Customer Focused, Science Driven, Results Led

Free-From – What Does It Really Mean??

Barbara Hirst–Consultant Food Safety & Quality

Free-From – What does it Mean?

• Regulatory

– Absolute claim unless there is a regulatory threshold

• Consumer

– Absolute claim regardless of medical or lifestyle choice

• Retailer

– Free-from different retailers = different rules

• Manufacturers

– How to guarantee the claim every time

• Catering

– Some equate “does not contain” to “free-from”

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Free-From – How Much Is Not?

• Regulatory

– Recall Level? Gluten = clear, Milk ≠ clear

• Consumer

– Any level above 0 is unacceptable – How to measure?

• Retailer

– May set acceptable levels based on which test / kit?

• Manufacturers

– How to substantiate it every time? How much testing?

• Catering

– Unlikely to do any testing – rely on other controls

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REGULATORY

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Claims

Claims – Regulations

• Gluten-Free is the only allergen for which specific legislation exists

– EU Regulation (EC) No 41/2009 established the rules for the use of the

terms gluten-free (≤ 20ppm) and very low gluten (≤ 100ppm). From 20

July 2016, rules relating to gluten will be governed by Regulation (EU) No

1169/2011 and set out in Commission implementing Regulation (EU) No

828/2014. Additional statements – “suitable for people intolerant to

gluten” or “suitable for coeliacs” will be allowed.

• All other claims are regulated through General Food Law Regulation (EC) No 178/2002

Lactose

• EU Directive 2006/141/EC

– Threshold for making a Lactose-free claim have only been

defined for infant formula and follow-on formula should be

≤10 mg/100 kcal (2.5 mg/100 kJ)

• EFSA Opinion in 2010

– EFSA Journal 2010;8(9):1777

• A precise threshold for galactose/lactose intake below which adverse effects are not elicited cannot be given

CONSUMER

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Consumer Choice

• Consumers purchase Free-from food for many reasons

– Have a diagnosed allergy / intolerance themselves

– Caring for or providing food for someone with a diagnosed allergy

/ intolerance

– They believe they have an allergy / intolerance

– They have made a lifestyle choice

• Personal / moral / ethical / religious reason

– Perceive free-from to be a heathier choice

• Standard for Free-from needs to be the same regardless

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RETAILER

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Retailers

• Growth of the Free-from market (Mintel Feb 2016)

– Sales in UK of free-from 2015 £470m, estimated to grow to

£531m in 2016 (up 13%)

– 48% of those who eat / buy free-from are likely to increase

consumption

– Up to 1/3 Brits have bought / eaten free-from (22% gluten-free,

19% dairy substitutes, 16% wheat-free and 16% lactose-free)

• Of these 27% healthy lifestyle, 19% allergy / intolerance

– 12% of new product launches in the UK in 2015 carried a GF

claim

• Drive to gain market share

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MANUFACTURER

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Manufacturers

• Encouraged to supply free-from as market growth increases

• Dedication for free-from

– Site fully dedicated

• The free-from allergen not allowed anywhere on site

– Production site fully dedicated

• The free-from allergen is not allowed in production, but allowed in staff

rooms and offices

– Production site semi-dedicated

• Free-from production zoned off

– Production non-dedicated

• Shared lines / equipment

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Dedication = Level of Risk

• Fully dedicated site

– Only risk is from incoming raw material suppliers

• Production fully dedicated

– Additional risk from staff into production area

• Production site semi-dedicated

– Risk from management of segregation controls

• Non-dedicated

– Risk is the whole site

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Low

High

New Guidance Free-From Nov 2015

https://www.fdf.org.uk/corporate_pubs/brc-free-from-guidance.pdf

Risk Assessment for Pre-Packed Foods

1. Supplier Quality Assurance

2. Facility Design

3. Production Controls

4. Product Testing

5. Distribution and Transport Practices

Raw Materials

• Need to ensure ALL raw materials for free-from production are free-from

– Raw materials, packaging, cleaning materials, engineering

materials

– Apply a risk based approach to prioritise raw materials

surveillance

• Use sampling program to confirm audit findings

• Do not use rapid tests to screen raw materials

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Physical Validation of Controls

• Warehouse Storage

– Challenge control systems based on location, scanning,

paper recording

– Challenge behaviour – reaction, speed and correction

• Staging

– Challenge control systems and people based on paper

recording

• Packaging

– Challenge control systems and people on all aspects of

packaging

• Training – knowledge checks and culture

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• If through risk assessment, cleaning has been identified as a control measure – it must be validated

• If verification of the cleaning is going to be used, it must be validated

•Monitoring of cleaning must be to a non-residue visible clean and ideally have independent sign off

Cleaning as a Control

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Choices for Analysis

• You do not have to validate every allergen or every line if

process and clean are similar

• Select a product that contains significant quantities of the

allergenic ingredient – test as a positive control

• Select an allergen for which a reliable quantitative test exists

– Ensure the test has been fully validated – Lowest LOQ Best test

• Clean after product that does contain the allergen

• Collect samples of swabs / rinse waters

• Always test next product made that does not contain the

allergen

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Choosing the Right Lab

• Are they independently accredited?

– BS EN ISO/IEC 17025

• Both the laboratory and for the

test you need?

• Do they have both expertise and

experience in this area?

• Can they advise you on sampling?

• Can they advise you on the right test?

• Can they advise you on what the result means?

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Scientific Integrity

Good sound advice

What does it mean to

me?

Sampling and Analysis

• Positive control – Ensure the test can recover a high level of expected amount

• Take swab samples from all different surfaces

• Take swab samples from difficult to clean / reach areas

• Swabs– Ensure results are reported in ug/swab, not ppm

• Next made product – Ensure that if the allergen was present the test and lab would detect it!

• Process should be repeated 3 times

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Acceptable Cleaning Validation

• Clean to a non detectable level and no allergen detected in Finished Product following the clean

• Use an accredited and expert lab and best available test

• Initial validation should be done 3 times with different shifts / teams to demonstrate effectiveness

• Repeated if anything changes and periodically

• Process fully documented with rationale recorded for choices of sampling and testing

Verification and Monitoring

• Cleaning must be to a standard procedure

• Visual no residue clean

• Independently checked and signed off

• Photos and KIPs can help

• Risk assessment to decide on verification testing

– May be reduced over time as evidence builds

• Rapid on site tests MUST be validated

• Only use for clean samples, not on ingredients / FP

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CATERING

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New Guidance Free-From Nov 2015

https://www.fdf.org.uk/corporate_pubs/brc-free-from-guidance.pdf

Risk Assessment for Catering

1. Catering Environment

2. Ingredients – Must buy Free-From

3. Staff Training

Validation in Catering

• Storage of Free-From ingredients

• Preparation of dishes

• Area for Free-From to be Made

• Time for Free-From to be made

• Go-To person on site – At All Times

• Communication is most critical

• Does not contain Free-From

• Training – Need to ensure accuracy, consistency and verification

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People - Communication

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CLOSING THOUGHTS

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Increase in Allergen Alerts in EU

UK – 2016 Increase on 2015

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Recalls in 2016

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Thank You

• Barbara.j.hirst@rssl.com

• www.rssl.com

• 0118 918 4000

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