1. Regulation of Food Allergens in New Zealand and Internationally Leigh Henderson NZFSA Allergen Seminar 21 March 2007

2. Standard 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

3. Australia & New Zealand Australia New Zealand Food Standards Code (the Code), Standard 1.2.3. December 2002 EUDirective 2003/89/EC – effective November 2004 USA Food 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 JapanFood Sanitation Law, effective April 2002

4. What foods are labelled for allergens?

5. The 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

6. Australia & New Zealand Codex, plus sesame EU Codex plus celery, mustard, sesame (tree nuts specified; sulphur dioxide included) USACodex CanadaCodex, plus sesame Japan Eggs, milk, wheat, buckwheat and peanuts, plus a longer list of ‘recommended’ substances (24 in total)

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

8. Australia & 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

9. EU Some 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 Canada Exemption for fining agents derived from milk, egg or fish (when used in alcoholic beverages) Japan Alcoholic beverages exempt; some exemptions e.g. lactose from milk

10. EU temporary exemptions Cereals Wheat and barley-based syrups; cereals used in distilled spirits EggsLyzoyme in wine; albumin a fining agent in wine and cider Fish Gelatin (carrier for vitamins and flavours, fining agent); isinglass SoyFully refined oil and fat, phytosterols and esters MilkWhey used in distilled spirits, lactitol, casein (fining agent) NutsSpirit distillates and walnut flavour in spirits CeleryLeaf and seed oil MustardOil, seed oil and oleoresin

11. How should they be declared?

12. Australia & New Zealand No conditions specified EU Requires clear reference to the name under which the allergen is known USA Identification in ‘plain, common language’, must state source and derivative; species of nut and species of fish to be declared Canada Specified – in list of ingredients, by common name stating source and derivative Japan Guidance relating to ease of identification. However not necessary to state specific allergen

13. What about those ‘may contain’ statements?

14. Australia & 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

15. USA The 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

16. Japan ‘May contain’ statement prohibited Can use statements relating to allergens handled on the same line, etc.

17. Impact 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

18. And what about food sold in restaurants etc?

19. Australia & New Zealand Requirements 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)

20. USA 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

21. United Kingdom Issued draft guidance on provision of allergen information for 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

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

23. USA Threshold Working Group Report 2006 Likely to consider it on a case-by-case basis, as a result of a petition for exemption

24. Other 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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