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Emerging evidence on tests for analysing gluten

Analysis of gluten in fermented and hydrolysed products involves state of the art methods, but there are technological challenges raising some questions about the best testing method. At Coeliac UK we ensure that our advice is in line with the experts who we refer to for the best information and evidence. We are now leading the call for a solution to the questions we need to answer.

We want our community to have more certainty but we can’t do this alone. We need manufacturers and scientific organisations involved in analysing gluten to support our call for more research to advance knowledge in this area. In the meantime, we’re championing an approach that will give the consumer more information to make informed choices and we will also be asking you for your views and experiences in a survey.

What’s the issue?

In the UK and Europe, gluten free products must meet the requirements of the law and contain no more than 20 parts per million (ppm) of gluten. When a product is made from gluten containing cereals, even when the gluten has been removed to meet the law on gluten free, the ingredient which contains gluten must be emphasised in the ingredients list (wheat/barley/rye).

There are emerging questions around the best test method for determining the gluten content in products made from a gluten containing grain (wheat/barley/rye) which are fermented and hydrolysed and the gluten is removed during processing. We need further research to investigate these questions and develop the best approach going forward.  

The R5 Competitive ELISA is the validated test for measuring gluten in beer and other fermented and hydrolysed products and is the best test we have available to us at present.

Hilary Croft, CEO of Coeliac UK said:

“As is often the case with evolving research, you don’t have all the answers. We have questions that require further research to advance  knowledge about the test method for determining the gluten content in hydrolysed and fermented products such as gluten free beer.

“It is important to clarify that products, labelled as gluten free in the UK and Europe are operating within the law for labelling of gluten free.

“The issue is that the evidence base is potentially challenging the best test for fermented and hydrolysed products but the current weight of evidence remains that the R5 Competitive ELISA method is the validated test, supported by the experts in this area, such as the Prolamin Working Group.

“We are determined to end any uncertainty for the gluten free community and have developed a programme to work with food producers, legislators and other patient organisations.”

 

In the meantime, we are asking producers to provide additional information to help you make an informed choice. On gluten free beers advertised with Coeliac UK or listed in our Food and Drink Information you will see one of the following statements:

1.    Our gluten free beers are made from gluten containing grains where the gluten has been removed.

OR

2.    Our gluten free beers are made from ingredients that do not contain gluten.

 

We want to share further information so you can understand the background to this situation

1.   Emerging research asks questions about the best test method for determining the gluten content in hydrolysed and fermented gluten free food and drink products.

Advances in food sciences and research have led to the introduction of new techniques for detailed analysis of gluten in food and drink products, such as liquid chromatography mass spectrometry (LC-MS/MS). This method is more sensitive than the current validated R5 Competitive ELISA test method, but the LC-MS/MS is not currently able to determine the quantity of gluten and it is not known if it ever will be validated to do this. This is important because gluten free foods must be 20 ppm or less and so any test that is validated for the food industry needs to be capable of measuring the quantity of gluten, not just its presence. Current research in this area is not conclusive and no better test methods have been validated or recommended. We need to know more.

2.   The US Food and Drug Administration (FDA) has issued a ruling for gluten free labelling of foods using fermented, hydrolysed ingredients

The FDA acknowledges that the R5 competitive ELISA can be used to measure gluten in fermented and hydrolysed products but, due to variations in processing and the end products, it can make it difficult to interpret the results. This does not mean the test is not capable of analysing gluten, it means that it can be difficult to do so. The FDA ruling is that the R5 Competitive ELISA method is not suitable for the detection and quantification of gluten in fermented or hydrolysed foods or ingredients. 

The R5 Competitive ELISA is approved by the Cereals and Grains Association, AACC Method 38-55.01 and the Association of Analytical Chemists, AOAC Method 2015.05 for analysing gluten in fermented and hydrolysed products. It is considered by the Prolamin Working Group, experts in the area of gluten analysis, to be the current state of the art and the best validated method currently available.

With the new FDA ruling, this means the requirements for labelling fermented, hydrolysed products gluten free in the USA and the UK and Europe are different. Like with many drugs and other products, we have different laws in the UK and Europe to the USA.  Coeliac UK, manufacturers, testing laboratories in Europe and the UK continue to look to the experts such as The Prolamin Working Group.

