International Perspective on Gluten-Free

1. International Perspective on Gluten-Free July 14, 2005 Rhonda R. Kane, M.S., R.D. Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration

2. Examples of International & NationalDefinitions of Gluten-FreeFoods • Codex Alimentarius • Codex Standard 118-1981 (amended 1983) • Proposed Draft Revised Standard for Gluten-Free Foods At Step 7 (ALINORM 03/27/26, Appendix III) • Canada’s Food and Drug Regulations - Section B.24.018 (effective May 1, 1996) • Australia New Zealand Food Standards Code (ANZFSC) - Standard 1.2.8, Clauses 1 &16

3. Codex Standard 118-1981 (amended 1983) • Gluten: those proteins commonly found in wheat, triticale, rye, barley or oats to which some persons are intolerant • Gluten-free: total nitrogen (N) content of gluten-containing cereal grains used in the product does not exceed 0.05 gm N per 100 gm dry cereal grain

4. Codex Standard 118-1981 (amended 1983) • Standard does not apply to foods which in their normal form do not contain gluten. • Gluten-free foods are those: • That contain the cereal ingredients wheat, triticale, rye, barley or oats or their constituents, which have been rendered gluten-free • In which any ingredients normally present that contain gluten have been substituted by other ingredients that do not contain gluten

5. Codex Proposed Draft Revised Standard for Gluten-Free Foods At Step 7 • Gluten: protein fraction from wheat, rye, barley, [oats]* or their crossbred varieties & derivatives to which some persons are intolerant & that is insoluble in water & 0.5M NaCl *Inclusion of oats is pending. • Prolamins: fraction from gluten that can be extracted by 40-70% aqueous ethanol (including gliadin from wheat, secalin from rye, hordein from barley, & avenin from oats)

6. Codex Proposed Draft Revised Standard for Gluten-Free Foods At Step 7 • Proposed standard applies to those foodstuffs & ingredients which have been especially processed or prepared to meet the dietary needs of persons intolerant to gluten. • There arethree proposed categories of gluten-free foods where their definitions include specified limits on gluten content.

7. Codex Proposed Draft Revised Standard for Gluten-Free Foods At Step 7 Gluten-free foods consisting of ingredients which do not contain any prolamins from wheat or all Triticum species (e.g., spelt, kamut & durum wheat), rye, barley, [oats]*, or their crossbred varieties cannot have a gluten level that exceeds [20 ppm]*. *Gluten level and inclusion of oats are pending.

8. Codex Proposed Draft Revised Standard for Gluten-Free Foods At Step 7 Gluten-free foods consisting of ingredients from wheat, rye, barley, oats, spelt or their crossbred varieties that have been rendered gluten-free cannot have a gluten level that exceeds [200 ppm]*. *Gluten level is pending.

9. Codex Proposed Draft Revised Standard for Gluten-Free Foods At Step 7 Gluten-free foods consisting of any mixture of ingredients as described in the other two categories of gluten-free foods cannot have a gluten level that exceeds [200 ppm]*. *Gluten level is pending.

10. Basis for Codex Proposed Draft Revised Definitions of Gluten-Free • The two proposed gluten levels, 20 ppm & 200 ppm: • Accommodate different views of Codex member countries on the gluten limit in gluten-free foods that would be adequately protective of sensitive consumers • Are pending additional discussion by the Codex Committee on Nutrition and Foods for Special Dietary Uses • Proposed detection limit of the method should be at least 10 ppm gluten in the product on a dry basis.

11. Canada’s Food and Drug Regulations – Section B.24.018 “No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food unless the food does not contain wheat, including spelt and kamut, or oats, barley, rye, triticale or any part thereof.”

12. Basis for Canada’s Gluten-Free Definition • Reviewed the scientific literature • Consulted with the Canadian Celiac Association & considered public comment on proposed regulation • Determined that there was insufficient scientific evidence to establish a safe level of gluten intake for all persons with celiac disease

13. ANZFSC - Standard 1.2.8, Clauses 1 &16 • Gluten: “the main protein in wheat, rye, oats, barley, triticale and spelt relevant to the medical conditions, Coeliac disease and dermatitis herpetiformis”(Clause 1,fully effective December 20, 2002) • Defines foods that are(Clause 16, as amended October 14, 2004): • gluten free • low gluten

14. ANZFSC - Standard 1.2.8, Clause 16 • Gluten free foods contain: • No detectable gluten • No oats or their products • No cereals containing gluten that have been malted or their products • Low gluten foods contain: • No more than 20 mg gluten per 100 gm of food

15. Basis for ANZFSC Gluten-Free & Low Gluten Definitions • Reviewed the scientific literature, consulted with experts & considered public comment on proposed regulations • Interpreted fair trading laws as prohibiting the term gluten free to be used for products that contain any detectable gluten

16. Basis for ANZFSC Gluten-Free & Low Gluten Definitions • Influenced by lack of reliable analytical methods to detect gluten in oats and malted cereals containing gluten • Provides a choice for persons with celiac disease, based upon their level of gluten tolerance & advice of their health care providers

17. Staff Acknowledgements • Canadian Food Inspection Agency & Health Canada • Food Standards Australia New Zealand