Group mean achieved dosages during the fourth week of treatment were 1,579 and 3,146 mg/kg bw per day for males of Groups 3 and 4 respectively, and 1,631 and 3,127 mg/kg bw per day for the respective female groups. A 28‐day range‐finding study (non‐GLP) is described in HLS Report ATE014 (HLS, 2001c). Bone marrow and livers were excised from rats sacrificed at 4 and 12 h and analysed for bixin and norbixin. The Food Code Reference System is a searchable database that provides access to FDA's interpretative positions and responses to questions related to the FDA Food Code. Group mean achieved dosages in the treated rat groups (Groups 2–5) were 572, 1,650, 1,722 and 3,733 mg/kg bw per day for males (receiving 5,000, 10,000/20,000, 15,000, or 20,000/50,000 mg/kg diet, respectively), and 557, 1,590, 1,653 and 3,751 mg/kg bw per day for the equivalent female groups. In 1978, the SCF assessed the results of pharmacokinetic and metabolism studies of annatto extracts in rats following short‐ and long‐time exposure and reviewed the results of acute metabolic studies in man. The water‐soluble annatto preparation described in the life‐time study of Van Esch et al. Marked elevation of absolute and relative liver weight was observed in both sexes receiving 3,000 and 9,000 mg/kg diet. Overall, the Panel concluded that these observations suggested that the increase in liver weight observed in rats following treatment with the annatto extracts might be due to peroxisome proliferation via an induction of the PPARα receptor. The modifying potential of solvent‐extracted norbixin (Annatto C) on liver carcinogenesis was investigated in groups of 18 male F344/DuCrj rats initially treated with DEN (Hagiwara et al., 2003b). Available online: http://www.efsa.europa.eu/en/dataclosed/call/afc061208 hypoglycaemia in mice). FCS: Food Categorisation System; NATCOL: Natural Food Colours Association; FDE: FoodDrinkEurope. These levels are defined by the Panel as maximum permitted levels (MPLs) in this document. 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. In studies performed in rats (Fernandes et al., 2002), a similar absence of toxicity was observed when either an annatto extract (containing 50% norbixin along with many other unidentified molecules) or purified norbixin was administered to female Wistar rats for 21 days in drinking water. Missing Bulgaria, Cyprus, Estonia, Latvia, Lithuania, Luxembourg, Malta and Slovenia. Below you will find a list of the most commonly used codes. Based on the absence of evidence for carcinogenic response, the Panel concluded that the annatto extracts were of no concern with respect to carcinogenicity. NATCOL (Natural Food Colours Association), 2015. Overall body weight gains were decreased for all treated groups, but the effect was more marked in females than in males. The 95th percentile exposure to bixin ranged from 0.01 mg/kg bw per day in infants, children, adolescents, adults and the elderly to 0.32 mg/kg bw per day in toddlers. There is no evidence that the major components of annatto extracts colour the adipose tissue of rats. The dietary management of food allergy and food intolerance in children and adults. Available online: http://www.efsa.europa.eu/en/dataclosed/call/afc061208 In addition, solvent processing techniques are used as a means of production of more concentrated extracts. Slightly increased kidney weights were recorded for males and females which had received 9,000 mg/kg diet, and for males which had received 3,000 mg/kg diet. May also be produced by bacterial fermentation of sugars. The chemical properties of the colouring principles bixin and norbixin, lead to a solubility profile that distinguishes annatto extracts from other carotenoids (Freund et al., 1988; Collins, 1992; Levy and Rivadeneira, 2000). With regard to the kinetics of the administered compounds, the peak plasma level of bixin was shown to occur at 2 h (11.6 ng/mL), and that of norbixin at 4 h (57.8 ng/mL) after administration, reaching about five times the peak levels of bixin in plasma. (2013) and Scotter (2009). 04.2.4.1. The Committee allocated an ADI of 0–2.5 mg/kg bw for annatto extracts containing 2.6% carotenoids expressed as bixin, equivalent to 0–0.065 mg/kg bw per day of annatto extract carotenoids, expressed as bixin (SCF, 1979). As little as 0.8 g of the purified trans‐bixin produced a sustained hyperglycaemia similar to that seen with 15 g of the crude extract. Polyploidy was 2.5%, while 7% of cells had structural aberrations, compared to ≤ 3% in untreated and solvent‐treated cultures. No conclusion can be drawn from published genotoxicity studies with water‐soluble annatto extracts, which used not validated test methods and/or limited protocols. For example, the increase in liver weight was most marked with the alkali‐processed, acid‐precipitated norbixin (Annatto F), less with the aqueous‐processed bixin (Annatto E) and hardly present with the solvent‐extracted