How does USA and UK gluten free labelling differ?

Throughout the world, there are differences in the way things are labelled because the laws are different in each country. The USA has reviewed the gluten free labelling of hydrolysed and fermented products made from a gluten containing grain, and the final ruling is the result of this review. This means that unless the ingredients that contain gluten can be verified as gluten free before they are processed (hydrolysed or fermented), they cannot be included in a product labelled gluten free.

In the UK, as long as the final product, even if it has been fermented and hydrolysed, meets the requirements of the gluten free law (20 ppm of gluten or less), it can be labelled gluten free.

Another important difference with the USA is that in the UK and Europe, consumers have the ability to identify a gluten containing grain within a product by looking at the label. This helps the consumer to distinguish from products made with naturally gluten free ingredients and those that contain a gluten containing grain, where the gluten has been removed, so they can make a personal choice. This is not always possible in the USA because their labelling laws are different.

See the table below for more on the differences in labelling:

 

  UK USA
What will be on the label? Gluten removed gluten free beer Naturally gluten free beer Hydrolysed / fermented food Gluten removed beer Naturally gluten free beer Hydrolysed / fermented food
Ingredients list NO NO YES NO YES YES
Contains statement about a gluten containing grain YES N/A NO Possibly Possibly YES
 Does the label have to emphasise or highlight wheat/rye/barley within ingredients list or within a contains statement? YES N/A YES Only wheat N/A Only wheat
Can you label it gluten free? YES YES YES NO Possibly Possibly

 

Our programme of work in this area

Resolving the uncertainty is a priority for our community and for us. We want to ensure confidence for our community.

  • We are calling on the brewing and manufacturing industry, scientific organisations and researchers to support us in advancing the knowledge on the testing of gluten in hydrolysed and fermented products, which we launched with a webinar with them on 29 September 2020.
  • We are working closely with the Association of European Coeliac Societies (AOECS) registered observer at The Codex Alimentarius Commission (the body that sets food standards for international trade).
  • We will be surveying our community to understand your experience and any concerns on this matter and to take your views into account.
  • We have consulted the Prolamin Working Group on this subject and they have issued a statement which is supportive of our approach.
  • We are looking to create a subgroup of our Food Standards Committee to focus on gluten analysis and toxicity.

Consumer choices

As well as safeguarding health, we know that choice is also a priority for our gluten free community. While we are working to understand the issue and advance our knowledge, we are providing the information so that you can be empowered to make your own decision using the tools available to you through gluten free and allergen labelling laws and the additional guidance and signposting we are providing through our Food Information Services. 

Read our FAQs to help you decide what is right for you.

Frequently Asked Questions

How can I identify if a product has used a gluten containing cereal?

Products made from gluten containing cereals (wheat, barley, rye) can only be labelled gluten free if they have been processed to remove the gluten and contain no more than 20 ppm gluten. The grain wheat/barley/rye must also be labelled and will be emphasised in the ingredients list if it is in a food. If you are looking at a beer, there will be a ‘contains wheat/barley/rye’ statement. This helps the consumer to distinguish between products made with naturally gluten free ingredients and those with a gluten removed grain, so they can make a personal choice.

 

We are also asking producers to provide additional information to help you make an informed choice. On beers advertised with Coeliac UK or listed in our Food and Drink Information you will see one of the following statements:

 

1.    Our gluten free beers are made from gluten containing grains where the gluten has been removed.

 

OR

 

2.    Our gluten free beers are made from ingredients that do not contain gluten.

What does the USA’s FDA decision mean for the UK?

The ruling doesn’t impact products sold in the UK because the ruling only applies to gluten free products sold in the USA. Manufacturers selling in the UK and Europe can continue to label fermented and hydrolysed products with gluten free labelling as long as they meet the requirements of the law on gluten free.

 

The ruling will impact anyone wanting to export gluten free products containing fermented, hydrolysed ingredients to the USA.

Should I be avoiding these products?

Many of the fermented and hydrolysed foods eg cheese, plain yogurt, white wine vinegar, cider vinegar are made from ingredients that do not contain gluten and are suitable for a gluten free diet. It’s always best practice to check that no ingredients containing gluten have been added to these products.

