# Presentation: 675815

## 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 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 **