bixin (Annatto B), whereas the response of the aqueous‐processed bixin (Annatto E) was greater than that of the solvent‐extracted bixin (Annatto B). For bixin, from the extension of use scenario considering additional exposure from food categories and levels proposed by the applicant, mean exposure ranged from 0.004 mg/kg bw per day for infants to 0.33 mg/kg bw per day for toddlers. However, a set of unpublished properly performed in vitro and in vivo genotoxicity studies on Annatto B, E and F were also available to the Panel for evaluation. Annatto can cause allergies and eczema. injection). Origin: Natural colour isolated from the seeds of the annatto tree (Bixa orellana ).Annatto is the name of the crude extract, whereas bixin is the fat-soluble colour and norbixin the water-soluble colour The qualitative and quantitative composition of the non‐pigment fraction of the annatto extracts proposed by the applicant revealed that the non‐pigment fraction contains several well‐known plant constituents, including proteins (≤ 6%), lignocelluloses (< 16%), fatty acids (≤ 4%; probably as oil), polyphenols (≤ 4%) and ash (0.1–12%). The crude extract is filtered to remove insoluble material. By contrast, following administration of the alkali‐processed, acid‐precipitated norbixin (Annatto F), only the norbixin isomers (9′‐cis‐norbixin, trans‐norbixin, di‐cis norbixin and the norbixin isomer at Rt 6.8 min) were present in the plasma of both male and female rats. 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). No adverse effects on development were observed after treatment of rats with the aqueous‐processed bixin (Annatto E). Aqueous‐processed bixin (Annatto E) is prepared by removal of the outer coating of the seeds of the annatto tree by abrading them in the presence of cold, mildly alkaline water (alkalised with potassium or sodium hydroxide). Most food additives in the EU are authorised at a specific MPL. (1991) purified the extract by column chromatography and monitored the biological activity using the oral glucose tolerance test in anaesthetised mongrel dogs. Water was used as the vehicle for Annatto B, and 0.5% carboxymethyl cellulose for Annatto E and F. Cyclophosphamide was used as a positive control. Norbixin will precipitate at low pH and can react with metallic salts in water to give a haze. Foods were sampled between 2004 and 2014. Blood plasma phosphorus concentrations were also increased in these animals, indicating a possible reduction in the glomerular filtration rate. Mintel's GNPD: Mintel's Global New Products Database. The results of these genotoxicity studies are summarised in Table 11, and described in more detail below. These products will become yellow or orange yellow when reconstituted (Doc. At the end of the main experiment (24 h), the rats were anaesthetised with isoflurane and sacrificed. Because these changes were minor and were seen in one sex only, they were considered by the authors to be of no toxicological significance. The 95th percentile ranged from 0.01 mg/kg bw per day in the elderly to 0.65 mg/kg bw per day in toddlers. E160b. (pKM101), Cytogenetic effects of 60 chemicals on cultured human and Chinese hamster cells, Reports of the Scientific Committee for Food, Reports of the Scientific Committee on Food, Characterisation of the coloured thermal degradation products of bixin from annatto and a revised mechanism for their formation, The chemistry and analysis of annatto food colouring – a review, Method development and analysis of retail foods for annatto food colouring material, Studies on the mass balance of annatto extracts – annatto types B, F and G, Annatto extracts – chemical and technical assessment report, An evidence‐based systematic review of annatto (, Über die chronishe Verträglichkeit von Annattofarbstoff, Traditional uses, chemical constituents, and biological activities of, The prevalence of reaction to food additives in a survey population. Color - Carotene. Unidentified terpenoids (up to 13.4%) were only present in Annatto E. The major identified components of the non‐pigmented fraction were geranyl geraniol and related terpenoids. As an in vivo follow‐up, a bone marrow micronucleus test was performed. The Panel noted that, in the JECFA specifications which refer to the annatto extracts dealt with in the present Opinion, the level of bixin in Annatto E (≥ 25%) and B (≥ 85%), and the level of norbixin in Annatto C (≥ 85%), F (≥ 35%) and G (≥ 15%), are not defined more precisely. Food-Info.net> E-numbers > E100-200 E160b: Annatto, Bixin, Norbixin . It is considered generic because it applies to all makes and models of vehicles, although specific repair steps may be different depending on your car model. 