 

Products made from gluten containing cereals (wheat, barley, rye) which have been fermented or hydrolysed such as beer, soy sauce are only suitable for a gluten free diet if they have been processed to remove gluten, have been tested to be 20 ppm or less of gluten and are labelled gluten free. The products made from gluten containing cereals must also have on their label the statement ‘contains wheat/barley/rye’ as appropriate so they can be distinguished from those made with naturally gluten free ingredients. While we find answers, you can make a choice that is right for you by using the label to see what is in the product and make a choice on whether you want to consume it.

What label can I trust?

Since 2012 all products labelled gluten free must meet the gluten free law which means they must contain no more than 20 ppm gluten to be labelled as such. Our Crossed Grain trademark which is licensed to manufacturers gives additional safeguards as test certificates have been issued to meet the requirements of the Standard and manufacturing processes have been audited.

 

Products that are fermented or hydrolysed and made from a gluten containing grain where the gluten has been removed will be tested to determine the gluten content and if they meet the requirements of the law, can be labelled gluten free.

How are fermented and hydrolysed foods tested for gluten in the UK?

Testing should be carried out in an accredited laboratory where the methods have been validated to perform the only current approved method for determining gluten in hydrolysed and fermented foods, which is the R5 competitive ELISA.

Beer is fermented but made in two ways – what is the difference between naturally gluten free beer and gluten removed gluten free beer?

Naturally gluten free beers are brewed from naturally gluten free cereals or pseudocereals such as buckwheat, sorghum and quinoa.

 

Gluten removed gluten free beers are brewed from gluten containing cereals, most commonly barley. The beer then undergoes a process called fermentation which breaks the gluten protein in gluten containing cereals into smaller fragments. These beers can be treated with an enzyme known as Brewers Clarex® which further breaks down gluten protein into smaller fragments.

 

For both types of beer, to be labelled gluten free in the UK, they must comply with the law, which is 20 ppm or less of gluten. To determine the gluten content they should be tested using the R5 competitive ELISA, validated to measure gluten in fermented foods containing hydrolysed gluten. Beers made from a gluten containing grain, such as barley, must also have ‘contains barley‘ on the label which allows you to distinguish between the two types of beer.

Should I be drinking gluten removed beer that is labelled gluten free?

Gluten free beer that has been made from removing the gluten content from barley (this means it contains a gluten containing grain but it tests at 20 ppm or less so by law can be labelled gluten free) must have ‘contains barley’ on the label. This enables you to distinguish it from gluten free beer that has been made from naturally gluten free cereals or pseudocereals and allows you to make a personal choice as to what is right for you.

 

We are also asking producers to go further and provide additional information to help you make an informed choice. On beers advertised with Coeliac UK or listed in our Food and Drink Information you will see one of the following statements:

 

1.    Our gluten free beers are made from gluten containing grains where the gluten has been removed.

 

OR

 

2.    Our gluten free beers are made from ingredients that do not contain gluten.

Why do some people report having symptoms when they drink gluten removed gluten free beers but others do not?

There is individual sensitivity amongst people with coeliac disease. Symptoms can be due to a range of issues. For anyone experiencing symptoms it is important that they speak with their local healthcare team as they are best placed to advise on an individual’s personal circumstances.

 

There have been no formal clinical investigations on how different types of beer might be tolerated by people with coeliac disease. It is unlikely that it would be ethically possible to develop a clinical trial where volunteers are requested to drink alcohol. An alternative may be an observational study, monitoring the different diets of the coeliac population and any impact on health outcomes.      

I am diagnosed with coeliac disease but have never experienced any symptoms when eating gluten. How would I know if my body is having a reaction to something?

Research has shown that people with coeliac disease who do not have symptoms when eating gluten have the most difficulty in adhering to a strict gluten free diet. Research has also shown that gluten intake can activate the immune system without producing symptoms and symptoms may be experienced without immune activation . In accordance with the NICE Guideline NG20, 2015, all people with coeliac disease should be offered an annual review and access to dietetic support for your gluten free diet to assist with effective disease management. Your local healthcare team is best placed to advise and assess your circumstances.

