Report of the Scientific Committee of the AESAN in relation to the shelf-life studies for Listeria monocytogenes in certain foodstuffs

Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs establishes that for RTE foods on which are able to support the growth of Listeria monocytogenes, the limit is absence in 25 g. However, a limit of 100 cfu/g is established for foodstuffs other than those intended for infants and for special medical purposes, given the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed this limit throughout the shelf-life. When necessary, food business operators will conduct studies in accordance with annex II of Regulation, especially on RTE foods that may support the growth of L. monocytogenes and may pose a risk for public health. Evidence proving that the limit of 100 cfu/g will not be exceeded throughout the product shelf-life shall be based on shelf-life studies, initially consisting of information on the product specific composition (intrinsic and extrinsic characteristics) and of comparison with data from relevant scientific literature on the pathogen growth and survival characteristics. The repository of data of manufactured products, the predictive microbiology and the specific shelf-life studies conducted in laboratory (durability and challenge studies) are additional tools to be used in case the studies on foodstuff composition, the process conditions and comparison to published data on scientific journals are not enough to prevent any doubt on L. monocytogenes ability to grow. Nevertheless, challenge studies on foodstuffs should be avoided and be used with caution. It is recommended these studies be conducted by food business operators only if they count on the means, training and experience on these microbiological techniques. In this document some guidelines are given for the implementation of the stipulations in annex II of Regulation ...ES; en; pfefsa@msssi.e