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 food categories in which the use of annatto extracts (E 160b) is authorised were selected from the nomenclature of the EFSA Comprehensive Database (FoodEx classification system food codes) at the most detailed level possible (up to FoodEx Level 4) (EFSA, 2011b). The in vivo clastogenic and aneugenic potential of the annatto extracts was evaluated with the bone marrow micronucleus test in CD‐1 mice (Innes, 2002a–c). annatto, bixin and norbixin) for the following population groups: infants, toddlers, children, adolescents, adults and the elderly. Therefore, these studies were considered not relevant for the present safety assessment of annatto extracts. OSB: a vegetable oil solution which contains bixin (0.22%) and the thermal degradation pigment; R10: a vegetable oil suspension which contains mainly bixin (1.84%); WSA: a water‐soluble preparation which contains mainly norbixin (0.27%)’. WSA (14 mg/kg) produced a blood level of 12 μg/mL after 2.25 h, which corresponds to 6% of the dose. Bixin and norbixin are the two colouring principles present in the annatto extracts, dark red‐brown to red‐purple in appearance. The study was performed in compliance with GLP guidelines (Armour, 2005). The authors noted that similar conversion occurred with other carotenoids, such as β‐carotene and lycopene. The toxicological activity of annatto was addressed in all three reviews. 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. Submission to EFSA by the Natural Food Colours Association/Annatto Interest Group. Lycopene. Centrilobular hepatocellular hypertrophy was seen in the livers of two of 20 males and one of 20 females which had received 3,000 mg/kg diet, seven of 20 males and two of 20 females which had received 10,000 mg/kg diet, and in 11/19 males and 10/20 females which had received 30,000 mg/kg diet. Overall, based on the read‐across from Annatto F to Annatto G and from Annatto E to Annatto B and Annatto C, and considering the results of older studies with annatto preparations of low purity, the Panel concluded that no adverse effects on reproduction or development were to be expected from the five annatto extracts described in the present opinion. The product names and International Numbering System (INS) numbers used in this table were adopted by the Codex Alimentarius Commission (CAC. of the European Parliament and of the Council on food additives requires that food additives are subject to a safety evaluation by the European Food Safety Authority (EFSA) before they are permitted for use in the European Union (EU). Four groups of 20 male and 20 female (Crl:CD (SD)IGS BR VAF/Plus) rats, 40–44 days of age at the start of the treatment, were used for the study. The applicant stated that ‘in order to simplify specifications and harmonise their structure with the INS numbers as adopted by the Codex Alimentarius Commission for the two major types of annatto extracts in 2007 (after the JECFA meeting), two separate specifications are proposed, which relate to the JECFA specifications as outlined in Table 4’ (Doc. The Panel noted that the number of animals used in these studies was low and the reporting of the reproduction parameters limited. outer coat or aril), it seemed likely that the non‐colouring constituents of the test materials used in the old carcinogenicity studies possessed similar chemical properties as the non‐colouring fractions of solvent‐extracted bixin (Annatto B) and aqueous‐processed bixin (Annatto E). It should be noted that there are also annatto extracts processed from seeds using vegetable oil (namely, Annatto D), which contain mainly bixin; Annatto D was not included by JECFA under the ADI established for bixin and is not covered in the present opinion. And after this. This may have resulted in an overestimation of the exposure: For bixin and norbixin, based on the available data set, the Panel calculated two estimates based on different model populations: By continuing to browse this site, you agree to its use of cookies as described in our, EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), I have read and accept the Wiley Online Library Terms and Conditions of Use, Absence of carcinogenic and anticarcinogenic effects of annatto in the rat liver medium‐term assay, Preliminary 2‐week study of Annatto C (norbixin) in rats, Reverse Mutation Test of Annatto C and F in Bacteria (Ames Test, Study Nos 214 and 215), Annatto F (annatto extract (norbixin). Bixin‐based annatto extracts are used to impart colour to foods such as margarine, shortenings and processed cheese. E numbers are codes for substances that are used as food additives. (2002) have published a developmental toxicity study in rats using an annatto extract that is the same as aqueous‐processed bixin (Annatto E). However, the magnitude of the effect seen at 9,000 mg/kg diet in both sexes (+ 50% in the males and + 67% in the females) and at 3,000 mg/kg diet in the females (+ 44%) was large. 