COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1254 
of 19 September 2018 
concer ning the denial of author isation of ribof lavin (80 %) produced by Bacillus subtilis 
KCCM-10445 as a feed additiv e belonging to the functional group of vitamins, pro-vitamins and 
chemically well-def ined subst ances having similar effect 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting or deny ing such author isation. Article 10 of that Regulation provid es for 
the re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). 
(2)  Ribof lavin (vitamin B2) was author ised without a time limit by Directive 70/524/EEC as a feed additive belonging 
to the group of vitamins, pro-vitamins and chemically well-def ined substances having similar effect, for all animal 
species. That product was subsequently entered in the Register of feed additives as an existing product, in 
accordance with Article 10(1) of Regulation (EC) No 1831/2003. 
(3)  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitte d for the author isation of ribof lavin, with a purity of minimum 80 %, produced by the 
genetically modifi ed strain Bacillus subtilis KCCM-10445, as a feed additive for all animal species. The applicant 
request ed that the additive be classified in the additive cate gory ‘nutr itional additives ’. That application was 
accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
(4)  In 2010, in accordance with Article 7(3)(f) of Regulation (EC) No 1831/2003 and Article 3 of Commission 
Regulation (EC) No 378/2005 (3), the applicant sent samples of the feed additive, in a form in whic h the feed 
additive was intended to be placed on the market, to the Reference Laborator y under Regulation (EC) 
No 1831/2003 (‘the Reference Laboratory’). In 2013, in accordance with Article 3(3) of Regulation (EC) 
No 378/2005, the applicant supplied the Reference Laboratory with new samples to replace those expired. 
(5)  The European Food Safety Authority (‘the Author ity’) concluded in its opinion of 4 December 2013 (4) that 
neither the production strain nor its recombinant DNA (‘rDNA ’) was detect ed in the final product having regard 
to the information provi ded by the applicant and that theref ore, the final product did not raise any safety 
concer n with rega rd to the genetic modific ation of the production strain. It was also concluded that the additive 
did not have an adverse effect on animal health, human health or the environment. 
(6)  Howe ver, the Commission was informed by the Reference Laboratory that, in the context of an official control 
performed by a national compet ent author ity, the presence of viable cells and of rDNA from the production 
strain was detected in some reference samples of the additive by a national laborat ory compet ent for official 
controls. Those referen ce sam ples consisted of a first set submitted to the Reference Laboratory in 2010 together 
with the application for author isation and an updat ed set submitte d to the Reference Laboratory in 2013. Such 
detection result ed from the use of a polymerase chain reaction (‘PCR’) analysis method developed by a national 
laborat ory compet ent for official controls in accordance with Article 11(2) of Regulation (EC) No 882/2004 of 
the European Parliament and of the Council (5). 20.9.2018 L 237/5 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). 
(3)Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 
of the European Parliament and of the Council as regar ds the duties and tasks of the Community Reference Laboratory concer ning 
applications for author isations of feed additives (OJ L 59, 5.3.2005, p. 8). 
(4)EFSA Jour nal 2014;12(1):3531. 
(5)Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 Apr il 2004 on official controls perfor med to ensure 
the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). (7)  The Commission and the Reference Laborat ory informed the applicant on those findings and gave him the 
oppor tunity to provi de a suitable method of analysis both for the detection of rDNA and for the presence of 
viable cells from the production strain in order to proceed to further analysis of various samp les of the additive. 
For that purpose, the applicant requeste d several laboratori es, established both in China and in a Member State , 
to perf orm new analyses of the samples. The results of those analyses were negative as regar ds the detection of 
both rDNA and viable cells from the specif ic production strain. Howe ver, it appeared that the new analyses 
carried out by the applicant did not concer n the samp les submitted in 2010 to the Reference Laboratory . 
