EU to add two new food labels for gluten intolerant in 2016

World Trade OrganizationThe EU has notified the World Trade Organization (WTO) that it intends to allow two new labels on foods for people intolerant to gluten:

  • “gluten-free”: max. 20 ppm gluten (unchanged).
  • “very low gluten”: max. 100 ppm gluten (unchanged).
  • New label: “suitable for people intolerant to gluten”: may accompany “gluten-free” or “very low gluten” labels, without further requirements.
  • New label: “specifically formulated for people intolerant to gluten”: may accompany “gluten-free” or “very low gluten” labels, if the product is specially produced to
    • reduce the gluten content of gluten containing ingredients (i.e. gluten-free wheat starch), or
    • substitute the gluten containing ingredients with other ingredients naturally free of gluten.

Furthermore, the regulation explicitly forbids the use of these labels on baby milk, pointing to an earlier directive forbidding the use of gluten-containing ingredients in all baby milk.

Although the notification was sent to the WTO on 25 March 2014 already, it seems to have gone unnoticed by the celiac community until now, probably because the document was never really announced and is unlikely to be stumbled upon.


The draft was uploaded to a specific EU-WTO notification database called TBT, without further announcement to the general public. In fact, the European Commission seems to stall individual celiacs asking about this regulation by having them watch sources through which no publications on this regulation can be found even until today (1 June 2014), while food industry representatives were able to comment on an earlier draft of the legislation in November 2013 already. (Update 3 June 2014: Mr. Mathioudakis states that the Commission shared the early draft with Member States, not with stakeholders and that “[t]he fact that certain stakeholders managed to obtain a copy of it might depend on the policy of national authorities for consulting stakeholders”.)

Source documents

(The Serious Celiac did not possess or know of these documents or their contents before 31 May 2014.)

Personal commentary
My frustration about the lack of transparency aside, I must say the Commission found a good way to satisfy all parties by establishing two new optional labels in addition to the two existing ones. However, I have a few remarks: with the additional label for foods of which the gluten content of gluten containing ingredients was reduced. However, I have quite a few remarks regarding the rest of the proposal:

  • The proposal allows products that are “specially produced” to “substitute gluten containing ingredients with other ingredients naturally free of gluten” to carry the label “specifically formulated for people intolerant to gluten”. However, the proposal fails to explain how it should be determined that there were “gluten containing ingredients” in the first place. Does the original recipe of the producer’s grandmother count? If his grandmother’s recipe called for wheat flour in the sauce, but the producer decided to use corn flour instead, can he then label his product as “specifically formulated for people intolerant to gluten”? Or should we further consider his intentions, by asking him if he did this “specially” for the celiacs, or not? Details need to be filled in here, and hopefully the Commission does not intend to let local authorities make those decisions, because that will once again lead to differences between member states.

    Update 2 June 2014: I just noticed that this new category even exceeds the mandate given to the European Commission:

    Furthermore, the Commission should consider how to ensure that people who are intolerant to gluten are adequately informed of the difference between a food that is specially produced, prepared and/or processed in order to reduce the gluten content of one or more gluten-containing ingredients and other food that is made exclusively from ingredients naturally free of gluten. — Recital 41, Regulation (EU) No 609/2013

    Remember this recital came after long and heated debate in both the European Parliament and the Council. In the end, they agreed to only ask the Commission to come up with a solution for foods of which the gluten content of gluten-containing ingredients was reduced, in other words: foods with stuff like gluten-free wheat starch. Not to invent some completely new “ingredients substituted” category.

