Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
Abstract Following an application from Biosearch Life, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the...
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doaj-c588188c555949f6b0f59cd931acea872021-09-09T18:10:49ZengWileyEFSA Journal1831-47322017-07-01157n/an/a10.2903/j.efsa.2017.4917Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)Dominique TurckJean‐Louis BressonBarbara BurlingameTara DeanSusan Fairweather‐TaitMarina HeinonenKaren Ildico Hirsch‐ErnstInge MangelsdorfHarry J McArdleAndroniki NaskaMonika Neuhäuser‐BertholdGrażyna NowickaKristina PentievaYolanda SanzMartin SternDaniel ToméHenk Van LoverenMarco VincetiPeter WillattsAmbroise MartinJohn Joseph StrainAlfonso SianiAbstract Following an application from Biosearch Life, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Lactobacillus fermentum CECT 5716 and decreases the Staphylococcus load in breast milk. High Staphylococcus load in breast milk is a risk factor for infectious mastitis. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The Panel considers that Lactobacillus fermentum CECT 5716 is sufficiently characterised. In the context of this application, the Staphylococcus load in breast milk can be considered a risk factor for the development of infectious mastitis, as long as evidence is provided that the consumption of Lactobacillus fermentum CECT 5716 reduces the Staphylococcus load in breast milk as well as the incidence of infectious mastitis. Three human intervention studies investigated the effect of Lactobacillus fermentum CECT 5716 on the Staphylococcus load of breast milk in lactating women. One of these studies was conducted in lactating women free of infectious mastitis at baseline. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim owing to important methodological limitations. The other two studies were conducted in lactating women with infectious mastitis and, therefore, the effect of the intervention on the incidence of infectious mastitis cannot be assessed. The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis.https://doi.org/10.2903/j.efsa.2017.4917Lactobacillus fermentum CECT 5716Staphylococcusbreast milkinfectious mastitishealth claim |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Dominique Turck Jean‐Louis Bresson Barbara Burlingame Tara Dean Susan Fairweather‐Tait Marina Heinonen Karen Ildico Hirsch‐Ernst Inge Mangelsdorf Harry J McArdle Androniki Naska Monika Neuhäuser‐Berthold Grażyna Nowicka Kristina Pentieva Yolanda Sanz Martin Stern Daniel Tomé Henk Van Loveren Marco Vinceti Peter Willatts Ambroise Martin John Joseph Strain Alfonso Siani |
spellingShingle |
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Dominique Turck Jean‐Louis Bresson Barbara Burlingame Tara Dean Susan Fairweather‐Tait Marina Heinonen Karen Ildico Hirsch‐Ernst Inge Mangelsdorf Harry J McArdle Androniki Naska Monika Neuhäuser‐Berthold Grażyna Nowicka Kristina Pentieva Yolanda Sanz Martin Stern Daniel Tomé Henk Van Loveren Marco Vinceti Peter Willatts Ambroise Martin John Joseph Strain Alfonso Siani Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 EFSA Journal Lactobacillus fermentum CECT 5716 Staphylococcus breast milk infectious mastitis health claim |
author_facet |
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Dominique Turck Jean‐Louis Bresson Barbara Burlingame Tara Dean Susan Fairweather‐Tait Marina Heinonen Karen Ildico Hirsch‐Ernst Inge Mangelsdorf Harry J McArdle Androniki Naska Monika Neuhäuser‐Berthold Grażyna Nowicka Kristina Pentieva Yolanda Sanz Martin Stern Daniel Tomé Henk Van Loveren Marco Vinceti Peter Willatts Ambroise Martin John Joseph Strain Alfonso Siani |
author_sort |
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) |
title |
Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 |
title_short |
Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 |
title_full |
Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 |
title_fullStr |
Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 |
title_full_unstemmed |
Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 |
title_sort |
lactobacillus fermentum cect 5716 and a reduction of the staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to article 14 of regulation (ec) no 1924/2006 |
publisher |
Wiley |
series |
EFSA Journal |
issn |
1831-4732 |
publishDate |
2017-07-01 |
description |
Abstract Following an application from Biosearch Life, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Lactobacillus fermentum CECT 5716 and decreases the Staphylococcus load in breast milk. High Staphylococcus load in breast milk is a risk factor for infectious mastitis. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The Panel considers that Lactobacillus fermentum CECT 5716 is sufficiently characterised. In the context of this application, the Staphylococcus load in breast milk can be considered a risk factor for the development of infectious mastitis, as long as evidence is provided that the consumption of Lactobacillus fermentum CECT 5716 reduces the Staphylococcus load in breast milk as well as the incidence of infectious mastitis. Three human intervention studies investigated the effect of Lactobacillus fermentum CECT 5716 on the Staphylococcus load of breast milk in lactating women. One of these studies was conducted in lactating women free of infectious mastitis at baseline. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim owing to important methodological limitations. The other two studies were conducted in lactating women with infectious mastitis and, therefore, the effect of the intervention on the incidence of infectious mastitis cannot be assessed. The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis. |
topic |
Lactobacillus fermentum CECT 5716 Staphylococcus breast milk infectious mastitis health claim |
url |
https://doi.org/10.2903/j.efsa.2017.4917 |
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