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E160b / Colours

Annatto, bixin, norbixin

Selected sources checked · Scope & sources

Safety in brief

Safe

Recorded EatMatrix rating, not a new clinical review. The amount, your sensitivities and country rules still matter.

Watch for
Recorded sensitivities: annatto sensitivity (rare).
Our advice
Read the whole food label and consider how often you eat the product. A name or E number does not tell you the amount, and an ingredient rating cannot assess the entire food.
What it is

Annatto, bixin, and norbixin are natural orange-red colorants derived from the seeds of the achiote (annatto) tree. Bixin is the oil-soluble pigment and norbixin is the water-soluble form derived from it. These colorants are widely used in cheese, butter, snack foods, and beverages as a natural alternative to synthetic dyes. While generally recognized as safe, annatto has been associated with rare but notable hypersensitivity reactions, including anaphylaxis in a small number of documented cases.

Also appears on labels as: Annatto, Bixin, Norbixin, Annatto extract, Annatto seed extract, E160b, E 160b, E-160b, Natural orange-yellow color, Food color annatto, Bixin/norbixin colorant, Annatto pigment.

What are E160b, annatto, bixin and norbixin?

Annatto is a food colour extracted from the seeds of the annatto tree, Bixa orellana. Bixin and norbixin are its main colouring pigments and can give food yellow to red colour. Colouring food is their technical purpose; it does not establish a health benefit.

The FSA guide lists E160b(i) as annatto, bixin and E160b(ii) as annatto, norbixin. The EU 2020 amendment separates these two codes because their properties and uses differ. This entry groups both names for lookup: check which subtype your food label actually names.

See how EatMatrix reads an ingredient list before trying the app. Compare a scan with the physical label.

Identity and food-use sources checked . The E number alone does not tell you the amount in a product. Wider scientific and market checks are described below.

Dietary information

Vegan
Yes
Halal
Yes
Gluten-free
Yes
Allergens
Caution

Recorded ingredient information. Check the product label or certification: sources, other ingredients and cross-contact can vary.

Research & body effects

Selected research on E160b

How to read study types
  1. Regulator reviewEFSA review of annatto colours (bixin and norbixin)

    No DNA concern. Safe daily limits are 6 mg bixin and 0.3 mg norbixin per kg of body weight. Norbixin reached its limit only for high-eating toddlers in one country, which EFSA judged not a health concern.

Summaries of each source's published abstract or statement, checked . This is a selection of sources, not a complete literature review. Authority assessments apply to the uses and places they cover.

Health notes from our ingredient record

  • Rare but documented hypersensitivity reactions, including urticaria (hives) and, in isolated case reports, anaphylaxis.
  • EFSA has set an Acceptable Daily Intake for bixin and norbixin; typical food-use levels stay within this limit.
  • Generally recognized as safe at typical food-use levels for the general population.

Other references from our ingredient record

These links come from the original ingredient record. They are separate from the source reviews above and have not all been checked for the exact ingredient, amount consumed or claim. Dates are shown newest first.

  1. The safety of annatto extracts (E 160b) as a food additive — EFSA Panel on Food Additives, EFSA Journal (2016). Official EFSA scientific opinion (bibliographic reference, imported 2026-10-13). It covers the additive as a group assessment and is not an individual human study; read the opinion for its findings.
Country rules

Country checks for E160B

Permission depends on the market, type of food, amount and conditions. A scientific opinion or an E-number alone does not establish a legal use. These checks are separate from the stored EatMatrix rating.

Compare all eight markets and their sources
MarketWhat is checked
European Union

No exact code match in the Annex II Part B list (version 2026-08-18, read 2026-10-07). Identity, subform and legal-use review are pending. This does not establish a permission or a ban.

Great Britain

No verified exact register record in this review. Identity and current use rules need checking; missing a record does not establish a ban.

United States

Complete current-use review pending. Any scoped provision in the label guide above applies only to the stated use. FDA explains the applicable food-additive and GRAS framework.