    If nobody asked the Commission to create this category, then why did they do it? I don’t know if it came directly from the dietetic foods industry, but it suits them rather well. Regular food producers will be scared away from this disease-related, poorly defined label and thus the dietetic food industry gets some market protection after all. The problem I have with this two-class labeling for essentially the same foods (naturally gluten-free, max. 20 ppm gluten), is that it will reduce attention for the existing “gluten-free” label. Patients will be misled, thinking the “gluten-free” labelled products are not as safe as the “specially formulated” ones (while actually, both can have max. 20 ppm)… And, actually, maybe they are right: With two-class labelling, food authorities might even become less inclined to enforce the maximum gluten content of the simply “gluten-free” labelled foods (“Oooh, you really cannot have gluten? Why didn’t you choose the one specially formulated for your disease then?”)… Reduced demand for “gluten-free” labelled foods (as opposed to “specially formuled” foods) will lead to reduced supply from regular food producers… Result: Reduced (or more expensive) choice for the celiac consumer.

    I can accept, for Italy’s sake, that we create this additional “specially formulated” label, but only for a clearly defined category of foods then (Article 3(3)(a) of the proposal: the gluten free wheat starch type of foods), and not for some vaguely defined subset of naturally gluten-free foods like “ingredients substituted” (Article 3(3)(b)). Taking that notion out of the proposal again would be in line with the mandate of EU 609/2013. (end of update 2 June 2014)

    Update 6 June 2014: Actually, I also don’t agree with the creation of the “suitable for”-category, for many of the same reasons mentioned above: It has no additional requirements, so adds no better protection whatsoever, thus only creating a false impression that foods carrying only a “gluten-free” label are not, or do not need to be, suitable for people intolerant to gluten. Regular food producers and food authorities will feel less responsible towards celiacs, because they never claimed their product was suitable for this group. We should remember that the “gluten-free” label exists for the people intolerant to gluten, not for the people choosing to eat gluten-free as a lifestyle-choice (GF as a fad/diet/trend). By allowing ourselves to be pushed out of the now popular “gluten-free”-segment and into a new “suitable for people with the actual disease”-segment, we loose control over all the new choices that were acquired thanks to the lifestyle-trend. Instead of allowing ourselves to be pushed into a little corner again, we should hold on to the “gluten-free” label, embrace all the new choices that the regular foods industry tries to introduce under that label, and focus on making sure that they all adhere to the requirements that we set for that label, perhaps in the long term tighten those requirements. A new “suitable for” label only protects the dietetic foods industry market, protects the regular foods industry against complaints by patients (“if you really cannot have gluten, why did you not choose the food suitable for your disease?”), but does nothing to protect the patient. It was also not called for in Regulation (EU) No 609/2013, so here the Commission is again exceeding its mandate.

    So, I propose the entire Article 3(2) is taken out as well.

    Update 6 June 2014 (cont.): Considering the only remaining new category that I can, for Italy’s sake, agree with (Article 3(3)(a), foods specially produced to reduce the gluten content of gluten containing ingredients, i.e. gluten-free wheat starch), I think the wording currently proposed does not reflect the true meaning of this category and wrongly suggests that these foods are a better choice for people intolerant to gluten than naturally gluten-free foods. I propose the following wording:

    The food information referred to in paragraph 1 may* be accompanied by the statement “specifically formulated to reduce the gluten content of the gluten containing ingredients” if the food is specially produced, prepared and/or processed to reduce the gluten content of one or more gluten containing ingredients. — My proposal

    (end of update 6 June 2014)

    * Update 12 June 2014: It would be even better if the label was mandatory (“must be accompanied” instead of “may be accompanied”), so it can serve as a warning label for the many celiacs who try to avoid foods of this category. (end of update 12 June 2014)

  • Regarding the explicit prohibition of “gluten-free” labels on baby milk, I personally would like to see a “gluten-free” label on baby milk, even if all baby milks are gluten free, because I simply did not know that all baby milks are gluten free by law! Are all new parents supposed to know about European Directive 2006/141/EC? I don’t think so. I also don’t really see why any baby milk producer would not want to communicate this fact to their customers. Even if some producers don’t, then I think the producers that do want to should at least be allowed to make some statement. According to Fratini Vergano, a European law firm, the Germans came up with the idea of forbidding “gluten-free” on baby milk, suggesting the statement “produced without gluten-containing ingredients according to the law” instead. Even though this phrase could also lead to questions (“according to the law” sounds like a caveat), it’s better than nothing. But the Commission did not adopt this alternative statement in its proposal. It forbid the use of “gluten-free” on baby milk, but forgot to allow the alternative.