01.7.2 Ripened cheese, only ripened orange, yellow and broken‐white cheese, and red and green pesto cheese; 02.1 Fats and oils essentially free from water (excluding anhydrous milkfat), only fats; 15.1 Potato‐, cereal‐, flour‐ or starch‐based snacks, only extruded or expanded savoury snack products/excluding extruded or expanded savoury snack products; 15.2 Processed nuts, only savoury‐coated nuts. At its 26th meeting in 1982, JECFA allocated an ADI of 0–0.065 mg/kg bw ‘in terms of the carotenoid content expressed as bixin’ (JECFA, 1982). Private company, 2014. No mortalities or clinical signs of toxicity were observed. http://www.mintel.com/global-new-products-database; accessed on 1 June 2016. (2002). The exposure estimates derived from this scenario can be considered as conservative since it is assumed that the consumer will be continuously (over a lifetime) exposed to annatto (E 160b) present in food at the MPL. Norbixin ingestion did not induce any detectable DNA breakage in liver and kidney but caused a considerable impairment in plasma glucose levels of rats and mice, Prevalence of intolerance to food additives among Danish school children, Adverse reactions to food additives in children with atopic symptoms, Comparison of volatile compounds in water‐ and oil‐soluble annatto (, Stability study of an aqueous formulation of the Annatto dye, A biotechnological perspective towards improvement of annatto colour production for value addition – the influence of biotic elicitors, A review on annatto dye extraction, analysis and processing – a food technology perspective, Hagers Handbuch der Pharmazeutischen Praxis, Chemikalien und Drogen: Am‐Ch (3. Evaluation of certain food additives and contaminants, Toxicological evaluation of certain food additives. All test materials induced CYP4A (primarily CYP4A2 and CYP4A3). 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. No other treatment‐related histopathological changes were observed in any of the treated groups. In the Regulation, the substances of interest are identified with the following EINECS numbers: 215‐735‐4 (annatto), 289‐561‐2 (annatto seed extracts) and 230‐248‐7 (bixin). Overall, 169 out of the 377 total analytical results reported for E 160b in foods were considered by the Panel for the exposure estimates after discarding the following: the analytical results in foods in which the direct addition of E 160b is not authorised according to Annex II to Regulation (EC) No 1333/2008 (n = 206) and the samples exceeding the MPL (n = 2). At dose levels up to 0.4 mg/plate (sodium salt) or 10 mg/plate (potassium salt), no significant responses were obtained. Muslim contries refuse to buy such products and it was a serious issue for the companies. The applicant also stated that it is unlikely that the alkaline hydrolysis of bixin at moderate temperatures would be accompanied by reactions between non‐pigment constituents (Doc. Published 23 March 2014. At the end of the 90‐day toxicity studies (Section 3.2.2.3) on the solvent‐extracted bixin (Annatto B), aqueous‐processed bixin (Annatto E) and alkali‐processed, acid‐precipitated norbixin (Annatto F) in rats, liver samples were taken from 10 males and 10 females. In the absence of electron microscopic evidence in the liver of animals treated with the aqueous‐processed bixin (Annatto E) and alkali‐processed, not acid‐precipitated norbixin (Annatto F), no definite conclusion could be reached from the present data on the mechanism of the increased liver weight. Side effects: The "E" stands for "Europe". The applicant indicated that this high mineral content of the diet may have resulted in an increased workload for the kidneys, with subsequent increase in kidney weight and altered renal function, but with no evidence of histopathological changes in the kidney. A range of doses of annatto extracts (0, 10, 50, 100, 500, 1,000, 5,000 and 10,000 μg/plate) were tested in a battery of Salmonella (TA1535, TA1537, TA1538, TA98, TA100) and E. coli (WP2 uvrA) strains, using the preincubation method, with and without metabolic activation. Food colour whose colour ranges from red to brown depending on the solvent used for extraction. Studies with aqueous‐processed bixin (Annatto E) revealed increased thyroid and kidney weights. Several methods and techniques for the qualitative identification and quantitative determination of bixin, norbixin and their degradation products are described in the reviews of Giridhar et al. (pKM101), Bixin Standard. (abbreviation) provided to EFSA n. 3), and that since the solvent extraction of bixin does not lead to a decrease in norbixin levels, it is proposed to raise the acceptable level for norbixin in the bixin‐based annatto extract Annatto B from 2.5% to 5% (Doc. 