The exposure per food category was subsequently added to derive an individual total exposure per day. No mortalities or clinical signs of toxicity were observed. It contains information on over 2 million food and beverage products, of which more than 800,000 are or have been available in the European food market. Control animals received diet alone, and positive controls received the enzyme‐inducing agent, 3‐methylcholanthrene. The very small difference in mean plasma peak concentrations (Cmax) and area under curve (AUC) of cis‐bixin between the 100 and 1,000 mg/kg bw dose levels also suggested non‐linear kinetics of bixin‐based annatto extracts. The Panel agreed with the authors that this finding was related to the treatment‐induced increase in the metabolic activity of the liver and, hence, increased metabolism of thyroid hormones. After dosing with the norbixin‐based extract Annatto F at 100 and 1,000 mg/kg bw, there were quantifiable amounts of 9′‐cis‐norbixin in urine, but these accounted for less than 3% of the dose. The authors suggested that the findings show that annatto extract was not toxic in the rat. In a subsequent study, Morrison et al. When treatment was continued in two further generations for 7 and 8.5 months, there was no adverse effect on growth or reproduction, and no teratogenic effects, or effects on mortality or tumour incidence were seen (Van Esch et al., 1959). 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. 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. 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. Bixin‐based products also contain norbixin (JECFA, 2004a). This may have resulted in an overestimation of the exposure: For the proposed extension of use (15 categories for bixin and seven for norbixin), all the food categories proposed either for bixin or norbixin were taken into account in the respective scenarios. Thus, according to the EFSA Scientific Committee guidance criteria on genotoxicity testing strategies (EFSA, 2011c), the available in vivo studies were considered not sufficient to rule out a genotoxic concern. The caecal preparation completely decolourised the annatto extract. The Commission asks EFSA to re‐evaluate the safety of food additives already permitted in the Union before 2009 and to issue scientific opinions on these additives, taking especially into account the priorities, procedures and deadlines that are enshrined in the Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re‐evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. E numbers are codes for substances that can be used as food additives for use within the European Union and Switzerland. 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. Solvent‐extracted norbixin (Annatto C) is obtained from the outer coating of the seeds of the annatto tree with one or more of the following food grade solvents: acetone, alkaline alcohol, ethanol, ethyl acetate, hexane, methanol, isopropyl alcohol or supercritical carbon dioxide. The auto repair labor rates vary widely across the country, and even within the same city. The SCF has previously evaluated the annatto extracts, the last time, in 1979 when the SCF allocated an acceptable daily intake (ADI) of 2.5 mg/kg body weight (bw) for an annatto extract (containing 2.6% carotenoid expressed as bixin) equivalent to 0–0.065 mg/kg bw for carotenoids of annatto expressed as bixin. 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. The Panel noted that the material tested was considered not representative of the annatto extracts used as food additive. The amount of seeds not used as a food colour source is consumed locally, mainly for seasoning (Smith and Wallin, 2006). The product names and International Numbering System (INS) numbers used in this table were adopted by the Codex Alimentarius Commission (CAC. Learn more. No effects on nutrients have been reported. 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. 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. The solvent‐extracted bixin (Annatto B) induced structural chromosomal aberrations in the presence of S9 mix at concentrations of 75 and 100 μg/mL and in the absence of S9 mix (48 h harvest) at 15 and 30 μg/mL. 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. Most computers use ASCII codes to represent text, which makes it possible to transfer data from one computer to another. The solvent‐extracted bixin (Annatto B) was not mutagenic in mouse lymphoma L5178Y cells. For Groups 3 and 4, which both received 40,000 mg/kg diet during week 4, mean group achieved dosages were 3,339 and 4,570 mg/kg bw per day for males, and 3,234 and 4,526 mg/kg bw per day for females, respectively. In subsequent studies provided by the applicant, four annatto extracts, representing four (Annatto B, E, F and C) of the extracts evaluated in the present opinion, were subjected to a 90‐day repeated dose toxicity testing. provided to EFSA n.3), several systematic reviews on annatto have been published (Lim, 2012; Ulbricht et al., 2012; Vilar et al., 2014). Likewise, R10 was metabolised more slowly than WSA. Based on the manufacturing processes described for bixin‐based and norbixin‐based annatto extracts (Figure 2), the following read‐across approaches were proposed by the applicant (NATCOL, 2015). 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. 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. 