NATCOL's application covers the five annatto extracts for which JECFA has established full ADIs: (i) aqueous‐processed annatto extracts, bixin‐based, (ii) solvent‐processed annatto extracts, bixin‐based, (iii) alkali‐processed, acid‐precipitated annatto extracts, norbixin‐based, (iv) alkali‐processed, not acid‐precipitated annatto extracts, norbixin‐based and (v) solvent‐processed annatto extracts, norbixin‐based. non‐compliance controls). Mean recoveries obtained from spiked food samples of 12 different food matrices spiked with annatto at levels up to 27.7 mg/kg and ranged from 61% to 96%; the LOQ was reported to be 0.1 mg/kg (LOD, 0.01 mg/kg). Full histopathological examination of all tissues was carried out on all animals of Groups 1 and 4 and of the skin and liver of all other groups, and all abnormal appearing tissues observed at necropsy. 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). Some toxicological effects were observed. Industry provided EFSA with data on use levels (n = 99) of E 160b in foods for all 22 food categories in which it is authorised. Within the food colour legislation of the EU (Commission Regulation (EU) No 231/201244 The dietary management of food allergy and food intolerance in children and adults. : (i) solvent‐extracted bixin and norbixin; (ii) alkali‐extracted annatto; and (iii) oil‐extracted annatto. The only exceedance observed for norbixin was in the brand‐loyal scenario at the 95th percentile for infants (in one country), toddlers (in three countries) and children (in one country). Sodium and potassium salts of annatto extract (i.e. JECFA agreed at its 46th meeting (JECFA, 1997) to revise the specifications for annatto extracts and split them according to the methods of manufacturing into two: one to cover oil‐ and alkali‐extracted products, the other to cover solvent‐extracted products. It is noted that the predetermined limit of 5,000 μg/plate exceeded the limits of solubility in agar medium for all extracts. This was considered to be a direct effect of the highly coloured diets. These were due to the intense colour of the annatto extract. To assess the dietary exposure to annatto (E 160b) from its use as a food additive, the exposure was calculated based on (1) maximum permitted levels (MPL) set out in the European Union (EU) legislation (defined as the regulatory maximum level exposure assessment scenario); (2) the reported use levels (defined as the refined exposure assessment scenario); and (3) use levels proposed by the applicant for the extension of use (defined as extension of use scenario). The Panel considered that in the absence of measurement of volume of distribution and of biliary excretion of both compounds, the absorption cannot be adequately determined. For solvent‐extracted products, higher minimum carotenoid content (75% for bixin‐rich extracts and 25% for norbixin rich extracts) was requested, whereas, for the other products, the minimum limit of 0.2% was replaced by ‘as stated by the vendor’. For the purpose of this Scientific Opinion, the GNPD1111 Liquid‐solid extraction was carried out using acetonitrile, while quantification was achieved by HPLC‐PDA, using two wavelengths (458 and 486 nm). The patient's serum immunoglobulin E (IgE) recognised a 50‐kDa protein in the annatto extract, considered by the authors to be a contaminant from the pericarp of the seed in the preparation of the annatto extract. The code indicates an ingredient which is some type of food additive. In a subsequent study, Morrison et al. At necropsy on day 29, no lesions were observed, but, in the kidneys of two out of the 10 treated female rats examined, apoptosis occurred in restricted areas without proliferation or tubular segments modification. Therefore, these studies were considered not relevant for the present safety assessment of annatto extracts. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. No annatto pigments were detected in the urine samples and none were detected in faeces samples collected the next day. Further evidence of an effect on hepatic metabolism was seen in the increased alkaline phosphatase and ALT activities recorded in males receiving 9,000 mg/kg diet, together with the increased glucose and triglyceride concentrations seen in animals receiving 9,000 mg/kg diet, and the changes in plasma proteins, noted in animals receiving 3,000 or 9,000 mg/kg diet. It was concluded that Annatto E did not clearly induce DNA damage in the liver or stomach of rats treated with up to 2,000 mg Annatto E/kg per day. Plasma concentrations of 9′‐cis‐norbixin were higher than 9′‐cis‐bixin after administration of all the three annatto extracts, although the bixin‐based extracts contained more than 90% 9′‐cis‐bixin. The samples differed significantly in their all‐trans‐ and di‐cis‐norbixin isomer contents, which was indicative of their respective production histories. provided to EFSA n. 3). Administration of the test material to