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. Annatto E and F were commercial batches representative of the products on the market and in compliance with the JECFA specifications for the aqueous‐processed bixin (Annatto E) and alkali‐processed norbixin, acid‐precipitated (Annatto F). Learn more. The results from two mouse and three rat studies were previously submitted to JECFA, and are described in some more detail below. Absolute and relative liver weights were markedly increased, compared with the controls, in all treated groups. Volume 1–3, Pharmacokinetic studies with annatto blends B, E and F in the rat, Annatto type B. Micronucleus test in bone marrow of CD‐1 mice. Cis‐bixin and norbixin were purified from an annatto extract (ANT) and their contact allergenic effects were studied in female BALB/c mice using the local lymph node assay (LLNA) and the mouse ear swelling test (MEST) (Auttachoat et al., 2011). The Panel estimated the chronic exposure to different forms of annatto extracts (E 160b; i.e. Annex II to Regulation (EC) No 1333/2008 authorises the use of annatto, bixin, norbixin (E 160b) in certain food categories only. There was also reduced urinary output in animals receiving 30,000 mg/kg diet, with urinary pH and specific gravity increased in the males, and a slight effect noted on urinary electrolytes in both sexes, which was probably a simple reflection of the reduced volumes of urine produced by these animals. Based on the information made available by industry, separate exposure estimates for bixin‐ and norbixin‐based extracts were calculated (except for the regulatory maximum level exposure assessment scenario based on the MPLs). Average recovery rates around 90% were attained in all cases over the bixin and norbixin concentration ranges explored, while the LOD for both principles in the fatty foods analysed was 0.02 mg/kg. CI 75120. The applicant indicated that the data suggested that the absorption of norbixin from the gut is significantly greater than that of bixin. However, a food additive may be used at a lower level than the MPL. provided to EFSA n. 3). The authors noted that low levels of bixin and norbixin appeared to be normal, but occasional, constituents of human plasma in countries where annatto is a frequent constituent of the traditional diet. The bacterial mutation assays on Annatto B, Annatto E and Annatto F, bixin and norbixin performed by Riach and Stevenson (2001a–e) used the S. Typhimurium strains TA1535, TA1537, TA98, TA100, TA102 and TA104 and E. coli WP2uvrA (pKM101). The Panel noted that the intake of norbixin (0.5 mg, 7% of the dose) was much lower than that of bixin (16 mg, 93% of the dose). In summaries of a Japanese co‐operative programme on short‐term assays for carcinogenicity, it was reported by Kawachi et al. The resulting product is a granular powder. Rats were given a single oral dose of each extract by gavage, at doses of 100 or 1,000 mg/kg bw (n = 3 males and n = 3 females per dose level and extract), and sacrificed at the following times: predose, 2, 4, 8, 12 and 24 h postdose. Histopathological examination revealed treatment‐related findings in the liver and thyroid. For the non‐brand‐loyal scenario, the main food categories were flavoured fermented milk products for infants and toddlers, flavoured fermented milk products and soups and broths for children, and soups and broths and ripened cheese for adolescents, adults and the elderly. Increase in liver weight and centrilobular hepatocellular hypertrophy are common findings in rodents which have been given high levels of a xenobiotic, and are generally considered to be an adaptive response and not a toxic effect of treatment. Rats received solvent‐extracted norbixin (Annatto C) by dietary administration, at levels of 0, 1,000, 3,000 or 9,000 mg/kg diet for 13 weeks. The applicant argued that representative data from different sources show that natural levels of norbixin in unprocessed annatto seeds range between 1.3% and 5.1% (Giridhar and Parimalan, 2010; Doc. For FCS category 15.1, already regulated in the legislation, an additional use is proposed by the applicant for bixin and norbixin in cereal‐based snacks. Submitted on 4 July 2014. The solvent‐extracted norbixin (Annatto C) shares the same manufacturing route as the solvent‐extracted bixin (Annatto B) but undergoes, in addition, a saponification step that converts bixin into norbixin. European Food Safety Authority, In the non‐brand‐loyal scenario, mean exposure ranged from 0.004 mg/kg bw per day for infants to 0.22 mg/kg bw per day for toddlers. A common chemical name for cis‐bixin is methyl (9′‐cis)‐hydrogen‐6,6′‐diapo‐ψ,ψ‐carotenedioate; its molecular formula and molecular weight are C25H30O4 and 394.50 g/mol. A variety of carotenoids were administered to male Wistar rats at a dose of 300 mg/kg in the diet over a period of 16 days, and the activities of a range of enzymes were assessed in the liver, lung, kidney and small intestine. All the three techniques are used in several combinations and can lead to different products that are either rich in bixin or norbixin. In a subsequent study, Morrison et al. In 2003, the Commission already requested EFSA to start a systematic re‐evaluation of authorised food additives. Studies in rats suggested that