Annatto Extracts

Identifiers

Annatto extract
INS No. 160b(i); Annatto extracts, bixin-based
INS No. 160b(ii); Annatto extracts; norbixin-based
E160b(i); Annatto bixin
E160b(ii); Annatto norbixin
CAS No. 1393-63-1

Physical Description

Annatto extracts occur as dark red solutions, emulsions, or suspensions in water or oil or as dark red powders. The extract is prepared from annatto seeds, Bixa orellana L., using a food-grade extraction solvent. Bixin is the principal pigment of oil-soluble annatto extracts. Norbixin is the principal pigment of alkaline water-soluble annatto extracts.

Common Uses

Annatto extracts have been used for over two centuries as a food color, especially in cheese, and various types are now used in a wide range of food, drugs and cosmetic products, including butter, margarine, salad dressing, ice cream and other frozen desserts, confectionery, egg products, fish and fish products, meat products, cereals, cakes, beverages, soup mixes, fruit products, snacks, bakery products, spices and seasonings, and sausage casings.

Specifications

JECFA

US FDA
EU Commission

Codex GSFA Provisions

The Codex Alimentarius Commission has finalized adoption of MPLs for Annatto extracts, bixin-based (160b(i)) in 6 food categories and for Annatto extracts, norbixin-based (160b(ii)) in 7 food categories.  A large number of other applications of annatto extracts, both bixin and norbixin-based as a color additive in foods and beverages have been proposed and are pending adoption, following completion of the review and comments process.

Regulatory Approvals

JECFA: 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 (67th meeting, 2006).

USA: Annatto extract is a color additive exempt from certification and permanently listed for use in foods generally (21 CFR 73.30), for use in drugs generally, including those for eye area (21 CFR 73.1030), and as annatto for use in cosmetics generally, including those for eye area (21 CFR 73.2030) at levels consistent with GMP.

EU: ADI of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. (EFSA, 2016) EFSA has authorized uses for annatto bixin and annatto norbixin in specific food and beverage categories at maximum use levels via Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives  

Safety Reviews

Safety Evaluation of Certain Food Additives and Contaminants (Sixty-seventh meeting of the Joint WHO/FAO Expert Committee on Food Additives)  WHO Food Additives Series No. 58, 2007. Available online

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

EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), 2019. Scientific Opinion on the safety of annatto E and the exposure to the annatto coloring principles bixin and norbixin (E 160b) when used as a food additive. EFSA Journal 2019;17(3):5626, 28 pp. Available online