An overview of the Category Framework for assessing raw milk products
Introduction
Food Standards Australia New Zealand (FSANZ) is currently assessing the requirements in the Australia New Zealand Food Standards Code for the sale of raw milk products in Australia through Proposal P1007 Primary Production and Processing Requirements for Raw Milk Products. As part of Proposal P1007, FSANZ has developed a framework in which to consider the various products that could be considered. This Category Framework Approach defines three categories, taking into account the effect of production methods and the intrinsic characteristic of the final product in assessing the potential food safety risk.
FSANZ has based the development of the Category Framework approach on preliminary results of microbiological risk assessments currently being undertaken by the agency, which have examined production factors and intrinsic properties of selected dairy products. Processing factors include curd cooking temperature, acidification and storage time. Intrinsic factors include moisture content, acidity and salt concentrations.
Category Framework Approach
The three categories in the framework are defined by the effect that production methods and intrinsic characteristicsof the final products have on pathogen survival and growth. If the survival and growth of pathogens is more likely in some products, these products present a greater food safety risk compared to products where pathogen growth and survival is less likely.
The potential food safety risk associated with each category increases from Category 1 to Category 3, as shown below:

While cheese is the major commercial raw milk product being considered, the framework approach will endeavour to achieve outcomes that are applicable to all products, including cultured milk, yoghurt, butter, ice cream etc. Therefore, the scope of this Proposal will examine all activities associated with the production of raw milk products, from on-farm milk production through to retail sale and use by the consumer.
Category 1
Products in this category are defined as those products where intrinsic characteristics and/or processing techniques eliminatepathogens that may have been present in the raw milk.
Examples of products in this category would include the extra hard grating cheeses. These cheeses are made from raw milk by heating the curd to greater than 48 ° C, have low moisture content(<36%) and a long maturation/ripening period – steps that result in the death of pathogens and that lead to cheeses have an equivalent level of safety to pasteurised products.
Category 2
Products in this category are defined as those products where intrinsic characteristics and/or processing techniques may allowthe survival of pathogens present in the raw milk, but do not support the growth of these pathogens.
This category would apply to products where there is survival, but not growth, of pathogens that may have been present in the raw milk. In this case, control measures would need to ensure that the raw milk used to produce products is of an appropriate microbiological quality and that processing steps would achieve the necessary critical limits to control pathogens.
To produce these products, potentially a combination of control measures and verification activities will need to be applied to provide an acceptable level of microbial safety for consumption by the general population.
Category 3
Products in this category are defined as those products where intrinsic characteristics and/or processing conditions are likely to allow the survival of pathogens that may have been present in the raw milk and may support the growth of these pathogens.
Category 3 products are those where the processing steps that are applied would not reduce pathogens to an acceptable level. In general, if pathogens are present, they would be expected to multiply during manufacture. This category would include products such as raw drinking milk including raw goat’s milk and likely to include high-moisture content cheeses.
Application of Category Framework approach
Following the completion of the risk assessment and consumer research, FSANZ will use the outcomes to assess whether the nature of the hazards and the level of risk warrant permissions within the categories for the production of raw milk products for sale.
This would involve a variation to current regulatory requirements for the production of milk and dairy products in the Food Standards Code and other industry management interventions. The appropriate control measures underpinning any permission will be presented in assessments reports prepared during the development of a Primary Production and Processing Standard for Raw Milk Products.
December 2008