28. The Committee recalled that the above Draft Revised Standard had been under revision for seven years and that the last Session of the CCNFSDU recognized that the development of a reliable method of analysis for gluten was the key point in the revision, therefore the Standard had been returned to Step 6 for further comments.
29. The Observer of the Working Group on Prolamin Analysis and Toxicity (PWG) informed the Committee that currently two approaches were used: i.e. clinical and analytical. He pointed out that the clinical approach based on dietary surveys and calculations of gluten was unreliable: analysis were carried out on a small number of patients, for some patients it did not cause problems, however for some other patients even 100mg of gliadin, as it was carried out by Catassi, was found to be toxic. The analytical approach based on the current ELISA (Skerritt) method was not sufficient, not specific and sensitive enough and a new ELISA (Mendez) method with the defined extraction, availability of gliadin standard and collaborative trials carried according to AOAC was underway. The Observer indicated that it would be possible to have a sensitive method of analysis for gluten, accurate at the low levels of detection by the end of the year 2001 and suggested to have one single limit for gluten free foods which could be kept in square brackets.
30. The Committee had an extensive debate on levels of gluten to be used for the definition of gluten free foods. Several delegations supported a single maximum level of gluten; however they proposed different amounts: some of them were in favour of 20 mg/kg, some preferred to have the level of 100ppm in ready to eat foods and a few delegations suggested 200 mg/kg. The Delegation of Canada supported by India and some other delegations indicated that two different levels of gluten in gluten free foods would be confusing for consumers and proposed 20 mg/kg of gluten while some other delegations pointed out that this type of consumers was well informed and under medical supervision. In addition there were consumers that could tolerate some amounts of gluten in their diets and it was their right to choose the type of food they consumed. Some delegations proposed that two levels of gluten be established especially for naturally gluten-free foods and reduced in gluten, however it was recalled that the decision on that had been taken earlier. The Delegation of Spain wished to have only a single level established at 20 mg/kg and supported with a reliable method of determination.
31. Some delegations were in favour of having two different maximum levels of gluten: 20 mg/kg for products naturally free from gluten and 200 mg/kg for products rendered gluten free that were ready for consumption. It was indicated that a single level of 200 mg/kg was not acceptable as there were consumers suffering from adverse reactions to products with an amount of gluten of 70 mg/kg. The Delegation of Finland pointed out that wheat-starch based gluten-free foods had been widely available on the market for more than 30 years and that no evidence of increased morbidity and mortality had been observed among the individuals maintaining wheat starch based gluten-free diet.
32. The Observer of AOECS indicated that consumers want to have the right to choose under the well-known term "gluten-free" by nature and food rendered "gluten-free" and that wheat starch based products should have the safest possible level.
33. It was proposed to take out Sections 6 and 7 from the current Draft Standard as it was not possible to accept the proposed method which was not validated. The Delegation of Spain proposed to amend this section instead of deleting it however no decision was made.
34. Some delegations stressed that the establishment of limits for gluten without a reliable method of analysis was not scientifically justified and therefore was premature. It was pointed out that it would not be possible to implement such decision.
Status of the Draft Revised Standard for Gluten-Free Foods
35. The Committee recognized that there was no consensus either on levels or on the method of determination of gluten at this time, therefore decided to keep the current Draft Standard at Step 7 and to seek the Commission s advice on how to deal with this issue.
