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

Examples of International & National Definitions of Gluten-Free Foods Codex Alimentarius –Codex Standard (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 (effective May 1, 1996) Australia New Zealand Food Standards Code (ANZFSC) - Standard 1.2.8, Clauses 1 &16

Codex Standard (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

Codex Standard (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

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)

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 are three proposed categories of gluten-free foods where their definitions include specified limits on gluten content.

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.

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.

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.

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.

Canada’s Food and Drug Regulations – Section B “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.”

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

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

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

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

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

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