Post by kickingfrog on Feb 1, 2011 9:02:18 GMT
Maximum tolerable daily level of gluten.
Copyright by Michael Jones, Bill Elkus, Jim Lyles, and Lisa Lewis 1995, 1996 - All rights reserved worldwide.
Maximum tolerable daily level of gluten.
...............
11
......................The study of Catassi et. al. ["Dose dependent effects of protracted ingestion of small amounts of gliadin in coeliac disease children; a clinical and jejunal morphometric study". Gut 34: 1515-1519, 1993] presented evidence that 100 mg per day of gliadin is potentially harmful mainly on the basis of patients showing infiltration of intraepithelial lymphocytes. ..........
16
Most of our celiac patients are ingesting wheat starch. Despite that, their clinical outocome seems to be good. We did not find any increase in maligant diseases, and the survival did not differ from that in the general population (Gut 1994;35:1215-8 ) ........................
17
In all Nordic countries, UK, Holland and Germany (some other countries too) strict gluten-free means that wheat starch is allowed in gluten-free flours and the amount of gluten is according to Codex standards.
An adult CD patient in Finland may consume perhaps 200 g/day of gluten-free flours. Assuming that these flours contain max 200 ppm of gluten (= 20 mg of gluten/100 g dry weight) we come to figures that the daily intake of gluten is 40 mg (20 mg glidin).
Our children with celiac disease are followed routinely at the outpatient clinic. On our strict gluten-free diet (but allowing wheat starch) symptoms disappear, endomysium, reticulin human umbilical cord and gliadin antibodies disappear also and the mucosa recoveres. I have had cases where I do not see negative seroconversion for example in endomysium antibodies. ................................
www.enabling.org/ia/celiac/mxgluten.html
****************************
Codex Alimentarius Wheat Starch and GF diet & CD
Codex Alimentarius Wheat Starch and the Gluten-Free Diet & Celiac Disease
From Celic com
**********
In the European Union there is a directive on foods for special dietary uses (89/398/EEG), and this directive is the basis for all national legislation in the countries of the European Union. Though the directive deals with gluten-free foods there is no assigned limiting level of gluten for GF food yet, so it is up to the national regulatory bodies of the member states to set their own level. There is however, an international body handling these matters: Codex Alimentarius.
Codex Alimentarius is a Geneva-based International organization jointly run by the World Health Organization and FAO , and its aim is to establish worldwide standards for foods in the broadest sense. Food legislation in many countries is based on Codex Standards, although it is not mandatory to implement them in all cases. There is a Codex committee producing standards on food labeling, on hygiene, on composition etc., etc. There is a committee on Foods for Special Dietary Uses (FSDU) and ... there is a Standard on gluten-free Food!
The oldest Standard dates from 1981, and it says that foods may be labeled as "gluten-free" only if the nitrogen content of the protein derived from wheat is less than 50 mg N/100 gm on dry matter, which may be equivalent to about 20-30 mg gliadin in wheat starch. The calculation is quite complicated by the fact that most of the protein in wheat starch is "starch granule protein" and not gluten.
There is a new Codex Standard in preparation, and a proposal to set the limiting level of gluten to 200-mg gluten/kg (20-mg/100 g) gluten-free food on dry matter. If we assume that half of the gluten is gliadin, this equals 10-mg gliadin/100 g o.d.m., so the level has gone down by a factor two in comparison to the "old" standard. If accepted, the new standard will be valid for end products and not for raw materials. In my previous posting I already mentioned that there are comments on the proposal from Sweden (<20 PPM "GF" and <200 PPM for "gluten reduced"), and from the European celiac societies <40 PPM for "GF". Another proposition was to change the units again to mg/100 g rather than PPM (mg/kg).
One of the reasons why the level in the Standard has not yet been effected (the proposal has been dealt with already two years ago) is that there is no validated analytical method (ring-tested) available to check compliance to this level. Though it might look rather simple to analyze gluten, it is generally done with an Enzyme Linked Immuno Sorbent Assay - ELISA, it is in fact very tricky, and especially as the term gluten is very imprecise. Gluten is a mixture of gliadin and glutenin - each composed of several sub-fractions - and its composition with respect to sub-fractions is cultivar dependent. There is also an effect on the recovery caused by the heat processing of the food, and although excellent work has been done by Dr Skerrit of CSIRO in Australia to circumvent this problem (he designed a method based on omega gliadin, which is the most heat stable gliadin fraction), there is still a feeling that this method still needs to be improved. Remember that agencies charged with enforcement of food laws must be able to bring suits against producers of non-complying GF foods. So analytical methods need to be robust and accurate.
