Annatto, Bixin, Norbixin. company (Doc. The bixin‐based extracts (Annatto B and E) were suspended in corn oil, and the norbixin‐based extract (Annatto F) was suspended in sterile water with 0.5% carboxymethyl cellulose containing approximately 25 or 250 mg of Annatto F/g for the two dose levels tested. Annatto extracts. The rats and mice, when treated in this way, demonstrated hyperinsulinaemia and hypoinsulinaemia, respectively, indicating that the pancreatic β‐cells were functional. For the following food categories, the proposed restrictions could not be taken into account, and therefore the whole food category was considered in the exposure estimates. The application by NATCOL covers the five annatto extracts for which JECFA has established full ADIs (JECFA, 2007): (i) aqueous‐processed bixin (Annatto E); (ii) solvent‐extracted bixin (Annatto B); (iii) alkali‐processed norbixin, acid‐precipitated (Annatto F); (iv) alkali‐processed norbixin, not acid‐precipitated (Annatto G); and (v) solvent‐extracted norbixin (Annatto C). Norbixin‐based extracts are prepared by three different processes (JECFA, 2007, 2015; Doc. E160b - Annatto extracts: Annatto, sometimes called roucou or achiote, is a derivative of the achiote trees of tropical regions of the Americas, used to produce a yellow to orange food coloring and also as a flavoring. The fact that WSA‐fed rats do not have coloured fat also suggests that the major annatto pigments are not involved in the coloration. The order of priorities for the re‐evaluation of the currently approved food additives should be set on the basis of the following criteria: the time since the last evaluation of a food additive by the Scientific Committee on Food (SCF) or by EFSA, the availability of new scientific evidence, the extent of use of a food additive in food and the human exposure to the food additive taking also into account the outcome of the Report from the Commission on Dietary Food Additive Intake in the EU33 Positive results were also reported from a mouse dominant lethal test using the same test materials (CE and BE) (Aranez and Bayot, 1997). These ADIs differ by an order of magnitude; the ADI for bixin is in the range 0–12 mg/kg bw, the group ADI for norbixin and its salts is 0.6 mg/kg bw. The solvent‐extracted norbixin (Annatto C) is derived from the solvent‐extracted bixin (Annatto B); they share the small quantity of non‐pigment material. For the regulatory maximum level exposure assessment scenario, the main food categories contributing to the total mean exposure to annatto (E 160b) were fine bakery wares, flavoured fermented milk products, and fats and oils, and for infants, fine bakery wares and flavoured fermented milk products for toddlers, children and adolescents, and fine bakery wares for adults and the elderly. Its scent is described as "slightly peppery with a hint of nutmeg" and flavor as "slightly nutty, sweet and peppery". Food ingredient numbers: (E-numbers) E-Numbers represent specific food additives, used by the food industry in the manufacture of various food products. In the absence of any macroscopic or histopathological changes noted in the kidneys, the Panel considered these findings to be of only minor, if any toxicological importance. As an in vivo follow‐up, a micronucleus test in mouse bone marrow and a comet assay in rat stomach and liver, the main target tissues following oral exposure, were performed. Engelbreth‐Holm and Iversen (1955) reported that body weights of animals treated with the annatto extract (not further specified) for 26 months were similar to those of the controls, that treated animals did not turn yellow, and that no toxic or carcinogenic effects occurred. The precipitate is filtered, dried and milled to give a granular powder. Dietary concentrations used in this study were based on the results from the preliminary 4‐week range‐finding study discussed in the previous subsection (HLS, 2001b). The test material complied with the specifications for solvent‐extracted bixin (Annatto B) (actual content of the tested batch: 84.7%). In 1974, JECFA established a temporary ADI of 1.25 mg/kg bw for the sum of bixin and norbixin (expressed as bixin) (JECFA, 1975), which was endorsed by the EU SCF in 1975 (SCF, 1975). Available online: http://www.efsa.europa.eu/en/dataclosed/call/afc061208 Norbixin can complex with proteins to give a product more stable to light that is redder