Safety and efficacy of Sacox® microGranulate (salinomycin sodium) for rabbits for fattening.

Abstract

Sacox® microGranulates, containing salinomycin sodium (SAL‐Na), for chickens for fattening and chickens reared for laying have been recently re‐evaluated by Panel on Additives and Products or Substances used in Animal Feed. Following an urgent request from the European Commission, the safety and efficacy of the product when fed to rabbits for fattening was assessed based on the available data submitted by the applicant at the beginning of the assessment. SAL‐Na is largely absorbed and metabolised. Metabolites have a reduced ionophoric activity. SAL is the marker residue. SAL‐Na is not genotoxic and not a carcinogen. A no observed adverse effect level (NOAEL) of 0.5 mg/kg body weight (bw) per day is derived from a study in dogs. Only data on feed intake and body weight were available to conclude on the safety of SAL for rabbits. Levels of 35 mg SAL/kg feed and higher were not tolerated by growing rabbits. The Panel considers the available data indicate that the additive is tolerated by rabbits for fattening up to 25 mg/kg. The safety of SAL in rabbits for fattening needs to be established by a tolerance study compliant with the current standards. Adverse effects on breeding does cannot be excluded. The simultaneous use of SAL‐Na with certain medicinal substances (e.g. tiamulin and valnemulin) and bentonite is contraindicated. Consumer exposure to residues of toxicological concern complies with the acceptable daily intake (ADI) of 0.005 mg/kg bw, after 1‐day withdrawal. A provisional maximum residue limit (MRL) of 0.01 mg/kg liver would ensure consumer safety. A 5‐day withdrawal period as proposed by the applicant is supported. SAL‐Na in feed for rabbits will not pose a risk for the aquatic environment. A risk for the terrestrial ecosystem is considered unlikely. Efficacy and effective dose of SAL‐Na under present farming conditions could not be established.