Codex Alimentarius bases its standard on scientific facts, and that's why there is no zero tolerance. There is simply no scientific evidence that this is required (at least there is no concordant view among scientists about the maximum tolerable gluten intake), and it is reasoned that any unduly reduction in the permissive level will reduce the number of GF food available unnecessary.
Though Codex Alimentarius has been criticized in the past for being a food-producer driven body it is still the only world-wide forum for food standards, and its role within the framework of the GATT and WTO makes its work of sterling importance in settling trade disputes. In 1993 the National Food Alliance (UK NGO) produced a report titled "Cracking the Codex." This report stated that even though the voting in Codex is nationwide, and quite often by consensus, there is a large impact of the producer lobby, especially in the preliminary stages of decision making.
Even though there is no implemented standard in national legislation many countries will stick to the Codex Standard. The conclusion is that in many countries food labeled as "gluten free" will almost definitely contain gluten. As the regulatory agencies of most countries will not press charges against producers of GF foods if the level is below the Codex Standard limit (though, as said, some countries may have lower regulatory levels). Codex Standards still do not have the status of national laws.
************************
A Safe Gluten Threshold
Research Study on the Establishment of a Safe Gluten Threshold for Celiac Disease Patients
...the researchers ...conclude that “(t)he ingestion of contaminating gluten should be kept lower than 50 mg/d in the treatment of celiac disease.”....
….we can determine how many slices of 20ppm and 200ppm gluten-free bread a person with celiac disease would have to eat to consume 50mg of gluten. Here is the math:
20ppm x 30g/1,000 = 0.6 mg. So each slice of 20ppm gluten bread contains 0.6mg of gluten. To get 50mg of gluten per day while eating this type of bread you would have to consume 83.33 slices of it!
200ppm x 30g/1,000 = 6 mg. So each slice of 200ppm gluten bread contains 6mg of gluten. To get 50mg of gluten per day while eating this type of bread you would have to consume 8.33 slices of it. …..
www.celiac.com/
***************************
Codex allowance
Posted by Charlotte, oxford on 23/5/2007
GF board
…………you can interpret UK Bread with Codex Alimentarius wheat-starch (max 100ppm) like this:
one slice----@100ppm = 30g weight = 3mg gluten
two slices---@100ppm = 60g weight = 6mg gluten
four slices--@100ppm = 120g weight = 12mg gluten
six slices---@100ppm = 180g weight = 18mg gluten
whole loaf --@100ppm = 400g weight = 40mg gluten
*********************
The safe threshold for gluten contamination in gluten-free products. Can trace amounts be accepted in the treatment of coeliac disease?
P. COLLIN*, L. THORELL , K. KAUKINEN* & M. MA¨ KI
Aliment Pharmacol Ther 2004; 19: 1277...1283.
*Department of Medicine, Tampere University Hospital, and Medical School, University of Tampere, Tampere, Finland;
Abstract:
Summary Background
: Gluten contamination in gluten-free products cannot totally be avoided. The safe threshold for gluten remains obscure. Aim
: The purpose was to estimate a reasonable limit for residual gluten, based on current literature and measurement of gluten in gluten-free products on the market. Methods
: The gluten content of 59 naturally gluten-free and 24 wheat starch-based gluten-free products were analysed by enzyme-linked immunosorbent assay. The daily intake of flours was calculated in 76 adults on gluten-free diet, and the intake compared with mucosal histology. Results
: A number of both naturally gluten-free (13 of 59) and wheat starch-based gluten-free (11 of 24) products contained gluten from 20 to 200 ppm (=mg/kg). The median daily flour consumption was 80 g (range: 10-300). Within these limits, the long-term mucosal recovery was good.
