Whether your field is aquatic products, fish breeding, veterinary pharmaceutical or disinfectants, Cefas can meet your needs in terms of residue depletion studies, incurred reference materials and radiolabelled metabolism studies.
Common EU harmonised legislation includes extensive and complex laws controlling the approvals of pharmaceutical and immunological products for use in veterinary medicine, especially for food species within the EU.
Data for withholding periods for new pharmaceuticals is required as part of a dossier submission to gain market authorisation. Older data supporting drug withholding period claims may require replacement with modern data to ensure consumer safety.
Cefas can deliver bespoke tank-based marker residue depletion studies to establish product withdrawal periods studies in accordance with VICH GL 48 guidelines.
Incurred reference materials
Some countries from which the UK imports fish products have less rigorous aquaculture regulations than we are used to. This means that the use of illegal medicines in aquaculture remains a real concern.
In order to confirm that standards are high, testing laboratories need access to incurred residue samples. These samples are produced by exposing live fish to potentially harmful substances, which allows proper validation of analytical methods. This enables us to reliably detect the presence of these harmful substances in fish meat.
Cefas can produce samples of tissues in a range of fish and crustacean species, with the harmful residues present in the way that they are incurred in nature.
For consumer safety, evidence must be produced to show that the proposed withholding period for new pharmaceuticals is sufficient to ensure that product residues (in fish this is in muscle and skin) will be below the EU-defined maximum residue level (MRL) at slaughter. The MRL defines, for foodstuffs of animal origin, the maximum level of residues that can be present without presenting any harm to the consumer.
Cefas can deliver tank-based metabolism studies in accordance with VICH GL 46 guidelines, to determine the quantity and identify the nature of residues. Bespoke tank studies are designed to assess total radioactive decline of radiolabelled products (typically 14C or tritium) in a range of fish species.
Our highly experienced scientists act as either study director or principle investigators in multisite studies that are Good Laboratory Practice (GLP)/Good Manufacturing Practice (GMP) compliant. For metabolism studies we partner with analytical laboratories who deliver the radiobiological and chemical analysis.
For more information on any of the above, please contact our team of experts.