Northern Ireland

Review pending. Check the applicable EU rules and territory arrangements; the GB register alone does not establish this status. FSA guidance is a starting source, not a verified permission for this entry.

Canada

Named preparation located; broader identity needs matching

The located colour name is annatto. Bixin, norbixin, extracts and salts must be matched to the applicable preparation and specifications.

EatMatrix reading: Match the named preparation, specifications, food, purpose and every limit below before using these rows for a product decision.

Name and category review: . This describes the legal source check, not a finding that the ingredient is safe, unsafe or untested.

Sources and names checked

Names checked: Annatto, bixin, norbixin; Annatto.

All 15 Health Canada permitted-additive lists were checked by exact name, with the reviewed alternatives above. E-numbers alone are not Canadian ingredient names.

The Justice Canada consolidation read was current to 21 September 2026. A complete product decision also requires its composition, specifications, intended food and use, quantities, applicable separate provisions and any later changes.

Named food-use records located. Health Canada lists the preparations below for specified foods and purposes. This is conditional permission for those uses, not approval of every product or a personal safety verdict.

The located colour name is annatto. Bixin, norbixin, extracts and salts must be matched to the applicable preparation and specifications.

Source tables captured . List publication dates are shown separately. Good Manufacturing Practice (GMP) is a condition of use, not an unlimited amount or a recommended intake.

Food and Drug Regulations B.16.003 requires the listed source, purpose, amount and other conditions to match. The official consolidation read was current to 21 September 2026; product specifications and applicable later changes still need checking.

Read 8 listed food-use conditions

Annatto

Health Canada: List of Permitted Food Colours. List published ; item A.5.

  • Food: (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; Icing sugar; (Naming the fruit or fruits) jam with pectin; (Naming the fruit or fruits) jelly with pectin; Liqueur; Lobster paste; (Naming the flavour) milk; (Naming the flavour) partly skimmed milk; (Naming the flavour) partly skimmed milk with added milk solids; (Naming the flavour) skim milk; (Naming the flavour) skim milk with added milk solids; Pickles and relishes; Pineapple marmalade with pectin; Rhubarb and (naming the fruit or fruits) jam; Sherbet; Smoked fish; Tomato catsup

    Purpose: (a) Food colour

    Limit and conditions: (a) Good Manufacturing Practice

  • Food: (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

    Purpose: (b) Food colour

    Limit and conditions: (b) Good Manufacturing Practice

    Source modification reference: NOM/ADM-0122 (see the official list).

  • Food: (c) Calorie-reduced margarine; Margarine

    Purpose: (c) Food colour

    Limit and conditions: (c) Good Manufacturing Practice

  • Food: (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 (naming the added ingredients); Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients)

    Purpose: (d) Food colour

    Limit and conditions: (d) Good Manufacturing Practice

  • Food: (d.1) (Naming the flavour) essence; (Naming the flavour) extract; (Naming the flavour) flavour

    Purpose: (d.1) Food colour

    Limit and conditions: (d.1) Good Manufacturing Practice

    Source modification reference: M-FAA-24-14 (see the official list).

  • Food: (e) Longaniza; Tocino

    Purpose: (e) Food colour

    Limit and conditions: (e) Good Manufacturing Practice. The amount not to exceed 1,000 ppm in the finished food.

  • Food: (f) Sausage casings

    Purpose: (f) Food colour

    Limit and conditions: (f) 1.0%. The amount not to exceed 0.01% in the sausage prepared with the casing.

  • Food: (g) Unstandardized foods, except those unstandardized foods set out in paragraph (f) of this item

    Purpose: (g) Food colour

    Limit and conditions: (g) Good Manufacturing Practice

EatMatrix reading: match the exact preparation and food first. A manufacturing limit is not an acceptable daily intake (ADI). A label without the amount cannot establish exposure, and an unlisted name here does not establish a ban.

