“We knew we had a good dossier, and we were confident we would secure this registration for the extension of use of Rovabio Excel in sows within a few months,” a spokesperson for Adisseo told feednavigator.
EFSA’s opinion in May noted that the results of a meta-analysis did show 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, its FEEDAP 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.”
It said it could not conclude on the efficacy of the enzyme for use with sows as a result.
The Adisseo representative said EFSA’s findings then had been totally “unexpected” as the submitted data had “strongly supported” the claim of minimization of body reserve mobilization of sows during lactation.
Commission’s decision-making process
The Commission agreed with that view: The regulation published on 27 October in the Official Journal of the European Union says the in vivo studies provided by the French company “meet the conditions for the demonstration of the efficacy in lactating sows.”
A spokesperson for the EU Directorate for Consumer Health, DG Sanco, told us the decision to approve Rovabio Excel was taken during the two-day meeting of the Standing Committee on Plants, Animals, Food and Feed (PAFF) in September.
She said the members concluded that the effect of weight reduction shown in in vivo studies submitted by Adisseo, even if it was at a low level, satisfied the condition for the demonstration of the efficacy in lactating sows and, thus, the condition laid down in Article 5(3) of Regulation (EC) No 1831/2003.
"Consequently, the Committee delivered a favorable opinion by qualified majority on the draft authorization Regulation, allowing the Commission to adopt it," added the DG Sanco representative.
This regulatory backing has been “eagerly awaited” by the EU swine industry, said Adisseo.
“This is the first NSP enzyme to get EU authorization for use in sows,” added the company spokesperson.
EFSA dismissed the idea that the EU regulator's approval of Rovabio Excel would, in any way, undermine the standing of the Parma based agency, despite its questioning of the rigor of the efficacy trials in the dossier Adisseo had submitted.
“EFSA has no involvement in authorization decisions taken by the European Commission regarding food or feed additives. This is absolutely normal and central to the principle in EU food safety regulation that scientific risk assessment be separated from risk management decisions,” a spokesperson told us.
The EFSA opinion of May 2014 on Rovabio Excel can be read here.