  • The proposal is not clear about the use of “gluten-free” labels on naturally gluten free foods. From what I understand about the situation under current legislation (sorry, no sources), some national food authorities can be very uptight about (what they call) “misleading” use of gluten-free labels, forbidding a producer to put a “gluten-free” label on food that is actually gluten free for the sole reason that that particular authority deems all similar foods to be gluten free.

    I think European regulations should not allow local judgement calls on this matter. For starters, the term “similar foods” allows different interpretations. Food categories might seem gluten free at first glance (e.g. yoghurt), but can be found in supermarkets mingling with gluten-containing variants (e.g. breakfast yoghurt containing wheat, yoghurts containing wheat fibre for digestion, etc.). As a celiac consumer, I would like to see “gluten-free” logos on yoghurts, but producers that try to use them might run into uncooperative officials, depending on the country where they are located.

    Second, there are those cases of foods that should just be gluten free, because they are by nature, but end up in the shops with gluten contamination, such as millet, rice, buckwheat, sorghum, soy, spices, sauces, etc. The list of naturally gluten free foods found to have been affected by cross-contamination keeps growing and growing and seems to be only limited by the number of gluten tests that are performed. Internet forums are filled with celiac consumers avoiding entire (naturally gluten free!) food categories, such as corn, soy, chocolate, etc., because they cannot make any distinction between the cross-contaminated ones and the truly gluten free ones. At the same time, individual producers that go out of their way to ensure their product is really gluten free are not certain they will be allowed to communicate the results of their efforts to the market by means of a “gluten free” label!

    In this environment of cross-contamination and blurring boundaries between food categories, there should be no obstacle for any food producer that is sure that his food is gluten free, to label it as such. Unfortunately, the current proposal only aggravates this problem, because, no matter what your opinion is, Recital 10 is simply… incomprehensible:

    (10) It should also be possible for a food containing ingredients naturally free of gluten to bear terms indicating the absence of gluten, provided that the general conditions on fair information practices set out in Regulation (EU) No 1169/2011 are complied with. In particular, food information should not be misleading by suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics. — Recital 10 of 25 March 2014 draft

    It starts out good, stating that it should be possible for naturally gluten free foods to carry a gluten-free label, but then suddenly starts to turn around by making a vague reference to the FIC about “fair information practices” and ends up even copying a part of it (Art. 7(1)(c)), thereby suggesting that it is actually not allowed! What a mess! And why?? My best guess is that the Commission is afraid to be stepping out of bounds, afraid it would be turning over part of a EP/Council Regulation (the FIC) in a mere implementing act…

    On the contrary, I think the Commission has room enough to make a decision on this issue:

    The Commission shall adopt implementing acts on the application of the requirements referred to in paragraph 2 of this Article — Article 36(3) FIC (emphasis added)

    Food information provided on a voluntary basis shall [..] not mislead the consumer, as referred to in Article 7 — Article 36(2) FIC

    Food information shall not be misleading, particularly [..] by suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics, in particular by specifically emphasising the presence or absence of certain ingredients and/or nutrients — Article 7 FIC

    In summary, the Commission is tasked to adopt an act on the application of the requirement that food information should not be misleading by emphasising the absence of gluten when in fact gluten is absent in all similar foods. If national authorities have difficulties determining whether this description applies to a certain food or not (and it is my impression that some find it applicable more readily than others), the Commission is clearly tasked to solve this problem. The Commission should not forsake this duty with an ambiguous recital, but should provide a clear provision, preferably contained in a proper Article.

