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Allergen Management, Supporting Your Business Ruth Bell, AF Associates International Food Safety and Quality Management Specialists [email protected] www.af-associates.co.uk www.ifsqn.com

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Page 1: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

Allergen Management, Supporting

Your Business

Ruth Bell, AF Associates

International Food Safety and Quality Management

Specialists

[email protected]

www.af-associates.co.uk

www.ifsqn.com

Page 2: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

www.ifsqn.com

Ruth Bell MSc, FIFST

Specialisms:

• Implementation of Quality and Food Safety Management

Systems based around BRC/ISO/IFS/SQF/AIB standards

• Technical & Legal support

• 3rd Party Auditor

[email protected]

Page 3: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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AF AssociatesInternational Food Safety and Quality Management Specialists

AF Associates is a leading provider of QFSM Consultancy, Auditing and Training to all sectors of the Feed & Food Industry.

• Quality and Food Safety Management System Development

• BRC/IFS/SQA Standard Advice

• ISO 22000 Standard Advice

• Auditing

• Food Legislation & Technical Support

• Bespoke & Certificated Training

• E-Learning courses

Page 4: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Allergen Management

• Allergens

• Differences between allergy and intolerance

• Principles of allergen management

Page 5: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Why do we need Allergen Management?

• Increase consumer confidence in label

information

• Reduce number of incidents / alerts

• Reduce number of recalls / withdrawals

• Brand protection

Page 6: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Poll

• Have you had an allergen incident at your

premises?

• Yes

• No

Page 7: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Allergens

Allergens remain a big

food safety news story

Page 8: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Allergens

• > 120 foods cause allergies

• Limited number considered public health

concern

• Foods most commonly causing serious allergic

reactions worldwide: Cereals containing

gluten, milk, egg, tree nuts, peanuts,

soybeans, fish, crustacea

Page 9: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Allergen Labelling Requirements

• Most countries require labelling of the

common allergy causing foods

• Foods causing allergy differ between

geographical region

• Some countries have additional foods which

must be declared as allergens

Page 10: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Food Allergens

Which allergens do you handle at your site?

Page 11: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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FSA Recalls

• Food Standards Agency Incident Report 2013

– 91 allergen alerts in 2013

– First significant drop since records started in 2006

FSA Annual Report of Incidents 2013

Page 12: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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FSA Recalls

All resulting

in Product

Recall

FSA Annual Report of Incidents 2013

Page 13: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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FSA Recalls

• Does not include “withdrawals”

– Not reported to FSA

– Allergen contamination at manufacturing

– Real figure likely to be much higher

Page 14: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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FSA Recalls

• Costs of product recalls

– Tangible and Intangible

Page 15: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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FSA Recalls

• Labelling issues

• Cross packing issues

• Cross contamination issues

Page 16: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Alerts

• Recall of gluten free product due to the

presence of gluten 10.06.15

• Recall of strawberry cheesecakes as they

contain trifle which has egg as an ingredient

08.06.15

• Recall of dried cranberries as they contain

sulphur dioxide not declared on the label

22.05.15

Page 17: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Adverse reaction to food Abnormal reaction

Predictable in population

toxicological pharmacological biological

e.g. histamine e.g. alcohol e.g. Salmonella

aversion intolerancetrue food

allergy

Metabolic

defect

Metabolic

defect

e.g. Coeliac

disease

e.g. Coeliac

disease

sensitisation

IgE

medicated

IgE

medicated

Classification of reactions to food

Page 18: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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What is …….

Intolerance

Is a negative reaction to food and may be:

• Immune system related (allergy)

• Related to lack of enzymes or chemicals to digest certain foods in the body

• Reaction to certain chemicals (natural or otherwise) in the food

Page 19: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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What is Intolerance?

• Intolerance

– Reaction by body to food consumed

– No immune system response

– Typically occurs if larger amounts of food consumed

– Body usually unable to produce particular chemical reaction to break down the food

Page 20: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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What is Intolerance?

• Common food intolerances

– Lactose intolerance

– Coeliac disease (Gluten intolerance)

– Some food additives

– Phenylketonuria (PKU)

Page 21: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Typical Symptoms of Food Intolerance

• Nausea

• Bloating

• Abdominal pain

• Diarrhoea

Page 22: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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What is……

Allergy

Occurs when the immune system reacts adversely to a

food substance that is harmless to most people.

Anaphylaxis

Is at the extreme end – a severe, rapidly occurring

allergic reaction

Page 23: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Typical Symptoms of Allergic Reaction

– Swelling (Throat & Mouth)

– Restriction of Airways

– Weakness

– Light-headedness

– Unconsciousness

Death or serious long term health issues

Page 24: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Typical Symptoms of Anaphylaxis

Page 25: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Definition of True Food Allergen

A form of food intolerance associated with a

hypersensitive immune response – a so called

immunoglobulin E (IgE) – mediated reaction in

which antibodies are formed.

Page 26: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Food Allergy Reactions

• A reaction to a protein in the food

• The body’s immune system mistakenly identifying a normally harmless substance for a dangerous ‘invader’

• The effect is incurable, being life-long with very small quantities of protein causing a severe reaction

• A reaction only occurs to sensitive individuals

Page 27: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Treatments

There is NO CURE

How is allergy diagnosed?

