Annatto Colour: Label Names, ADIs and Market Rules

Annatto is a yellow to red food colour from the seeds of the annatto tree, Bixa orellana. In the EU's consolidated additive list of 18 August 2026 it appears as two additives, E 160b(i) Annatto bixin and E 160b(ii) Annatto norbixin; Regulation (EU) 2020/771 split them because the two have different acceptable daily intakes.

Where Does Annatto Come From and What Is It Called?

The EU's Regulation (EU) 2020/771 describes annatto as coming from the seeds of the annatto tree (Bixa orellana L.) and as conferring a yellow to red colour to food. It names bixin and norbixin as the main pigments.

Singapore's National Parks Board lists common names for Bixa orellana that include Anatto, Achiote, Kesumba and Kesumba Keling. In the Philippines, a product sheet from the Food and Nutrition Research Institute refers to "annatto or achuete" as a colour enhancer.

Our article on beverage flavouring also covers natural colours.

Which E and INS Numbers Name Annatto?

Regulation 2020/771 replaced the single EU entry "Annatto, Bixin, Norbixin (E 160b)" with the two additives E 160b(i) and E 160b(ii). Its Article 3 allowed Annatto, Bixin, Norbixin (E 160b) itself to continue to be placed on the market until 2 January 2021 under the rules applicable before 2 July 2020. Foods containing it that were produced and labelled under those rules could also continue to be placed on the market until 2 January 2021, and remain on the market after that until stocks were exhausted.

Regulation (EU) No 231/2012, in its 18 August 2026 consolidation, lists two specification entries for Annatto bixin, "SOLVENT-EXTRACTED BIXIN" and "AQUEOUS-PROCESSED BIXIN", and three for Annatto norbixin, "SOLVENT-EXTRACTED NORBIXIN", "ALKALI-PROCESSED NORBIXIN, ACID-PRECIPITATED" and "ALKALI-PROCESSED NORBIXIN, NOT ACID-PRECIPITATED". Annex II to Regulation (EC) No 1333/2008, in the same consolidation, allows the more specific E numbers and names in Regulation 231/2012 to be used instead, excluding synonyms, if those additives have indeed been added.

JECFA's 2015 specifications give solvent-extracted bixin the number INS 160b(i) and solvent-extracted norbixin INS 160b(ii). Thailand's Notification No. 468 of 2025 lists "ANNATTO EXTRACTS, BIXIN-BASED" as INS 160b(i) and "ANNATTO EXTRACTS, NORBIXIN-BASED" as INS 160b(ii). BPOM Regulation No. 11 of 2019 lists "Ekstrak anato CI. No. 75120 (berbasis bixin) (Annatto extracts, bixin based)" with the number 160b(i).

Subject to Article 21 and the exception in Article 20(b), Annex VII Part C of Regulation (EU) No 1169/2011 requires additives in its listed categories, which include colour, to be designated by their category followed by their specific name or, where appropriate, E number. Where several categories apply, the category must reflect the ingredient's principal function in that food. Malaysia's regulation 11(1)(g) requires the functional class with the additive's name or INS number in brackets where an INS number exists; without an INS number, it requires the functional class and the additive's name. Singapore's First Schedule lets any colouring be declared by the generic term "Colouring or colouring matter".

What Have JECFA and EFSA Concluded on Safety?

At its 67th meeting in June 2006, JECFA set an ADI for bixin of 0 to 12 mg/kg body weight and a group ADI for norbixin and its sodium and potassium salts of 0 to 0.6 mg/kg body weight, expressed as norbixin. Each applies to named annatto extracts provided they comply with the respective specifications. JECFA stated that the evaluation could not be applied to oil-processed bixin.

EFSA's 2019 opinion records that in 2016 its ANS Panel derived an ADI of 6 mg bixin/kg body weight per day and an ADI of 0.3 mg norbixin/kg body weight per day. In 2019 its FAF Panel concluded that annatto E, an aqueous-processed bixin, does not raise concern for genotoxicity, so the 2016 ADIs can also be applied to it. For norbixin, the ADI was reached at the high level (p95) for toddlers in the refined exposure assessment scenarios in one country, and the FAF Panel concluded that, considering the uncertainties and the very likely overestimation of the exposure, the level of exposure does not raise a health concern.

