TY - JOUR

T1 - Safety and efficacy of a feed additive consisting of lactic acid produced by Weizmannia coagulans (synonym Bacillus coagulans) DSM 32789 for all animal species except for fish (Jungbunzlauer SA)

AU - Azimonti, Giovanna

AU - Bampidis, Vasileios

AU - Bastos, Maria de Lourdes

AU - Christensen, Henrik

AU - Dusemund, Birgit

AU - Fašmon Durjava, Mojca

AU - Kouba, Maryline

AU - López-Alonso, Marta

AU - López Puente, Secundino

AU - Marcon, Francesca

AU - Mayo, Baltasar

AU - Pechová, Alena

AU - Petkova, Mariana

AU - Ramos, Fernando

AU - Sanz, Yolanda

AU - Villa, Roberto Edoardo

AU - Woutersen, Ruud

AU - Maradona, Miguel Prieto

AU - Anguita, Montserrat

AU - Galobart, Jaume

AU - Pettenati, Elisa

AU - Tarrés-Call, Jordi

AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

N1 - Publisher Copyright: © 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.

PY - 2022

Y1 - 2022

N2 - 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 the safety and efficacy of lactic acid produced by a non-genetically modified strain of Weizmannia coagulans (synonym of Bacillus coagulans) (DSM 32789) for all animal species except for fish. The production strain qualifies for the QPS approach for safety assessment. Although uncertainty remains concerning the possible presence of viable cells and/or spores of the production strain in the final product, this does not raise safety concerns for the target species, humans and the environment. The lactic acid is safe at 50,000 mg/kg complete feed for functional ruminants and pigs and at 20,000 mg/kg feed for all the other animal species and categories except for pre-ruminants for which a safe level cannot be established. The corresponding safe levels in water for drinking would be 15,000 mg/L water for pigs and 8,000 mg/L for other non-ruminant species. Although no safe concentration of lactic acid in water for drinking for ruminants can be derived, the Panel considers that the use in water for drinking is safe in ruminants when the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of the additive under assessment in animal nutrition is considered safe for the consumers and for the environment. It is considered corrosive to the skin, eyes and mucous membranes. Lactic acid is used in food as a preservative. It is reasonable to expect that the effect seen in food will be observed in feed when it is used at comparable concentrations and conditions. However, the FEEDAP Panel has reservations about its effectiveness as a preservative in complete feed with a moisture content of ≤ 12%.

AB - 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 the safety and efficacy of lactic acid produced by a non-genetically modified strain of Weizmannia coagulans (synonym of Bacillus coagulans) (DSM 32789) for all animal species except for fish. The production strain qualifies for the QPS approach for safety assessment. Although uncertainty remains concerning the possible presence of viable cells and/or spores of the production strain in the final product, this does not raise safety concerns for the target species, humans and the environment. The lactic acid is safe at 50,000 mg/kg complete feed for functional ruminants and pigs and at 20,000 mg/kg feed for all the other animal species and categories except for pre-ruminants for which a safe level cannot be established. The corresponding safe levels in water for drinking would be 15,000 mg/L water for pigs and 8,000 mg/L for other non-ruminant species. Although no safe concentration of lactic acid in water for drinking for ruminants can be derived, the Panel considers that the use in water for drinking is safe in ruminants when the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of the additive under assessment in animal nutrition is considered safe for the consumers and for the environment. It is considered corrosive to the skin, eyes and mucous membranes. Lactic acid is used in food as a preservative. It is reasonable to expect that the effect seen in food will be observed in feed when it is used at comparable concentrations and conditions. However, the FEEDAP Panel has reservations about its effectiveness as a preservative in complete feed with a moisture content of ≤ 12%.

KW - efficacy

KW - lactic acid

KW - preservatives

KW - QPS

KW - safety

KW - technological additives

KW - Weizmannia coagulans DSM 32789

U2 - 10.2903/j.efsa.2022.7268

DO - 10.2903/j.efsa.2022.7268

M3 - Journal article

C2 - 35505780

AN - SCOPUS:85130764731

VL - 20

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 4

M1 - e07268

ER -