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. Considering that the raw material for the preparations described by Iversen and Lam (1953) and Diemair and Zacharias (1951) was the annatto seed (i.e. The administration of all four test materials to rats for 13 weeks did not result in any treatment‐related deaths, and the general condition and behaviour of the animals were not affected by treatment. Absorption of annatto pigments in human volunteers was reported by Levy et al. Under this assumption, the applicant concluded that the findings of the developmental toxicity study with the aqueous‐processed bixin (Annatto E) performed by Paumgartten et al. There was no increase in embryolethality and no reduction in fetal or placental weight. The two carboxyl groups of norbixin render the molecule water‐soluble. Blood samples were taken 2, 4, 6, 8, 24 and 48 h after ingestion. Some toxicological effects were observed. E160c. non‐compliance controls). The study design included a vehicle control (three male rats) and a positive control group (three male rats) that received 150 mg/kg ethylmethanesulfonate in a single oral administration at 21 h (day 2). 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 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. For these population groups, food consumption data were available from 33 different dietary surveys carried out in 19 European countries (Table 8). Table 2 presents the annatto extracts evaluated in the present opinion. 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). 0 h + 24 h oral dosing and 48 h sampling, Primary mutagenicity screening of food additives currently used in Japan, Über den Farbstoff in Annatto‐Butterfarben, Toxicological evaluation of some food colours, enzymes, flavour enhancers, thickening agents, and certain food additives, Toxicological evaluation of certain food additives. Given: (a) that read‐across among the five bixin‐ and norbixin‐based annatto extracts was feasible; (b) the availability of adequate 90‐day toxicity studies with Annatto B, C, E and F; (c) the absence of concern for mutagenicity, carcinogenicity, reproductive and developmental toxicity of Annatto B, C, F and G, whereas the mutagenicity of Annatto E is equivocal, the Panel concluded that the safety of the currently authorised solvent‐extracted bixin and norbixin (E 160b(i)), alkali‐extracted annatto (E 160b(ii)) and oil‐extracted annatto (E 160b(iii)), with the specifications defined in Commission Regulation (EU) No 231/2012, could not be assessed due to the lack of data, both in terms of identification and toxicological studies; 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 and its norbixin salts) should comply with the specifications as recommended by the Panel. The aqueous solution is filtered and acidified to precipitate the norbixin. Lycopene. ,1414 In the non‐brand‐loyal scenario, mean exposure ranged from 0.003 mg/kg bw per day for infants to 0.18 mg/kg bw per day for toddlers. Decreased overall body weight gains were noted for males receiving 30,000 mg Annatto E/kg diet and in females receiving 30,000 and 10,000 mg Annatto E/kg diet. The annatto extract (Annatto F) did not induce any increase in the incidence of externally visible, visceral or skeletal abnormalities in the exposed offspring at doses up to 160 mg/kg bw per day. A two‐ and three‐generation study in rats has been reported as part of long‐term toxicological investigations (Van Esch et al., 1959). However, for practical purposes, annatto principles appear to be sufficiently stable under the common conditions of food storage and use (Levy and Rivadeneira, 2000; Scotter, 2009; Balaswamy et al., 2012; Gallardo‐Cabrera and Rojas‐Barahona, 2015). Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. The Panel noted that complete information on the methods of analysis (e.g. 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. In particular, oxidation can be exacerbated by the presence of light and heat, especially above 70°C. In contrast to the positive control, Annatto C did not significantly increase the quantitative values for GST placental form positive liver cell foci observed after DEN initiation. By considering the plasma levels of bixin and norbixin obtained in this study at different times before and after the oral administration, the Panel considered that these two compounds are absorbed in humans. When compared with the controls, reduced food intake was seen in all treated groups throughout, but most markedly in the first week of the study. Likewise, the specifications for residual solvents (applicable to solvent‐extracted bixin and norbixin only, i.e. The amphoteric nature of norbixin makes it suitable in products where the pigment is absorbed by protein and/or starch, stabilising it thereby and making it less soluble in water. NATCOL (Natural Food Colours Association), 2008. This ADI applied to both bixin‐ and norbixin‐rich extracts, which were described in the specifications prepared at the 26th meeting of JECFA defining ‘Annatto extracts’ as either annatto extracts in oil (containing mainly bixin) or water‐soluble annatto extracts (containing mainly norbixin). The potential of Annatto B, E and F to induce DNA damage in the liver and stomach of rats was tested in the alkaline comet assay (Beevers, 2015a: Annatto B; Beevers, 2015c: Annatto E; Beevers, 2015b and Kobbelgaard, 2015: Annatto F). Five groups of five male and five female Crl:CD BR rats were used. Mean group achieved dosages during the fourth week for Group 2 receiving 30,000 mg/kg diet were 2,872 mg/kg bw per day for males and 2,886 mg/kg bw per day for females. It represents FDA's best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. Origin of the extract line with the alkali‐processed, acid‐precipitated norbixin ( annatto C ) tested negative ’... A short‐term toxicity study in rats has been reported as part of risk management ( e.g Maintenance diet ) above. To 0.32 % of the organs examined in foods of production of food additive and! Placental weight OSB ( 7 mg/kg ) produced a sustained hyperglycaemia similar to the proposed levels... Between $ 75 and $ 150 per hour 0.003 mg/kg bw per day for.. Either with or without metabolic activation females and group 3 males concentration data food! Foreseen that food additives permitted in the treated groups were not significantly different from that of.. 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