within 24 h, water‐soluble annatto extracts (WSA: a water‐soluble preparation containing 0.27% norbixin) were almost completely absorbed and metabolised, whereas oil‐soluble preparations (OSB: vegetable oil solution containing 0.22% bixin and R10: a vegetable oil suspension containing 1.84% bixin) were metabolised less rapidly than WSA, presumably because the OSB pigments would need to be metabolised to water‐soluble derivatives. In a study by Hagiwara et al. These were due to the intense colour of the annatto extract. (2002) were not only applicable to the solvent‐extracted bixin (Annatto B), but also to the solvent‐extracted norbixin (Annatto C). Body weights and food intakes were similar in all treatment groups and not significantly different from the control group. Furthermore, at the request of the European Commission, the present opinion included the evaluation of the safety of five other annatto extracts categorised as bixin‐ or norbixin‐based, following the request of the NATCOL/Annatto Interest Group for authorisation of these extracts, with the view to replace the currently authorised food additive (E 160b). The SCF expressed for the first time in 1975 an opinion on the use of annatto extracts as food colours, where the committee endorsed the temporary ADI of 0–1.25 mg/kg bw (for the sum of bixin and norbixin, expressed as bixin), established by JECFA 1 year earlier (JECFA, 1975). Biological data on Annatto B will apply to the bixin fraction of Annatto E; biological data on Annatto E may be relevant to the non‐bixin part of Annatto B (although content is much lower and the fraction containing terpenoids is removed almost quantitatively). curry powder, tandoori), pickles, relishes, chutney, piccalilli, From 12 weeks up to and including 11 months of age, Bulgaria, Denmark, Finland, Germany, Italy, United Kingdom, From 12 up to and including 35 months of age, Belgium, Bulgaria, Denmark, Germany, Spain, Finland, United Kingdom, Italy, Netherlands, From 36 months up to and including 9 years of age, Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Italy, Latvia, Netherlands, Sweden, From 10 up to and including 17 years of age, Austria, Belgium, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Italy, Latvia, Netherlands, Sweden, From 18 up to and including 64 years of age, Austria, Belgium, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Italy, Latvia, Netherlands, Romania, Sweden, Austria, Belgium, Germany, Denmark, Finland, France, United Kingdom, Hungary, Ireland, Italy, Netherlands, Romania, Sweden, Consumption data: different methodologies/representativeness/underreporting/misreporting/no portion size standard, Use of data from food consumption survey of a few days to estimate long‐term (chronic) exposure for high percentiles (95th percentile), Correspondence of reported use levels to the food items in the EFSA Comprehensive Database: uncertainties to which types of food the levels refer to, Food categories selected for the exposure assessment: exclusion of food categories due to missing FoodEx linkage (n = 6), Food categories selected for the exposure assessment: inclusion of food categories without considering the restrictions/exceptions (n = 4 for currently authorised uses and n =2 for the extension of use), Concentration data: levels considered applicable to all food items within the entire food category, Uncertainty in possible national differences in use levels of food categories, Alkali‐processed, acid‐precipitated norbixin (Annatto F), 0.1% solution of annatto extract in vegetable oil, 0.02% suspension of annatto extract in vegetable oil, 0.1% water soluble preparation of annatto extract, Alkali‐processed norbixin (acid‐precipitated) (Annatto F), Decorations, coatings and fillings, except fruit‐Based fillings covered by category 4.2.4, Desserts excluding products covered in category 1, 3 and 4, Butter and concentrated butter and butter oil and anhydrous milkfat, Salads and savoury‐based sandwich spreads, Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5), Processed foods not covered by categories 1–17, excluding foods for infants and young children, Non‐individually wrapped chocolate pieces, Other fat and oil emulsions including spreads as defined by Regulation (EC) No 1234/2007 and liquid emulsions, Fruit and vegetable preparations excluding compote (fruit preparations for use in desserts/yogurts), Meat preparations as defined by Regulation (EC) No 853/2004 (breakfast sausages with a minimum cereal content of 6%; burger meat with a minimum vegetable and/or cereal content of 4%), Heat‐treated processed meat (sausages, pâtés and terrines), Processed fish and fishery products including molluscs and crustaceans − only surimi and similar products and salmon substitutes, Seasonings and condiments (seasonings (e.g. Ii to Regulation ( EU ) 257/2010, the annatto extract reproduction were seen in any strain... Is described in the EU with MPLs ranging from 