PRECAUTIONARY ALLERGEN LABELLING – HOW CAN PAL REFLECT ACTUAL RISK?

Food Matters Live ExCeL London 22-24 November 2016

René Crevel

OUTLINE

• Precautionary allergen labelling: current

perspectives

• Risk and risk assessment

• Are we there yet?

3

…… PRECAUTIONARY (ADVISORY – “MAY

CONTAIN”) ALLERGEN LABELLING

• Introduced in the 1990s

• First suggested by CFIA/Health

Canada

• Voluntary

• Twin roles, closely intertwined

• Risk management and risk communication

• Effective outcome: people at risk avoid the

product

• Ineffective outcome: people at risk don’t believe

it and/or are confused by it and disregard it

THE PROBLEM WITH

PRECAUTIONARY LABELLING TODAY

»Numerous phrases with different risk

implications (although not necessarily

associated with real differences in levels of risk)

»Lack of transparency over its application

• No generally agreed set of reference values as

the basis for precautionary labelling

• Risk assessment process often unclear

»Allergic consumers are confused and many do

not trust precautionary labelling

»Significant numbers ignore it at least part of the

time, putting themselves at risk

VARIETY OF PAL PHRASES

Survey of allergen advisory labelling and allergen content of UK retail pre-

packed processed foods – Report for FSA by RSSL (2014)

PAL PHRASES: FURTHER VARIATIONS

ON A THEME OF “MAY CONTAIN”

and many more

Survey of allergen advisory labelling and allergen content of UK retail pre-packed

processed foods – Report for FSA by RSSL (2014)

8

…… PRECAUTIONARY (ADVISORY – “MAY CONTAIN”)

ALLERGEN LABELLING TODAY - SUMMARY

• No consistent standards for

application:

use dependent on internal

company standards and

perception of risks

• Negative perception by

consumers and health care

practitioners

• Result: misunderstanding and

mistrust, lack of observance and

consequently higher risks to

allergic consumers

1 Annex II food 10 Annex II foods

PAL statement not

expected on

product

PAL IS NOT MEETING ITS OBJECTIVES

9

0%10%20%30%40%50%60%70%80%90% Ben-Shoshan et al. JACI (2012) 129: 1401

Never purchase if labelled

0%

5%

10%

15%

20%

25%

30%

35%

40% Cochrane et al. Clin Trans Allergy (2013) 3: 31.

• Allergic consumers are disregarding PAL

statements to a significant extent

WHAT DOES/CAN A PAL STATEMENT MEAN?

10

Dunngalvin A, Chan CH, Crevel R et al. Precautionary Allergen Labelling:

Perspectives from key stakeholder groups. Allergy 2015, 70, 1039-1051

RISK AND RISK

ASSESSMENT

• The answer is in the question (at least partly):

Base it on risk

• Some considerations

• What is risk?

• What risk are we talking about?

• What do we need to know in order to base PAL

on risk?

SO HOW CAN PAL REFLECT ACTUAL RISK?

13

WHAT DO WE MEAN BY RISK?

Fundamental principle of toxicology:

“The dose makes the poison” (Paracelsus, 15th Century)

Implication: the key parameter is risk not hazard

Risk »the likelihood that, under particular conditions of exposure, an

intrinsic hazard will represent a threat to human health.

» Risk = f (hazard, exposure)

with a consideration of the nature of the effects

Characterising the hazard is therefore a critical step

FOOD ALLERGENS: DOSE AND EFFECT

Considerations

- Zero risk does not exist in practice

- What is an acceptable/tolerable risk?

- In terms of the nature (severity) of the effects?

- In terms of the frequency of effects (how many will be affected)?

RISK ANALYSIS IN FOOD

Three parts

Interactive and iterative process

Risk Analysis

Risk Assessment

Risk Management

Risk Communication

©2016

16

ASSESSING THE RISK FROM FOOD

ALLERGENS: HOW MUCH IS TOO MUCH?

What is the relationship

between dose and frequency /

severity of response?

How many people are likely to

suffer a reaction, and how severe

will the reaction be?

How much are people

exposed to?

Risk

characterisation Hazard

identification

Exposure

assessment

Hazard

characterisation What is the toxicological

concern?

PEANUT DOSE DISTRIBUTION:

CHARACTERIZING THE HAZARD

17

Cum

ula

tive P

erc

enta

ge o

f R

esponses

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Log-Normal Dose of Protein (mg)

0.01 0.1 1 10 100 1000 10000 100000

Discrete Cumulative

ED 01

ED 05

18

VITAL SCIENTIFIC EXPERT PANEL RECOMMENDATIONS

AND PROPOSED ACTION LEVELS.

