# Presentation: 036343

## Sue Hattersley
Food Allergy Branch,
Food Standards Agency, UK

- Food Allergy Branch,
- Food Standards Agency, UK

**FDA Public Hearing ****Allergen Advisory Labelling**** ****16 September 2008**

## Issues I will cover

- who I am
- current UK FSA guidance
- why we produced guidance
- status of the guidance
- main aims of the guidance
- future plans
- evaluation of current guidance
- training for enforcement officers and food businesses
- setting allergen management thresholds
- validating analytical methods

## UK Food Standards Agency

- Government Department
- allergen labelling (both statutory and voluntary)
- raising awareness with stakeholders and providing information
- commissioning research, including scientific research into causes and mechanisms of food allergy and consumer research to understand consumer needs and attitudes
- enforcement of labelling legislation is by         Local Authority Enforcement Officers

## Legislative position

- Directive 2000/13/EC, as amended, requires labelling of allergenic foods when used as ingredients in pre-packed foods, whatever the level of inclusion
- only deliberate ingredients are allowed to be listed in the ingredients list - i.e. ‘last ingredient listing’ is not allowed
- legislation does not cover allergenic foods present accidentally as a result of cross-contamination at  some point in food production/manufacturing chain

## Best Practice Guidance on  Allergen Management and Advisory Labelling (‘May Contain’)Published July 2006http://www.food.gov.uk/foodindustry/guidancenotes/labelregsguidance/maycontainguide

## Guidance on Allergen Management and Advisory Labelling

- main guidance document aimed at medium and large businesses and enforcement officers
- leaflet aimed at small and micro businesses
- disseminated via industry and enforcement stakeholders involved in drafting guidance and through Agency training courses for enforcement officers

## Slide 7

**Notes:**
In fact it will have a similar format to the Guidance on Allergen Management and Consumer information.

## Slide 8

## Why was Allergen Advisory Labelling Guidance Needed?

**Consumers perspective**
- confusion:
- do different words reflect different levels of risk?
- overuse:
- devaluation of impact
- restriction in choice
- risk taking by consumers based on misconceptions

## Consumer research

- consumer research with food allergic teenagers about their information needs
- simplistic view of food manufacturing – the manufacturer should know whether the allergen is there or not
- I’ve eaten foods with May Contain warnings before, that means I can tolerate that level of cross-contamination, so I can ignore all     May Contain warnings

## Why was Allergen Advisory Labelling Guidance Needed?

**Industry perspective**
- genuine desire to help allergic customers
- no authoritative guidance on threshold levels for allergens, leading to lack of consistency across industry on decisions whether or not to use advisory labelling
- no legislation or authoritative guidance document on how to manage allergen cross-contamination
- lack of guidance on appropriate analytical methods to test for allergen cross-contamination

## Key Aims

- consistent use of advisory labelling by businesses – _**only**_ used after a risk assessment when real risk remains
- consumers understand and can use any advisory labelling that is used
- help for enforcement officers when advising businesses

## Main Approach

- Encourage food manufacturers and retailers to **think about risks **of allergen cross-contamination - where they occur and whether they can be reduced or eliminated
-      		**1. RISK ASSESSMENT**
**	****	****2. RISK MANAGEMENT**
**	****	****3. RISK COMMUNICATION**

**Only use advisory labelling after a thorough risk assessment**

## What to put on the advisory label?

- keep wording as simple as possible
- needs to be easy to find, easy to read and easy to understand
- two phrases recommended
- ‘May Contain X’
- ‘Not suitable for someone with                   X allergy’

## What the Guidance doesn’t do

**No allergen thresholds/management levels**

-  some semi-quantitative threshold information included in first draft of guidance that was issued for public consultation but later removed, because:
-  no consensus on clinical thresholds for allergens
-  lack of detection methods for certain allergens
-  lack of standard reference materials
-  aim to produce revised guidance in due                course with allergen management levels

## Future plans

- evaluating current guidance
- training for enforcement officers and food businesses
- setting allergen management thresholds
- validating analytical methods

## Evaluation of guidance 

- is it being used?
- by food industry
- by enforcement officers
- assessing any effects on industry labelling decisions
- big manufacturers, small businesses and large retailer ‘own brand’ products
- any improvements needed?

## Training for enforcement officers and food businesses

- Agency has provided training courses on food allergy for enforcement officers for a number of years
- e-learning module being launched in September 2008 – freely available to anyone via Agency website at **www.allergytraining.food.gov.uk**

## Setting allergen management thresholds

## Workshop in Madrid in May 2007 hosted by FSA and EuroPrevall“Approaches to Risk Assessment in Food Allergy”

- Purpose was to:
- investigate whether risk assessment strategies used in toxicology can be used for food allergy risk assessment
- discuss the advantages and disadvantages of a number of different approaches
- determine any research needed to take the approach(es) forward
- aim to publish paper based on presentations            and discussions

## Allergen risk assessment issues(food businesses and consumers)

- how to determine agreed threshold levels for industry to use for decisions on whether or not an advisory warning of possible cross-contamination is appropriate or necessary?
- limit of detection is a moving target and does not necessarily relate to consumer risk
- lack of quantitative management thresholds may lead to over-use of warning labelling
- excessive use of warnings leads to restrictions in choice for consumers if they take notice of every warning, or increases risks for consumers if         such warnings are ignored

## Allergen risk assessment issues (regulators)

- should the legislation include risk-based thresholds below which the deliberate use of an allergenic ingredient does not need to be specifically declared? (there is already a level for sulphites in 2003/89/EC)
- what level of cross-contamination is high enough to justify a product recall/withdrawal?
- what level of the allergen is sufficiently       low to justify a “free from” claim?

## Further research

-     Agency is seeking to commission further research to:
- investigate dietary patterns and food choices behaviours of food allergic consumers
- determine effect of extrinsic factors on severity of response and threshold dose of allergic reactions to food

## Development and validation of analytical methods

- do we have robust analytical methods for the major food allergens covered by legislation?
- are these methods specific and sensitive?
- are these methods rapid and suitable for use by the food industry and enforcers?
- are these methods validated and recognised internationally?
- do we have standard reference     materials?

## Contact Details

Sue Hattersley

Address: Food Allergy Branch, Aviation House
125 Kingsway, London, WC2B 6 NH, UK

Telephone: (00) 44 20 7276 8509

Email: sue.hattersley@foodstandards.gsi.gov.uk

**Sue Hattersley**
**Address:** Food Allergy Branch, Aviation House
- 125 Kingsway, London, WC2B 6 NH, UK
**Telephone:** (00) 44 20 7276 8509
**Email:** sue.hattersley@foodstandards.gsi.gov.uk

**Any Questions?**** **