Conclusions
: The threshold for gluten-contamination can safely be set at 100 ppm. Provided that the daily flour intake is even 300 g, a level of 100 ppm results in 30 mg of gluten intake. This has been shown to be safe, when correlated to histology, in clinical and challenge studies. The level can be achieved by the industry, and does not make the diet too cumbersome.
Document Type: Research article
DOI: 10.1111/j.1365-2036.2004.01961.x
Affiliations: 1: Department of Medicine, Tampere University Hospital, and Medical School, University of Tampere, Tampere, Finland 2: Arla Foods, Innovation Centre, Stockholm, Sweden 3: Department of Paediatrics, Tampere University Hospital, and Medical School, University of Tampere, Tampere, Finland
www.ingentaconnect.com/content/bsc/apt/2004/00000019/00000012/art00007
*************************************
FSA/Coeliac UK Gluten-free Threshold Research Project
(CUK January 07 Newsletter)
The systematic review of the evidence available on gluten-free threshold levels has been completed and the final report has submitted to the Food Standards Agency.
The aim of the study, funded by the FSA and project managed by Coeliac UK, was to determine whether there is sufficient evidence to support a threshold dose or level of gluten in gluten-free foods that can be tolerated by all people with coeliac disease and to assess the robustness of the evidence base for the current Codex standard for gluten-free wheat starch products (a maximum of 200ppm gluten).
The results reveal that the current Codex standard of 200 ppm is not sufficiently protective for all people with coeliac disease and so there may be a case for lowering the current maximum level of gluten permitted in gluten-free foods.
However, there is not the evidence available to support a single definitive threshold level of gluten in foods that would be tolerated by all patients with coeliac disease. Most people with coeliac disease include gluten-free products containing codex wheat starch in their diets and remain healthy. Reducing the standard may restrict availability of GF product ranges and potentially affect compliance to the gluten free diet.
It is likely that it is the total amount of gluten ingested, rather than the concentration of gluten in the food products that is important. Another factor to consider is that, the higher the level of gluten allowed in 'gluten-free' substitute foods (i.e. the Codex standard), the greater the amount of gluten that an individual will consume, because of the additive effect.
Key outcomes of the systematic review:
• There is not enough evidence available to support the current Codex standard of 200ppm so this level would appear not to be sufficiently protective for all people with coeliac disease.
• Results from the studies reviewed suggest that some patients exhibit symptoms at much lower doses of gluten than others.
• A daily consumption of 200mg or more of gluten clearly induced mucosal changes and/or symptoms.
• There is not enough evidence available to be able to derive a specific threshold dose that would be tolerated by all people with coeliac disease.
These findings were submitted to the Codex meeting in Thailand in Oct -Nov 2006 and there will be further discussion at international level on the Codex standard for gluten-free labelling purposes. For further information on the recent Codex meeting refer to
www.codexalimentarius.net/web/archives.jsp?lang=en
*****************************
FAO /WHO Revised Standard for GF foods
JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE
ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES
28thSession
Chiang Mai,
Thailand,
30 October - 3 November 2006
DRAFT REVISED STANDARD FOR GLUTEN-FREE FOODS
Comments from:
ARGENTINA
BRAZIL
CANADA
COSTA RICA
EUROPEAN COMMUNITY
MEXICO
PERU
PHILIPPINES
UNITED STATES OF AMERICA
AAF - European Starch Industry Association
AOECS - Association Of European Coeliac Societies
ISDI – International Special Dietary Foods Industries
IWGA - International Wheat Gluten Association
WGPAT - Report of the Working Group on Prolamin Analysis and Toxicity
webcache.googleusercontent.com/search?q=cache:mwM2OZyooJgJ:ftp://ftp.fao.org/Codex/ccnfsdu28/nf28_05e.pdf
************
Consumption of gluten-free products: should the threshold value for trace amounts of gluten be at 20, 100 or 200 p.p.m.?
Eur J Gastroenterol Hepatol. 2006 Nov;18(11):1187-95.
Gibert A, Espadaler M, Angel Canela M, Sánchez A, Vaqué C, Rafecas M.
