EFSA finds sow feed additive dossier falls short
Adisseo's Rovabio Excel is already approved by the European Food Safety Authority (EFSA) in terms of safety and efficacy for use in a wide range of livestock from chickens and turkeys for fattening, laying hens, weaned piglets and pigs for fattening, ducks, guinea fowl, quails, geese, pheasants and pigeons.
The French manufacturer was seeking an extension of the additive’s use in lactating sows.
Safety affirmed
EFSA's Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) said at the recommended dose - 1500 glucanase U and 1100 xylanase U per kilogram of feed – the additive would be safe for use with lactating sows.
“The results of a tolerance study showed that 200 fold the recommended dose was tolerated well by the sows when offered for a period of seven weeks, including gestation and lactation,” said the EFSA feed team.
But the Panel said it cannot conclude on the efficacy of Rovabio Excel from the efficacy studies provided by the company.
Opinion 'unexpected'
“This opinion is unexpected as the submitted data strongly supported the claim of minimization of body reserve mobilization of sows during lactation. We'll make every effort to gain registration for this extension of use,” a spokesperson for Adisseo told us today.
She said Rovabio Excel is the first NSP enzyme application for lactating sows evaluated by the European Food Safety Authority (EFSA) and, because of its impact on sow performance over time and the subsequent financial return, approval for extension of its use in sows "is eagerly awaited by the EU swine industry”.
Supporting trial documentation
The FEEDAP Panel, in its opinion on the safety and efficacy of the additive published yesterday, said a total of nine efficacy trials were assessed.
Three trials were “not considered in the assessment because their durations were shorter than 28 days and therefore did not follow the requirements established in the EFSA guidance on tolerance and efficacy trials in target animals.”
The results of a meta-analysis, said the EFSA team, showed a significant but very limited reduction of body weight loss in lactating sows fed Rovabio Excel at the recommended dose given at least one week before farrowing and during the whole lactation period.
“This may indicate some potential of the additive to be efficacious,” said the experts.
However, the Panel questioned the biological and physiological relevance of this finding, due to the fact that “the impact on the following weaning to oestrus interval and on the next reproductive cycle of the sows was not measured.”
They also noted that, in one trial, a significant increase was seen in the fecal digestibility of energy from the diet containing Rovabio Excel at a higher dose than recommended.
The FEEDAP opinion can be read here.