CD rats for 13 weeks at dietary concentrations of 5,000, 16,000 and 50,000 mg/kg diet was well tolerated. A marginal effect was seen in the kidney, with raised protein concentrations noted in urine samples obtained from males receiving 50,000 mg Annatto B/kg diet. Based on validation data, the HPLC method proposed appeared to have a good reliability for the simultaneous analysis of phenolic compounds and carotenoids in annatto seeds. No toxicity was detected by plasma chemistry. (2002). Due to their different chemical and toxicological properties, commercially available annatto extracts are categorised as either bixin‐ or norbixin‐based (CAC, 2007; JECFA, 2007). (1959), no adverse effect on reproduction or development were to be expected from the five annatto extracts described in the present opinion, which all show higher concentrations of bixin or norbixin. However, the maximum limits for the impurities of toxic elements (arsenic, lead, mercury) should be revised in order to ascertain that the annatto extracts as food additives will not be a significant source of exposure to these toxic elements in foods. The structural difference between bixin and norbixin – namely, an esterified carboxyl group – leads to appreciable differences in the physicochemical properties of the two molecules. In these studies, the oral administration of Annatto B, E and F up to the maximum recommended dose did not induce any detectable genetic damage in mouse bone marrow, in which, however, no evidence of exposure was obtained; clearly negative results were, however, also obtained with comet assays in rat stomach and, for Annatto B and F, in rat liver. Scientific Opinion on genotoxicity testing strategies applicable to food and feed safety assessment, Conclusion on the peer review of the pesticide risk assessment of the active substance geraniol, Scientific opinion on the risk for public health related to the presence of mercury and methylmercury in food. The Panel calculated two refined exposure estimates based on different assumptions: a brand‐loyal consumer scenario, where it is assumed that the population is exposed over a long period of time to the food additive present at the maximum reported use levels for one food category and to the mean reported use levels for the remaining food categories; and a non‐brand‐loyal scenario, where it is assumed that the population is exposed over a long period of time to the food additive present at the mean reported use levels in all relevant food categories. The Panel considered these kidney effects adverse and concluded that the no‐observed‐adverse‐effect level (NOAEL) in this study is the dietary concentration of 16,000 mg Annatto B/kg diet (equivalent to 1,311 mg Annatto B/kg bw per day, or 1,206 mg bixin/kg bw per day in males, and to 1,446 mg Annatto B/kg bw per day or 1,330 mg bixin/kg bw per day in females). Artificial food additives numbers and codes, their list can be printed out. Annatto is the name of the crude extract, whereas bixin is the fat-soluble colour and norbixin the water-soluble colour. The solvent‐extracted norbixin (Annatto C) was tested separately in one bacterial mutation assay. In total, 377 analytical results were reported to EFSA by 3 countries: the Czech Republic (n = 14), Germany (n = 317) and Ireland (n = 46). Annatto can cause allergies and eczema. A 28‐day range‐finding study (non‐GLP) is described in HLS Report ATE012 (HLS, 2001a). Processing methods may be aimed at the production of the native bixin from the seeds, which requires a neutral liquid such as water or organic solvents, or may involve aqueous alkaline hydrolysis with the simultaneous production of norbixin. Daily intake: The exposure per food category was subsequently added to derive an individual total exposure per day. OJ L 83, 22.3.2012, p. 1. Studies have been reported in the literature in the mouse, rat and dog, and the results for all the three species were discussed in previous evaluations of the SCF and JECFA. Plasma creatinine concentrations were increased in animals receiving 3,000 or 9,000 mg/kg diet, and urea concentrations were increased in males receiving 9,000 mg/kg diet and in treated females. The main food categories contributing to the total mean exposure to bixin from the currently authorised uses in the brand‐loyal scenario were fats and oils and flavoured fermented milk products for infants, toddlers, children, flavoured fermented milk products and ripened cheese for adolescents, and fats and oils and ripened cheese for adults and the elderly. If you do not receive an email within 10 minutes, your email address may not be registered, Overall, based on the available experimental data, the Panel concluded that Annatto B and F do not raise concern for genotoxicity, whereas for Annatto E an additional in vivo study is needed to clarify the genotoxic potential in rat liver. 75120; C.I. A 28‐day range‐finding study (non‐GLP) is described in HLS Report ATE013 (HLS, 2001b). 