National Reference Laboratory for Control of Residual Quantities of Active Substances of Veterinary Drugs and Feed Additives

National Reference Laboratory of Veterinary Drug Residues Control

Foundation of the National Reference Laboratory of Veterinary Drug Residues Control (hereinafter referred to as the Reference Laboratory) within the State Scientific Research Control Institute of Veterinary Medicinal Products & Feed Additives (SCIVP), approved by the State Veterinary and Phytosanitary Service of Ukraine and approved by the Order №40 of April 15, 2016. The Reference Laboratory was established to carry out the research in the field of control of the content of active pharmaceutical ingredients (APIs) and their target metabolites of the registered veterinary medicinal products and feed additives, as well as of growth promoters prohibited by national legislation in food products of animal origin. The above activities were aimed to implement the articles of “The Law on Veterinary Medicine of Ukraine”, in particular Articles 17, 61 and 65 and other bylaws in force at the time.

The Reference Laboratory was created on the basis of the Laboratory of Instrumental Methods of Control, which was a part of the Testing Centre of SCIVP. In accordance with current national and international legislation, the Testing Centre is accredited by the National Accreditation Agency of Ukraine (NAAU), in accordance with the requirements of EN ISO/IEC 17025:2017. To comply with current legislative requirements, in particular with the resolution of the Cabinet of Ministers of Ukraine of January 10, 2019 №10 “On approval of the Procedure and criteria for authorization of accredited laboratories, including reference laboratories, and the Procedure for verification of compliance by authorized accredited laboratories, including reference laboratories, criteria of authorization and deprivation of such authorization”, the Reference Laboratory was accredited by EN ISO/IEC 17043:2010, and was recognized by the State Service for Food Safety and Consumer Protection as meeting the criteria for authorization of reference laboratories (Order №13 from 06.01.2022). The activities of the Reference Laboratory are also in line with the current version of the Law on Veterinary of Ukraine and the Law of Ukraine “On state control over the compliance with the legislation on food, feed, animal by-products, veterinary medicine and animal welfare”, the Law of Ukraine “On Safety and Hygiene feed”, the resolution of the Cabinet of Ministers of Ukraine of August 22, 2018 №648 “Procedure for the performance of arbitration laboratory researches (tests) and taking into account their results for the purposes of state control”, and other current national legislation.