Allergen Basis of

reference dose

Reference dose

(mg Protein)

50 g Serving

Size: Action

Level (ppm)

250 g Serving

Size: Action

Level (ppm)

Peanut ED01 0.20 4.0 0.80

Milk ED01 0.10 2.0 0.40

Egg ED01 0.03 0.6 0.12

Hazelnut ED01 0.10 2.0 0.40

Soy ED05 95LCI 1.00 20.0 4.00

Wheat ED05 95LCI 1.00 20.0 4.00

Cashew ED05 95LCI 2.00 40.0 8.00

Mustard ED05 95LCI 0.05 1.0 0.20

Lupin ED05 95LCI 4.00 80.0 16.00

Sesame ED05 95LCI 0.20 4.0 0.80

Shrimp ED05 95LCI 10.00 200.0 40.00

Celery Insufficient data

Fish Insufficient data

1

9

VITAL 2.0 REFERENCE DOSES

»Defined by reference to population health-

based outcomes (proportion likely to react)

»Serve as benchmarks for allergen management

• Define what is judged safe

• Define when additional risk management

measures are required e.g. PAL

RISK ASSESSMENT: EXPOSURE

Crevel RWR, Baumert JL, Baka A, Houben GF, Knulst AC, Kruizinga AG, Luccioli

S, Taylor SL, Madsen CB. Development and evolution of risk assessment for food

allergens. Food Chem Tox (2014) 67, 262-276.

HOW SAFE ARE VITAL 2.0 REFERENCE

DOSES: SINGLE DOSE CHALLENGES

2

1

• Concept

• Run in routine allergy clinics

• Challenge every patient attending for

the food allergy of interest (no exclusions)

• Single dose – ED05 selected as balance

between good safety and numbers

needed to be challenged for statistical

robustness

• Open challenges

• Information generated for risk assessment

• Validation of ED05 derived from dose distribution

modelling

• Severity profile at ED05

ED05

SINGLE DOSE CHALLENGES:

PEANUT STUDY

2

2

• 375 clinic attendees with peanut allergy

• Three centres: Cork, Melbourne, Boston

• 6mg whole peanut in a cookie (except for

participants allergic to other ingredients in the

cookie)

• Open challenge

• 2-hour post-challenge follow-up

• Data support the VITAL ED05 value of 1.5mg for

peanut protein

Full results expected to be published soon!

ARE WE THERE YET?

Chapter V. Article 36

“3. The Commission shall adopt implementing acts on the application of the

requirements referred to in paragraph 2 of this Article to the following voluntary food

information:

(a) information on the possible and unintentional presence in food of substances

or products causing allergies or intolerances;”

24

NEW REQUIREMENTS FOR VOLUNTARY

ALLERGEN INFORMATION (REG 1169/2011)

Precautionary labelling remains voluntary (Article 36)

»However mandatory requirements are introduced (e.g. name of

allergenic food)

»Specific rules apply:

“2. Food information provided on a voluntary basis shall meet

the following requirements:

(a) it shall not mislead the consumer, as referred to in Article 7;

(b) it shall not be ambiguous or confusing for the consumer;

and

(c) it shall, where appropriate, be based on the relevant

scientific data.”

WHAT COULD IT ALL MEAN?

(a) shall not mislead: PAL should be accurate, i.e.

use must be justified

(b)shall not be ambiguous or confusing:

terminology should be clear and limited to one

(or a few) well-understood terms

(c) be based on the relevant scientific data: PAL

should be based on a thorough risk assessment

(preferably quantitative)

DG SANTE-JRC STAKEHOLDER WORKSHOP

(GEEL, BELGIUM 16-17 JUNE 2016)

Participants (46): Delegates (19) from Member States' competent

authorities and delegates representing relevant stakeholders (e.g.

FoodDrinkEurope and the European Federation of Allergy and Airways

Disease Patients Association).

AIMS (provided by DG SANTE-JRC)

»Background: Regulation (EU) 1169 /2011 on the provision of

food information to consumers and the observed proliferation

of precautionary allergen labelling by food producers.

»To identify the sequence of steps required for framing the

current use of precautionary allergen information and its

enforcement across the EU.

DG SANTE-JRC STAKEHOLDER WORKSHOP

(GEEL, BELGIUM 16-17 JUNE 2016)

Agenda

SESSION 1: Legislative and Allergy Sufferers Requirements (DG SANTÉ,

EFA)

SESSION 2: Risk Based Approaches to Allergen Management

(FoodDrinkEurope, iFAAM)

SESSION 3: The Role of Analysis in Enforcing Legislation (JRC-IRMM)

» Breakout groups after each session

SESSION 4: Conclusions from Discussion Topics

» Topic 1: Legislative perspective on precautionary labelling, its current wording and conditions of

use

» Topic 2: Risk based approaches

» Topic 3: Comparing results from analytical measurements

DG SANTE-JRC STAKEHOLDER WORKSHOP

(GEEL, BELGIUM 16-17 JUNE 2016):

CONCLUSIONS 1

Legislative perspective on precautionary labelling, its current wording and

conditions of use.