SMAP Celíacs de Catalunya, Coeliac Society, Barcelona, Spain. agibert@celiacscatalunya.org
OBJECTIVE: The threshold of gluten contamination in gluten-free products of both dietary and normal consumption is under debate. The objective of this study was to gather information on consumption of gluten-free products intended for dietary use of people under a gluten-free diet. This information is essential to ascertain the exposure of coeliac patients to gluten through their diet and deduce the maximum gluten content that these products should contain to guarantee a safe diet.
METHODS: A diet diary of consumption of gluten-free products intended for dietary use was distributed to the coeliac societies of two typical Mediterranean countries (Italy and Spain) and two Northern countries (Norway and Germany). The diet diary included a self-weigh table of the selected food items and a 10-day consumption table. Results were reported in percentiles as distributions were clearly right skewed.
RESULTS: The respondents included in the study accounted for 1359 in Italy, 273 in Spain, 226 in Norway and 56 in Germany. Gluten-free products intended for dietary use contributed significantly to the diet of coeliac patients in Italy, Germany and Norway and to a lesser degree in Spain. The most consumed gluten-free product in all countries was bread, and it was double consumed in the Northern countries (P<0.001). Mediterranean countries showed consumption of a wider variety of gluten-free foods and pasta was eaten to a large degree in Italy.
CONCLUSIONS: The differences between Northern and Mediterranean countries were not in the total amount of gluten-free products but in the type of products consumed. The observed daily consumption of gluten-free products results in the exposure to rather large amounts of gluten, thus the limit of 200 p.p.m. should be revised. A limit of 20 p.p.m. for products naturally gluten-free and of 100 p.p.m. for products rendered gluten-free is proposed to guarantee a safe diet and to enable coeliac patients to make an informed choice. These limits should be revised as new data become available.
PMID: 17033440 [PubMed - indexed for MEDLINE
*********************************
Trace Amounts of Gluten Acceptable in the Treatment of Celiac Disease
Alimentary Pharmacology & Therapeutics, Volume 19 Issue 12 Page 1277 - June 2004
Celiac.com 06/28/2004 – According to celiac disease researchers gluten contamination in gluten-free products cannot be totally avoided. With this in mind they set out to determine the safe threshold of gluten in the diets of those with celiac disease………………..
The researchers conclude that the threshold for gluten in the diets of those with celiac disease can safely be set at 100 ppm. Even those in the study who consumed flour at the high end--300g per day with a gluten level of 100 ppm--only consumed 30mg of gluten per day. The researchers determined that this level was safe when correlated to their histology in both clinical and challenge studies. Last, this level can be achieved by the food industry, will not make the diet too cumbersome, and will have the additional benefit of encouraging additional food companies to get into the gluten-free food market.
www.celiac.com/articles/794/1/Trace-Amounts-of-Gluten-Acceptable-in-the-Treatment-of-Celiac-Disease/Page1.html
*****************************************
Systematic Review: Tolerable Amount of Gluten for People With Coeliac Disease
A. K. Akobeng; A. G. Thomas
Posted: 08/28/2008; Alimentary Pharmacology & Therapeutics. 2008;27(11):1044-1052. © 2008 Blackwell Publishing
Summary
Background: The threshold amount of gluten in ‘gluten-free’ products that can be tolerated by people with coeliac disease is unclear.
Aim: To investigate the threshold amount of gluten and the threshold concentration of gluten in food products that can be tolerated by people with coeliac disease.
Design: Systematic review of studies published between 1966 and May 2007.
Methods: The data sources used were MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL, and reference lists of retrieved articles. We included studies that evaluated the amount of dietary gluten or the concentrations of gluten in food products that can be tolerated by people with coeliac disease whatever their design, method or language of publication.
Results: Thirteen studies (three randomized controlled, one cohort, two crossover, and seven cross-sectional) met the inclusion criteria. The daily amount of tolerable gluten varied widely between studies. Whilst some patients tolerated an average of 34-36 mg of gluten per day, other patients who consumed about 10 mg of gluten per day developed mucosal abnormalities. The effect of the consumption of ‘gluten-free’ products with different degrees of gluten contamination was also inconsistent.