Main areas of activity

Participation in the development, testing and correction of measures provided for by the National Targeted Economic Program for Monitoring of Residual Quantities of Veterinary Drugs and Contaminants in Live Animals, Products of Animal Origin and Feed, as well as Food Products Controlled by the Veterinary Service.
Collection and analysis of information about the current world maximum residue levels (MRL) of registered APIs of veterinary medicinal products, the sensitivity of the available methods of prohibited substances control and providing the recommendations to State Service of Ukraine for Food Safety and Consumer Protection.
Assessment of possible risks from the use of new registered veterinary medicinal products related to the effects of their residues and metabolites on the safety of products of animal origin.
Cooperation with domestic institutions subordinate to other ministries and agencies, in order to coordinate measures to reduce the risk from veterinary drugs residues and contaminants in food.
Scientific support of the development of the annual plan of state monitoring of veterinary drug residues and contaminants in animals, products of animal origin and feed.
Development, approval, validation and introduction of new effective methods of control of veterinary drug residues and contaminants in products of animal origin, feed and feed additives into the relevant laboratories under the management of State Service for Food Safety and Consumer Protection.
Approbation and adaptation to the conditions of the above laboratories of new modern methods, test systems and equipment used in the field of control of veterinary drug residues and contaminants in animals, products of animal origin, feed and feed additives.
Adaptation of the developed methods to the conditions of laboratories which conduct research with certain types of agricultural products and feeds, provided for in the annual plan of state monitoring of veterinary drug residues and contaminants.
Carrying out training, internship and certification of employees of laboratories under the management of the State Service of Ukraine for Food Safety and Consumer Protection in the field of methods of control of veterinary drug residues and contaminants in animals, products of animal origin, feed and feed additives.
Development and certification of reference matrices of products of animal origin to verify the suitability and precision of methods for the determination of veterinary drug residues.
Participation in the organization of proficiency testing rounds for the laboratories under the management of the State Service of Ukraine for Food Safety and Consumer Protection, in the field of methods of control of veterinary drug residues and contaminants in live animals, products of animal origins, feed and feed additives.
Development of methods for control of new pharmacological substances or new dosage forms of veterinary medicinal products.
Study of bioequivalence of new veterinary medicinal products by comparing their pharmacokinetics with reference veterinary medicinal products in order to establish scientifically based proposals for their withdrawal.
Verification (and, if necessary, additional research) in order to confirm the optimal withdrawal period of active substances of veterinary drugs within the procedure of registration of new veterinary drugs.
Carrying out arbitration studies of residual quantities of veterinary drugs, prohibited APIs and their metabolites in animals, products of animal origin, feed and feed additives of domestic and foreign production.
Participation in European and international scientific forums on the control of residual amounts of veterinary drugs, prohibited substances, contaminants and their metabolites in products of animal origin, feed and feed additives.
Cooperation with international scientific, governmental and independent organizations working in the field of control of veterinary drug and their metabolites residues in animal products.
Creation of electronic databases on physicochemical properties and biological activity of medicinal substances, metabolites, methods of their control in live animals, products of animal origin, feeds and feed additives.
Carrying out the research to study the effectiveness of modern antimicrobial drugs to continue their use with minimal risk of antimicrobial resistance, the introduction of new substances and the search for alternative ways that can be used in animal husbandry to replace antimicrobial agents.

The structure of National Reference Laboratory of Veterinary Drug Residues Control

The Reference Laboratory includes:

a) a unit of clinical and pharmaceutical analytics, which performs a comprehensive study of veterinary medicinal products, in order to establish scientifically based proposals for withdrawal periods after their use, as well as investigates the effectiveness of new veterinary medicinal products by studying their bioequivalence;

b) a unit for the control of veterinary drug residues, which performs the analysis of product of animal origins (milk, meat, eggs, aquaculture, etc.) for the residues of APIs of veterinary medicinal products and feed additives.

A separate area of work of this unit is the control of safety of beekeeping products; its activities are aimed at the compliance with veterinary and sanitary requirements for honey and bee products in terms of their quality and safety through control of veterinary drug residues, prohibited and undesirable substances in accordance with applicable national and international legislation. These activities are aimed to implement the legislation related to the effective use of antimicrobial and antiparasitic agents in beekeeping in accordance with OIE standards and to aid in the fight against the use of unlicensed and counterfeit products.

The presentation of scientific developments in the field of control of honey safety during the scientific conference XXXXVI International Congress on Beekeeping Apimondia, September 2019, Montreal.

Accreditations:

The Reference Laboratory has been accredited by the national authority (NAAU) in accordance with EN ISO/IEC 17025:2017, and in accordance with EN ISO/IEC 17043.

The Reference Laboratory performances:

the development and validation of LC-MS/MS and ELISA methods of drug residues assay in food of animal origin, animal tissues, parenchymal organs, plasma and serum;
UPLC-MS/MS and ELISA control of drug residues in food of animal origin;
UPLC-MS/MS, HPLC and ELISA study of pharmacokinetics and withdrawal periods of veterinary drugs;
in vivo preparation of incurred reference matrices of animal tissues by administering animals with medicated feed or veterinary drugs (according to the principles of bioethics and Council Directive 86/609/EEC) and the determination of analyte’s concentration by the developed LC-MS/MS methods;
application of classic and innovative blood sampling techniques (e.g., dried blood spot, Mitra^TM Microsampling);
providing of homogeneity of reference matrices according to ISO 13528:2015;
providing of PT rounds of honey assay on antibiotics residues according to
EN ISO/IEC 17043;
AAS determination of trace elements in various samples;
participation in international PT rounds.