» PAL terminology: should be simple, easy for consumers to understand

• “may contain” recommended

» Use of PAL should be subject to defined conditions and transparent:

» Documented risk assessment

» Allergen management procedures in place

» No PAL statement below reference dose

» Benchmarks need to balance degree of protection/safety and choice for

allergic consumerss (reference doses) need endorsement by EFSA

» Communication to users (both consumers and health care practitioners) is

crucial

DG SANTE-JRC STAKEHOLDER WORKSHOP

(GEEL, BELGIUM 16-17 JUNE 2016):

CONCLUSIONS 2

Risk-based approaches »Guidance on good risk assessment practice EU-wide required

»Protein is the hazard and should be basis of the risk assessment

»Stakeholders want acceptance (by the authorities) of the RDs defined

by VITAL

» They wish to encourage FBOs to use them and evaluate how well they work.

»Commission role to develop a framework based on general principles

» detail to be developed by other stakeholders (e.g. authorities, trade associations)

»Questions on readiness of FBOs for application of RDs (VITAL/iFAAM)

DG SANTE-JRC STAKEHOLDER WORKSHOP

(GEEL, BELGIUM 16-17 JUNE 2016):

CONCLUSIONS 3

Comparing results from analytical measurements

» Expressed results in units that can be directly applied to the risk assessment,

i.e. mg total protein/kg of food

» This links analysis to the materials used for clinical food challenges.

» Could be looked at in the context of Infrastructure to support framework:

• existing structures may provide a possible model e.g. Veterinary Medicines

» Priority allergens: wheat, milk and egg, based on frequency of RASFF

notifications for these allergens

» Guidance to good analytical practice for food allergens should be developed

• Nordic group could lead, based on their experience

» Further workshops likely needed as work developed

CONCLUDING REMARKS

Precautionary allergen labelling (PAL) continues to fail

allergic consumers

PAL needs to be based on transparent, understood and

accepted risk assessment

The VITAL 2.0 scheme proposed scientifically sound and

transparent reference doses, based on a human data which

form a basis for this risk assessment

Developing scientific and regulatory perspectives offer

opportunities to introduce a robust framework for the

application of PAL

Acting on these opportunities can restore the value of PAL

and thereby help allergic consumers as well as FBOs

THANK YOU FOR YOUR ATTENTION

33

Seven secrets to successful nutritional

labelling …….

…..and the seven sins commonly made with

health and nutrition claims

Mike Peters Dr Andy Bowles

Seven secrets to

successful nutritional

labelling – Mike Peters

Despite

Brexit !

Nutritional labelling is here to stay!

What’s in a label – take

a holistic approach!

Product Development

Portion &

cooking instructions

Fortification

Functional

Formulation

Nutrient reduction

or increase

On pack comments/claims

Food trends

Widen appeal

Nutritional analysis

The UK’s nutrition imbalance

*Vitamin A, riboflavin, iron, calcium,

magnesium, potassium, zinc, iodine

Not

enough F&V, Fibre

Omega 3

Vitamins/

minerals*

Too much Saturated fat

Sugar

Salt

Weight!

Sampling Matters!

Egg Milk Rye Wheat Biscuits French

beans

No. of labs 18 18 19 19 19 18

Mean

(g/100g dry wt)

37.8 27.3 2.6 3.0 11.6 2.7

Range 29.4-44.2 24.5-30.0 1.6-4.5 1.8-5.8 9.9-15.4 1.2-5.8

CV (within) 2.0 2.0 24.5 30.6 2.7 25.7

CV (between) 8.7 5.4 36.4 29.3 10.3 54.0

• Within labs the same methods are

used

• Different labs use different methods

• Less repeatable at lower

concentrations

• Less accurate at lower

concentrations

Eurofoods trial 1985: Leading European laboratories

Hollman & Katan, 1988, Journal of the American Medical Association

Variation in nutrient content of foods

Natural variation Extrinsic differences

• Different animals/plants

• Season

• Feeding regime

• Country of origin

• Growing conditions

• Storage

• Change in recipe

• Fortification practices

• Home prepared dishes not

regulated

• Length of cooking time

• Water used to cook with

• Cooking utensils

Analytical values are a snapshot of what was analysed and composition of

any individual sample may differ considerably. There are two main reasons

for the variability, in addition to analytical variation.