    I suggest Recital 10 to be replaced by the following text:

    (10) Considering the omnipresence of gluten contamination in foods and the lack of clear boundaries between food categories, it should also be possible for a food containing ingredients naturally free of gluten to bear terms indicating the absence of gluten. — My proposal

    Period. That’s it, no more suggestive remarks about “misleading” gluten free labels. Then, a proper Article, let’s say Article 3(4):

    4. The food information referred to in paragraphs 1 to 3 can not be considered a misleading suggestion under Article 7(1)(c) of Regulation (EU) No 1169/2011 solely by the fact that it is indicated on a food containing ingredients naturally free of gluten. — My proposal

    Based on personal symptom experiences, many celiacs choose to avoid foods made with gluten-free wheat starch, oats, foods containing 100 ppm gluten, or even foods containing 20 ppm gluten. Yet all these categories get their special labels suggesting that they are good choices for celiacs! In such a constellation it is unacceptable that naturally gluten free foods, which many celiacs prefer over dietetic foods, are not unambiguously allowed to carry a gluten free mark as well.

Tight schedule

According to the WTO notification form, the European Commission aims to adopt the new legislation this month already. However, it also still needs to be discussed within the Standing Committee on the Food Chain and Animal Health (SCFCAH). Summaries of their meetings from 2012 until now show no traces of gluten discussion whatsoever, and their next meeting is scheduled 13 June 2014 (first one after that is 17 October 2014).

Possible explanations for the short time schedule could be that the matter has already been agreed upon in back room discussions, or that the discussion did take place in a SCFCAH meeting, but was left out of the minutes. The discussion of the preceding delegated act in a 24 May 2013 meeting of the FIC Expert Group was also announced in the Agenda, but omitted from the Summary report. According to Basil Mathioudakis, head of the responsible Commission unit, no discussion took place in that meeting on the substantial rules.

How to voice your opinion

Considering the late discovery of these documents, the little time left according to the Commission schedule, the half year head start given to the food industry, and the lack of information about the individual SCFCAH members, I suggest that if you have any important comments, you either contact Basil Mathioudakis directly, or make a comment on this blog post, to which I will send him a link. You could also ask your national ministry, food authority, patient support group, university or research centers if they know who is going to the SCFCAH meeting. Please share your findings with other celiacs in the comments below.

Comments allowed in any EU language. Use Google Translate to read comments by others.

7 thoughts on “EU to add two new food labels for gluten intolerant in 2016”

  1. Thank you, what an excellent analysis of what is going on regarding the legislation about providing information about gluten in food to consumers who are intolerant to gluten. I am glad you informed us. This is my opinion.

    Very low gluten?

    Products with the label ‘very low gluten’ are in the Netherlands usually not recommended to people with celiac disease; doctors and dieticians tell their patients that these products are not safe to eat. Eating more products with 100 ppm gluten a day, may cause adverse health effects, because the total amount of ingested gluten may increase above 10 mg. For patients with celiac disease, it is recommended to stay beneath that level. I have a pretty good overview of all the gluten-free products in our country and in fact I know only one item, biscuits, that says ‘very low gluten’ on the label. Hundreds of other gluten-free food products contain gluten below 20 ppm. Consumers don’t want products with higher amounts of gluten in it. They want to eat products that are palatable, healthy and safe. This <100 ppm category is not helpful in daily life for people with celiac disease in the Netherlands. We can do without it.