If there is evidence to suggest that the current test method for determining the gluten content in gluten removed gluten free beer is being challenged by other methods in development, why can the beer still be labelled gluten free?

In the UK and Europe, the R5 competitive ELISA is an approved and validated method used for analysing gluten in fermented and hydrolysed foods.

 

As with all science, newer techniques emerge over time, such as liquid chromatography mass spectrometry (LC-MS/MS). This method is more sensitive than the R5 ELISA but it has not yet been validated to reliably quantify the amount of gluten in beer so it is not an approved method of analysing gluten.

 

In the UK and Europe, the law allows beer to be labelled gluten free providing it has 20 ppm or less of gluten.

 

Gluten free beers made from a gluten containing grain, such as barley, where the gluten has been removed, must also have ‘contains barley’ on the label. This allows you to distinguish these beers from beers made from naturally gluten free cereals or pseudocereals.

The liquid chromatography mass spectrometry (LC-MS/MS) method is being explored as a potential new method for analysing gluten in fermented and hydrolysed foods and has identified fragments of gluten in products that are not seen by the current approved R5 competitive ELISA method, is this a cause for concern?

The LC-MS/MS method is extremely sensitive and can pick up on small fragments of gluten which may not be within the scope of the R5 competitive ELISA method or any ELISA method. However, what this means in real life terms of the amount of gluten which could be recognised by the body isn’t known. There is no verified method using LC-MS/MS to measure the quantity of gluten. This is important because the legal definition of gluten free is 20 parts per million (ppm) of gluten or less.

 

We do not know if the gluten fragments seen by the LC-MS/MS will cause an immune reaction. Some of the fragments contain sequences that, if not broken down by gut digestion, could be recognised by immune cells. However, it is likely that many of these fragments will be digested and further broken down in the gut and not be capable of triggering a reaction, but we need further research to answer these questions.

 

Practical experience seen in the clinics of our Health Advisory Council and Health Advisory Network, where patients are consuming gluten free fermented, hydrolysed products, has shown that most people with coeliac disease can tolerate these products.



Why don’t gluten removed gluten free beers in the EU and UK say ‘processed/crafted to remove gluten’ on their label so that the consumer can identify these beers easily?

In the UK and EU you can identify gluten removed gluten free beers that have been made from barley as the label must state ‘contains barley’ as barley is a cereal containing gluten which is one of the 14 allergens in EU legislation and means it must be declared on the label.

 

In the USA, the FDA does not approve of the R5 Competitive ELISA test method for the quantitation of gluten in beer that is produced from a gluten containing grain, so they highlight that the beer has been ‘processed/crafted to remove gluten.’ This gives the USA consumer the information that a beer is made with a gluten containing grain where the gluten has been removed. Also in the USA, barley is not one of the 8 allergens that must be highlighted on the label according to US legislation.

 

We are also asking producers to provide additional information to help you make an informed choice. On beers advertised with Coeliac UK or listed in our Food and Drink Information you will see one of the following statements:

 

1.    Our gluten free beers are made from gluten containing grains where the gluten has been removed.

 

OR

 

2.    Our gluten free beers are made from ingredients that do not contain gluten.

Must food products made with gluten removed gluten free beer also be tested with the R5 competitive ELISA?

Yes.

What about barley malt extract?

Malt extract and malt flavourings are commonly made from barley, although they can be produced from other grains. You might find barley malt extract as an additional ingredient in breakfast cereals and chocolates.  

 

Foods that contain small amounts of barley malt extract can be eaten by people with coeliac disease if they contain 20 parts per million (ppm) of gluten or less. These foods will still have barley highlighted in the ingredients list due to labelling laws, and you won’t be able to tell how much has been used from the list alone, unless the product is labelled gluten free.

 

Previously, we would only list products which contained barley malt extract if we’d received confirmation that the product contained 20 ppm or less of gluten. Under our new policy, we are asking food manufacturers who produce products made with ingredients from gluten containing grains, such as barley malt extract, to not only confirm to us that their products have been tested and shown to have no more than 20 ppm gluten, but also to label them gluten free. In the absence of a gluten free label they will no longer be included in our Food Information listings. We are continuing to engage with the manufacturers to achieve a commitment to enable these products to be labelled gluten free in the future and we will also be asking you for your views and experiences in a survey.

