C. butyricum FERM BP-2789 Feed Additive Assessment
The present assessment is based on data submitted by the applicant in the form of a technical dossier4 in support of the authorisation request for the use of C. butyricum FERM BP‐2789 (Miya‐Gold®) as a feed additive. In accordance with Article 38 of the Regulation (EC) No 178/20025 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39 e of the same Regulation, and of the Decision of EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality,6 a non‐confidential version of the dossier has been published on Open.EFSA.7According to Article 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations,8 EFSA carried out a public consultation on the non‐confidential version of the application from 28 November to 19 December 2022. Two entries were registered but the comments submitted dimmed as not relevant to the scope of the public consultation, and therefore, were not considered further. The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, to deliver the present output. The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of the C. butyricum in animal feed are valid and applicable for the current application.9
Bampidis V., Azimonti G., Bastos M.D., Christensen H., Dusemund B., Durjava M., Kouba M., López‐Alonso M., López Puente S., Marcon F., Mayo B., Pechová A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Brozzi R., Pettenati E., Revez J., Anguita M., Galobart J, & Ortuño J. (2023). Modification of the conditions of the authorisation of Clostridium butyricum FERM BP‐2789 (Miya‐Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd). EFSA Journal, 21(2), e07818.
Authorization request for the use of C. butyricum FERM BP-2789 (Miya-Gold®) as a feed additive
dependent variables
Evaluation of the data submitted by the applicant in the form of a technical dossier
control variables
Compliance with Article 38 of Regulation (EC) No 178/2002
Protection of confidential information and personal data in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002
Practical arrangements concerning transparency and confidentiality as per the Decision of EFSA's Executive Director
Conclusions and recommendations reached in the previous assessment regarding the methods used for the control of C. butyricum in animal feed
positive controls
None specified
negative controls
None specified
Annotations
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