GUIDANCE NOTE 18 Validation of Product Shelf-life (Revision 3) Guidance Note No. 18: Validation of Product Shelf-life (Revision 3)
Guidance Note No. 18 Validation of Product Shelf-life (Revision 3) Published by: Food Safety Authority of Ireland Email:
[email protected] Website: www.fsai.ie ©FSAI 2017 Applications for reproduction should be made to the FSAI Information Unit ISBN 1-904465-33-1
CONTENTS ABBREVIATIONS 1 1. INTRODUCTION 2 2. SCOPE 2 3. LEGAL REQUIREMENTS AND RESPONSIBILITIES FOR SHELF-LIFE 3 4. SETTING AND VALIDATING SHELF-LIFE OF FOOD 4 4.1 Describe the Food 6 4.2 Establish the Characteristics of the Food 7 4.2.1 Intrinsic characteristics 10 4.2.2 Extrinsic characteristics 19 4.2.3 Consultation of scientific literature 23 4.3 Predictive Microbiology 25 4.4 Laboratory Testing 26 4.4.1 Durability studies 27 4.4.2 Challenge testing 33 APPENDIX 1. SHELF-LIFE STUDIES FOR L. MONOCYTOGENES IN READY-TO-EAT FOODS UNDER REGULATION (EC) NO 2073/2005 ON MICROBIOLOGICAL CRITERIA FOR FOODSTUFFS 34 APPENDIX 2. SAFETY AND SHELF-LIFE OF FOODS WITH RESPECT TO CLOSTRIDIUM BOTULINUM 37 APPENDIX 3. HISTORICAL DATA 39 APPENDIX 4. LABELLING AND FOOD INFORMATION FOR CUSTOMERS 41 REFERENCES 43