in colour (Smith and Wallin, 2006). The studies by Dunham and Allard (1960) were not relevant for the annatto extracts used as a food colour, as they refer to extracts obtained from the roots of B. orellana, rather than from the outer seed case, which is the source of the food colour, and since dosing was not via the oral route. Following a request from the European Commission to the European Food Safety Authority (EFSA), the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re‐evaluating the safety of annatto extracts (E 160b(i), (ii), (iii)) when used as a food additive. (pKM101), Bixin Standard. The mutagenicity was decreased or even abolished in presence of S9, and was observed only at high doses, which were associated with visible precipitation of the dye. Studies in rats using three annatto extracts of the present opinion revealed that the more polar free acid form norbixin was better absorbed than the less polar bixin. The applicant concluded that no evidence of reproductive toxicity of annatto extracts (E 160b) has been observed in the multigeneration and developmental toxicity studies in rats with fat‐soluble or water‐soluble annatto extracts (E 160b). European Food Safety Authority, Cultures were treated for 6 h in the presence, and 6 or 22 h in the absence of S9 mix. Annatto extracts (E 160b) of lower purity than the ones evaluated in the present opinion were without significant toxicity when administered in long‐term studies to mice and rats. Five specifications have been established for the annatto extracts covered by the established ADIs, but only tentative specifications were established for the oil‐processed bixin for which no ADI has been established. In experiments without exogenous metabolic activation, all three annatto extracts (Annatto B, E and F) were weakly mutagenic in S. Typhimurium TA100 (and also in E. coli in the case of Annatto F), inducing approximately twofold increases in revertants at dose levels where precipitation occurred (from 1,000 μg/plate onwards). These levels were within the same general range as those of other carotenoids. Unidentified terpenoids (up to 13.4%) were only present in Annatto E. Moisture content was less than 10% in Annatto E and F samples. These were due to the intense colour of the annatto extract. For application in aqueous products, emulsions are the more appropriate product forms (Doc. Out of this data set, analytical results of E 160b were not detected (< LOD) in 173 samples, not quantified (< LOQ) in 72 samples and were numerical values (quantified) in 132 samples. The present applications of the water‐soluble annatto extracts include sausage casing, sausages, puddings, tomato sauce, breakfast cereals, milk desserts, chocolate fillings, smoked fish and pet food. The Panel considered that the available database did not indicate a high allergenic potential of the annatto extracts (E 160b) used as food additive in humans. The applicant provided results from a study in Sprague–Dawley rats on the absorption, distribution and excretion of bixin and norbixin from the annatto extracts evaluated in the present opinion (Hughes, 2002). Four groups of five male and five female Crl:CDBR rats were used. OJ L 80, 26.3.2010, p. 19. No mortalities or clinical signs of toxicity were observed. The resulting preparation may be acidified, followed by the removal of the solvent, drying and milling. At dose levels up to 0.4 mg/plate (sodium salt) or 10 mg/plate (potassium salt), no significant responses were obtained. Testing for mutagenic activity with Salmonella typhimurium TA1535, TA1537, TA100, TA102, TA104 and Escherichia coli WP2uvrA (pKM101), Annatto Type E. Testing for mutagenic activity with Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA102, TA104 and Escherichia coli WP2uvrA, Annatto Type F. Testing for mutagenic activity with Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA102, TA104 and Escherichia coli WP2uvrA. Subsequently, De Oliveira et al. The principle pigment in the seeds is the carotenoid cis‐bixin; processing may involve aqueous alkaline hydrolysis with simultaneous production of cis‐norbixin (Figure 1). Submitted on 29 November 2013. These numbers are also used in … The bixin is hydrolysed to norbixin in hot alkaline solution. Current and proposed uses and use levels of annatto extracts. To this aim, an in vivo comet assay, which is an adequate follow‐up test for gene mutagens