Regulation of Food Allergens in Regulation of Food Allergens in New Zealand and InternationallyNew Zealand and Internationally

Leigh Henderson

NZFSA Allergen Seminar

21 March 2007

Standard 1.2.3Standard 1.2.3• Specifies when mandatory declaration of

allergenic substances is required

• Sets out which allergens should be labelled

• Directs when the declaration should be on the label and when it may be provided on request

Australia & New Zealand

Australia New Zealand Food Standards Code (the Code), Standard 1.2.3. December 2002

EU Directive 2003/89/EC – effective November 2004

USAFood allergen labeling and Consumer protection Act, effective on foods labelled after 1 January 2006

Canada

Will be part of Food and Drug Act. Proposed in 2004, to be effective soon. At present ‘voluntary’ but covered by prohibition on ‘erroneous impression’ clause

Japan Food Sanitation Law, effective April 2002

What foods are labelled for allergens?What foods are labelled for allergens?

The Codex listThe Codex list• Cereals containing gluten and their products

• Crustacea and their products

• Egg and egg products

• Fish and fish products

• Milk and milk products

• Peanuts and soybeans, and their products

• Tree nuts and their products

• Added sulphites in concentrations of 10 mg/kg or more

• Any allergen present in a food or food ingredient obtained through biotechnology transferred from any of these

Australia &

New ZealandCodex, plus sesame

EUCodex plus celery, mustard, sesame

(tree nuts specified; sulphur dioxide included)

USA Codex

Canada Codex, plus sesame

JapanEggs, milk, wheat, buckwheat and peanuts, plus a longer list of ‘recommended’ substances (24 in total)

What does and what doesn’t What does and what doesn’t require labelling?require labelling?

Australia & New ZealandAustralia & New Zealand“The presence in a food of any of the substances listed….must be declared….when present as –

(a) An ingredient; or(b) An ingredient of a compound ingredient; or(c) A food additive or component of a food additive; or(d) A processing aid or component of a processing aid.”

Includes: all derivatives, regardless of presence of protein

Exemption to declaration: beer and spirits derived from cereals

EUSome derivatives provisionally exempted until Nov 2007

USA

Exemption for any highly refined oil (or ingredient derived from)

Petitions for exemptions (soy lecithin processing aid; soy derived growth media, hydrolyzed casein etc) rejected

CanadaExemption for fining agents derived from milk, egg or fish (when used in alcoholic beverages)

JapanAlcoholic beverages exempt; some exemptions e.g. lactose from milk

EU temporary exemptionsEU temporary exemptionsCereals

Wheat and barley-based syrups; cereals used in distilled spirits

Eggs Lyzoyme in wine; albumin a fining agent in wine and cider

FishGelatin (carrier for vitamins and flavours, fining agent); isinglass

Soy Fully refined oil and fat, phytosterols and esters

Milk Whey used in distilled spirits, lactitol, casein (fining agent)

Nuts Spirit distillates and walnut flavour in spirits

Celery Leaf and seed oil

Mustard Oil, seed oil and oleoresin

How should they be declared?How should they be declared?

Australia & New Zealand

No conditions specified

EURequires clear reference to the name under which the allergen is known

USAIdentification in ‘plain, common language’, must state source and derivative; species of nut and species of fish to be declared

CanadaSpecified – in list of ingredients, by common name stating source and derivative

JapanGuidance relating to ease of identification. However not necessary to state specific allergen

What about thoseWhat about those ‘may contain’ statements? ‘may contain’ statements?

Australia & New ZealandAustralia & New Zealand

• Not regulated by the Code

• Products found to contain one of the specified allergens but only labelled with ‘may contain’ would be in breach of the Code

USAUSAThe FALCP Act directs FDA to report to Congress

by June 2007 on unintentional contamination to include:

– incidence

– wording variations used

– extent of use

– consumer usage of such statements

to assess effectiveness of current cross contact issues

JapanJapan

• ‘May contain’ statement prohibited

• Can use statements relating to allergens handled on the same line, etc.

Impact of RegulationsImpact of Regulations

20/52 Australian food recalls in 2005 were due to allergens

11/37 Australian food recalls to date in 2006 due to allergens

Food Allergen labelling Recalls

20052006

0

1

2

3

4

5

6

7

8

Year

Nu

mb

er

of

recalls Gluten

Egg

Milk

Peanut

Soy

Tree nuts

Sulphite

And what about food sold in And what about food sold in restaurants etc?restaurants etc?

Australia & New ZealandAustralia & New ZealandRequirements relating to foods exempt from labelling

(includes unpackaged food; food made and packaged on the premises from which it is sold, food packaged in presence of purchaser; delivered packaged & ready for consumption):

– declared on or in connection with the food; OR– on request

Under review (Proposal P272)

USAUSA• Labelling requirements apply to retail and food service

establishments that package and label products, but not to foods prepared to a consumer’s order

• Preparing guidelines for food establishments, including restaurants, delis, bakeries and school cafeterias

• Will address preparation of allergen-free foods

United KingdomUnited KingdomIssued draft guidance on provision of allergen informationfor foods that are not pre-packed

• Covers catering, retail, schools, hospitals, institutions, etc.

• Recognition of greater risk from non-prepacked foods (75% of UK deaths from anaphylaxis due to non-prepacked foods)

• Voluntary - considered but rejected a regulatory option

• Awareness and education of food preparers

• Best practice for managing ingredient information

• Avoiding cross-contamination

• Still at draft

How are different jurisdictions How are different jurisdictions dealing with the threshold issue?dealing with the threshold issue?

USAUSA

• Threshold Working Group Report 2006

• Likely to consider it on a case-by-case basis, as a result of a petition for exemption

Other CountriesOther Countries

• EU – EFSA has considered thresholds for individual allergens but considered these can not be defined

• Australia & New Zealand – considering application for exemption for isinglass

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