Annatto Extract

Synonyms/Identifiers
Annatto, Bixin, Norbixin
E160b
EINECS No. 215-735-4
CAS No. 1393-63-1
CI Natural Orange 4
CI No. 75120
Orlean
Terre orellana
L. Orange

Solvent-extracted bixin and norbixin

  • INS No. 160b(i) Annatto Extracts (Solvent-Extracted Bixin)
  • INS No. 160b(ii) Annatto Extracts (Solvent-Extracted Norbixin)
  • E160b(i)
  • Annatto B (Bixin)
  • Annatto C (Norbixin)

Physical Description
Annatto extracts are obtained via extraction of the color from the seeds of the fruit of the Bixa orellana L. tree grown in South America, Africa and the Caribbean in one or more of the approved, food grade materials taken from a list that includes various solvents, edible vegetable oils and fats, as well as alkaline, aqueous and alcohol solutions. The main pigments are the water soluble norbixin and the oil soluble bixin, producing color ranges from light yellow to orange. The color is moderately stable in light and has good stability toward oxidation, change in pH, and microbiological attack. Bixin is very stable toward heat up to 100° C, fairly stable at 100-125°C, and unstable above 125°C, where it tends to form 13-carbomethoxy-4,6-dimethyltridecahexanoic acid.

Common Uses

Annatto is used to color butter, margarine, salad dressing, cheese and processed cheese, ice cream and other frozen deserts, confectionery, egg products, fish and fish products, meat products, cereals, cakes, beverages, soup mixes, fruit products, snacks, bakery products, spices and seasonings, sausage casings, drugs and cosmetics.

Specifications
US FDA
JECFA

EU defined in Commission Regulation (EU) No 23/2012

Codex Provisions
The Codex Alimentarius Commission has finalized authorization of Annatto extracts, bixin-based (160b(i)) for use in butter (food category number 02.2.1) with a maximum permitted level (MPL) of 20 mg/kg, as noted in the General Standard of Food Additives (GSFA) (CODEX STAN 192-1995, 2016). A large number of other applications of Annatto extracts, bixin based, as well as Annatto extracts, norbixin-based (160b(ii)) as a color additive in foods and beverages have been proposed and are pending authorization, following completion of the review and comments process. Most applications are pending approval at Step 7 of the Step Process with few at Step 4 of the Process (Joint FAO/WHO Food Standards Program, 2016). The MPL for most of these applications range from 200-500 ppm, with few exceptions of lower limits in selected types of foods.

Regulatory Approvals/Consumption Limits
USA: GMP (21 CFR 73.30)

JECFA: An ADI for bixin of 0.-12 mg/kg bw and a group ADI for norbixin and its disodium and dipotassium salts of 0-0.6 mg/kg bw expressed as norbixin were established at the 67th JECFA (2006).

EU: ADI of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. 10-50 mg/kg in specified foodstuff (EFSA, 2016)

Safety Assessment
Annatto is not genotoxic by a weight of evidence analysis. The extremely low acute toxicity of oil and water soluble annatto extracts are demonstrated by rat oral LD50 values > 50 g/kg and >35 g/kg, respectively. The LD50 of the water extract of the roots of the Bixa orellana is 700 mg/kg in male mice when administered intraperitoneally. Lifetime toxicity studies revealed that annatto did not produce toxic effects in rats or mice whether administered orally, by painting of the skin, or by subcutaneous injections. Two-and three-generation studies in rats fed 250-500 mg/kg bw/day of water-soluble annatto in the diet did not cause deleterious effects on reproduction or the development of offspring.

Safety Reviews
JECFA (2006). Safety Evaluation of Certain Additives and Contaminants. WHO Food Add. Series No. 58. Sixty-seventh meeting of the Joint WHO/FAO Expert Committee on Food Additives. Available online

EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to
Food), 2016. Scientic opinion on the safety of annatto extracts (E 160b) as a food additive. EFSA
Journal 2016;14(8):4544, 87 pp. doi:10.2903/j.efsa.2016.4544. Available online

Full safety monograph, including references, available to IACM members or upon request.