How Does the EU Limit Annatto?

Annex II to Regulation 1333/2008, in its 18 August 2026 consolidation, allows an additive only in the foods and under the conditions set out in its Part E. For ripened cheese, Part E sets 15 mg/kg each for Annatto bixin and Annatto norbixin in ripened orange, yellow and broken-white cheese and red and green pesto cheese, with separate norbixin levels of 50 mg/kg for red Leicester and 35 mg/kg for Mimolette. For entries marked with footnote (94), when Annatto bixin and Annatto norbixin are added in combination, the higher individual maximum level applies to their sum, and neither individual maximum may be exceeded.

The same Annex states that E 160b(i) and E 160b(ii) may not be sold directly to the consumer. For additives sold other than to the final consumer, Article 22(1) requires packaging or containers to identify each additive by name and/or E number, indicate its intended food use, identify the batch or lot, and give maximum-quantity information for quantitatively limited components and/or appropriate information enabling the purchaser to comply. Article 22(3) requires substances added to facilitate storage, sale, standardisation, dilution or dissolution to be listed in descending order of their percentage by weight of the total. Article 22(4) allows the information in paragraph 1(e) to (g) and paragraphs 2 and 3 to appear only in consignment documents supplied with or before delivery, provided "not for retail sale" appears on an easily visible part of the packaging or container.

What Do Singapore and Malaysia Permit?

Singapore's regulation 20(2), in the version current on 11 October 2026, prohibits importing, selling, advertising, manufacturing, consigning or delivering food for human consumption containing added colouring other than a Fifth Schedule permitted colouring, and colouring for such food use other than a Fifth Schedule permitted colouring. The Fifth Schedule names annatto among colouring matter of vegetable origin and also permits the pure colouring principles of those colours, whether isolated or produced synthetically. Under regulation 15(4), a permitted additive's purity must meet the specifications in that Part, or where none are given, those recommended by JECFA.

Malaysia's regulation 21, in the consolidation updated until August 2026, makes the substances in Tables I and II of the Seventh Schedule the permitted colouring substances and prohibits adding colouring substance to food except as the Regulations permit. Table II lists annatto among colouring matter natural to edible fruits or vegetables, with their pure colouring principles. Regulation 19(3) prohibits adding a food additive to food except as permitted by the Regulations, permitted under the Codex Alimentarius, or authorised by the Director's prior written approval.

For colouring sold in Malaysia, regulation 21 requires a colouring preparation to contain not less than 4 per cent of permitted colouring substance, made up only with the permitted diluents in Table III, and labelled with the common name and total percentage of the colouring substance. Regulation 19(6) requires the chemical name or INS number followed by "as permitted" and the additive type, directions for use, and "For Food Use" or words of the same significance close to the name or INS number. The First Schedule includes colouring substance among the foods for which regulation 3 requires the manufacturer, distributor or dealer, when selling to a vendor, to provide a written warranty or other written statement under section 30 of the Act.

What Do Indonesia, Thailand and the Philippines Require?

Pasal 5(1) of BPOM Regulation No. 11 of 2019 sets a maximum use limit for each type of food additive and food category (our translation). Its entry for bixin-based annatto extract gives an ADI of 0 to 12 mg/kg body weight as bixin and expresses its limits as bixin, with norbixin at most 28 per cent relative to bixin (our translation). Under Pasal 19 and 20, food additives to be produced, brought into Indonesia and distributed must hold a distribution permit from the Head of BPOM and meet the Indonesian Food Codex specifications; where a specification is not yet included there, the JECFA Compendium of Food Additive Specifications is used (our translation).