(8)  In parallel, at the request of the Commission and the Reference Laboratory , further analyses of the samples of the 
additive were carried out by a national laborat ory compet ent for official controls. On its basis, it was concluded 
that viable cells from the production strain were present in the samples of 2010 and that rDNA from the 
production strain was present in the samples of 2010 and 2013. That laborat ory sent sam ples to another 
national laboratory compet ent for official controls for further analysis, whic h confir med the presence of rDNA 
from the production strain in the samples of 2010 and 2013. Those results were obtained through the use of 
a PCR analysis method developed by a national laborat ory compet ent for official controls in accordance with 
Article 11(2) of Regulation (EC) No 882/2004. 
(9)  In 2015, in order to resolve the diverg ence of results, it was agreed between the Commission and the Reference 
Laboratory on one hand and the applicant on the other hand that each of them would request an independent 
laborat ory accredited for a PCR method to perform further analysis of the additive. For that purpose, the samples 
of 2010 and 2013 would be used and the applicant was invit ed to provide, among others, sam ples in the form 
in which the additive was placed on the mark et at that time. It was agreed that both the analytical methods used 
by the applicant and by the national laborat ories compet ent for official controls would be shared and used. 
(10)  Howe ver, the applicant subsequently refused to have the sam ples submitted in 2010 and 2013 analysed and to 
provid e sam ples corresponding to the additive placed on the mark et in 2015. The applicant refused to further 
cooperat e with the Commission and the Reference Laborat ory as long as a ‘unif ied analysis standard’ method for 
the detection of rDNA in ribof lavin was not established under Union legislation. 
(11)  Under Regulation (EC) No 1831/2003, the burden is on the applicant to adequat ely and suffic iently demonstrate 
that the additive satisfi es the conditions for author isation laid down in that Regulation, its implementing 
measures (1) and applicable Author ity's guidance (2), in particular through the submission of relevant samples of 
the additive, all information related to the genetic modific ation of the production strain, the PCR -based method 
used, the prot ocol for extraction of the DNA and other relevant data allowing the Author ity to determine the 
absence of rDNA or viable cells from the production strain. 
(12)  On the basis of those data indicating the presence of viable cells and rDNA from the production strain in the 
additive, in August 2016 the Commission request ed the Auth ority to deliver a new opinion on the safety of 
ribof lavin (80 %) produced by the genetically modified strain Bacillus subtilis KCCM-10445 as a feed additive for 
all animal species. 
(13)  In order to under take its assessment, the Auth ority requested the applicant to provide supplementar y information 
and data, relat ed in particular to the method of analysis for the detection of the presence of viable cells of the 
production strain in the additive. Such supplementar y information and data was submitted by the applicant. The 
Author ity also request ed the Reference Laborator y to provi de further information and data concer ning the 
analyses perf ormed by the national laboratories compet ent for official controls, whic h was also furnished. 
(14)  The Auth ority concluded in its opinion of 7 Marc h 2018 (3) that the new data provi ded by the national 
laborat ory compet ent for official controls show that referen ce samples of the additive contain viable cells and/or 
DNA from the production strain. The production strain Bacillus subtilis KCCM-10445 carries four antimicrobial 
resistance genes, three of them introduced by genetic modific ations. Theref ore, the Authority concluded that the 
additive poses a risk for the target species, consumers, users and the environment due to the potential for the 
spread of viable cells and DNA of a genetically modifi ed strain-harbour ing genes coding for resistance to anti­
microbials of human and veteri nary importance. 20.9.2018 L 237/6 Official Jour nal of the European Union EN     
(1)Commission Regulation (EC) No 429/2008 of 25 Apr il 2008 on detailed rules for the implementation of Regulation (EC) 
No 1831/2003 of the European Parliament and of the Council as regar ds the preparation and the presentation of applications and the 
assessment and the author isation of feed additives (OJ L 133, 22.5.2008, p. 1). 
(2)In particular , Guidance for the preparation of dossiers for nutr itional additives (EFSA Jour nal 2012;10(1):2535) and Guidance on the risk 
assessment of genetically modified microorgan isms and their products intended for food and feed use (EFSA Jour nal 2011;9(6):2193). 
(3)EFSA Jour nal 2018;16(3):5223. (15)  Consequently , it has not been established that ribof lavin (80 %) produced by Bacillus subtilis KCCM-10445 does 
not have an adverse effect on animal health, human health or the environment, when used as a feed additive 
belonging to the functional group ‘vitamins, pro-vitamins and chemically well-def ined substances having similar 
effect’. 