    Consumers should not be misled or confused

    I totally agree with the statement that people who eat gluten-free for health reasons, should not be misled or confused by information on the package. But… the current interpretation of ‘gluten-free’ is already misleading to many patients. They don’t expect that ‘gluten-free’ products can still contain small amounts of gluten. They believe that these products contain no gluten at all (0 ppm). In fact, even gluten-free bread, pasta and flour contain small amounts of gluten (above 0 ppm and below 20 ppm). Besides that, every celiac disease organization knows that a part of the patients with celiac disease cannot tolerate products that are called ‘gluten-free’ but contain ‘modified/ hydrolyzed/ gluten-free wheat starch’. This means that eating gluten-free is not automatically a risk-free option. People with celiac disease have to find out if products with modified wheat starch are safe or not, fitting to their personal tolerability level. Unfortunately it is not known how many people are confronted with health problems after consuming products with modified wheat starch, but it is a fact that many people do (as can be confirmed by celiac disease organizations in countries where these products are available). This leads to my next remark.

    ‘Suitable for people intolerant to gluten’

    In the current proposal, food information on the package of gluten-free/ very low gluten products may in the future be accompanied by the statement ‘suitable for people intolerant to gluten’. Says who? My doctor? My dietitian? The food industry? The European Union? I do have a great problem with this statement. It shifts the attention from characteristics of the product towards characteristics of the consumer. How do you know if the food product is safe for/ can be tolerated by a particular consumer? This is a health statement that should not be made. What happens when the product contains too much gluten for the individual with celiac disease who is very sensitive? Or when the product contains ingredients that are not tolerated well by the individual patient? Where do consumers go to, when they experience adverse health effects after eating supposedly ‘suitable’ products? When their antibodies against gluten don’t disappear in their blood, when their intestinal damage remains, when they get another auto-immune disease, when they experience complications besides celiac disease? So let the consumer decide if the food product is safe/ suitable for him or her. There are many reasons why gluten-free food products actually might not be suitable for anyone with celiac disease: because of the (too high) amount of gluten in it, because of the presence of modified wheat starch, because of the presence of lactose or other ingredients that people are intolerant to (seeds, guar gom, hydroxypropylmethylcellulose, yeast, wheat hydrolysates like dextrose, etc.) or grains that are not tolerated well (like teff or oats). And this is beside the health aspects of the products, the amount of fiber, vitamins and minerals, and the amount of sugar and fat. One product may be more suitable to the dietary needs of an individual than the other. The consumers have to decide about this. Not the supplier, or the manufacturer, or the legislator. The legislator has to ensure that a variety of food products is available, which suits the needs of the gluten-free consumers. I am totally happy with the text ‘gluten-free’ on many food products, I really don’t want a statement ‘suitable for people intolerant to gluten’ that is not true for part of the celiac community.

    Different levels of tolerance to gluten

    The proposed regulation states that the tolerability to gluten may differ between people intolerant to gluten. This raises the question: how much gluten can be tolerated? This differs between patients with celiac disease, and this can even change over time in the same individual. After being diagnosed with celiac disease, patients can become more sensitive to gluten, or the opposite might happen, that disease symptoms disappear completely, and that accidental exposure to gluten does not cause any detrimental effects. Patients with celiac disease should be the captains of their own gluten-free diet. This means: choosing the options that fit to their own needs, for example with enough fiber, or with high iron content, no lactose or no wheat derivatives. The information on the package should provide consumers with the information they need. They can find the amount of fiber, the presence of (modified) wheat, the amount of carbohydrates, fat, peptides, etc. But one thing is missing: they cannot find the amount of gluten they are ingesting. And that is the most important information for patients with celiac disease! To know that food contains less than 20 ppm of gluten is not enough. It makes a huge difference whether a person with celiac disease eats gluten-free bread with 15 ppm gluten on a daily basis, or with 3 ppm gluten, especially when symptoms don’t disappear, blood tests reveal high antibody titers and the intestines remain damaged (which is a great concern to many patients, with and without symptoms). Some manufacturers put a text on the label of their gluten-free product like ‘below 5 ppm’, which is very welcome. Manufacturers should be encouraged to provide consumers with information about the amount of gluten in their products. In addition to this, particularly one group of patients has no ‘varied choice of gluten-free products’ at all. I am referring to the patients that turn to a ‘gluten contamination elimination diet’ (Hollon, http://www.biomedcentral.com/1471-230X/13/40) and who are considered to have ‘refractory celiac disease’ (their intestines don’t heal and this may be a life threatening situation) but who in fact consume too much gluten. A 0 ppm option for gluten-free bread, flour and pasta is still lacking. These patients turn to a diet without any ‘gluten-free’ bread and dietary products (which are always slightly contaminated with gluten), but stick to fresh fruits, fresh vegetables, potatoes and rice (in the book ‘Glutenfreedom’ Alessio Fasano tells about the many people with nonresponsive celiac disease; they are placed on this ‘0 ppm gluten’ diet because of remaining symptoms that cannot be explained by their eating patterns after dietal survey from a skilled dietician; when the amount of ingested gluten is drastically reduced, symptoms disappear in the majority of nonresponsive celiac disease patients and the amount of cases of refractory celiac disease is reduced).