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. 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). Extracts contain mainly the potassium or sodium salt of norbixin, as the major colouring matter. Lancaster and Lawrence (1995) determined annatto pigments – (bixin and norbixin) – in high‐fat dairy products (cheese and butter), margarine and hard candy by solvent extraction followed by HPLC and spectrophotometric determination at 500 nm. As colours were among the first additives to be evaluated, these food additives should be re‐evaluated with the highest priority. 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). Additionally, analytical results from the Member States were collected through the EFSA call for concentration data. –77 Call for scientific data on selected food additives permitted in the EU. Norbixin was the major component present in plasma and urine, even following oral administration of bixin‐based extracts, most likely derived from both the norbixin present in the extract, as well as metabolism of bixin to norbixin. For the analysis of several samples of extruded corn snack food, De Oliveira and Mercadante (2004) described a method involving enzymatic digestion with α‐amylase at room temperature of the ground sample (pretreatment), followed by multiple extractions of the aqueous phase with ethyl acetate. The Panel recommended that the alkali‐extracted annatto (E 160b(ii)), the oil‐extracted annatto (E 160b(iii)) and the solvent‐extracted bixin and norbixin (E 160b(i)), currently authorised in the EU, should be replaced by the solvent‐extracted bixin (Annatto B); solvent‐extracted norbixin (Annatto C); alkali‐processed, acid‐precipitated norbixin (Annatto F) and alkali‐processed, not acid‐precipitated norbixin (Annatto G). –77 Call for scientific data on selected food additives permitted in the EU. For norbixin, a group ADI that included also salts of norbixin was adopted. and you may need to create a new Wiley Online Library account. These products will become yellow or orange yellow when reconstituted (Doc. No adverse effects on mortality, growth or reproduction were seen. Published 23 March 2014. CAS: Chemical Abstracts Service; EINECS: European Inventory of Existing Commercial chemical Substances. E160b. 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 norbixin, mean exposure ranged from 0.002 mg/kg bw per day in infants and the elderly to 0.11 mg/kg bw per day in toddlers. Annatto seeds and extracts have been used for over 200 years in Europe and North America to impart a yellow to red colour to foods, especially dairy products, such as cheese (Doc. Since the test material contained 92% bixin, these achieved doses corresponded to 374, 1,206 and 3,865 mg bixin/kg bw per day in males, and 413, 1,330 and 4,146 mg bixin/kg bw per day in females. E160e No adverse effects of the annatto extract on the dams were noted, there was no increase in embryolethality and no reduction in fetal body weight. In an in vivo comet assay, no increase in DNA breakage was detected in the liver and kidney of mice treated with an annatto extract containing 50% norbixin (56 and 351 mg annatto extract/kg bw per day) or purified norbixin (0.8, 7.6, 66 and 274 mg norbixin/kg bw per day) in drinking water for 21 days (Fernandes et al., 2002). A 28‐day range‐finding study (non‐good laboratory practice (GLP)) is described in HLS Report ATE010 (HLS, 2000). JECFA requested data on the non‐colouring fraction of the oil‐processed bixin extract by the end of 2008. Based on the origin of the annatto extracts (i.e. One treated female dog died with hepatocellular degeneration, which was thought to be due to an intercurrent infection. Adult females were examined macroscopically at necropsy on day 20 after mating, the uterus and contents weighed, corpora lutea counted, and living and dead fetuses and resorptions were recorded. Side effects: The purities of the samples tested were not stated. In addition, solvent processing techniques are used as a means of production of more concentrated extracts. Color- Carotene. Rats received Annatto E by dietary administration at levels of 3,000, 10,000 or 30,000 mg/kg diet for 13 weeks. The 95th percentile exposure ranged from 0.01 mg/kg bw per day in infants, children, adolescents, adults and the elderly to 0.26 mg/kg bw per day in toddlers. The latter and the subsequent implications for its use in the colouring of foods, food processing, and the analysis of foods and beverages were discussed, along with important mechanistic, thermodynamic and kinetic aspects. For these population groups, food consumption data were available from 33 different dietary surveys carried out in 19 European countries (Table 8). provided to EFSA n. 3). (2002) are not only applicable to the solvent‐extracted bixin (Annatto B), but also to the solvent‐extracted norbixin (Annatto C). 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