Biosearch : Hereditum LC40, otro probiótico rechazado por la EFSA

After over a year in the assessment process, the European Food Safety Authority (EFSA) has rejected the application submitted by Biosearch Life under Article 14 of Regulation (EC) No 1924/2006: 'Lactobacillus fermentum CECT5716 decreases the Staphylococci count in breast milk. A high count of Staphylococci in milk is a risk factor for mammary bacterial dysbiosis / mastitis '.

Lactobacillus fermentum CECT5716, Hereditum LC40, is a probiotic strain isolated from the human breast milk of healthy mothers and under a Biosearch Life patent. This strain has been widely studied by Biosearch Life for over 15 years. The strain is perfectly characterized and numerous studies have shown its powerful antibacterial and immunomodulatory properties.

The scientific dossier * presented by Biosearch Life was prepared according to the requirements established by EFSA for obtaining a positive opinion on claims for the use of ingredients for reduction (or beneficial alteration) of an infection risk factor and contained 3 clinical studies ** which involved over 900 lactating women and all studies that demonstrate the potent antibacterial and immunomodulatory power of the strain as supporting material. The research has shown that consumption of the strain Lactobacillus fermentum CECT5716 reduced the Staphylococcus count in milk by 80% in women with mastitis and breast pain during lactation and in about 40% of healthy women during lactation. The reduction in the Staphylococcus count also translated into a significant reduction in the severity of inflammation and symptomatology, as well as a 51% reduction in the incidence of mastitis during lactation.

In the opinion published by EFSA, a high Staphylococcus count in breast milk is recognised as a risk factor for the development of infectious mastitis. Nevertheless, it considers that the data submitted correlating the consumption of the probiotic strain with the reduction of Staphylococcus in breast milk are not sufficient. In reaching this conclusion, EFSA has not taken into account the clinical studies conducted on women with mastitis, and it has pointed out limitations in the main research conducted on healthy lactating women, associated to the high rate of abandonment of the study.

In Biosearch Life's opinion, these limitations did not affect the outcome, as they did not affect the homogeneity of the experimental groups, they were not associated with the product's consumption and the research maintained sufficient statistical power. The reasons for leaving the research were due to cessation of breastfeeding, even in a lower percentage than described in the research population and the high demand for care required by the baby during the first weeks of life.

As recommended by EFSA in the 'Guide for general guidelines for scientific guidance applied to health claims related to the immune system, gastrointestinal tract and defence against pathogenic microorganisms,' Biosearch Life provided clear evidence that Hereditum LC40 reduces the burden of pathogens as a risk factor as well as the incidence and severity of the infection. Furthermore, according to the EFSA guidelines, the effect has been verified in a healthy population. Therefore, the dossier met all of the requirements established by EFSA for obtaining a positive opinion on the use of ingredients for the reduction (or beneficial alteration) of infection risk factor claims.

EFSA's negative opinion does not surprise and much less discourages Biosearch Life. It was well known that obtaining a health claim was a difficult task by the history of opinions published by EFSA, which repeatedly denies the scientific evidence demonstrating the beneficial effects certain probiotic strains can offer to the population. Despite EFSA, the market response is the best sign of effectiveness and it is greatly satisfying to receive recognition from women who have tested the product. We will continue working just as we have been doing so far, not for the purpose of obtaining recognition from EFSA but in order to obtain our customers' recognition by offering effective products to resolve health issues affecting our society.