    Label ‘gluten-free’ on naturally gluten-free products

    I agree with every sentence of your comment on this issue. The everyday menu of patients with celiac disease does not only consist of dietary products like gluten-free bread, pasta and cookies, but also contains many other products, like coffee, soups, sauces, icecreams, desserts, candy, nuts, meat products, etc. It is very pleasant for consumers to know if the nuts they buy are safe or not, if the yoghurt they want to eat is safe, etc. It is a myth to think that ‘all similar products are gluten-free’. The risk of contamination has grown dramatically, especially since the last ten years the production of wheat has doubled (http://www.wageningenur.nl/nl/Publicatie-details.htm?publicationId=publication-way-343531373735) and since the price of wheat in Europe has become lower than the price of maize (since 2010/2011, information from my personal contact with many manufacturers). Gluten/ wheat is not only a cheap ingredient, it has many convenient characteristics for the food industry. It can be used as a binder, a filling agent, sweetener, preservative, glazing agent, etc. Furthermore the use of ‘vital wheat gluten’ in the food industry has increased substantially (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3573730/). In this light, eating gluten-free has become a challenge. Two opposing developments have taken place in recent years. On the one hand the maximum gluten content allowed in gluten-free foods has decreased from 200 ppm to 20 ppm. On the other hand the risk of contamination has increased dramatically. Don’t forget that the ingredients on the package just tell half of the story. That is what the manufacturers intentionally put in the product. But the other part of the story is the reality that people with celiac disease are confronted with many products contaminated with gluten, which forms a threat to their health. Unfortunately the label does not help, as the presence of gluten and the amount of gluten is not expressed on the label. Like you, I want manufacturers of ‘naturally glutenfree products’ to have the opportunity to express the absence of gluten on the label of their product (as well as the presence…)

    Gluten-free infant formulae

    It is well known, that in Sweden a celiac disease epidemic occurred among young children. That happened at the moment that baby-milk was enriched with proteins derived from wheat. When they discovered that the use of wheat proteins was the cause of the celiac disease epidemic, the wheat derived proteins were taken immediately out of the baby milk. For parents with small children, it is necessary to know that the baby milk they buy is free from gluten, and has no wheat derived ingredients in it.

    Removal of gluten from gluten-containing grains

    My last point of concern regards the safety of products in which the amount of gluten is reduced by technological methods. It is well known that some beers that carry a ‘gluten-free’ label are not safe for celiac disease patients (mass spectrometrie reveals substantially higher amounts of gluten than ELISA methods). In the US the rules for the declaration of gluten in beer have been recently established: http://celiac.org/blog/2014/03/10/ttb-revises-gluten-free-guidelines-in-light-of-recent-fda-ruling/ The US label on beer must tell the consumers that the gluten content of beer cannot be measured properly. I don’t know which products are meant in the proposed regulation and which techniques are applied to lower the amount of gluten: products with hydrolysed wheat? With sourdough (recently mass spectrometrie revealed that the ELISA test underestimates the amount of gluten in sourdough products)? With fermented soy? I hope the CODEX Commission will adopt better test methods to guarantee the safety of the food in which gluten has been removed.

