Annatto Extracts

 

Identifiers

Annatto
Annatto extract

Oil-soluble Annatto
Annatto Butter Color
Annatto Margarine Color

INS160b(i-ii)
Annatto extracts, bixin-based
Annatto extracts, norbixin-based

E160b(i-iii)
Annatto, Bixin, Norbixin
Solvent-extracted bixin and norbixin
Alkali extracted annatto
Oil extracted annatto

CAS No. 1393-63-1
CI Natural Orange 4
CI No. 75120

Physical Description

Annatto extracts are obtained from the outer layer of the seeds of the tropical tree Bixa orellana. The principal pigment is cis-bixin, which is contained in the resinous coating of the seed itself, producing color ranges from light yellow to orange.

Common Uses

Annatto extracts have been used for over two centuries as a food colors, especially in cheese, and various types are now used in a wide range of food 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, along with 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 three food categories and Annatto extracts, norbixin-based (160b(ii)) for use in flavored fluid milk drinks, as noted in the General Standard of Food Additives (GSFA). 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 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. 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

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

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

JECFA established an ADI for bixin of 0–12 mg/kg bw on the basis of the NOEL of 1311 mg/kg bw per day from a 90-day study in male rats fed an extract containing 92% bixin, corrected for pigment content and applying a safety factor of 100. The Committee established a group ADI for norbixin and its sodium and potassium salts of 0–0.6 mg/kg bw (expressed as norbixin) on the basis of the NOEL of 69 mg/kg bw per day from a 90-day study in male rats fed an extract containing 91.6% norbixin, corrected for pigment content and applying a safety factor of 100. The Committee further evaluated compositional data on aqueous processed bixin and alkali-processed norbixin (acid-precipitated), together with toxicological
data on annatto extracts for which NOELs had been identified in 90-day studies of toxicity. It concluded that the use of these annatto extracts as sources of bixin or norbixin would not raise safety concerns, provided that they complied with the relevant specifications. Accordingly, the ADIs given above could be applied to bixin and norbixin derived from those annatto extracts. The Committee noted that the pigment in alkali-processed norbixin (not acid-precipitated) consists of sodium or potassium salts of norbixin and that compositional data on this extract, complying with the specifications, did not raise safety concerns. Consequently, the Committee concluded that the group ADI for norbixin and its sodium and potassium salts could be applied to norbixin salts from this source. If all the pigment ingested were bixin, the estimated dietary exposure of 1.5 mg/day would result in an intake of bixin of 26 μg/kg bw per day, corresponding to approximately 0.2% of the ADI (0–12 mg/kg bw). Similarly, if all the pigment were norbixin, the estimated dietary exposure of 1.5 mg/day would result in an intake of norbixin of 26 μg/kg bw per day, corresponding to approximately 4% of the ADI (0–0.6 mg/kg bw).

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

Safety evaluation of certain food additives and contaminants (2003). Prepared by the 61st meeting of the JECFA. WHO food additives series 52. Available online

EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added toFood), 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