Supporting document 2 Guide to the validation of raw milk products Proposal P1022 – Primary Production & Processing Requirements for Raw Milk Products INTRODUCTION The safety of raw milk products is ensured through implementing appropriate through chain control measures. The food safety program for a raw milk product should document these controls from primary production through to the end of manufacture. Control measures that are specified in Standard 4.2.4 (e.g. specific cooling requirements) do not require additional validation by the business unless it wants to apply alternative parameters or procedures to meet those controls. A business must, however, validate the production process to be used for the manufacture of a raw milk product. The validation process should demonstrate that the combination of identified control measures (the process and product criteria used) is actually capable, on a consistent basis, of achieving the desired food safety outcome. The trial involved in validation of the process include (CAC/GL 69 2008; ICMSF 2011): – Identify the hazards intended to be controlled and determine the most resistant pathogen (most likely to survive the process) Identify the outcome required (the level of inactivation needed to achieve the acceptable level of hazard) Identify the measures that need to be validated (process and product criteria) Decide on the approach or combination of approaches Define the critical limits that need to be met during processing Define the specific equipment and operating parameters for the proposed process Assemble relevant validation information and conduct studies where needed Analyse the results Document and review the validation This document has been prepared to assist processors and enforcement agencies with the validation of the safety of raw milk products, in particular raw milk cheese. Further information to support this validation guide can be found in the FSANZ document Scientific information for the assessment of raw milk products cheeses. –
Supporting document 2 Guide to the validation of raw milk products – Proposal P1022 Primary Production & Processing Requirements for Raw Milk Products INTRODUCTION The safety of raw milk products is ensured through implementing appropriate through chain control measures. The food safety program for a raw milk product should document these controls from primary production through to the end of manufacture. Control measures that are specified in Standard 4.2.4 (e.g. specific cooling requirements) do not require additional validation by the business unless it wants to apply alternative parameters or procedures to meet those controls. A business must, however, validate the production process to be used for the manufacture of a raw milk product. The validation process should demonstrate that the combination of identified control measures (the process and product criteria used) is actually capable, on a consistent basis, of achieving the desired food safety outcome. The involved in validation of the process include (CAC/GL 69 – 2008; ICMSF 2011): Identify the hazards intended to be controlled and determine the most resistant pathogen (most likely to survive the process) Identify the outcome required (the level of inactivation needed to achieve the acceptable level of hazard) Identify the measures that need to be validated (process and product criteria) Decide on the approach or combination of approaches Define the critical limits that need to be met during processing Define the specific equipment and operating parameters for the proposed process Assemble relevant validation information and conduct studies where needed Analyse the results Document and review the validation This document has been prepared to assist processors and enforcement agencies with the validation of the safety of raw milk products, in particular raw milk cheese. Further information to support this validation guide can be found in the FSANZ document Scientific information for the assessment of raw milk products – cheeses. trial
P1022-PPPSRawmilk-1CFS-SD2.docx