    This is my response from a patients perspective, with kind regards, Tine Aarsen

    1. Hi Tine,

      Thanks for your comments, glad you liked my piece! You bring up a couple of good points.

      Regarding the “very low gluten” (max. 100 ppm) label, I have no need for it either. Actually the Codex (Art. 2.1.2) leaves the decision on the marketing of such products to the national states, so the EU is quite free to repeal this label. This might be exceeding the mandate for this proposal, but should certainly be considered next time.

      As I wrote in my update of yesterday, by now I also realize that the “suitable for people intolerant to gluten”-label needs to go. It adds nothing and detracts from the credibility of the “gluten free” label. (It took a couple of days of letting the proposal sink in for me to realize this.)

      I agree that producers should be allowed to voluntarily make claims of gluten contents below 20 ppm, such as “< 5 ppm gluten”.

      Regarding the 0 ppm gluten/Fassano/gluten contamination elimination diet you mention, I assume the requirements for this should be: 1. ingredient requirement (“naturally gluten free ingredients”), 2. process requirement (“specially produced to prevent to avoid contamination”), and 3. the strictest output requirement (“no detectable gluten”). In my eyes, products adhering to all three of these requirements can even label themselves as ”best choice for people intolerant to gluten”. Alternatively, these three requirements could be applied to the otherwise useless “suitable for”-label.

      Regarding the use of wheat or gluten in baby milk, Directive 2006/141/EC disallows the use of ingredients containing gluten as carbohydrate sources in follow-on formula, and provides that starch used in infant formula should be naturally gluten free, but I don’t immediately see where it would disallow the use of wheat as a source for carbohydrates such as glucose and malto-dextrin. Regarding proteins, there are three categories of baby milk: 1. proteins from cows’ or goats’ milk, 2. protein hydrolysates, and 3. soya protein isolates, possibly mixed with cows’ or goats’ milk proteins. As far as I can see now, there are no requirements regarding the source of the hydrolyzed proteins for that second category, so it seems these can be wheat-derived as well. Again, I’m not an expert on this Directive, so correct me if I’m wrong. Anyway, the composition of baby milk is out of the scope for the labelling proposal we are talking about now.

      Regarding the shortcomings of R5 ELISA as a detection method: Unfortunately the EU does not have much maneuvering space, because the Codex designated R5 as the Defining Method (Type I), meaning this method is the only method allowed, even if other methods are (currently) superior. This was done at the explicit request of Hertha Deutsch of the Association Of European Coeliac Societies (AEOCS) (Codex meeting 2010, item 115). Her remark at the recent 2014 Codex meeting (page 7) seems to indicate she now also wants to reconsider this rigid choice. It is also interesting to note that developing countries have complained about the costs of designating a proprietary method as a Type I or II-method (e.g. item 64 of this 2012 Codex meeting, and China’s comments), providing another reason why the status of R5 ELISA should be lowered and alternative detection methods should be allowed.

      Best regards,
      Peter

  2. Hi Peter,

    Very low gluten (100 ppm)

    I am glad you agree that the ‘very low gluten’ label of max. 100 ppm can be missed. Moreover, that’s the general opinion amongst Dutch medical experts in the field of celiac disease, like pediatrician Dr. Kneepkens, who argues that products with 100 ppm should not appear on the menu of celiac disease patients, especially in the light of the high risk of contamination with gluten in regular food items (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3378840/).

