ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of September 26, 2023 No. 721

About approval of the Veterinary sanitary standard establishing analytical methods of determination of remaining balance pharmacological of the active agents used at animals from whom receive foodstuff, and about interpretation of results

Based on part (3) article 27 of the Law No. 221/2007 on veterinary and sanitary activities (repeated publication: The official monitor of the Republic of Moldova, 2021, Art. No. 13-20, 10), with subsequent changes, and parts (1) article 9 of the Law No. 50/2013 on official control for the purpose of check of compliance to the fodder and food law and the rules concerning health and wellbeing of animals (The official monitor of the Republic of Moldova, 2013, Art. No. 122-124, 383), with subsequent changes, DECIDES: the Government

1. Approve the Veterinary sanitary standard establishing analytical methods of determination of remaining balance pharmacological of the active agents used at animals from whom receive foodstuff (are applied).

2. Recognize invalid:

1) the Order of the Government No. 265/2009 about approval of Regulations about application of test methods and interpretation of results in the field of veterinary sanitation, with subsequent changes, (The official monitor of the Republic of Moldova, 2009, Art. No. 75-77, 321);

2) the Order of the Government No. 782/2010 about approval of Veterinary sanitary standard on selection of official tests from live animals and from animal products (The official monitor of the Republic of Moldova, 2010, Art. No. 160-162, 871).

3. To impose control over the implementation of this resolution on the National agency on safety of foodstuff.

Approved by the Order of the Government of the Republic of Moldova of September 26, 2023 No. 721

The veterinary sanitary standard establishing analytical methods of determination of remaining balance pharmacological of the active agents used at animals from whom receive foodstuff

This Veterinary sanitary standard establishing analytical methods of determination of remaining balance pharmacological of the active agents used at animals from whom receive foodstuff shifts Executive regulations of the Commission (EU) No. 2021/808 of March 22, 2021 about application of analytical methods for determination of remaining balance pharmacological of the active agents used at farm animals and about interpretation of results, and also about methods which will be used for sampling, and cancellation of Decisions 2002/657/EU and 98/179/EC, CELEX: 32021R0808, published in the Official magazine of the European Union by L 180 of May 21, 2021 with the last amendments made by Executive Regulations of the Commission (EU) No. 2021/810 of May 20, 2021 and Regulations of the Commission (EU) No. 2019/1871 of November 7, 2019 about reference levels of effect of the active agents which are not permitted pharmacological containing in foodstuff of animal origin and also about cancellation of the Decision 2005/34/CE, CELEX: 32019R1871, published in the Official magazine of the European Union by L 289 of November 8, 2019.

1. The veterinary sanitary standard establishing analytical methods of determination of remaining balance pharmacological of the active agents used at animals from whom receive foodstuff (further - Veterinary sanitary standard) is applied when carrying out the official control directed to check of observance of requirements for availability of remaining balance pharmacological of active agents and establishes the rules concerning the methods of the analysis used for sampling and laboratory analyses concerning remaining balance pharmacological of active agents in live animals from whom receive foodstuff, their parts of body and liquids, excrement, fabrics, animal products, by-products of animal origin, sterns and water.

2. In this Veterinary sanitary standard the concepts determined in the Law No. 306/2018 on safety of foodstuff, the Order of the Government No. 195/2011 on approval of the Provision establishing measures and procedures for determination of the most admissible levels of remaining balance of active pharmaceutical agents in foodstuff of animal origin and also the following concepts are used:

absolute extraction - exit at the final stage of analytical process for anolyte, divided into the amount of anolyte in initial test expressed as a percentage;

accuracy - proximity of compliance between result of testing and the accepted true reference value determined by assessment of truth and pretsizionnost;

alpha () - mistake - probability that the examinee sample conforms to requirements even if the inappropriate result of measurement is received;  

anolyte - component of the analyzed system;

the permitted substance - pharmacological the active agent permitted for use at animals from whom receive foodstuff, according to provisions of the Law No. 119/2018 on medicines of veterinary assignment;

beta () - mistake - probability that the tested sample really does not conform to requirements even if the corresponding result of measurement was received;  

systematic error - difference between calculated value of test result and the accepted reference value;

standard - traceable standard for measurements which represents amount of the interesting substance in such a way that its value contacts reference base;

the certified reference material (CRM) - the reference material accompanied with documentation issued by authorized body, and providing one or several preset values of properties with the corresponding uncertainty and traceability using admissible procedures;

joint chromatography - method in case of which unknown substance is applied on hromatografichesky substrate together with one or several known connections counting on the fact that the relative behavior of unknown and known substances will help with identification of the unknown;

joint survey - the analysis of the same sample (samples) with use of the same method for determination of work characteristics of method in different laboratories when the research allows to calculate random error of measurement and laboratory error for the used method;

confirmatory method - method which provides the complete or additional information allowing to identify unambiguously substance and, if necessary, quantitatively to determine at the maximum level of remaining balance (further - MUO) or the maximum level for the permitted substances, in case of reference values for the prohibited or not permitted substances concerning which reference value, or at minimum possible level of concentration for the prohibited or not permitted substances concerning which reference value is not established is established;

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