Safety of erythrosine for ornamental fish

摘要

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of erythrosine for ornamental fish. Erythrosine is a sensory additive belonging to the functional group colourants. In 2015, the FEEDAP Panel calculated the safe concentration in complete feed of ornamental fish to be 59 mg/kg complete feed. Considering that erythrosine contains 56.5% iodine, the safe level in feed of ornamental fish was recalculated taking into account the currently authorised maximum content of total iodine in complete feed and resulted to be 35 mg erythrosine/kg complete feed. The applicant submitted a new tolerance study in rainbow trout to demonstrate the safety of erythrosine for ornamental fish at doses higher than 59 mg/kg complete feed. The FEEDAP Panel noted that the study shows several limitations: (i) blood biochemistry was not measured, although required according to the guidance on the assessment of the safety of feed additives for the target species (ii) a low number of replicates (3 per treatment) which does not permit to obtain a reliable estimate and may not be sufficient to evidence differences between the groups (with no indication on the a priori power of the study design), and (iii) the use level group was not included in the study design. Owing to these three limitations, the FEEDAP Panel is not in the position to change its previous conclusions that the safe level of erythrosine in ornamental fish is 59 mg/kg complete feed. This safe level is reduced to 35 mg erythrosine/kg complete feed, when considering the iodine content of erythrosine and the currently authorised maximum content of total iodine in complete feed for fish.