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 & NationalDefinitions of Gluten-Free Foods

• 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

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

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

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.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.”

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