ANNEX IISupplementary provisions
ANNEX II The studies referred to in Article 3(2) shall include: — specifications for physico-chemical characteristics of the product, such as pH, a w , 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.