Scientific Opinion on the substantiation of a health claim related to silymarin BIO-C<sup>®</sup> and increase in production of breast milk after delivery pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Following an application from MILTE ITALIA S.p.A. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to silymarin BIO-C® and increase in production of breast milk after delivery. The food constituent silymarin BIO-C®, an extract of milk thistle (Silybum marianum (L.) Gaertn.) seeds, which is the subject of the health claim, is sufficiently characterised. Increase in production of breast milk after delivery might be a beneficial physiological effect. The target population is women who wish to increase breast milk production. The applicant identified five references as being pertinent to the health claim: two human studies (one published and one unpublished) and three animal studies. The unpublished study investigated the absence of silymarin in breast milk of breastfeeding women who received silymarin and the Panel notes that this study did not address relevant endpoints for the claimed effect. The published human study was a placebo-controlled intervention study conducted with silymarin BIO-C® in breastfeeding women. The Panel notes that this study, which investigated the quantitative and qualitative profile of the milk from the women, suffered from several shortcomings and no conclusions could be drawn for the scientific substantiation of the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of silymarin BIO-C® and increase in production of breast milk after delivery.