Information about the new withdrawal period of Toltrazuril
Notice from the Federal Office for Safety in Health Care on measures to ensure drug safety:
Important information from the Federal Office for Safety in Health Care on the new withdrawal period for veterinary medicinal products containing toltrazuril for oral administration to chickens.
Concerns the following Austrian marketing authorizations:
- Baycox Direct 25 mg/ml solution for administration via drinking water for chickens and turkeys (Z.Nr. 835735)
- Zuritol 25 mg/ml solution for administration via drinking water for chickens (Z.Nr. 8-01100)
Summary
In the interest of consumer safety in the European Union, the Netherlands initiated a procedure under Article 35 of Directive 2001/82/EC on 10 December 2021 for veterinary medicinal products containing toltrazuril for oral administration to chickens. Due to the demonstrated very long retention of toltrazuril in the eggs of treated birds, it was considered that a withdrawal period of 4 weeks before the start of the laying period (as indicated in the product information of several veterinary medicinal products authorized in the EU) may not be sufficient to ensure compliance with the recommended maximum residue limit in eggs of 140 μg/kg.
The withdrawal period was considered too short to ensure that residues in eggs do not exceed the acceptable daily intake for humans, potentially posing a risk to consumers.
Subsequently, the European Medicines Agency's (EMA) Scientific Committee for Veterinary Medicinal Products (CVMP) reviewed all available residue data and recommended an extension of the withdrawal period before the start of the laying period, which was published by a corresponding Commission implementing decision dated Nov. 9, 2022.
Accordingly, the withdrawal period for eggs of veterinary medicinal products containing toltrazuril for oral administration to chickens shall be respected with immediate effect as follows:
Withdrawal Period
Not for use in birds producing or intended to produce eggs for human consumption.
Do not use within 6 weeks before the start of the laying period.
Further information
Evaluation of the European Medicines Agency (EMA):
https://www.ema.europa.eu/en/medicines/veterinary/referrals/veterinary-medicinal-products-containing-toltrazuril-be-administered-orally-chickens