Conclusions: The amount of tolerable gluten varies among people with coeliac disease. Although there is no evidence to suggest a single definitive threshold, a daily gluten intake of <10 mg is unlikely to cause significant histological abnormalities.
www.medscape.com/viewarticle/578637
********************************
Copyright by Michael Jones, Bill Elkus, Jim Lyles, and Lisa Lewis 1995, 1996 - All rights reserved worldwide.
Maximum tolerable daily level of gluten.
...............
11
......................The study of Catassi et. al. ["Dose dependent effects of protracted ingestion of small amounts of gliadin in coeliac disease children; a clinical and jejunal morphometric study". Gut 34: 1515-1519, 1993] presented evidence that 100 mg per day of gliadin is potentially harmful mainly on the basis of patients showing infiltration of intraepithelial lymphocytes. ..........
16
Most of our celiac patients are ingesting wheat starch. Despite that, their clinical outocome seems to be good. We did not find any increase in maligant diseases, and the survival did not differ from that in the general population (Gut 1994;35:1215-8 ) ........................
17
In all Nordic countries, UK, Holland and Germany (some other countries too) strict gluten-free means that wheat starch is allowed in gluten-free flours and the amount of gluten is according to Codex standards.
An adult CD patient in Finland may consume perhaps 200 g/day of gluten-free flours. Assuming that these flours contain max 200 ppm of gluten (= 20 mg of gluten/100 g dry weight) we come to figures that the daily intake of gluten is 40 mg (20 mg glidin).
Our children with celiac disease are followed routinely at the outpatient clinic. On our strict gluten-free diet (but allowing wheat starch) symptoms disappear, endomysium, reticulin human umbilical cord and gliadin antibodies disappear also and the mucosa recoveres. I have had cases where I do not see negative seroconversion for example in endomysium antibodies. ................................
www.enabling.org/ia/celiac/mxgluten.html
****************************
Codex Alimentarius Wheat Starch and GF diet & CD
Codex Alimentarius Wheat Starch and the Gluten-Free Diet & Celiac Disease
From Celic com
**********
In the European Union there is a directive on foods for special dietary uses (89/398/EEG), and this directive is the basis for all national legislation in the countries of the European Union. Though the directive deals with gluten-free foods there is no assigned limiting level of gluten for GF food yet, so it is up to the national regulatory bodies of the member states to set their own level. There is however, an international body handling these matters: Codex Alimentarius.
Codex Alimentarius is a Geneva-based International organization jointly run by the World Health Organization and FAO , and its aim is to establish worldwide standards for foods in the broadest sense. Food legislation in many countries is based on Codex Standards, although it is not mandatory to implement them in all cases. There is a Codex committee producing standards on food labeling, on hygiene, on composition etc., etc. There is a committee on Foods for Special Dietary Uses (FSDU) and ... there is a Standard on gluten-free Food!
The oldest Standard dates from 1981, and it says that foods may be labeled as "gluten-free" only if the nitrogen content of the protein derived from wheat is less than 50 mg N/100 gm on dry matter, which may be equivalent to about 20-30 mg gliadin in wheat starch. The calculation is quite complicated by the fact that most of the protein in wheat starch is "starch granule protein" and not gluten.
There is a new Codex Standard in preparation, and a proposal to set the limiting level of gluten to 200-mg gluten/kg (20-mg/100 g) gluten-free food on dry matter. If we assume that half of the gluten is gliadin, this equals 10-mg gliadin/100 g o.d.m., so the level has gone down by a factor two in comparison to the "old" standard. If accepted, the new standard will be valid for end products and not for raw materials. In my previous posting I already mentioned that there are comments on the proposal from Sweden (<20 PPM "GF" and <200 PPM for "gluten reduced"), and from the European celiac societies <40 PPM for "GF". Another proposition was to change the units again to mg/100 g rather than PPM (mg/kg).
One of the reasons why the level in the Standard has not yet been effected (the proposal has been dealt with already two years ago) is that there is no validated analytical method (ring-tested) available to check compliance to this level. Though it might look rather simple to analyze gluten, it is generally done with an Enzyme Linked Immuno Sorbent Assay - ELISA, it is in fact very tricky, and especially as the term gluten is very imprecise. Gluten is a mixture of gliadin and glutenin - each composed of several sub-fractions - and its composition with respect to sub-fractions is cultivar dependent. There is also an effect on the recovery caused by the heat processing of the food, and although excellent work has been done by Dr Skerrit of CSIRO in Australia to circumvent this problem (he designed a method based on omega gliadin, which is the most heat stable gliadin fraction), there is still a feeling that this method still needs to be improved. Remember that agencies charged with enforcement of food laws must be able to bring suits against producers of non-complying GF foods. So analytical methods need to be robust and accurate.
