EFSA received directly from the applicant the technical dossier in support of this application. 0000015947 00000 n
J’ai des problèmes d’intestin depuis longtemps, Les différentes recommandations pour ma flore ne sont pas assez efficaces, Avec l’âge, je veux entretenir ma flore intestinale. Technical dossier/Section III/Annex III‐2. Technical dossier/Supplementary information November 2018.
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The applicant submitted a tolerance trial with horses. 0000006292 00000 n
The Executive Summary of the EURL report can be found in Annex A.55 However REA and RAPD are fingerprinting techniques not suitable for species identification. The European Commission received a request from ProEquo AB22 The applicant originally submitted an application including the re‐evaluation of the authorisation as a silage additive (Art 10). Working off-campus? The applicant claimed that ProEquo® is intended to be poured on the top of the feed and immediately consumed by the animal. Consequently, the QPS approach to safety assessment cannot be applied and separate studies on target animals, consumer and environmental safety are required.
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Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.
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ProEquo® should be considered a respiratory sensitiser. The feed additive is intended to be added poured on top of other feed. ■■■■■1010 However, none could be further considered due to weaknesses in the experimental design and/or reporting ■■■■■2020 Technical dossier/Section IV/Annexes IV‐2 and IV‐3. European Food Safety Authority, 140 (1991). However the Applicant did not provide any supporting experimental data. The strain Lactobacillus plantarum Lp-115 is deposited at the DSMZ under number DSM22266. Technical dossier/Section II/Annex II‐7. Swedish researchers have recently reviewed the effectiveness of a particular probiotic organism, Lactobacillus plantarum, in terms of its effectiveness in reducing gut wall permeability. Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. 0000014517 00000 n
EN 15787 and/or NMKL method No. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety of ProEquo® for the target animals, consumers of products derived from animals fed the additive and the environment. No studies were provided on the irritancy or sensitisation potential of the additive.