According to the FDA's English translation, Notification No. 468 of 2025 was published in the Government Gazette on 11 December 2025, and Clause 1 provides for Annexes I and II of Notification No. 444 to be repealed and replaced by its Annexes I and II. The translation lists maximum use levels by food category; note 8 means "As bixin" and note 185 means "As norbixin". For clear sauces, it gives 400 mg/kg for the bixin-based entry and 10 mg/kg for the norbixin-based entry, and both rows also carry note XS302, which in the translation reads "Excluding products conforming to the Notification of Ministry of Public Health Re: Fish Sauce and the Standard for Fish Sauce (CXS 302-2011)." The FDA says the Thai text is the only authoritative version.

In the Philippines, Administrative Order No. 2026-0011, dated 2 July 2026, aims to provide guidelines specifying that only food additives listed in the Codex GSFA shall be used in processed food, and it provides that the latest GSFA is adopted automatically by the FDA. It states that additives should conform with the JECFA specifications adopted by the Codex Alimentarius Commission, and it requires a Certificate of Product Registration before food additives are sold or imported. Section IX of the order provides for repeal of Bureau Circular 2006-016, "Updated List of Food Additives", and Administrative Order No. 112 s. 1985, "Regulation Governing the Importation of Food Color Additives".

What Should You Ask an Annatto Supplier?

• Sub-type. Is it bixin or norbixin, and which entry does it meet: an EU entry under E 160b(i) or E 160b(ii), a JECFA specification, or a national list name? JECFA, EFSA, the EU and Thailand set ADIs or limits per sub-type.
• Specification. Ask which applicable specification the product meets: Singapore's prescribed purity specification, with JECFA as the fallback where none is provided; the Indonesian Food Codex specification, with the JECFA Compendium used where none is included (our translation); or the applicable JECFA specification adopted by Codex under the Philippine order dated 2 July 2026.
• Colour basis. Ask for annatto content on the basis used in the cited entry: bixin under note 8 or norbixin under note 185 in the Thai FDA's English translation, and bixin for BPOM's bixin-based annatto entry (our translation of the BPOM wording).
• Added substances. Ask the supplier to identify substances added to the additive, using the disclosure requirements in EU Article 22(3) and Malaysia's permitted-diluent rules.
• Paperwork. The Malaysian written warranty or other written statement, the Indonesian distribution permit and the Philippine Certificate of Product Registration, as they apply.

Version note: each text was read on 11 October 2026 in the version given in Sources. Regulations 1333/2008 and 231/2012 were read in their 18 August 2026 consolidations.

Is E 160b Still Used on EU Labels?

Regulation (EU) 2020/771 replaced "Annatto, Bixin, Norbixin (E 160b)" with E 160b(i) Annatto bixin and E 160b(ii) Annatto norbixin. Foods containing E 160b that were produced and labelled under the rules applicable before 2 July 2020 could continue to be placed on the market until 2 January 2021, and remain on the market after that until stocks were exhausted.

What Is the Difference Between Bixin and Norbixin Limits?

At its 67th meeting in 2006, JECFA established an ADI of 0 to 12 mg/kg body weight for bixin and a group ADI of 0 to 0.6 mg/kg body weight for norbixin and its sodium and potassium salts, expressed as norbixin. These apply to the specified annatto extracts provided they comply with the respective specifications; the evaluation does not apply to oil-processed bixin. EFSA's 2019 opinion reports that its ANS Panel derived ADIs in 2016 of 6 mg bixin/kg body weight per day and 0.3 mg norbixin/kg body weight per day. The EU's 18 August 2026 consolidated list treats them as separate additives with food-category-specific maximum levels.

Does Annatto Carry the EU Warning on Children's Activity?

No. Annex V to Regulation (EC) No 1333/2008, in its 18 August 2026 consolidation, lists six colours, Sunset yellow, Quinoline yellow, Carmoisine, Allura red, Tartrazine and Ponceau 4R, whose foods must state that they may have an adverse effect on activity and attention in children. Annatto is not among them.

Is Annatto a Permitted Colour in Singapore?

Yes. The Fifth Schedule to Singapore's Food Regulations, in the version current on 11 October 2026, names annatto among permitted colouring matter of vegetable origin. Regulation 20(2) applies the Fifth Schedule restriction to importing, selling, advertising, manufacturing, consigning or delivering food for human consumption with added colouring, and colouring intended for such food use.