Bixin and Norbixin (Annatto)
Score impact
-0.60
points/product
Description
Bixin and norbixin are the natural pigments that constitute the active principle of the annatto colorant, identified with the code E160BII in the European numbering system.
It is a food additive of plant origin extracted from the outer coating of the seeds of the shrub Bixa orellana, a plant native to tropical regions of the Americas, especially countries such as Peru, Brazil, Mexico, and Colombia. Historically, annatto was used by pre-Columbian civilizations such as the Aztecs, Mayans, and Incas, who employed it not only as a food colorant but also as a dye for textiles, body paint, and in religious ceremonies.
The approval of E160BII as a safe food additive in the European Union dates back to Directives 78/663/EEC and 81/712/EEC, where its toxicological profile was first evaluated. Subsequently, the European Food Safety Authority (EFSA) has reassessed its safety on several occasions, establishing an Acceptable Daily Intake (ADI) of 0 to 6 milligrams of bixin per kilogram of body weight per day.
Chemically, bixin is a fat-soluble apocarotenoid with the formula C25H30O4, while norbixin (C24H28O4) is its water-soluble form, obtained by alkaline hydrolysis. The industrial production process involves maceration of the seeds, followed by extraction with authorized solvents, vegetable oil for bixin, or alkaline water for norbixin. The resulting color ranges from pale yellow to intense orange-red, depending on the concentration and pH of the food.
E160BII is very stable to heat and oxidation, but degrades with prolonged exposure to sunlight. Currently, its use is regulated in the European Union by Regulation (EC) 1333/2008 on food additives, which classifies it as a natural colorant without significant restrictions beyond good manufacturing practices.
Unlike problematic artificial colorants such as E102 or E110, E160BII has not been linked to neurotoxic effects or childhood hyperactivity, making it a preferred option for the clean label food industry.
E160BII is widely used in the food industry to provide yellow, golden, orange, or reddish hues to a wide variety of products.
In the dairy sector, it is very common in cheeses such as British Cheddar, Red Leicester, French Mimolette, Dutch Edam, and other hard cheeses, as well as in butter, margarine, flavored yogurts, and dairy desserts. In the snack and appetizer industry, it is found in potato chips, extruded corn snacks, seasoned pork rinds, and coated nuts. In the breakfast cereal segment, it is used in golden corn flakes, puffed rice cereals, and granola mixes.
In fish and seafood products, it is used to color smoked herring fillets, cold-smoked salmon, caviar substitutes without roe, fish pâtés, and canned anchovies. In processed meat products, it appears in Frankfurt sausages, mortadella, liver pâtés, salami, and turkey or chicken cold cuts.
It is also used in sauces such as Dijon mustard, ketchup, salad dressings like Caesar or blue cheese, dehydrated soup mixes, concentrated broths, and packaged vegetable creams. In bakery and ice cream, it is added to savory and sweet cookies, wafers, cake glazes, vanilla or caramel ice creams, industrial pastry fillings, and orange-colored white chocolate coatings. In the beverage sector, it is used in orange or strawberry soft drinks, brightly colored energy drinks, pasteurized fruit juices, and creamy liqueurs.
European legislation allows its use in most food categories in quantum satis amounts (as much as needed to achieve the desired effect, without a numerical maximum limit), except in some products such as unprocessed cheese where it is not permitted. Limits in specific foods range from 10 to 25 milligrams per kilogram in meat and fish products, according to Regulation (EU) 1129/2011.
In the United States, the FDA considers it generally recognized as safe (GRAS), while in Japan and Australia its use is also fully authorized without major restrictions.
E160BII has extremely low toxicity in humans, and documented adverse effects are rare and generally mild. EFSA concluded in its 2016 opinion that there is no evidence of genotoxicity or carcinogenicity at current consumption levels. No negative effects on fertility, fetal development, or endocrine function have been observed, unlike some synthetic additives.
The main side effects are allergic or pseudo-allergic in nature and affect a small proportion of susceptible individuals. Cases of acute urticaria (red, intensely itchy hives), angioedema (swelling of lips, eyelids, tongue, or glottis), and rarely severe anaphylaxis with respiratory difficulty and drop in blood pressure have been reported.
Also described in the medical literature is so-called annatto asthma, a syndrome of bronchospasm triggered by inhalation of the colorant dust or after ingestion, especially in people with a history of aspirin-sensitive asthma (Widal triad).
At very high doses far above permitted levels (several grams), mild laxative effects and gastrointestinal discomfort such as mild diarrhea, nausea, or abdominal distension have been described in experimental animals, but these levels are impossible to achieve through normal food consumption.
No significant drug interactions between E160BII and common medications have been documented. Particularly sensitive populations include people with multiple allergies to natural colorants (such as turmeric or paprika), uncontrolled asthmatics, and patients with mastocytosis or mast cell activation syndrome.
In clinical practice, cases of severe reaction are exceptional, with fewer than 60 cases documented in half a century of global use. The probability of experiencing an adverse effect is much lower than that of allergies to nuts, shellfish, or dairy.
Therefore, E160BII does not require additional warning labeling on food products, and its safety profile is comparable to other natural colorants such as curcumin (E100) or anthocyanins (E163).
- Bixin and Norbixin
- Annatto
- Achiote
- Bixin
- Norbixin
- Urucum
- Uruku
- Onoto
- Roucou
- Annatto extract
- Orelline
- Thermolabile bixin
- Annatto norbixin
- Annatto extract
- CI 75120
Products containing it
Examples found in our database
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