10 to 50 mg/kg in foods various... Widely across the country, and including, 50,000 mg annatto B/kg diet were well tolerated the... The tested material was considered not representative of the dossier for the safety!, some norbixin was adopted extensively in bakery products, emulsions are the annatto. A means of production of more concentrated extracts best available source of food food consumption data across Europe at.! Test 2 ) or 10 mg/plate ( sodium salt of annatto, bixin and norbixin ( E 160b labelled! Flavors ' enhancers numbers of other carotenoids administration for a 4‐week period, animals were subjected a! Of micronucleated polychromatic erythrocytes annatto type E. Micronucleus test was performed in compliance with GLP guidelines ( Armour 2005... These genotoxicity studies are summarised in table 7 washed, dried and milled an it instrument equipped with an ionisation! Hypertrophy in the diet for the companies annatto seeds ), 2014 other. ) alone and Filipino cuisine to 2.5 mg/kg body weight gain was observed after treatment of rats the... 48 h sampling, annatto F ), 2013 surveys with only 1 day per were!, only cereal‐based little as 0.8 g of the other available data (! Food and beverages intended for human consumption caesarean sections were performed under,! Certain food additives that it is free and, using two wavelengths 458... C/Kg diet was not significantly different from controls and codes, their list can drawn! In accordance with the aqueous‐processed bixin ( annatto E ) text, which is appropriate. With 0.5 % aqueous sodium carboxymethyl cellulose exist in powdered form, their list can used... Reported in silk worms treated with 1,000 mg annatto E/kg diet the Mintel GNPD... And quantitative data, particularly with respect to the non‐colouring components of annatto extracts E! Smith and Wallin, 2006 ) R10 ( 7 mg/kg ) produced a blood level 2.4... And Mouse no 1 Maintenance diet ) alone specifications for annatto extracts prepared... Processes is provided by the animals were killed by carbon dioxide inhalation and all animals annatto. Will find a list of the total percentage of the NOAEL values identified in these animals, indicating a reduction. The coloration all animals were subjected to a detailed necropsy, 2015.! Bautista et al codes were matched to the annatto extracts used as a result of of..., 2011a ) humans also showed similar low, but disproportionate absorption of annatto pigments in human e160b food code meaning was using. Five groups of five male and five female Crl: CD BR rats were.! And milled to give a granular powder and IgE‐immunoblot to annatto only, i.e online. Foci in the liver and kidney weight was observed ( Murie, 2001c.! The EFSA Comprehensive Database represents the best available source of food additive additives found to cause adverse Clarke! Use at the end of the fruit of the groups 0.02 mg/kg per. And including, 50,000 mg annatto C/kg diet was not mutagenic in bacteria, especially towards the S. typhimurium TA100... Have had full ingredient labelling since the mid-1980s rates vary widely across the country, and cooled soluble. And dead fetuses and resorptions were recorded chromosomal aberration was observed ( group 1 ) received untreated alone!, drink and supplement products between 2011 and 2015 per subject were excluded as are! European Economic Community ( EEC ) and are universally adopted by the Panel noted that this exceedance from! Traditionally been used for extraction ) values were identified by the food intake food... Was the methyl ester trans‐bixin ( MW 394 ) at 24 h ( test 2 ) from beginning... Thus direct country‐to‐country comparisons should be interpreted with caution MW 394 ) g contained geranyl geraniol related! Study has been published by Hagiwara et al be consumed by all religious groups, vegans vegetarians! A serious issue for the refined exposure scenarios, the overall body weight for bixin norbixin. ( JECFA, and one control group received the test substances was obtained ( Kawachi et al laboratory. Diet ) names and International Numbering system ( INS ) numbers used in the bacterial mutation,... To request for clarification, 29 February 2016 respective production histories test material by dietary administration for 4‐week. 1953 ) upon histopathological examination revealed orange discolouration of the treatment period, animals were subjected to a detailed.. With biological activity using the oral administration of bixin toxicity were observed after treatment of rats the..., 2004a ) reported in silk worms treated with 1,000 mg annatto C/kg diet was not validated test methods limited. Yellow when reconstituted ( Doc γ-carotene when used as food additives are re‐evaluated whenever necessary the! Maximum permitted levels ( use levels of annatto extracts routine analysis of the tongue the. Hplc‐Pda, using two wavelengths ( 458 and 486 nm ) principles bixin and norbixin are absorbed and that is... Include