It was early 2018 when EFSA published their Scientific Opinion on the Safety of vitamin B2 (80%) as riboflavin produced by Bacillus subtilis KCCM-10445 for all animal species.[1] In it they concluded that the additive poses a risk for the target species, users and the environment due to the potential for the spread of viable cells and DNA of genetically modified (GM) strain-harbouring genes coding for resistance to anti-microbials of human and veterinary importance. This was after analytical testing of reference samples of the additive resulted in viable cells and/or DNA from the production strain being present.

As a consequence, this led to the denial of authorisation and withdrawal from the market of  riboflavin (80%) produced by Bacillus subtilis KCCM-10445.[2] This legislative document also outlined the short withdrawal periods as follows:

1. Existing stocks of the additive referred to in Article 1 shall be withdrawn from the market by 10 November 2018.

2. Existing stocks of premixtures produced with the additive referred to in paragraph 1 shall be withdrawn from the market by 10 January 2019.

3. Feed materials and compound feed intended for food-producing animals, which have been produced with the additive referred to in paragraph 1 or with premixtures referred to in paragraph 2 before 10 January 2019 shall be withdrawn from the market by 10 April 2019. 20.9.2018 L 237/7 Official Journal of the European Union EN.

4. Feed materials and compound feed intended for non-food producing animals, which have been produced with the additive referred to in paragraph 1 or with premixtures referred to in paragraph 2 before 10 January 2019 shall be withdrawn from the market by 10 July 2019.

It is important to note that Premier Nutrition was not implicated in any recall and/or withdrawal of this additive.

Following on from the denial of authorisation of  riboflavin (80%) produced by Bacillus subtilis KCCM-10445, in May 2019 vitamin B2 authorisations were voted on by SCoPAFF which has led to the publication of Commission Implementing Regulation (EU) 2019/901.[3]

In it, there are two key points to note from the publication of this legislation

1. Only GM versions of the additive have approval. There is now no non-GM version authorised and available for use

2. There are now two registration numbers to identify the GM organism used in the production of the additive as follows, both of which are approved and used interchangeably here at Premier Nutrition:

     3a825i Riboflavin produced by Ashbya gossypii DSM 23096

     3a825ii Riboflavin produced by Bacillus subtilis DSM 17339 and/or DSM 23984

DSM - Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH – the German collection of microorganisms and cell cultures

This is important to note and take action on should you, in the rare instance, declare vitamin B2 additive declarations on pack and declare by stating their authorisation number.

Additionally, there is also the authorisation of 3a826 which refers to Riboflavin 5’-phosphate monosodium salt, which must be produced from phosphorylation of riboflavin 95% produced by Bacillus subtilis DSM 17339 and /or DSM 23984.

Transitional measures have been specified as follows:

1. The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 23 June 2019 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until 23 December 2019.

2. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 23 June 2020 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 23 June 2021 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Legislative Documents:

[1] EFSA Journal 2018;16(3):5223; https://www.efsa.europa.eu/en/efsajournal/pub/5223

[2] Commission Implementing Regulation (EU) 2018/1254 of 19 September 2018 concerning the denial of authorisation of riboflavin (80%) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group of vitamins, pro-vitamins and chemically well-defined substances having similar effect; https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R1254&from=EN)

[3] Commission Implementing Regulation (EU) 2019/901 of 29 May 2019 concerning the authorisation of riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) (sources of vitamin B2) as feed additives for all animal species; https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0901&from=GA).

As with all things legislative, it can be complex to navigate. That’s why here at Premier Nutrition your Pet Nutrition Account Manager is always at hand to assist with any queries or concerns you may have. For further information, advice and guidance on this article please contact your Pet Nutrition Account Manager (contact details below), or, alternatively, please e-mail info@premiernutrition.co.uk

Andrew Miller                Andrew.Miller@premiernutrition.co.uk         +44(0)7969 246642

Sara Rowley                  Sara.Rowley@premiernutrition.co.uk            +44(0)7786 436712

Cara Freeston-Smith   Cara@premiernutrition.co.uk                        +39 345 892 3860

Graham Yeo                  Graham.Yeo@premiernutrition.co.uk            +44(0)7753 796215

Ruth Bishop                   Ruth.Bishop@premiernutrition.co.uk             +44(0)7711 171105

Clare McCafferty         Clare.McCafferty@premiernutrition.co.uk    +44(0)7525 141059