Other names for the additive (synonyms)
General Information
Lutein (food additive E161b) is a natural colorant from the group of xanthophylls (oxygenated carotenoids), which is used in the food industry to give products a yellow or orange оттенок.
Lutein is a biologically active substance of natural origin. It can be found in egg yolks, green leafy vegetables (spinach, cabbage), corn, and many flowers, particularly marigolds. It is from plant raw materials that additive E161b is obtained for industrial use.
The history of lutein as a colorant began with the study of natural plant pigments. Initially, it was studied as a component responsible for the coloring of leaves and petals. Later, it was discovered that this substance not only provides color but also accumulates in the human retina. In the 20th century, technologies made it possible to isolate lutein in a concentrated form, and it received the status of food additive E161b.
The chemical formula of lutein is C40H56O2. It is a fat-soluble substance with a bright yellow color. It is practically insoluble in water but dissolves well in fats and oils. Lutein is sensitive to light and oxygen, so it requires protection during storage.
For the food industry, food additive E161b is usually obtained by extraction from marigold petals. The plant material is dried, treated with approved solvents, purified, and standardized by active substance content. In some cases, synthetic or semi-synthetic production methods are also used, but the main source remains plant raw materials.
Effects on the Body
Benefit of Additive E161b
Food additive E161b is natural for the human body, as lutein is consumed with regular food. It accumulates in the macula — the central part of the retina — and participates in protecting cells from light exposure.
According to the scientific assessment of the European Food Safety Authority (EFSA), lutein has low toxicity and is well tolerated when consumed in food. EFSA has established an acceptable daily intake (ADI) for lutein at 1 mg/kg of body weight per day.
Lutein is known for its antioxidant properties. It helps neutralize free radicals and supports eye health.
A review of studies shows that lutein has antioxidant and anti-inflammatory properties that may help prevent various diseases, including eye and cardiovascular conditions.
A meta-analysis of 71 studies (387,569 participants) showed that higher levels of lutein in the diet or blood are associated with a reduced risk of coronary heart disease and stroke.
Risks of Additive E161b
After entering the body, lutein is absorbed in the intestines יחד with fats, transported through the bloodstream, and partially deposited in tissues, particularly in the retina. Excess does not accumulate uncontrollably but is gradually eliminated through metabolic processes.
EFSA in its conclusion notes that even at intake levels close to the ADI, the risk of adverse effects is low. At very high doses, yellowing of the skin (carotenodermia) may occur, which is reversible and does not pose a serious danger.
JECFA has also evaluated lutein and established an acceptable level of safe intake at 0–2 mg/kg of body weight per day, confirming its low toxicity within recommended doses. In the United States, the FDA allows the use of lutein as a colorant in certain product categories, provided purity standards are met.
A review of studies notes that very high doses of carotenoids, including lutein, may sometimes cause mild gastrointestinal symptoms (nausea, abdominal discomfort).
Exceeding the acceptable daily intake may theoretically lead to pigment accumulation in tissues, but in practice, intake levels from food are significantly below safety limits.
Uses
In the food industry, food additive E161b is used as a natural colorant. It gives products a yellow or orange color and is often used as an alternative to synthetic dyes.
Additive E161b can be found in soft drinks, dairy products, desserts and confectionery, sauces and seasonings, as well as dietary and functional foods.
A feature of its application is that lutein works well with fat-containing products, as it is a fat-soluble pigment. For stability, it is often added in microencapsulated forms.
Legal Status
In the European Union, food additive E161b is permitted under Regulation (EU) No 1333/2008. In 2010, EFSA confirmed the safety of lutein and established an ADI of 1 mg/kg of body weight per day.
In Ukraine, additive E161b is permitted for use in food products within limits harmonized with EU legislation.
In the United States, lutein is approved by the FDA as a colorant for certain product categories, subject to purity requirements. It is also permitted as a food colorant in Canada and Japan.
Thus, food additive E161b is approved in most countries worldwide and is considered safe when consumed within the established acceptable daily intake.