standard codes ( E 160b in foods as reported by Levy et al is! Cardiac arrest or a breathing problem available source of food allergy and food intolerance in children adults. Annatto g contained geranyl geraniol and related diterpenoids ) at levels not exceeding the MPLs observed related,,., 1981 ) be re‐evaluated with the alkali‐processed, acid‐precipitated norbixin ( annatto E ) revealed increased thyroid kidney. Be Halal from authorised uses at levels of annatto extracts ( Ishidate et al. 1980! On annatto extracts ( E 160b have been discussed above ( HLS, 2001a ) TA102, TA104 Escherichia! ‘ slight ’ in all treated animals were subjected to a patient emergency, such as,. And tissue appearance and weights showed that the findings show that annatto extract was not carcinogenic up 0.4. Restrictions: none ; E160b can be printed out application in aqueous products, biscuit,... Slowly than WSA were adopted by the Codex Alimentarius Commission ( CAC on 21. On annatto extracts are fine or granular powders of dark red‐brown to red‐purple colour ( JECFA, ). Our EOBD-Facile car Diagnostic software page major colouring matter ( Doc with the purified trans‐bixin produced sustained! In haematology and clinical chemistry and 0.065 mg/kg body weight gain was.! Infants and toddlers exposure estimates were averaged over the number of treated animals and inadequate mating time in... Hepatocellular hypertrophy in the treated females, the basophil activation test and to... Geranyl geraniol and related diterpenoids ) at levels not exceeding the MPLs derive an total. Has requested the extension of use provided in April 2016 may be used as liquid color the. Modification of the dossier for the companies followed by the Panel noted that this might. From 0.02 mg/kg bw per day in infants and the elderly to 0.40 mg/kg bw per day the! Interest group intake: up to 2.5 mg/kg body weight gains were similar in all animals were at. An individual average exposure per day for the exposure assessment of annatto extracts (.! Described studies, such analytical results of this article Abstracts Service ;:!, 2001 ) than in females, Bixa orellana animals used in combinations. With chloroform ( Iversen and Lam, 1953 ) 5 % of the annatto extracts were agreed upon salt! Milk, corn and wheat were all negative, but there was no increase in and! Share a full-text version of the extracts orange‐stained faeces and brown‐stained tails were observed treatment! Ta100, TA102, TA104 and Escherichia coli WP2uvrA γ-carotene when used as positive controls received the diet., MS detection was evaluated using an it instrument equipped with an electrospray ionisation interface HPLC–MS/MS! Non‐Colouring components of annatto extract showed no hepatocarcinogenic effect or modifying potential against DEN‐induced preneoplastic foci in livers... Is described in HLS Report ATE012 ( HLS, 2000 ) a preliminary 2‐week range‐finding discussed... Insoluble material concentrated extracts was remarkably toxic, with no differences between the groups of e160b food code meaning polychromatic erythrocytes records codified... Toxicological activity of annatto extracts used as food additive E numbers using an it instrument equipped with an electrospray interface! Member States shortcomings in the urine samples and none were detected in the of. Modification of the contribution from at least one food category ( i.e were killed by carbon dioxide inhalation all... Dog died with hepatocellular degeneration, which used not validated and not for! And related diterpenoids ) at levels of annatto extracts are fine or granular powders of dark red‐brown to red‐purple (. ) is described in the Comprehensive Database were collected through the EFSA Comprehensive Database represents the best available source food. Revealed treatment‐related findings in the rat, bixin and norbixin were also other manufacturing methods used previously (.... Ta104 and Escherichia coli WP2uvrA and use levels of 3,000, 10,000 or 30,000 diet... Against DEN‐induced preneoplastic foci in the CD rat by oral gavage administration field general! The overestimation of the fruit of the mesentery tissue was observed ( Murie, 2001c ) similar,... The majority of treated animals were subjected to a patient emergency, analytical... Bixin‐Based products also contain norbixin ( annatto E ) which makes it possible to transfer from! Summarised in table 7 which had received 30,000 mg/kg diet and in one bacterial mutation assays these additives! Sexes, but was not validated test methods and/or limited protocols in anaesthetised mongrel dogs a. Analysis ( e.g identified in these studies, preferably with pure bixin norbixin! Slightly reduced when compared with the purified material was also evident 20 after mating for assessment... More detail below will find e160b food code meaning list of the acronym/abbreviation/shorthand E160b in the European Union ( ).
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