Submitted by Milte Italia, the article 13.5 dossier sought a health claim for the silymarin Bio-C ingredient, contained in the dietary supplement Piùlatte.
Silymarin BIO-C is an extract of milk thistle (Silybum marianum (L.) Gaertn.) seeds, which is made up of flavanolignans (silychristin, silybin, isosilybin and silydianin). The dry extract is standardised to 40-80 per cent silymarin by adjusting it with “inert” material such as maltodextrin or by blending batches of extracts with different content of silymarin.
Milte Italia had sought a health claim based on new scientific evidence that the ingredient had a “galactagogue effect”.
In an opinion published this week, EFSA’s Panel on Dietetic Products, Nutrition and Allergies said that the ingredient was sufficiently characterised and that an increase in production of breast milk after delivery might be a beneficial physiological effect.
However, the panel said that the supporting science submitted in the dossier did not establish a cause and effect relationship.
Five studies had been submitted in support of the claim application, including two human and three animal studies.
EFSA dismissed the animal studies, saying they did not predict an effect of the ingredient on the increase in production of breast milk after delivery in humans.
Out of the two human studies, one was unpublished and investigated the absence of silymarin in breast milk of five breastfeeding women who received silymarin. However, EFSA said this study did not address relevant endpoints for 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. Women received 420 mg/day of silymarin BIO-C or placebo, and daily milk production was measured at base point, after one month and after two months by weighing the infants before and after breastfeeding and by voiding the breast glands thereafter by a breast-pump.
However, the EFSA panel said the study “suffered from several substantial shortcomings in study design and reporting as no information was provided on randomisation, blinding, sample size or power calculation”, prompting it to say that no conclusions can be drawn from the study on 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,” it said.
To read the full opinion, click here.