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Understanding 'Free-from' Food: Testing Implications, Myth vs Reality

Explore the legal requirements, historical context, due diligence, allergen control, sampling techniques, and ELISA tests for detecting gluten and milk. Learn about the cost implications, risk assessments, and the differences between 'free-from' claims and action levels.

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Understanding 'Free-from' Food: Testing Implications, Myth vs 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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