CLARIFICATIONS OF THE FAS OF RUSSIA ON THE USE OF IMMUNOASSAY TEST SYSTEMS HAVE BEEN SENT TO REGULATORY AND SUPERVISORY AUTHORITIES

The Southern Dairy Union has sent to the subordinate lower structures of Rosselkhoznadzor, Rospotrebnadzor and Rosakkreditatsiya the explanations received from the Federal Antimonopoly Service of Russia on the use of test systems to determine antibiotics within the framework of GOST 32219-2013 "Milk and Dairy Products. Immunoenzymatic methods for determining the presence of antibiotics", to provide a common understanding of the norms of the legislation, namely:
 
The response of FAS of Russia says that if IT is necessary to use test kits that are not included in GOST 32219-2013, they must be accompanied by certified (verified) methods with confirmed detection limits for each antibiotic to be determined. To confirm compliance with this standard, test kits must provide the required sensitivity and a list of measurable antibiotics within the limits specified in Table 1 of GOST, footnotes in GOST indicating test kits of specific manufacturers are recommended for use, respectively not mandatory.
 
It is also proposed to inform FAS about unreasonable refusal to certify methods for other test kits not included into GOST by sending to antimonopoly body an application according to requirements of Article 44 of the Law on Competition Protection and Administrative regulations of Federal Antimonopoly Service on execution of state function on initiation and consideration of cases on violation of antimonopoly legislation of the Russian Federation for initiation of proceedings on relevant grounds.
 
The work of the Southern Dairy Union to defend the interests of the industry and reduce the unreasonable costs of acquiring means of quality control of milk and dairy products continues. Continued in the comments
 

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