Scientific Opinion on the substantiation of a health claim related to silymarin BIO-C® and increase in production of breast milk after delivery pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2010;8(9):1774 [9 pp.].
doi
10.2903/j.efsa.2010.1774
Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
MILTE ITALIA S.p.A.
Question Number
EFSA-Q-2009-00957
Adopted
10 September 2010
Published
28 September 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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applicant identified five references as being pertinent to the health claim: two human studies (one published and one unpublished) and three animal studies. The unpublished study investigated the absence of silymarin in breast milk of breastfeeding women who received silymarin and the Panel notes that this study did not address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.

Summary

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 scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The food constituent that is the subject of the health claim is silymarin BIO-C®, which is contained in the food supplement “Piùlatte”. Silymarin BIO-C® is an extract of milk thistle (Silybum marianum (L.) Gaertn.) seeds (dry extract standardised to 40-80 % silymarin). Silymarin is comprised of flavanolignans (silychristin, silybin, isosilybin and silydianin) that can be measured by established methods. Standardisation of the extract is achieved by adjustment of the extract with inert material such as maltodextrin or by blending batches of extracts with different content of silymarin, and can contain fibres, cellulose and other components typical of plant material. The Panel considers that the food constituent, silymarin BIO-C®, which is the subject of the health claim, is sufficiently characterised.

The claimed effect is “galactagogue effect”. The target population is women who wish to increase breast milk production. The Panel considers that an increase in production of breast milk after delivery might be a beneficial physiological effect.

The applicant identified five references, which included two human studies (one published and one unpublished) and three animal studies, as being pertinent to the health claim.

The unpublished human study investigated the absence of silymarin in breast milk of five breastfeeding women who received silymarin. The Panel notes that this study did not address relevant endpoints for the claimed effect. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.

The published human study was a placebo-controlled intervention study, conducted in Peru, in 50 breastfeeding women who were reported by the authors to be borderline in their daily milk production. Volunteers received the test product, 420 mg/day of silymarin BIO-C® (n=25) or a placebo (refined sucrose) (n=25) for 63 days. The quantitative and qualitative (water, fats, carbohydrates and proteins) milk profile was reported at day 0, 30 and 63. The daily milk production was measured on days 0, 30 and 63 by weighing the infants before and after breastfeeding and by voiding the breast glands thereafter by a breast-pump. The Panel notes that this study suffered from several substantial shortcomings in study design and reporting as no information was provided on randomisation, blinding, sample size or power calculation. The late average post-natal age of the babies on day 0 of the study, the absence of information on body weight of babies and the diagnosis of borderline milk production were identified as further weaknesses of this study. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.

The Panel considers that the results from the animal studies do not predict an effect of silymarin BIO C® on the increase in production of breast milk after delivery in humans.

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.

Keywords
Silymarin BIO-C®, production of breast milk, health claims.
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Number of Pages
9