    0 ppm gluten products

    I agree with most of your remarks, they are very thoughtful. However, you might reconsider your suggestion to name 0 ppm gluten products ‘best choice’. In my opinion, it depends on the individual situation and the actual state of health of a patient with celiac disease. For many patients, the current 20 ppm label works fine – at least most of the time. But I feel that there should be more options within the gluten-free diet, with a consumers’ choice to select products that fit into their personal health state, on any time in life, and ranging from no gluten et at all (0 ppm) to products with a very low gluten level (‘below 5 ppm’ for example) or with wheat derivatives in it (which generally appear to be more palatable, but with a higher ppm of gluten). I know many celiac disease patients who remained ill after eating gluten-free bread on an every day basis with a level of 15 ppm gluten in it, but who recovered after starting to eat bread with less than 5 ppm of gluten.

    Instead of your label ‘best choice’ I suggest a formulation like ‘zero ppm gluten’ or ‘supersafe’. Until now the zero ppm options are missing in the gluten-free range of products. And that’s very strange, because more than 50% of celiac disease patients have signs of an (ongoing of temporary) active disease because of the ingestion of too much gluten (http://www.discoverymedicine.com/Rohini-R-Vanga/2014/05/22/novel-therapeutic-approaches-for-celiac-disease/). Of course new therapies are invented to give an alternative to the gluten-free diet, but why not give celiac disease patients more tools to ‘manage’ their gluten-free diet, choosing between products with more or less gluten, depending on their actual state of health? In this light, eating food that fits into a persons’ actual state of health, is also a treatment. And a very simple one… Patients with celiac disease who become inadvertently ‘glutened’ can temporarily reduce the amount of gluten being ingested, and regain health quicker. Patients with celiac disease who are very ill after being diagnosed might also choose to eat as little gluten as possible, to recover sooner (or to return to work sooner, or to leave hospital sooner, or to live without parental nutrition). And people with remaining complaints or with a relapse in their diet might also turn to zero ppm gluten food. Also patients who experience complications can choose products with a lower amount of gluten to optimize their health. And of course, the most sensitive patients will look for food products without any gluten at all. The three requirements you mention to create zero ppm gluten options, sound as music in my ears. New mass spectrometry methods can be used to safeguard the absence of gluten. I am really looking forward to the introduction of new food items with zero ppm gluten.

    Baby milk

    I am not an expert on baby-milk too, but if I had a baby right now, I would like to know if the baby-milk is gluten-free (especially since I know that celiac disease is present in our family), and also if this milk does not contain any peptides derived from wheat, because that might increase the risk of developing celiac disease in my child…. which is clearly demonstrated by the Swedish celiac disease epidemic.

    R5 ELISA

    My opinion is that we have to move forward and to take advantage of newer technologies that have been invented after the introduction of the R5 ELISA as ‘the number one method’. Better methods to accurately measure and reveal the presence of gluten in food products are very welcome, because it will improve the health of many celiac disease patients.

    With kind regards, Tine Aarsen

    1. Regarding the 0 ppm gluten category: I see your point, the wording of a label should not try to give some judgement on the suitability of the product for an individual, because everybody is different and has different circumstances. Labels like “suitable for…”, “specially formulated for…” and “best choice for…” should indeed be avoided. It’s best if a label can just clearly say what one can expect from the product, so I like your suggestion of simply calling it “zero ppm gluten” (a voluntary label with 3 requirements: naturally gluten-free ingredients, contamination prevention in the entire chain, and no detectable gluten in the end product).

  3. It is hard enough for most consumers to get their heads around the current 20ppm and 100ppm regulations so the suggestion that these should be enormously further complicated for the benefit of one special interest groups is totally unacceptable.
    Setting the 20ppm limit for ‘gluten free’ is not perfect and does not cover everyone’s needs, but it is workable; these proposed new regulations are totally unworkable and will only cause confusion resulting in poorer compliance and sicker people.
    I hope the commission realises this before they go any further with them.

    1. Hi Michelle,

      Thanks for your great comment. Before Friday, I will be sending an e-mail to Basil Mathioudakis of the Commission to tell him about to the comments that came in. But it never hurts to also try to influence your country’s representative in the SCFCAH, if you can find that person.

      All the best,
      Peter

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