international perspective on gluten-free july 14, 2005 rhonda r. kane, m.s., r.d. center for food...
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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