Customer Focused, Science Driven, Results Led The Testing Implications for Making Free-from Food Myth versus Reality Sonia J. Miguel.

Customer Focused, Science Driven, Results Led

The Testing Implications for Making ‘Free-from’ Food

Myth versus Reality

Sonia J. Miguel

• ‘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

Overview

• ‘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

‘Free-from’ Legal Requirements

•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

History of ‘Gluten-free’ Labelling

‘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!

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”

Concept of ‘Due Diligence’

•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

Does Size Matter?

Effective Allergen Control

Supply Chain Assessment

Sampling & Analysis

HACCPPrinciples

Training

Prerequisites (GMP)

InformedLabelling

ValidationVerificationMonitoring

•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:

How Much Sampling and How Often?

•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)

Analytical Techniques

•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)

ELISA

• Internal validation (spike recovery/inhibition studies)

Matrix Effects

Validation is vitalWide range of devices on the market

Rapid Lateral Flow Devices (RLFDs)

•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

Choosing the Best ELISA Test for the Detection of Gluten?

Choosing the Best ELISA Test for the Detection of Milk?

Allergenic contamination source

Antibodies Calibrator Conversion to total milk protein

Skimmed milk powder (SMP)

Casein Total milk proteins

Result

Beta-lactoglobulin

Total milk proteins

Result

Milk proteins Total milk proteins

Result

Milk proteins SMP Result * 0.36

Caseinates Casein Casein Result * 1.25

Whey proteins Beta-lactoglobulin

Beta-lactoglobulin

Result * 10

•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)

Who Can Do It for You?

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)

•Updates in current version

•Documented risk assessment to identify routes of contamination

•Documented policies and procedures to avoid cross contamination

•Policy prescriptive

BRC v6 Requirements

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

•Recommended allergen action levels VITAL 2.0

‘Free-from’ vs Action Levels

Allergen name Total protein from food (mg)

Peanut 0.2

Milk 0.1

Egg 0.03

Hazelnut 0.1

Soya 1

Wheat 1

Cashew 2

Mustard 0.05

Lupin 4

Sesame seeds 0.2

Shrimps 10

FIS Europe Jan 2012 Dr. Sylvia Pfaff

Free-from vs Action Levels

Thank you for your attention

Any questions?

[email protected]

0118 9184000