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.