Scientific Opinion on the re‐evaluation of mixed carotenes (E 160a (i)) and beta‐carotene (E 160a (ii)) as a food additive

,

doi:10.2903/j.efsa.2012.2593

Cited by 44 publications

(17 citation statements)

References 114 publications

(263 reference statements)

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“…There is similarly no evidence that conversion of β-carotene to vitamin A contributes to vitamin A toxicity, even when β-carotene is ingested in large amounts. Standard toxicological tests, including teratogenic, mutagenic, and carcinogenic assays, have been performed on β-carotene without any evidence of harmful effects, as reviewed in ref (47).…”

Section: Results and Discussionmentioning

confidence: 99%

Compositional Analysis of Genetically Engineered GR2E “Golden Rice” in Comparison to That of Conventional Rice

Swamy

Samia

Boncodin

et al. 2019

J. Agric. Food Chem.

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Compositional analyses were performed on samples of rice grain, straw, and derived bran obtained from golden rice event GR2E and near-isogenic control PSBRc82 rice grown at four locations in the Philippines during 2015 and 2016. Grain samples were analyzed for key nutritional components, including proximates, fiber, polysaccharides, fatty acids, amino acids, minerals, vitamins, and antinutrients. Samples of straw and bran were analyzed for proximates and minerals. The only biologically meaningful difference between GR2E and control rice was in levels of β-carotene and other provitamin A carotenoids in the grain. Except for β-carotene and related carotenoids, the compositional parameters of GR2E rice were within the range of natural variability of those components in conventional rice varieties with a history of safe consumption. Mean provitamin A concentrations in milled rice of GR2E can contribute up to 89–113% and 57–99% of the estimated average requirement for vitamin A for preschool children in Bangladesh and the Philippines, respectively.

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Section: Results and Discussionmentioning

confidence: 99%

Compositional Analysis of Genetically Engineered GR2E “Golden Rice” in Comparison to That of Conventional Rice

Swamy

Samia

Boncodin

et al. 2019

J. Agric. Food Chem.

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“…Nowadays, the exposure to these compounds is extensive and widespread in the food industry, especially through use of carrot, tomato and sweet potato powders. The estimated range of exposure to natural OxBC (1-22 mg per serving) is comparable to the level of safe intake of β-carotene (<15 mg/d) that results from the regular consumption of the foods in which β-carotene occurs naturally (5-10 mg/d), in addition to food additives and food supplements (European Food Safety Authority, 2012a). Consumption of common tomato-based products results in exposure to even higher levels of natural oxidized carotenoids (Burton et al, 2016).…”

Section: Discussionmentioning

confidence: 96%

“…Notably, several longer chain β-apocarotenoid cleavage products were identified as possible toxicity candidates in both types of simulated oxidized β-carotene product mixtures (Alija et al, 2005; Alija et al, 2004; Eroglu et al, 2012; Kalariya et al, 2009; Marques et al, 2004; Yeh and Wu, 2006). The physiological relevance of these in vitro studies has been questioned in a review in 2012 of the safety of β-carotene by an EFSA Panel (European Food Safety Authority, 2012a).…”

Section: Introductionmentioning

confidence: 99%

β-Carotene oxidation products - function and safety

Burton¹,

Mogg²,

Riley

et al. 2021

Preprint

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Abstractβ-Carotene oxidation products have newly discovered bioactivity in plants and animals. Synthetic fully oxidized β-carotene (OxBC) has application in supporting livestock health, with potential human applications. The safety of synthetic OxBC has been evaluated. An Ames test showed weak-to-moderate mutagenicity in only one cell line at high concentrations. A mouse micronucleus assay established a non-toxic dose of 1800 mg/kg body weight, and no bone marrow micronuclei were induced. Plant sources of β-carotene inevitably contain varying levels of natural OxBC. Vegetable powders and dried forages can be especially rich. Intakes of natural OxBC for humans and livestock alike have been estimated. The exposure range for humans (1-22 mg/serving) is comparable to the safe intake of β-carotene (<15 mg/d). In livestock, OxBC in alfalfa can contribute ~550-850 mg/head/d for dairy cattle but in forage-deficient poultry feed much less (~1 ppm). Livestock intake of supplemental synthetic OxBC is comparable to OxBC potentially available from traditional plant sources. Human intake of synthetic OxBC in meat from livestock fed OxBC is similar to a single serving of food made with carrot powder. It is concluded that consumption of synthetic OxBC at levels comparable to natural OxBC is safe for humans and animals.

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“…The safety of mixed carotenes and β-carotene was re-evaluated by the European Food Safety Authority (EFSA) in 2012 (EFSA ANS Panel, 2012a). EFSA concluded that the use of (synthetic) β-carotene and mixed β-carotenes obtained from palm fruit oil, carrots and algae as food colour is not of safety concern, provided the intake from this use as a food additive and as food supplement is not more than the amount likely to be ingested from the regular consumption of the foods in which they occur naturally (5-10 mg/day).…”

Section: Discussionmentioning

confidence: 99%

Safety of the proposed extension of use of acesulfame K (E 950) in foods for special medical purposes in young children

2016

EFS2

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Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion regarding the safety of the extension of use of the food additive acesulfame K (E 950) when added to dietary food for special medical purpose (FSMP) intended for young children aged 1-3 years. Acesulfame K was re-evaluated by the European Union (EU) Scientific Committee on Food (SCF) in 2000 who confirmed an acceptable daily intake (ADI) of 9 mg/kg body weight (bw). Acesulfame K is authorised in the EU for food use with exception for foods for young children. According to the applicant, the use of sweeteners is required to ensure palatable foods for the dietary management of patients whose compliance with the dietary regime (prescribed by healthcare professionals) is a key factor to their health. The exposure scenarios based on the proposed use by the applicant (4.1 or 5.9 mg acesulfame K/g protein) on the FSMPs and as specified in the mandate (9 mg acesulfame K/g protein, corresponding to 450 mg/kg (L)) indicated that if the daily protein intake (3 g protein/kg bw) is exclusively provided by the sweetened powdered product, the ADI would be exceeded. When the protein intake from the product is limited to either 10 or 20 g of protein/child at the concentration of 5.9 mg acesulfame K/g of protein, the ADI was exceeded in the 1 and 2 year age groups following consumption of 20 g protein/day. Considering the concentration of acesulfame K of 9 mg/kg day, only the 10 g protein scenario was below or close to the ADI. The ANS Panel concluded that the proposed extension of use of acesulfame K (E 950) at the level up to 9 mg/g protein while providing 10 g protein/day to 1-to 3-year-old children would not be of safety concern. © European Food Safety Authority, 2016Keywords: food additive, sweetener, acesulfame K, E 950, extension of use, FSMP, children

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Scientific Opinion on the re‐evaluation of mixed carotenes (E 160a (i)) and beta‐carotene (E 160a (ii)) as a food additive

Cited by 44 publications

References 114 publications

Compositional Analysis of Genetically Engineered GR2E “Golden Rice” in Comparison to That of Conventional Rice

Compositional Analysis of Genetically Engineered GR2E “Golden Rice” in Comparison to That of Conventional Rice

β-Carotene oxidation products - function and safety

Safety of the proposed extension of use of acesulfame K (E 950) in foods for special medical purposes in young children

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