Scientific Opinion on the substantiation of a health claim related to riboflavin (vitamin B2) and contribution to normal energy‐yielding metabolism pursuant to Article 14 of Regulation (EC) No 1924/2006

Products, Efsa Panel on Dietetic

doi:10.2903/j.efsa.2013.3410

Cited by 2 publications

(1 citation statement)

References 6 publications

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“…The safety of riboflavin and consumer exposure to riboflavin were reviewed in previous opinions (EFSA NDA Panel, 2013 ; EFSA FEEDAP Panel, 2014 , 2016 ). The FEEDAP Panel concluded that the supplementation of feed with riboflavin would not be of concern for the consumers.…”

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 for all animal species (Kempex Holland B.V.)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2023

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) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 as a nutritional feed additive for all animal species. The additive is produced by a genetically modified production strain. Although the production strain harbours some genes coding for resistance to antimicrobials, viable cells and DNA of the production strain were not detected in the final product. Therefore, the use of B. subtilis CGMCC 13326 to produce vitamin B2 does not raise safety concerns. The use of riboflavin 80% produced by B. subtilis CGMCC 13326 in animal nutrition does not represent a safety concern for the target species, consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential skin and eye irritation or potential toxicity by inhalation of the additive under assessment. Riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The additive under assessment is effective in covering the animals' requirements of vitamin B2 when administered via feed.

show abstract

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 for all animal species (Kempex Holland B.V.)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2023

EFS2

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show abstract

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.

show abstract

Scientific Opinion on the substantiation of a health claim related to riboflavin (vitamin B2) and contribution to normal energy‐yielding metabolism pursuant to Article 14 of Regulation (EC) No 1924/2006

Cited by 2 publications

References 6 publications

Safety and efficacy of a feed additive consisting of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 for all animal species (Kempex Holland B.V.)

Safety and efficacy of a feed additive consisting of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 for all animal species (Kempex Holland B.V.)

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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