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The Testing Implications for Making ‘Free-from’ Food Myth versus Reality

The Testing Implications for Making ‘Free-from’ Food Myth versus Reality. Sonia J. Miguel. Overview. ‘Free-from’ legal requirements Testing: how much, how and where? How do things change if you scale up? Economic implications ‘Free-from’ versus action levels.

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The Testing Implications for Making ‘Free-from’ Food Myth versus Reality

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  1. The Testing Implications for Making ‘Free-from’ Food Myth versus Reality Sonia J. Miguel

  2. Overview • ‘Free-from’ legal requirements • Testing: how much, how and where? • How do things change if you scale up? • Economic implications • ‘Free-from’ versus action levels

  3. ‘Free-from’ Legal Requirements • ‘Gluten-free’ food products are the only ‘free-from’ products currently covered by legislation • There is no legislation to cover the claims “dairy-free, milk-free, egg-free, nut-free or allergen-free” • But all should comply with: • Food Safety Act 1990 • EC/852/2004 Directive • Food Information Regulation 2011

  4. History of ‘Gluten-free’ Labelling • 1983 Codex Standard products labelled ‘gluten-free’ if <200 ppm gluten in finished product • Revised standard in 2007 • Reduced the limit to <20 ppm gluten (‘gluten-free’) • New claim of ‘very low gluten’ for products <100 ppm gluten • New EC Regulation No. 41/2009 came into force in January 2012

  5. ‘Gluten-free’ Labelling EC Regulation No. 41/2009 • Covers ‘gluten-free <20 ppm as sold, not consumed • ‘Very low gluten’ <100 ppm (food containing cereal ingredients that have been processed to remove gluten) • Covers all foods pre-packed and loose • Food containing cereal derived ingredients that are <20 ppm could be labelled ‘gluten-free’ but cereals would need to be declared as ingredients – potentially confusing to consumers!

  6. Concept of ‘Due Diligence’ Business has done everything reasonable practical to manage allergens “There is a system” Can prove that it has operated diligently “The system must be shown to work”

  7. Does Size Matter? • The size of the company doesn’t matter, the legal requirements are the same: • Food Safety Act 1990 • EC/852/2004 Directive • Food Information Regulation 2011 • ‘Gluten-free’ Labelling. EC Regulation No. 41/2009 • Same rules in all countries in the EU

  8. Effective Allergen Control • HACCP • Principles • Supply Chain Assessment • Training • Informed • Labelling • Validation • Verification • Monitoring • Prerequisites • (GMP) • Sampling & Analysis

  9. How Much Sampling and How Often? • Results only as representative as samples submitted • Sampling plan linked to risk analysis to maximise probability of detecting contamination (if present) • Plan must consider following factors:

  10. Analytical Techniques • Protein based techniques • Separation technique • Liquid chromatography-mass spectrometry (LC-MS) • Immunochemistry assays • Enzyme linked immunosorbent assay (ELISA) • Rapid lateral flow devices (RLFD) • DNA based technique • Polymerase chain reaction (PCR and PCR-RT)

  11. ELISA • Based on antibody/antigen interaction • Antibodies are raised mainly against specific allergenic proteins • Clinically relevant (proven to cause reaction) • Quantitative within a standard range • Very specific and sensitive method (low mg/kg)

  12. Matrix Effects • Internal validation (spike recovery/inhibition studies)

  13. Rapid Lateral Flow Devices (RLFDs) Validation is vital Wide range of devices on the market

  14. Choosing the Best ELISA Test for the Detection of Gluten? • Antibodies on the market: R5, Skerritt & Hill, polyclonal, G12 • Each antibody is specific to a different epitope = different sensitivity • Different extraction protocols = different recoveries • Codex endorsed the R5 antibody but the regulation does not

  15. Choosing the Best ELISA Test for the Detection of Milk?

  16. Who Can Do It for You? • UKAS accredited • Verify ELISA kit manufacturer’s claims • Validate all new matrices for each ELISA kit • Test for inhibitors in PCR reactions • Inter-lab ring-trials (FAPAS)

  17. From Your Kitchen to the Factory • Review your risk assessment • External support • Training of your staff • Awareness • Supplier chain • Retailer • Code of practice, usually different for each retailer • British Retail Consortium (BRC)

  18. BRC v6 Requirements • Updates in current version • Documented risk assessment to identify routes of contamination • Documented policies and procedures to avoid cross contamination • Policy prescriptive

  19. What Are The Cost Implications? • Testing • Risk assessment must guide you to how much and what kind of testing is most appropriate • Risk assessment • Training for awareness at different levels • Consumer complaints

  20. ‘Free-from’ vs Action Levels • Recommended allergen action levels VITAL 2.0 FIS Europe Jan 2012 Dr. Sylvia Pfaff

  21. Free-from vs Action Levels

  22. Thank you for your attentionAny questions?Sonia.j.miguel@rssl.com0118 9184000

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