“None of the submitted studies comply with the minimum requirements for an experimental design for the demonstration of efficacy,” said the Authority’s FEEDAP panel in a scientific opinion.
The four studies provided as evidence of the efficacy of the Hungarian company’s additive, branded as Diarr-Stop S Plus, were carried out in commercial farms, without replication, continued EFSA.
The product is a mixture of the sodium salt of ethylenediaminetetra acetic acid (Na2EDTA), a tannin-rich extract from Castanea sativa, thyme oil and oregano oil.
The additive is intended to be used in order to positively influence the intestinal microbiota of pigs for fattening, to reduce the incidence of dysentery caused by the bacterial spirochete Brachyspira hyodysenteriae, and thereby improve performance.
In relation to the inconclusive findings on the product’s efficiency, Dr Hutás István, managing director, Pharmatéka told FeedNavigator: “This registration has taken six years [to complete]. We are open to demonstrate the efficacy again, if needed.”
He said the company has “refuted” the EFSA conclusion on efficacy several times, and is still in communication with the Parma based risk assessor in relation to the findings.
"We didn’t have technical meetings, because EFSA rejected our request for an appointment. We have sent the aggregated trials results again," continued István, .
Feeding trials
István said it tested its additive for efficacy in feeding trials in five large-scale pig farms using a total of 12,945 pigs. “The production parameters [such as FCR, average daily weight gain] improved significantly [during the trial]. This improvement resulted from the better physiological state of pigs given the additive,” said the managing director.
The FEEDAP Panel did find the additive safe for pigs for fattening at the recommended dose of 1,000 mg/kg complete feed.
The additive had not previously been assessed for use as a feed additive in the EU or elsewhere. However, its individual components have been assessed for use in food/feed for a variety of purposes.
“None of the active constituents of Diarr-Stop S Plus raised safety concerns when considered individually and at the concentrations delivered to feed using the recommended dose,” said the EFSA feed experts.
The full opinion can be read here.