Australia

Review pending. Food Standards Code permissions and conditions need an additive-specific check. FSANZ food-additive rules is a starting source, not a verified permission for this entry.

New Zealand

Review pending. Food Standards Code permissions and conditions need an additive-specific check. FSANZ food-additive rules is a starting source, not a verified permission for this entry.

Japan

Review pending. The relevant list, identity and use standards need an additive-specific check. CAA food-additive lists is a starting source, not a verified permission for this entry.

Sources & review status

Check what each source covers: an authority’s conclusion, a research finding and a country’s legal permission answer different questions.

What this guide covers

Selected research
1 source summaries, with publication dates and study types. Several publications may describe the same study population.
Official assessment sources
Commission-listed EFSA references for E160B. Bibliographic identity checked; latest findings and current use rules need separate review.
Original ingredient record
1 research link; newest recorded date: . Sources added separately to this guide are not included in this count.

This guide brings together our ingredient record and the dated sources shown here. Missing information describes a gap in this guide; it does not mean an ingredient is untested, safe or harmful. This is not a complete review of every study, preparation or current country rule. The amount in a product and how it is used still matter.

How to read the ratings, research and country checks
Agency labels recorded by EatMatrix

These are imported database classifications, not verified current statements from each authority. Use the dated official sources below for their actual scope and conclusions.

AuthorityDatabase label
FDASafe
WHOSafe
EFSASafe
FSANZSafe
JapanSafe
UK FSASafe
Health CanadaSafe

Official assessment sources for E160B

The European Commission’s re-evaluation table lists official EFSA documents for this additive. Their identifiers and subjects were checked against publisher bibliographic records. A missing research link in the EatMatrix database does not mean the additive has never been assessed.

Name in the Commission table: Annatto, Bixin, Norbixin.

These are assessment references, including historical or group assessments. They do not establish the latest scientific conclusion, a human health benefit or risk, or current permission to use the additive in a particular food. Later assessments, corrections and food-use conditions need separate review. The recorded EatMatrix rating above is unchanged.

European Commission re-evaluation table, status as of . EatMatrix checked this bibliography on .

Database updated: . What does an E number mean on a food label?

Common questions

Frequently asked questions

What is EatMatrix's recorded rating for E160B?

The recorded EatMatrix rating for E160B (Annatto, bixin, norbixin) is “Safe”. It is calculated from labels stored in our ingredient database. These labels are not verified current regulator decisions or country permissions. A database update date is not a scientific review date.

Is E160B vegan, halal or gluten-free?

According to our ingredient data for Annatto, bixin, norbixin — vegan: yes, vegetarian: yes, halal: yes, kosher: yes, gluten-free: yes, dairy-free: yes. Manufacturing sources can vary between products; check the label if it matters to you.

What is E160B and why is it used?

Annatto, bixin, and norbixin are natural orange-red colorants derived from the seeds of the achiote (annatto) tree. Bixin is the oil-soluble pigment and norbixin is the water-soluble form derived from it. These colorants are widely used in cheese, butter, snack foods, and beverages as a natural alternative to synthetic dyes. While generally recognized as safe, annatto has been associated with rare but notable hypersensitivity reactions, including anaphylaxis in a small number of documented cases.

Does E160B contain allergens?

No known allergens are recorded for Annatto, bixin, norbixin, with a caution: annatto sensitivity (rare).

What is annatto used for in food?

Annatto is used as a food colour. Its main pigments, bixin and norbixin, produce yellow to red colouring. This explains its purpose in food, not its quantity or the health effects of a particular product.

What is the difference between E160b(i) and E160b(ii)?

E160b(i) identifies annatto, bixin; E160b(ii) identifies annatto, norbixin. They are separately named codes with different properties and food uses. Match the subtype on your label rather than treating every annatto reference as an identical formulation.

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This page shows information and classifications recorded in our ingredient database. Current scientific and market-specific verification remains pending as described above. It is general information, not medical advice.