Scientific Opinion on Safety and efficacy of Protural (sodium benzoate) as feed additive for weaned piglets

The feed additive Protural consists of sodium benzoate without carrier materials. It is intended for use in weaned piglets from weaning to 120 days of age (or 35 kg bw) at a dose of 4000 mg/kg complete feedingstuffs. Protural was tolerated by piglets at the level of three times the recommended dose. The FEEDAP Panel concludes that sodium benzoate (Protural) is safe for target species at the proposed dose with a margin of safety of approximately three. Sodium benzoate is rapidly excreted and no residues or accumulation occur. Since the administration of Protural to piglets is restricted to a maximum of 120 days of age, any potential residue in adult animals will be negligible and make no contribution to the established ADI for benzoic acid and benzoates. Consequently, Protural at the proposed dose can be considered safe for consumers. Protural is not irritant to skin and eyes but a skin sensitisation potential cannot be excluded. The particle size analysis indicates that any exposure of the respiratory system would be limited to the upper respiratory tract. Sodium benzoate is a natural substance widely occurring in the environment. Since the use of Protural as a feed additive is unlikely to measurably add to the concentration of benzoic acid and its salts naturally present, the FEEDAP Panel concludes that the use of Protural in weaned piglets is safe for the environment. The applicant provided five efficacy trials, two of which showed a significant benefit in terms of final body weight. In addition, a metaanalysis made by pooling data from the five trials showed a significant improvement of the feed to gain ratio. Consequently, the FEEDAP Panel concludes that Protural at a dose of 4000 mg/kg complete feed has the potential to improve performance in weaned piglets.