Proposal for MRLs and withdrawal period for Cycostat®66G for chickens and turkeys for fattening

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the proposal made by the applicant for the addition of MRLs in chickens for fattening and turkeys to the current authorisation of the additive Cycostat®66G and for the adaptation of the withdrawal period if applicable. Cycostat®66G containing 6.6 % robenidine hydrochloride is already authorised for use in chickens for fattening, turkeys and rabbits for fattening. Efficacy and safety of the product have been assessed by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) in two former opinions, establishing also an ADI. Consumer exposure from the consumption of tissues from chickens administered robenidine at the maximum authorised dose represents without withdrawal only a limited fraction of the ADI. Therefore, based on safety considerations, the FEEDAP Panel does not see the necessity for setting a withdrawal period for chickens for fattening and consequently of MRLs. The same conclusion applies to turkeys for fattening. The FEEDAP Panel considers robenidine as the marker residue in chickens and turkeys. Ratios for the marker residue to total residue could be established for a zero withdrawal time in both dpecies. If MRLs are required, the FEEDAP Panel proposes: • chicken – per kg wet tissue: 0.80 mg for liver, 0.35 mg for kidney, 0.20 mg for muscle and 1.30 mg for skin/fat, • turkey – per kg wet tissue: 0.40 mg for liver and skin/fat and 0.20 mg for kidney and muscle. The residue intake calculated from the above MRLs is below the ADI (95 % for chickens and 48 % for turkeys). These values overestimate the real exposure due to the insensitivity of the analytical method for the determination of tissue residues. Off-flavours were observed in edible tissues of chickens for fattening until three days after withdrawal. Despite the absence of data on the impact of robenidine on the sensory properties of turkey products, the FEEDAP Panel considers that chickens and turkeys should be regarded similarly. As a consequence, the FEEDAP Panel proposes a five-day withdrawal period for chickens and turkeys for fattening, to avoid off-flavours in edible tissues from poultry treated with robenidine. To guarantee the quality of the product, a Maximum (food product) Processing Compatible Residue (MPCR) should be introduced which would be considerably lower than the MRL. Due to the insufficient sensitivity of the available method of analysis and the absence of data at five-day withdrawal, the FEEDAP Panel cannot propose such an MPCR for robenidine.

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(FEEDAP), EFSA: Proposal for MRLs and withdrawal period for Cycostat®66G for chickens and turkeys for fattening. 2008.

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