Is gluten free soy sauce processed to remove gluten?

In the UK most soy sauces that are labelled gluten free are NOT made from gluten containing grains. These soy sauces are known as Tamari as they are not made with wheat.

What about barley malt vinegar?

Barley malt vinegar is made from barley, (a gluten containing cereal) and is found in pickles, chutneys and some sauces. If it is used in a food product the manufacturer must list and emphasise the word ‘barley’ in the ingredients list in line with European allergen labelling law.

 

Barley malt vinegar is made using a process called fermentation, which breaks the gluten protein in barley into smaller fragments. Foods that contain small amounts of barley malt vinegar can be eaten by people with coeliac disease if they contain 20 parts per million (ppm) of gluten or less. In addition, barley malt vinegar is usually only eaten in small amounts, for example, drained pickled vegetables, sauces with a meal or on chips.

 

We are asking food manufacturers who produce products made with ingredients from gluten containing grains, such as barley malt vinegar, to not only confirm to us that their products have been tested and shown to have no more than 20 ppm gluten, but also to label them gluten free. In the absence of a gluten free label they will no longer be included in our Food Information listings.

 

We are continuing to engage with the manufacturers to achieve a commitment to enable these products to be labelled gluten free in the future and we will also be asking you for your views and experiences in a survey.

 

There are alternative sources of vinegar that are not made from barley such as balsamic, cider, sherry, spirit, white wine and red wine vinegar.

Why have some of the pickle, gravy, vinegar and cereal products been removed from the GFFC app and the Food and Drink Guide?

Some of these products contain ingredients from gluten containing grains such as barley malt extract and barley malt vinegar. Where we have not been able to obtain information from the manufacturer that confirms the products have been tested and shown to have no more than 20 ppm gluten, and are labelled gluten free, they have been removed from our listings. We are continuing to engage with the manufacturers to achieve a commitment to enable these products to be labelled gluten free in the future and we will also be asking you for your views and experiences in a survey.

What are the views of Coeliac UK’s Food Standards Committee (FSC) and Health Advisory Council (HAC)?

The FSC is supportive of our pragmatic approach to inform and enable the community to make a choice that is right for them. Our HAC is also supportive of our current approach. Our HAC agrees and acknowledges that further research in this area is needed. Based on their clinical experience, the gluten free fermented and hydrolysed products seem to be suitable for the majority of people with coeliac disease with the exception of those who may require a super sensitive diet (see our FAQ on a super sensitive) under the supervision of their healthcare team. It is therefore felt that the proposed approach will provide the community with the information needed to make the choice that is right for them as to whether or not to include these products in their diet, while further research is sought to provide clarity and there has been an opportunity to ask the gluten free community for their views.

What is Coeliac UK going to do?

We want researchers, brewers, testing companies and laboratories performing gluten analysis to work with us to end this uncertainty for the gluten free consumer. We have been monitoring this emerging situation and we have a programme of work to address this issue. We will also be asking you for your views and preferences in a survey.

 

We are asking producers to provide additional information to help you make an informed choice. On beers advertised with Coeliac UK or listed in our Food and Drink Information you will see one of the following statements:

 

1.    Our gluten free beers are made from gluten containing grains where the gluten has been removed.

 

OR

 

2.    Our gluten free beers are made from ingredients that do not contain gluten.

What is a Super Sensitive Diet (SSD) and how will I know if I need to have one?

For some people with coeliac disease with ongoing gut damage, a more restrictive gluten free diet may be discussed with their healthcare team. You might hear this referred to as a super sensitive diet or a hypersensitive diet which might be trialled after first putting your gluten free diet under the spotlight, to ensure there is no accidental gluten creeping in. The super sensitive diet involves trialling a gluten free diet where certain foods which are normally included on a gluten free diet are avoided, such as gluten free oats, barley malt extract and gluten free wheat starch.

 

There is limited published research available on super sensitive/hypersensitive diets but experience from clinical practice indicates that this dietary approach is only suggested for a very small minority of people with coeliac disease.

 

It is essential that if you are having ongoing symptoms you discuss this with your healthcare team. The first step would be to investigate what is causing your symptoms as this is essential to guide treatment before considering a more restrictive gluten free diet.