ANNEX II
The studies referred to in Article 3(2) shall include:
specifications for physico-chemical characteristics of the product, such as pH, aw, salt content, concentration of preservatives and the type of packaging system, taking into account the storage and processing conditions, the possibilities for contamination and the foreseen shelf-life, and
consultation of available scientific literature and research data regarding the growth and survival characteristics of the micro-organisms of concern.
When necessary on the basis of the abovementioned studies, the food business operator shall conduct additional studies, which may include:
predictive mathematical modelling established for the food in question, using critical growth or survival factors for the micro-organisms of concern in the product,
tests to investigate the ability of the appropriately inoculated micro-organism of concern to grow or survive in the product under different reasonably foreseeable storage conditions,
studies to evaluate the growth or survival of the micro-organisms of concern that may be present in the product during the shelf-life under reasonably foreseeable conditions of distribution, storage and use.
The above mentioned studies shall take into account the inherent variability linked to the product, the micro-organisms in question and the processing and storage conditions.