Codex Alimentarius bases its standard on scientific facts, and that's why there is no zero tolerance. There is simply no scientific evidence that this is required (at least there is no concordant view among scientists about the maximum tolerable gluten intake), and it is reasoned that any unduly reduction in the permissive level will reduce the number of GF food available unnecessary.
Though Codex Alimentarius has been criticized in the past for being a food-producer driven body it is still the only world-wide forum for food standards, and its role within the framework of the GATT and WTO makes its work of sterling importance in settling trade disputes. In 1993 the National Food Alliance (UK NGO) produced a report titled "Cracking the Codex." This report stated that even though the voting in Codex is nationwide, and quite often by consensus, there is a large impact of the producer lobby, especially in the preliminary stages of decision making.
Even though there is no implemented standard in national legislation many countries will stick to the Codex Standard. The conclusion is that in many countries food labeled as "gluten free" will almost definitely contain gluten. As the regulatory agencies of most countries will not press charges against producers of GF foods if the level is below the Codex Standard limit (though, as said, some countries may have lower regulatory levels). Codex Standards still do not have the status of national laws.
************************
A Safe Gluten Threshold
Research Study on the Establishment of a Safe Gluten Threshold for Celiac Disease Patients
...the researchers ...conclude that “(t)he ingestion of contaminating gluten should be kept lower than 50 mg/d in the treatment of celiac disease.”....
….we can determine how many slices of 20ppm and 200ppm gluten-free bread a person with celiac disease would have to eat to consume 50mg of gluten. Here is the math:
20ppm x 30g/1,000 = 0.6 mg. So each slice of 20ppm gluten bread contains 0.6mg of gluten. To get 50mg of gluten per day while eating this type of bread you would have to consume 83.33 slices of it!
200ppm x 30g/1,000 = 6 mg. So each slice of 200ppm gluten bread contains 6mg of gluten. To get 50mg of gluten per day while eating this type of bread you would have to consume 8.33 slices of it. …..
www.celiac.com/
***************************
Codex allowance
Posted by Charlotte, oxford on 23/5/2007
GF board
…………you can interpret UK Bread with Codex Alimentarius wheat-starch (max 100ppm) like this:
one slice----@100ppm = 30g weight = 3mg gluten
two slices---@100ppm = 60g weight = 6mg gluten
four slices--@100ppm = 120g weight = 12mg gluten
six slices---@100ppm = 180g weight = 18mg gluten
whole loaf --@100ppm = 400g weight = 40mg gluten
*********************
The safe threshold for gluten contamination in gluten-free products. Can trace amounts be accepted in the treatment of coeliac disease?
P. COLLIN*, L. THORELL , K. KAUKINEN* & M. MA¨ KI
Aliment Pharmacol Ther 2004; 19: 1277...1283.
*Department of Medicine, Tampere University Hospital, and Medical School, University of Tampere, Tampere, Finland;
Abstract:
Summary Background
: Gluten contamination in gluten-free products cannot totally be avoided. The safe threshold for gluten remains obscure. Aim
: The purpose was to estimate a reasonable limit for residual gluten, based on current literature and measurement of gluten in gluten-free products on the market. Methods
: The gluten content of 59 naturally gluten-free and 24 wheat starch-based gluten-free products were analysed by enzyme-linked immunosorbent assay. The daily intake of flours was calculated in 76 adults on gluten-free diet, and the intake compared with mucosal histology. Results
: A number of both naturally gluten-free (13 of 59) and wheat starch-based gluten-free (11 of 24) products contained gluten from 20 to 200 ppm (=mg/kg). The median daily flour consumption was 80 g (range: 10-300). Within these limits, the long-term mucosal recovery was good.