• Warning signs – i.e. mild attacks

• Full blown attacks

• Testing

Page 28: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Treatments

• Epi-Pen

• Piriton – for milder cases

• Avoidance of foods

• Prevention of contamination by the food

industry

Page 29: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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The Anaphylaxis Campaign States:

“It is up to the individual to avoid the food and

carry necessary treatments,

BUT

it is up to the food industry to minimise risks by

prevention of contamination”

Page 30: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Avoidance & Prevention

• Avoidance & Prevention are both needed as

neither is good enough on their own, with

treatment as necesary

• Individuals must avoid

• Industry must prevent

Page 31: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Aims of an Allergen

Management System

Aims:

• Know what allergens are being intentionally

added

• Minimise / eliminate the presence of

unintentionally added allergens

Justify any advisory warning statement

Consistent approach to labelling

Page 32: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Management of Risk

A business must risk assess its capability to

provide safe food to people with food

allergies

Allergens need to be identified throughout the

process by risk assessment and managed to

avoid their unintentional presence in products

wherever possible.

Page 33: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Management of Risk

• Consider if ingredient/product intentionally contains an

allergenic foodstuff

• Do these foods have the potential to cross contaminate

ingredients coming into or foods on the premises (risk

assessment)

• Implement measures to avoid unintentional presence

Page 34: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

Allergens Intentionally PresentProduct Nuts Peanuts Sesame Fish Mollusc

s

Crustac

eans

Egg Milk Soya

Beans

Gluten Lupin Mustar

d

Celery Sulpher

Dioxide

Almond Tart Ground

Almond

s

(Powde

r)

Flaked

Almond

s (Solid)

Dried

Egg

White

(Powde

r)

Liquid

Egg

(Liquid)

Soya

Lecithin

in

Margari

ne

(Solid)

Wheat

Flour

(Powde

r)

Sugar

(Powder)

Apple Pie Liquid

Egg

(Liquid)

Butter

(Solid)

Whey

Powder

(Powde

r)

Soya

Lecithin

in

Margari

ne

(Solid)

Soya

Flour

(Powde

r)

Wheat

Flour

(Powde

r)

Glucose

Syrup

(Liquid)

Allergen not

used on site

Allergenic

ingredient used

in this product

as an

intentional

ingredient

Allergen used

on site but not

used in this

product as an

intentional

ingredient

www.ifsqn.com

Page 35: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Risk Assessment

Page 36: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Identify Probability of Unintentional

Presence of Allergens

Draw a detailed flow of all ingredients and raw materials through factory process indicating areas of concern

Risk assess each step for the potential of cross contamination of the finished product with unintended allergens

Page 37: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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How to Assess the Risk?

– HACCP Principles

– Ensure team covers all areas (not just technical)

– Identify risks from process flow

– Assess the risk at each stage

– Use a risk matrix

• Likelihood versus Severity

Page 38: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Allergen Risk Matrix

Page 39: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Interpretation of Risk Matrix

Low Risk

Established control measures are appropriate and should be sufficient to minimise /

eliminate risk, no further action is required, other than to ensure that controls are

maintained.

Medium RiskConsideration should be given as to whether the risk can be lowered to an

acceptable level, costs of additional risk reduction should be taken into account.

High Risk

Substantial effort should be made to reduce the risk, risk reduction measures should

be implemented urgently with a defined action plan in place for monitoring risk.

Interim control measures may need to be implemented, particularly if the risk levels

are associated with harmful consequences.

Page 40: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Detailed Assessment by Product

Allergen of

Concern

Product at Risk

(i.e. Does not

contain the

allergen as in

intentional

ingredient)

Pu

rch

ase

Inta

ke

Sto

res

Tra

nsf

er

to

Pro

du

ctio

n/B

ake

ry

Sie

ve

We

igh

Up

Mix

ing

Are

a

Sto

rag

e o

f W

IP

Ass

em

bly

Lin

es

Fre

ezi

ng

Pa

ckin

g

De

spa

tch

Sesame Almond Tart Low Low Low Low Low High HighMediu

mHigh Low Low Low

Milk Almond Tart Low Low Low Low High High High LowMediu

mLow Low Low

Mustard Almond Tart Low Low Low Low High High High LowMediu

mLow Low Low

Page 41: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Process Controls

Page 42: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Preventing Cross Contamination

The defences in preventing cross contamination

take 2 main forms:

• Systems/Procedures

• Process controls

Page 43: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Scheduling

• Production schedules should run no or low

risk allergenic products first and high risk

allergenic products last

• All product must not be allowed to cross

contaminate the next product to be produced

Page 44: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Procedures

• Procedures for the control of allergenic material, detailing responsibility, frequency of procedures, recording of results and corrective actions

• Staff must be trained against these procedures and refresher training provided as required

Page 45: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Process Controls

Page 46: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Allergen Control

• Monitoring of control measures

• Corrective action

• Verification through audit

Page 47: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Test Types

• Rapid Tests

– Qualitative test (presence/absence)

– Hand held system used on site

– Kits fairly cheap to purchase

– Use for verification and screening

Page 48: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Test Types

Picture © ESR 2007

Page 49: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Test Types

• ELISA Tests

– Enzyme Linked Immunosorbent Assay

– Specific types for different allergens

– Can be used on site

– LOD typically 1% but can be to 0.1%

Page 50: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Test Types

• PCR

– Polymerase Chain Reaction

– Identifies DNA within sample

– Professional lab use only

– LOD typically 0.01%

Page 51: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Allergen Risk Review

• Allergen management systems must be

monitored and reviewed to provide assurance

they are working correctly.

Page 52: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Reassessment

Review of allergenic status must be made when

modifying:

• Product formulation

• Processes/scheduling

This also applies to new products

Page 53: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Records

• Records must demonstrate effective allergen

management

• Effectively audited & documented

• Period of retention of records shall be defined

• Allergens should be included in Management

Review

Page 54: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Question

• What are you going to do now to manage

allergens?

Page 55: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Allergen Management

Page 56: Allergen Management Supporting Your Business Management Supporting Your Business.pdfAllergen Control •Monitoring of control measures •Corrective action •Verification through

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Thank you for listening

Questions?

Ruth Bell

AF Associates

www.af-associates.co.uk