(16)  As refer red to in Article 7(3)(i) of Regulation (EC) No 1831/2003, an additive falling within the scope of the 
Union legislation relating to the mark eting of products consisting of, containing or produced from genetically 
modified organisms should be subject to an author isation granted in accordance with that legislation. Such 
author isation has not been grant ed for the genetically modified strain Bacillus subtilis KCCM-10445 detec ted in 
the additive. 
(17)  The assessment of ribof lavin (80 %) produced by the genetically modifi ed strain Bacillus subtilis KCCM-10445 
shows that the conditions for author isation, as provi ded for in Article 5 of Regulation (EC) No 1831/2003, are 
theref ore not satisfied. 
(18)  According ly, the author isation of ribof lavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive 
belonging to the functional group ‘vitamins, pro-vitamins and chemically well-def ined substances having similar 
effect’, should be denied. As explained to the applicant on the occasion of exchanges with the Commission which 
took place after the adoptio n of the Auth ority's opinion of 7 Marc h 2018, the denial of author isation of the 
additive set out in this Implementing Regulation is without prejudice to the possibility of submitting a new 
application for author isation in accordance with Regulation (EC) No 1831/2003. 
(19)  Theref ore, the additive ribof lavin (80 %) produced by Bacillus subtilis KCCM-10445 and feed containing it should 
be withdra wn from the mark et as soon as possible. For practical reasons, howe ver, a limited period should be 
allowed for the withdrawal from the mark et of the existing stoc ks of the additive and feed containing ribof lavin 
(80 %) produced by Bacillus subtilis KCCM-10445, in order to enable operators to comply properly with the 
withdra wal oblig ation while taking into account legitimate factors relevant to the matt er under consideration. 
(20)  In particular , as ribof lavin (80 %) produced by Bacillus subtilis KCCM-10445 represents a signif icant part of the 
Union mark et concer ning ribof lavin to be used in feed, any risk of adverse effects on animal health or welfa re 
due to an undersupply of animals with ribof lavin should be avoided by providing the operat ors suffi cient time to 
adap t to the situation. 
(21)  In addition, the time and resources needed to retrieve and withdra w from the market premixtures containing the 
additive ribof lavin (80 %) produced by Bacillus subtilis KCCM-10445, and further down in the feed chain feed 
mate rials and compo und feed produced with that additive or those premixtures, should be considered. Such 
practical constraints for withdra wing the products from the mark et are even more acute for feed intended for 
non-f ood producing animals, as this type of feed usually involves higher inclusion rates of ribof lavin, long er shelf 
life and more compl ex destr uction methods. Theref ore, the time periods for the withdrawal from the mark et of 
the respective feed products concer ned should be provided according ly. 
(22)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Denial of author isation 
The author isation of ribof lavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the 
functional group ‘vitamins, pro-vitamins and chemically well-def ined substances having similar effect’ (‘the additive’) is 
denied. 
Article 2 
Withdrawal from the market 
1. Existing stoc ks of the additive refer red to in Article 1 shall be withdra wn from the mark et by 10 November 2018. 
2. Existing stoc ks of premixtures produced with the additive refer red to in paragraph 1 shall be withdra wn from the 
mark et by 10 Januar y 2019. 
3. Feed mater ials and compo und feed intended for food-producing animals, which have been produced with the 
additive referred to in paragraph 1 or with premixtures refer red to in paragraph 2 before 10 Januar y 2019 shall be 
withdra wn from the market by 10 Apr il 2019. 20.9.2018 L 237/7 Official Jour nal of the European Union EN     4. Feed mater ials and compound feed intended for non-f ood producing animals, which have been produced with the 
additive referred to in paragraph 1 or with premixtures refer red to in paragraph 2 before 10 Januar y 2019 shall be 
withdra wn from the market by 10 July 2019. 
Article 3 
Entr y into force 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 19 September 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  20.9.2018 L 237/8 Official Jour nal of the European Union EN