Vitamin and mineral declarations

The following vitamins and minerals may be added to the

nutrition table but only if they are present in significant

amounts

Vitamin A (µg) Folic acid (µg) Iron (mg)

Vitamin D (µg) Vitamin B12 (µg) Zinc (mg)

Vitamin E (mg) Biotin (µg) Copper (mg)

Vitamin K (µg) Pantothenic acid (mg) Manganese (mg)

Vitamin C (mg) Potassium (mg) Fluoride (mg)

Thiamin (mg) Chloride (mg) Selenium (µg)

Riboflavin (mg) Calcium (mg) Chromium (µg)

Niacin (mg) Phosphorus (mg) Molybdenum (µg)

Vitamin B6 (mg) Magnesium (mg) Iodine (µg)

See the bigger picture coming!

Seven sins commonly made with

health and nutrition claims

Dr Andy Bowles Specialist food law solicitor

Health and Nutrition claims

Nutrition claims

Energy

Nutrition

Health claims Any statement about a relationship between food and health

Health claims – the law

Types of health claims

“Function”

“Risk reduction”

“Childrens development”

Non-specific health claims

Only made where approved health claim listed

Register of nutrition and health claims http://ec.europa.eu/nuhclaims/

Other claims

“Natural”

“Fresh”

“Traditional”

“Home made”

Main principles

Claims must be

Substantiated

Accurate

Truthful

Not misleading

Not just on labels!

Most common sins…

1. “Packed with..” “bursting with….” for source of

claims.

2. Non-specific health claims “Good for you”

3. Health claims on unhealthy foods.

4. “Natural” with refined ingredients

5. “Free from” – applies to all similar products

6. Non- approved health claims.

7. Non-approved wording.

Come and see us…

ABC Food Law – Stand 592

ABC Legal Labels – Stand 642

IFR Extra - Stand RP20

Our Contact Details

Name &

Company

Contact Details What we can help you with

Mike Peters

Nutritional

Information

Solutions

Mike.Peters@ifr.ac.uk

Tel 01603 251431/07894 851527

www.nutritionalinformation.solutions

• Inexpensive nutrition label

information from your product

recipe, for front and back of pack,

independently checked and

verified to meet regulations

Dr Andy Bowles

ABC Food Law

Andy.bowles@abcfoodlaw.co.uk

Tel: 01603 274486

www.abcfoodlaw.co.uk

www.abc-legal-labels.co.uk

@abcfoodlaw

• Any food law issue including

• Food label/reviews

• HACCP

• Allergen control

• Import/export

• Traceability

• Novel foods

The impact of EU FIC Regulation for business and consumers

Sarah Howarth 22nd November 2016

www.howarthfoodsafety.co.uk

Agenda

www.howarthfoodsafety.co.uk

• Impact • Implementation • Enforcement • Conclusions

Aims of EU No 1169/2011

- A harmonised approach across the EU

- Free movement of safe and wholesome

food

- Allow more informed consumer choice

- Drive healthier food choices

- Simplify legislation

•

Impact for business

www.howarthfoodsafety.co.uk

Significant changes

Name of the Food List of Ingredients Naming of certain ingredients/categories Quantity of certain ingredients Allergens Nutritional information Net quantity of the food Date of minimum durability Special storage conditions/conditions of use Business name (FBO) and address in the EU Font size Distance selling Country of Origin

Impact for business

EU No 1169/2011Timescales

30 January 2008:

Commission proposal

24 Oct 2011:

Published

13 Dec 2014:

Application

Further reports

2013 : meat ingredients

2015 : TFA’s ; extension

COOL

13 Dec 2016:

Mandatory Nutritional information

www.howarthfoodsafety.co.uk

Key ingredients for implementation

New Label

Marketing and Sales

FIC Guidance

Supplier/manufacturing information

Common challenges

• Lack of clarity and guidance on the changes • Resources - budget ; skills ; time • Delay in obtaining supplier information • Inadequate in-house data/specifications • Amending internet sites • Fitting all mandatory information on pack • Packaging right-offs

Common areas of confusion

Allergens ????

Enforcement officers

www.howarthfoodsafety.co.uk

- Possess guidance to determine and ensure that their actions are reasonable, proportionate and commensurate with good practice

- Use a gradual and educative approach UNLESS they determine that there is Significant Risk for the public

- May move to formal actions if the desired change is not achieved in a reasonable time period

Where are we now? - Business

Understanding NI Consumer Needs Around Food Labelling (July 2016)

Overall, participant attention to labelling information appeared to be driven by a particular need; for example, if participants were following a specific diet or had specific dietary or allergen requirements. Outside of these circumstances, participants tended only to use labels to check the “use by” or “best before” dates, and occasionally checked labels when buying new or unfamiliar products.

Source : FSA Website

Conclusions - Have the aims of EU No 1169/2011 been achieved?

- A harmonised approach across the EU

- Free movement of safe and wholesome

food

- Allow more informed consumer

choice

- Drive healthier food choices

- Simplify legislation

•

Impact for Consumers?

Thank you!