Scientific Opinion on the modification of the terms of authorisation of Protural (sodium benzoate) as a feed additive for weaned piglets

The product Protural is a feed additive (zootechnical; other zootechnical additives) authorised for use in weaned piglets at a dose of 4000 mg active substance per kg complete feed. The applicant proposes a modification of the terms of the authorisation, reducing the minimum concentration of sodium benzoate from 99.9 % to 99.0 %. No change in the method of production is involved. The analysis of three batches of Protural showed a mean concentration of benzoic acid of 100 % (and water concentration of 1 %) compliant with the proposed specification. Concentrations of arsenic and heavy metals (as Pb) are < 3 mg/kg and 10 mg/kg, respectively. The FEEDAP Panel concludes that the additive Protural (sodium benzoate) with a minimum content of ≥ 99.0 % is as safe for the target species, consumer, user and the environment and efficacious as the previous formulation, under the same conditions of use.