Scientific Opinion on the re‐evaluation of riboflavin (E 101(i)) and riboflavin‐5′‐phosphate sodium (E 101(ii)) as food additives

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doi:10.2903/j.efsa.2013.3357

Cited by 7 publications

(14 citation statements)

References 60 publications

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“…EFSA's ANS Panel (EFSA ANS Panel, 2013) concluded that it is not appropriate to allocate an ADI to riboflavin and riboflavin-5-phosphate sodium due to the absence of carcinogenicity/chronic toxicity studies and the lack of relevant reproductive and developmental toxicity studies.…”

Section: Assessment Of Consumer Safetymentioning

confidence: 99%

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Scientific Opinion on the safety and efficacy of vitamin B2 (80 %) as riboflavin produced by Bacillus subtilis for all animal species, based on a dossier submitted by VITAC EEIG

2014

EFS2

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The additive riboflavin (80 %) is produced by fermentation of a genetically modified Bacillus subtilis strain. Neither the production strain nor its recombinant DNA was detected in the final product. Therefore, the final product does not give rise to any safety concern with regard to the genetic modification. The additive is safe for the target animals with a wide margin of safety provided that the current use levels for riboflavin are not exceeded. Setting a maximum content for riboflavin in complete feed is not considered necessary. Toxicological studies with the additive under assessment show that it has a low toxicity. The use of the additive in animal nutrition will not significantly alter the riboflavin content of food of animal origin. The FEEDAP Panel considers that the use of the additive in animal nutrition is not of safety concern for consumers. The FEEDAP Panel considers that the additive is an irritant to skin, eyes and the respiratory tract. It is unlikely to cause skin sensitisation. Workers might be exposed to a respirable dust when handling riboflavin, which should be regarded as being potentially harmful to their health. The use of the additive in animal nutrition does not pose a risk to the environment. The additive is regarded as an effective source of riboflavin in covering the animal's requirement when administered orally.

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Section: Assessment Of Consumer Safetymentioning

confidence: 99%

“…The EFSA ANS Panel (EFSA ANS Panel, 2013) recently assessed the safety of riboflavin and estimated the intake of the population and certain population subgroups of riboflavin. The EFSA Comprehensive Database was used as a basis to estimate the intake of riboflavin resulting from its use as a food additive.…”

Section: Consumer Exposurementioning

confidence: 99%

Scientific Opinion on the safety and efficacy of vitamin B2 (80 %) as riboflavin produced by Bacillus subtilis for all animal species, based on a dossier submitted by VITAC EEIG

2014

EFS2

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“…Although relatively heat-stable, riboflavin is readily degraded by light in solutions (Section 2.2.2.1). Riboflavin (E 101(i)) and riboflavin 5 0 -phosphate sodium (E 101(ii)) are also used as food colours (EFSA ANS Panel, 2013).…”

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confidence: 99%

Dietary Reference Values for riboflavin

Products¹,

Turck²,

Bresson³

et al. 2017

EFS2

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Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) derives dietary reference values (DRVs) for riboflavin. The Panel considers that the inflection point in the urinary riboflavin excretion curve in relation to riboflavin intake reflects body saturation and can be used as a biomarker of adequate riboflavin status. The Panel also considers that erythrocyte glutathione reductase activation coefficient is a useful biomarker, but has limitations. For adults, the Panel considers that average requirements (ARs) and population reference intakes (PRIs) can be determined from the weighted mean of riboflavin intake associated with the inflection point in the urinary riboflavin excretion curve reported in four intervention studies. PRIs are derived for adults and children assuming a coefficient of variation of 10%, in the absence of information on the variability in the requirement and to account for the potential effect of physical activity and the methylenetetrahydrofolate reductase 677TT genotype. For adults, the AR and PRI are set at 1.3 and 1.6 mg/day. For infants aged 7-11 months, an adequate intake of 0.4 mg/day is set by upward extrapolation from the riboflavin intake of exclusively breastfed infants aged 0-6 months. For children, ARs are derived by downward extrapolation from the adult AR, applying allometric scaling and growth factors and considering differences in reference body weight. For children of both sexes aged 1-17 years, ARs range between 0.5 and 1.4 mg/day, and PRIs between 0.6 and 1.6 mg/day. For pregnant or lactating women, additional requirements are considered, to account for fetal uptake and riboflavin accretion in the placenta during pregnancy or the losses through breast milk, and PRIs of 1.9 and 2.0 mg/day, respectively, are derived.

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“…The EFSA ANS Panel assessed the safety of riboflavin and riboflavin 5 0 -phosphate of different origin (EFSA ANS Panel, 2013) and concluded that riboflavin 'per se' has a low toxicity. This conclusion also applies to riboflavin 5 0 -phosphate.…”

Section: Toxicological Studiesmentioning

confidence: 99%

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Additives¹,

Bampidis²,

Azimonti³

et al. 2018

EFS2

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Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B 2 in the form of riboflavin 5 0 -phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and characterisation of the production strain, and on whether or not it is a genetically modified microorganism. Therefore, in the absence of adequate information, it is not possible to perform an assessment of the safety of the production strain. Riboflavin 5 0 -phosphate ester monosodium salt 'per se' is considered safe for the target animals, consumers and the environment. In the absence of data regarding the identity and characterisation of the production strain, the FEEDAP Panel cannot conclude on the safety for the target species, consumers, users and the environment of the riboflavin 5 0 -phosphate ester monosodium salt under assessment. Similarly, in the absence of data, no conclusion can be reached on the safety of the product for the users. Riboflavin 5 0 -phosphate ester monosodium salt is regarded as effective in covering the animal's requirement when administered via water for drinking. and Tarres-Call J, 2018. Safety and efficacy of vitamin B 2 (riboflavin 5 0 -phosphate ester monosodium salt) for all animal species when used in water for drinking. EFSA Journal 2018;16(12):5531, 15 pp. https://doi.org/10.

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Scientific Opinion on the re‐evaluation of riboflavin (E 101(i)) and riboflavin‐5′‐phosphate sodium (E 101(ii)) as food additives

Cited by 7 publications

References 60 publications

Scientific Opinion on the safety and efficacy of vitamin B2 (80 %) as riboflavin produced by Bacillus subtilis for all animal species, based on a dossier submitted by VITAC EEIG

Scientific Opinion on the safety and efficacy of vitamin B2 (80 %) as riboflavin produced by Bacillus subtilis for all animal species, based on a dossier submitted by VITAC EEIG

Dietary Reference Values for riboflavin

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

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