and clastogenes, has been performed on the main target tissues of oral exposure (i.e. A thirteen-week oral toxicity study of annatto extract (norbixin), a natural food color extracted from the seed coat of annatto (Bixa orellana L.), in Sprague-Dawley rats. Nowadays, it is very hard to identify halal e codes so people are eating with pig fat code in food items without their knowledge. Acute‐, intermediate‐ and long‐term studies have been carried out on these and related terpenoid compounds at high‐dose levels, including studies by the NTP, and no specific toxic or carcinogenic effects have been identified. Four groups of 20 male and 20 female (Crl:CD (SD)IGS BR VAF/Plus) rats, 35–39 days of age at the start of the treatment, were used for the study. This approach enabled identification and quantification of the major colour principles – 9′‐cis‐bixin, 9′‐cis‐norbixin and trans‐bixin – and semiquantitative determination of, among others, trans‐norbixin and the minor mono‐cis‐(other than the 9′‐cis forms) and di‐cis‐bixin, and norbixin isomers mono‐cis‐(other than the 9′‐cis forms) and di‐cis‐. Considering the proposed extension of use, the main food categories contributing to the total mean exposure to bixin in the brand‐loyal scenario were flavoured fermented milk products for infants, flavoured fermented milk products and other confectionary for toddlers, other confectionary and soups and broths for children, adolescents, and adults, and soups and broths and ripened cheese for the elderly. No evidence of histopathological damage was observed in any tissue, except for hepatocellular necrosis at the two highest dose levels of the solvent‐extracted norbixin (Annatto C). It is not always known which component in the mixture is the causative agent of the side effects. The only exceedance observed for norbixin was at the 95th percentile in the brand‐loyal scenario for infants (in one country), toddlers (in three countries) and children (in one country). After dosing of the aqueous‐processed bixin (Annatto E), the above isomers were detected in plasma of both genders plus an additional trans‐bixin species. The Panel concluded that the changes in renal function observed at the two highest dose levels, point to a NOAEL of 1,000 mg Annatto F/kg diet, equivalent to 79 mg Annatto F/kg bw per day in males and 86 mg Annatto F/kg bw per day in females, corresponding to 30 mg norbixin/kg bw per day in males and 33 mg norbixin/kg bw per day in females. New consumption surveys added in 2015 in the Comprehensive Database were also taken into account in this assessment.1313 Taking into account the low purity of the fat‐ and water‐soluble annatto preparations tested for carcinogenicity, the applicant considered it appropriate to extrapolate the conclusions from those old carcinogenicity studies to Annatto B, C, E, F and G. The Panel agreed with this assumption. Seven volunteers of both sexes ingested a single dose of 1 mL of a commercial annatto food colour containing 16 mg of cis‐bixin and about 0.5 mg cis‐norbixin in soybean oil. Three groups received the test material by dietary administration for a 4‐week period, and one control group received untreated diet alone. Additional data on annatto extracts (E 160b). Nevertheless, the EFSA Comprehensive Database represents the best available source of food consumption data across Europe at present. Alkali‐processed, acid‐precipitated norbixin (Annatto F) is prepared by removal of the outer coating of the seeds of the annatto tree with aqueous alkali (potassium or sodium hydroxide). 04.2.4.1. No conclusion can be drawn from published genotoxicity studies with water‐soluble annatto extracts, which used not validated test methods and/or limited protocols. The pharmacological activity of extracts of the root of B. orellana has been addressed in previous evaluations by JECFA (JECFA, 2004a,b). There were also other manufacturing methods used previously (e.g. LD50 values amounted to 700 mg/kg bw for a water‐soluble annatto extract (no further details given) upon intraperitoneal (i.p.) Based on the absence of evidence for carcinogenic response, the Panel concluded that the annatto extracts were of no concern with respect to carcinogenicity. Food conversion efficiency values were not significantly reduced in any of the groups. Two weeks after a single dose of DEN (200 mg/kg, i.p. 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