Reducing the risk of allergen contamination in the factory

Transcription

1 Reducing the risk of allergen contamination in the factory Barbara Hirst RSSL Sponsored by

2 Reactions To Food ADVERSE REACTIONS TO FOOD GENERIC May occur in anyone who consumes sufficient quantity of the food SPECIFIC Occurs only in susceptible individuals intolerant to specific food components FOOD ALLERGY Immunologic mechanisms involved FOOD POISONING Eg. Microbiological (Salmonella), Chemical (mycotoxins) POLLEN FOOD ALLERGY NON-ALLERGIC FOOD INTOLERANCE COELIAC DISEASE CHEMICAL SENSITIVITY FOOD AVERSION 2

3 Challenges in Industry Allergen management is expected by: Regulators Customers through Codes of Practices Consumers Auditing bodies Guidance available is not always clear on: What to do? How to do it? Is it good enough? Evidence required?

4 Range of Requests Clients with multiple retail customers Challenge is have to satisfy multiple and widely different COPs Clients with single retail customer Challenge is that retailer may not be at forefront of best practice Clients who produce branded products only Challenge is if don t have allergens expertise in-house BRC may be only audit / standard Are not subject to multiple views / opinions through external audits

5 Challenges Allergen management in most manufacturing sites is difficult Typical sites are handling multiple allergens with frequent change-overs Increased demand for free-from production in non-dedicated or semi-dedicated production sites Substantiating a free-from claim requires a higher degree of certainty Focus on cleaning validation disproportionately Increase in product recalls

6 Consumer Risk Cross Packing Right product, wrong pack Incorrect Recipe Wrong ingredient Gross Contamination Partial incorrect ingredient, no cleaning, gross environmental contamination, raw materials Residual Cross contamination Ineffective cleaning Residual environmental contamination High Risk Low Risk 6

7 Allergen Related Product Recalls And Withdrawals Problem continues to escalate globally EU mandatory labelling of 12 allergens since 2005; of 14 allergens since 2008 Allergens accounted a significant proportion of all recalls in US and UK 75% of allergen recalls due to ineffective change control practices Average cost of recall - 650k 1M!!! Root causes Number of Alerts Number of products impacted

8 Recalls

9 SUPPLIERS ALLERGEN RISK MANAGEMENT PACKAGING FINISHED PRODUCT RAW MATERIALS STORAGE & WAREHOUSING PRODUCTION PROCESSES CHANGEOVER & TRIALS PACKAGING & POST-PRODUCTION GMP Management REWORK & WASTE ENGINEERING & MAINTENANCE HYGIENE & SANITATION EQUIPMENT & FACTORY DESIGN VALIDATION, VERIFICATION & MONITORING PERSONNEL HYGIENE & TRAINING LABELLING, TRACEABILITY & DOCUMENTATION

10 Principles Of Risk Analysis (FSA 2006) Risk assessment - what's the risk? Risk management can the risk be managed? Risk communication how to warn consumers? Risk review has the risk changed?

11 Allergen Risk Analysis Overview of RSSL s Quantitative Allergen Risk Assessment Toolkit Eight Steps 1. Scope your risk assessment 2. Allergen mapping 3. Highlight points of unintentional allergen presence (UAP) 4. Evaluate likelihood UAP will occur 5. Hazard evaluation determine the hazard associated with the allergen presence 6. Can control measures manage out / minimize the identified risk? 7. Confirm effectiveness of control measures validation and verification 8. Do labelling / warnings reflect risk assessment outcome?

12 Designing A Cleaning Validation Programme

13 Importance of Getting It Right Risk To consumer and business: Allergen present, but not detected - false negative To business: Allergen not present, but detected - false positive Mitigation Test kits detecting allergen in processed food Exhaustive validation Spiking of unknown matrices with clear recovery criteria Exhaustive validation Extensive knowledge of crossreactivities in RSSL s constantly expanding database Proactive approach - analysis of potential cross contaminants

14 Summary - Choosing the Right Testing Approach Right lab Right allergen Right test method Independently accredited? (BS EN ISO/IEC 17025) The laboratory and the test? Do they have both expertise and experience in this area? Can they advise you on sampling and on the right test? Can they advise you on what the result means? Proficiency testing assessment of competency Actionable results Potential contamination route Potential concentration Casein vs. whey Sensitivity of the test Sensitivity Matrix interference Cross reactivity Reproducibility not all kits are equal Measurement of uncertainty typical +/ % Rapid tests must be validated

15 Case Study: The importance of getting it right A customer produced egg and non-egg containing product Non-egg product tested and rapid cleaning tests for years = all not detected RSSL tested product and found egg Egg was cooked; most ELISA tests poor at detecting cooked egg (published literature agreed) Egg containing sample sent to 3 UKAS labs Lab A 1.8 ppm whole egg powder Lab B 1.2 ppm egg white protein RSSL 5600 ppm egg protein Theoretical level = 6000 ppm egg protein! Choose the right lab + tests a positive control

16 Industry Links We are actively involved with the following: Industry Bodies FDF, FDE, BRC Retailers Scientific Panels EFSA, ILSI, ifaam Regulatory Groups FSA, European Commission, Codex Patient Groups Coeliac UK, Anaphylaxis Campaign

17 Any Questions?