Assessment of the application for modification of the terms of the authorisation of the feed additive consisting of Weizmannia faecalis DSM 32016 (TechnoSpore50®) for all poultry species for fattening, reared for laying/breeding and ornamental birds (Biochem Zusatzstoffe Handels‐ und Produktionsges. mbH)

TL;DR

This paper evaluates a request to modify the authorization of a feed additive for poultry, focusing on its compatibility with certain coccidiostats and safety for users and the environment.

Contribution

The paper provides new evidence supporting the compatibility of TechnoSpore50® with specific coccidiostats under revised conditions.

Findings

TechnoSpore50® is compatible with narasin+nicarbazin when using a revised microbiological method.

The additive is compatible with amprolium based on in vitro testing.

TechnoSpore50® is a skin and respiratory sensitiser, posing inhalation and dermal exposure risks.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the additive consisting of Weizmannia faecalis DSM 32016 (TechnoSpore50®) as a zootechnical feed additive, for all poultry species for fattening, reared for breeding and laying and ornamental birds. The additive is already authorised for use in feed and water for drinking for the above‐mentioned species. With this application, the company requested the modification of the current authorisations as regards the simultaneous use of the additive with the coccidiostats amprolium and narasin+nicarbazin. The FEEDAP Panel concluded that the proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of TechnoSpore50® for target species, consumers and the environment. Regarding user safety, the additive is not a skin/eye irritant but should be considered as a skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. In a former opinion, the compatibility of TechnoSpore50® with narasin+nicarbazin could not be established in an in vivo trial since the difference in colony counts of non‐heat‐treated caecal samples from the control group receiving only the additive and the respective treatment group receiving the additive and the coccidiostat was above 0.5 log. The applicant supplied a new in vivo trial suggesting that the microbiological method applied underestimated the counts of non‐heat‐treated samples since spores of W. faecalis DSM 32016 require a thermal treatment to germinate. Based on these findings, the Panel reconsidered the results of the in vivo trial formerly submitted and concluded that TechnoSpore50® is compatible to narasin+nicarbazin at the proposed conditions of use. TechnoSpore50® was found to be compatible with amprolium in an in vitro test.