Conclusions
: The threshold for gluten-contamination can safely be set at 100 ppm. Provided that the daily flour intake is even 300 g, a level of 100 ppm results in 30 mg of gluten intake. This has been shown to be safe, when correlated to histology, in clinical and challenge studies. The level can be achieved by the industry, and does not make the diet too cumbersome.
Document Type: Research article
DOI: 10.1111/j.1365-2036.2004.01961.x
Affiliations: 1: Department of Medicine, Tampere University Hospital, and Medical School, University of Tampere, Tampere, Finland 2: Arla Foods, Innovation Centre, Stockholm, Sweden 3: Department of Paediatrics, Tampere University Hospital, and Medical School, University of Tampere, Tampere, Finland
www.ingentaconnect.com/content/bsc/apt/2004/00000019/00000012/art00007
*************************************
FSA/Coeliac UK Gluten-free Threshold Research Project
(CUK January 07 Newsletter)
The systematic review of the evidence available on gluten-free threshold levels has been completed and the final report has submitted to the Food Standards Agency.
The aim of the study, funded by the FSA and project managed by Coeliac UK, was to determine whether there is sufficient evidence to support a threshold dose or level of gluten in gluten-free foods that can be tolerated by all people with coeliac disease and to assess the robustness of the evidence base for the current Codex standard for gluten-free wheat starch products (a maximum of 200ppm gluten).
The results reveal that the current Codex standard of 200 ppm is not sufficiently protective for all people with coeliac disease and so there may be a case for lowering the current maximum level of gluten permitted in gluten-free foods.
However, there is not the evidence available to support a single definitive threshold level of gluten in foods that would be tolerated by all patients with coeliac disease. Most people with coeliac disease include gluten-free products containing codex wheat starch in their diets and remain healthy. Reducing the standard may restrict availability of GF product ranges and potentially affect compliance to the gluten free diet.
It is likely that it is the total amount of gluten ingested, rather than the concentration of gluten in the food products that is important. Another factor to consider is that, the higher the level of gluten allowed in 'gluten-free' substitute foods (i.e. the Codex standard), the greater the amount of gluten that an individual will consume, because of the additive effect.
Key outcomes of the systematic review:
• There is not enough evidence available to support the current Codex standard of 200ppm so this level would appear not to be sufficiently protective for all people with coeliac disease.
• Results from the studies reviewed suggest that some patients exhibit symptoms at much lower doses of gluten than others.
• A daily consumption of 200mg or more of gluten clearly induced mucosal changes and/or symptoms.
• There is not enough evidence available to be able to derive a specific threshold dose that would be tolerated by all people with coeliac disease.
These findings were submitted to the Codex meeting in Thailand in Oct -Nov 2006 and there will be further discussion at international level on the Codex standard for gluten-free labelling purposes. For further information on the recent Codex meeting refer to
www.codexalimentarius.net/web/archives.jsp?lang=en
*****************************
FAO /WHO Revised Standard for GF foods
JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE
ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES
28thSession
Chiang Mai,
Thailand,
30 October - 3 November 2006
DRAFT REVISED STANDARD FOR GLUTEN-FREE FOODS
Comments from:
ARGENTINA
BRAZIL
CANADA
COSTA RICA
EUROPEAN COMMUNITY
MEXICO
PERU
PHILIPPINES
UNITED STATES OF AMERICA
AAF - European Starch Industry Association
AOECS - Association Of European Coeliac Societies
ISDI – International Special Dietary Foods Industries
IWGA - International Wheat Gluten Association
WGPAT - Report of the Working Group on Prolamin Analysis and Toxicity
webcache.googleusercontent.com/search?q=cache:mwM2OZyooJgJ:ftp://ftp.fao.org/Codex/ccnfsdu28/nf28_05e.pdf
************
Consumption of gluten-free products: should the threshold value for trace amounts of gluten be at 20, 100 or 200 p.p.m.?
Eur J Gastroenterol Hepatol. 2006 Nov;18(11):1187-95.
Gibert A, Espadaler M, Angel Canela M, Sánchez A, Vaqué C, Rafecas M.
