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EFSA rejects silymarin health claim

The European Food Safety Authority (EFSA) has rejected on 28/09/2010 a health claim application by Milte Italia linking a milk thistle extract to an increase in the production of breast milk after delivery. The supplement that is the subject of the health claim is silymarin BIO-C, an extract of milk thistle seeds, standardised to 40-80% silymarin. Silymarin is comprised of phytochemicals silychristin, silybin, isosilybin and silydianin.

The EFSA Panel considered that an increase in production of breast milk after delivery might be a beneficial physiological effect. Milte Italia referred to five scientific studies: two human studies and three animal studies. One of the human studies was unpublished and investigated only the absence of silymarin in breast milk of five breastfeeding women who received silymarin. No relationship between silymarin and the production of breast milk was established. The other human study was a placebo-controlled intervention study with 50 breastfeeding women who received daily 420 mg/day of silymarin BIO-C or a placebo for about 2 months. The milk production was measured at baseline, after 1 month and after 2 months. Although th scientists found a significant increase in daily milk production in women who toot silymarin, the EFSA found that this study suffered from several substantial shortcomings in study design and reporting. The Panel considered that no conclusions could be drawn from this study for the substantiation of the claimed effect. The results of the three animal studies could not be used to predict an effect of silymarin on breast milk production in humans.

The Panel concluded that a cause and effect relationship has not been established between the intake of silymarin BIO-C and increase in production of breast milk.

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