiction | Class | Permitted foods | Maximum level | List |
|---|---|---|---|---|
| Canada | Food Colours | (a) Apple and (naming the fruit or fruits) jam; Bread; Butter; Concentrated (naming the fruit) juice, except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix;... | (a) Good Manufacturing Practice | List of Permitted Food Colours |
| Canada | Food Colours | (b) Blend of prepared fish and prepared meat as set out in paragraph 18.1.3(g) of Volume 18 of the Food Compositional Standards Document | (b) Good Manufacturing Practice | List of Permitted Food Colours |
| Canada | Food Colours | (c) Calorie-reduced margarine; Margarine | (c) Good Manufacturing Practice | List of Permitted Food Colours |
| Canada | Food Colours | (d) Cheddar cheese; (Naming the variety) cheese; Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with... | (d) Good Manufacturing Practice | List of Permitted Food Colours |
| Canada | Food Colours | (d.1) (Naming the flavour) essence; (Naming the flavour) extract; (Naming the flavour) flavour | (d.1) Good Manufacturing Practice | List of Permitted Food Colours |
| Canada | Food Colours | (e) Longaniza; Tocino | (e) Good Manufacturing Practice. The amount not to exceed 1,000 ppm in the finished food. | List of Permitted Food Colours |
| Canada | Food Colours | (f) Sausage casings | (f) 1.0%. The amount not to exceed 0.01% in the sausage prepared with the casing. | List of Permitted Food Colours |
| Canada | Food Colours | (g) Unstandardized foods, except those unstandardized foods set out in paragraph (f) of this item | (g) Good Manufacturing Practice | List of Permitted Food Colours |
SOURCE
JECFA
JECFA ADI
JECFA ADI Values
JECFA ADI records and evaluation years.
| Jurisdiction | Chemical name | JECFA no. | CAS | ADI | ADI upper | Function | Evaluation year |
|---|---|---|---|---|---|---|---|
| JECFA | ANNATTO EXTRACTS | - | 1393-63-1 | BIXIN: 0-12 mg/kg bw; NORBIXIN AND ITS SODIUM AND POTASSIUM SALT: 0-0.6 mg/kg bw (group ADI, expressed as norbixin) | 12 | COLOUR | 2006 |
| JECFA | ANNATTO EXTRACT (alkali-processed NORBIXIN) | - | - | WITHDRAWN | - | COLOUR | 2006 |
| JECFA | ANNATTO G | - | - | no_data | - | - | 2006 |
| JECFA | ANNATTO EXTRACT (aqueous-processed BIXIN) | - | - | WITHDRAWN | - | COLOUR | 2006 |
| JECFA | ANNATTO E | - | - | no_data | - | - | 2006 |
| JECFA | ANNATTO EXTRACT (oil-processed BIXIN) | - | - | NO ADI ALLOCATED | - | COLOUR | 2006 |
| JECFA | ANNATTO D | - | - | no_data | - | - | 2006 |
| JECFA | ANNATTO EXTRACT (solvent-extracted NORBIXIN) | - | - | WITHDRAWN | - | COLOUR | 2015 |
| JECFA | ANNATTO F | - | - | no_data | - | - | 2006 |
| JECFA | ANNATTO EXTRACT (alkali-processed Norbixin, not acid-precipitated) | - | - | no_data | - | COLOUR | 2006 |
| JECFA | ANNATTO C | - | - | no_data | - | - | 2015 |
| JECFA | ANNATTO EXTRACT (solvent-extracted BIXIN) | - | - | WITHDRAWN | - | COLOUR | 2015 |
| JECFA | ANNATTO B | - | - | no_data | - | - | 2015 |
| JECFA | Annatto for test | - | - | no_data | - | COLOUR, Food Additives | - |
SOURCE
ingredients
ghs classifications
Cross-Reference to Cosmetics / Chemicals / Pharma
Same-CAS public rows from adjacent Roots verticals where available.
SOURCE
Cross-vertical comparison
ingredients | ghs classifications
Cross-Vertical Regulatory Divergence
This substance has different regulatory treatment across food, cosmetics, and industrial use.
SOURCE
FAQPage JSON-LD
public food renderer rows
Frequently Asked Questions
Food-use, safety, ADI, and cross-vertical answers mirrored into FAQPage JSON-LD.
What is Annatto used for in food?
Annatto appears in food-use rows as: Antioxidant/Color; Colour; Food Colours.
Is Annatto safe?
This page does not assign a standalone safety verdict; it renders public regulatory evidence. ADI/reference value: EFSA ADI = 0.3 mg/kg bw/day. EU status evidence: PUBLISHED. US/FDA evidence: FDA has no questions; some uses may require a color additive listing.
What is the ADI for Annatto?
Annatto has this ADI/reference value in the food-safety tables: EFSA ADI = 0.3 mg/kg bw/day. Source: EFSA FAF 2019.
Is Annatto also used in cosmetics?
Annatto has a same-CAS cosmetics cross-reference: Annatto (Bixin/Norbixin), EU status permitted.