Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions is the subject of this assessment. The active substance is considered to be CLA (t10,c12) methyl ester (ME). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA...

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Published inEFSA journal Vol. 17; no. 3; pp. e05614 - n/a
Main Authors Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Kouba, Maryline, Durjava, Mojca Kos, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto, Woutersen, Ruud, Costa, Lucio, Dierick, Noël, Flachowsky, Gerhard, García, Ana Belen, Mantovani, Alberto, Tarrés‐Call, Jordi, Wallace, Robert John
Format Journal Article
LanguageEnglish
Published United States John Wiley and Sons Inc 01.03.2019
Wiley
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Summary:A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions is the subject of this assessment. The active substance is considered to be CLA (t10,c12) methyl ester (ME). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA previously issued an opinion on the safety and efficacy of the product, in which it could not conclude on the efficacy of this additive for sows for reproduction and for cows for reproduction. The European Commission asked EFSA to deliver an opinion on the efficacy of this additive for sows and cows for reproduction, based on additional data submitted by the applicant. The FEEDAP Panel has performed the assessment of the new data following an approach in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents. In relation to the data on efficacy in sows for reproduction, owing to methodological shortcomings of the study submitted, including the duration of the study and the limited biological relevance of the effect observed, the FEEDAP Panel cannot conclude on the efficacy of CLA (t10,c12)‐ME for sows for reproduction. The data related to dairy cows indicate that dietary CLA (t10,c12)‐ME supplementation in the late dry period and/or lactation period showed an increase of the probability of pregnancy and a reduction of time to conception in the same reproductive cycle. However, considering that the minimum duration of efficacy studies for reproductive parameters is of at least two reproductive cycles, the FEEDAP Panel is not in a position to conclude on the efficacy of the additive for cows for reproduction.
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Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.
Acknowledgements: The EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) wishes to thank the following for the support provided to this scientific output: Montserrat Anguita, Rosella Brozzi, Jaume Galobart, Matteo Innocenti and Paola Manini.
Panel members: Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Adopted: 24 January 2019
Requestor: European Commission
Question number: EFSA‐Q‐2016‐00859
ISSN:1831-4732
1831-4732
2314-9396
DOI:10.2903/j.efsa.2019.5614