International Perspective on GlutenFree

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

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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)
• Canadas 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

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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

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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

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

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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.

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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.

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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.

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Canadas 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.

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Basis for Canadas 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

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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

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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

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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

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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

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Staff Acknowledgements

• Canadian Food Inspection Agency
  Health Canada
• Food Standards Australia New Zealand