SMAP Celíacs de Catalunya, Coeliac Society, Barcelona, Spain. agibert@celiacscatalunya.org
OBJECTIVE: The threshold of gluten contamination in gluten-free products of both dietary and normal consumption is under debate. The objective of this study was to gather information on consumption of gluten-free products intended for dietary use of people under a gluten-free diet. This information is essential to ascertain the exposure of coeliac patients to gluten through their diet and deduce the maximum gluten content that these products should contain to guarantee a safe diet.
METHODS: A diet diary of consumption of gluten-free products intended for dietary use was distributed to the coeliac societies of two typical Mediterranean countries (Italy and Spain) and two Northern countries (Norway and Germany). The diet diary included a self-weigh table of the selected food items and a 10-day consumption table. Results were reported in percentiles as distributions were clearly right skewed.
RESULTS: The respondents included in the study accounted for 1359 in Italy, 273 in Spain, 226 in Norway and 56 in Germany. Gluten-free products intended for dietary use contributed significantly to the diet of coeliac patients in Italy, Germany and Norway and to a lesser degree in Spain. The most consumed gluten-free product in all countries was bread, and it was double consumed in the Northern countries (P<0.001). Mediterranean countries showed consumption of a wider variety of gluten-free foods and pasta was eaten to a large degree in Italy.
CONCLUSIONS: The differences between Northern and Mediterranean countries were not in the total amount of gluten-free products but in the type of products consumed. The observed daily consumption of gluten-free products results in the exposure to rather large amounts of gluten, thus the limit of 200 p.p.m. should be revised. A limit of 20 p.p.m. for products naturally gluten-free and of 100 p.p.m. for products rendered gluten-free is proposed to guarantee a safe diet and to enable coeliac patients to make an informed choice. These limits should be revised as new data become available.
PMID: 17033440 [PubMed - indexed for MEDLINE
*********************************
Trace Amounts of Gluten Acceptable in the Treatment of Celiac Disease
Alimentary Pharmacology & Therapeutics, Volume 19 Issue 12 Page 1277 - June 2004
Celiac.com 06/28/2004 – According to celiac disease researchers gluten contamination in gluten-free products cannot be totally avoided. With this in mind they set out to determine the safe threshold of gluten in the diets of those with celiac disease………………..
The researchers conclude that the threshold for gluten in the diets of those with celiac disease can safely be set at 100 ppm. Even those in the study who consumed flour at the high end--300g per day with a gluten level of 100 ppm--only consumed 30mg of gluten per day. The researchers determined that this level was safe when correlated to their histology in both clinical and challenge studies. Last, this level can be achieved by the food industry, will not make the diet too cumbersome, and will have the additional benefit of encouraging additional food companies to get into the gluten-free food market.
www.celiac.com/articles/794/1/Trace-Amounts-of-Gluten-Acceptable-in-the-Treatment-of-Celiac-Disease/Page1.html
*****************************************
Systematic Review: Tolerable Amount of Gluten for People With Coeliac Disease
A. K. Akobeng; A. G. Thomas
Posted: 08/28/2008; Alimentary Pharmacology & Therapeutics. 2008;27(11):1044-1052. © 2008 Blackwell Publishing
Summary
Background: The threshold amount of gluten in ‘gluten-free’ products that can be tolerated by people with coeliac disease is unclear.
Aim: To investigate the threshold amount of gluten and the threshold concentration of gluten in food products that can be tolerated by people with coeliac disease.
Design: Systematic review of studies published between 1966 and May 2007.
Methods: The data sources used were MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL, and reference lists of retrieved articles. We included studies that evaluated the amount of dietary gluten or the concentrations of gluten in food products that can be tolerated by people with coeliac disease whatever their design, method or language of publication.
Results: Thirteen studies (three randomized controlled, one cohort, two crossover, and seven cross-sectional) met the inclusion criteria. The daily amount of tolerable gluten varied widely between studies. Whilst some patients tolerated an average of 34-36 mg of gluten per day, other patients who consumed about 10 mg of gluten per day developed mucosal abnormalities. The effect of the consumption of ‘gluten-free’ products with different degrees of gluten contamination was also inconsistent.
Conclusions: The amount of tolerable gluten varies among people with coeliac disease. Although there is no evidence to suggest a single definitive threshold, a daily gluten intake of <10 mg is unlikely to cause significant histological abnormalities.
www.medscape.com/viewarticle/578637
********************************