EC Regulation 853/2004, in its Annex III, Section IX, defines hygiene rules for raw milk, in particular on somatic cells. According to the EC Regulation 2074/2005 modified by the EC Regulation No 1664/2006, the Standard EN ISO 13366-1 (2008) “Milk - Enumeration of somatic cells in raw cow’s milk - Part 1: Microscopic method (Reference method)” must be applied as reference method for the enumeration of somatic cells in raw milk, for controls conducted in the frame of EC Regulation 853/2004.
According to the same EC Regulation 2074/2005 modified, the use of alternative analytical methods is acceptable:
- when the methods are validated against the reference method EN ISO 13366-1, in accordance with the protocol set out in ISO 8196 (2009) “Milk - Definition and evaluation of the overall accuracy of alternative methods of milk analysis” divided in 3 parts: Part 1 “Analytical attributes of alternative methods”, Part 2 “Calibration and quality control in the dairy laboratory”, Part 3 “Protocol for the evaluation and validation of alternative quantitative methods of milk analysis”,
- and when operated in accordance with ISO 13366-2 (2006) “Milk - Enumeration of somatic cells - Part 2: Guidance on the operation of fluoro-opto-electronic counters” or other similar internationally accepted protocols.
The purpose of this document is to specify the criteria for the validation of a certain type of alternative methods (instrumental methods based on epifluorescence), to assess that the use of these alternative methods is acceptable for hygiene controls conducted in the frame of EC Regulation 853/2004. The main Standards to be taken into account to define these validation criteria are ISO 8196-Part 3 and EN ISO 13366-2.
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Date:
Monday, January 21, 2013
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Wednesday, September 18, 2013
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2013/01
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