Friday 5 February 2016

Are Australian and NZ Gluten Free Food Manufacturers Disadvantaged By the Detection Limited Not Being Stated?

 In the past 5 to 10 years the regulations relating to gluten free food labeling in various countries have progressed substantially. More people have become aware of what it means to eat gluten free food and manufacturers have got on the band wagon and more and more gluten free foods are available for purchase from supermarkets and specialty health stores.


For consumer safety most countries have established food safety laws to protect people with food allergies and other eating requirements such as celiac disease. The laws on the labelling of food as gluten free are very tight and businesses who label product as gluten free must comply with the law of that country. Food manufacturers have a legal obligation as well as a duty of care to ensure that the food they serve to customers is safe and this extends to customers with celiac disease.

If a product is labeled as gluten free food then the manufacturer has to be absolutely sure that it is 100% gluten free to comply with the law. Food businesses have to make sure that they have processes and systems in place to ensure that the information they provide is accurate and can be checked by you the consumer.

These legal regulations provide consumers, especially those with celiac disease, the assurance that a gluten free claim on food products are consistent and reliable across the food industry. The regulations give consumers a standardised tool for managing their health and dietary intake. The good thing about having labelling laws is that it assures people with celiac disease that foods labelled gluten free have met a clear standard established and enforced by the FDA or other authorities.

The leading international authority on the labelling of gluten free food is the Codex Alimentarius, which is recognised as "The International Food Standard" and most countries have based their labelling laws on their criteria. The Codex standard for gluten was revised in 2008 and has a two-step approach for the classification of gluten free labeling. It specifies:

1.    Products can be labelled gluten free only if they meet the following criteria:

                              I.        not derived from gluten containing cereals and containing maximum 20 mg/kg (ppm) of gluten
                            II.        derived from gluten containing cereals which have been specially processed to remove gluten and the gluten level does not exceed 20 mg/kg (ppm) of gluten in total

2.    Rendered gluten free for products, such as specially processed wheat starch based products, with reduced gluten content above 20 to at a level of 100 mg/kg (ppm). How these products are labelled for the consumer has been left at a national level, so they could also be labeled Low Gluten Level or Very Low Gluten Level

The USA , Canada, UK and Southern European countries have all in the past few years adopted gluten free standards which adopt the Codex level of detection, yet the FSANZ standard  for Australian and NZ combined standard still require that food labeled as gluten free contains no detectable gluten:

1.    GLUTEN FREE - A claim to the effect that a food for special medical purposes is gluten free may be made only if the food contains no detectable gluten; and if it does not contain oats nor oat products; and it does not contain cereals containing gluten that have been malted, nor the products of such cereals.
2.    LOW GLUTEN CONTENT - A claim to the effect that a food for special medical purposes has a low gluten content may be made if the food contains no more than 20 mg gluten per 100 g of the food. (200 ppm)

This regulation results in Australia and NZ having the strictest standards for the labeling of 'gluten-free' foodstuffs which are out of whack with international best practice. This is because the detection limit required in the FSANZ standard is not specified, and as technical methods improve, detection limits are and will get lower and lower. This standard creates unnecessary compliance costs for food manufacturers in Australia and NZ, and unnecessarily limits the range of foodstuffs available to people suffering from celiac disease and dermatitis herpetiformis.

"Detectable" is not defined in the Code or in any piece of Australian or NZ regulatory guidance. Despite this, Australia's Competition and Consumer Commission (ACCC) has expressed the view that 'gluten-free' ought to mean "absolutely no gluten whatsoever".
Also, there is no regulation on the testing methodologies used to test for gluten. The most internationally adopted method used to detect gluten in foods is the Gliadin ELISA test. The Limit of Detection (LOD) of this method which is determined by the manufacturer is 3 ppm. 

However the sample itself can interfere and make testing at this low level unreliable. It is therefore currently generally accepted that the minimum level of gluten that can be accurately quantified across a range of different food matrices using recommended ELISA methods is 5ppm which is the Limit of Quantitation (LOQ).  Hydrolysed and fermented products require a different testing method and the LOQ may go up to around 10ppm.

This means that foodstuffs labelled as 'gluten-free' in Australia and NZ are effectively required to contain no traces of gluten over 3-5 ppm depending on the method used. This is in comparison to other countries where the detection limit is < 20 ppm. There are concerns that in the future, improvements in detection technology may result in even lower detection limits becoming possible, such as  <1 ppm. Developments of that kind may result in a further contraction in the range of products available to those with gluten intolerance in Australia and NZ.

Australian and NZ health professionals are divided on the issue of the toxicity of oats and malt in individuals with celiac disease.  NZ health professionals consider that small amounts of oats and malt can be consumed by people with celiac disease. Conversely, Australian health professionals believe that there are some people with celiac disease that are unable to tolerate even the smallest amounts of oats and malt.  This standard takes into consideration the opposing views of Australian and NZ health professionals in terms of the toxicity of oats and malt and the dietary management of celiac disease.  

The level of 20 ppm gluten being defined as gluten free has been internationally accepted as been safe by medical experts. There is no evidence that this level of gluten causes any problem for a person with celiac disease. To the contrary, gastroenterologists worldwide have confirmed that a foodstuff containing <20 ppm of gluten is considered safe for celiacs. This view is consistent with leading scientific studies commissioned by Codex and others, which conclude that safe levels for gluten ingestion by celiac disease sufferers are actually much higher than the Australian and NZ's standard suggests. However, there are some professionals who argue that 10 ppm or less would be safer levels for celiacs.

I believe that Australia and NZ need to adopt the CODEX definition to give a level of international uniformity and to keep up with the regulations in other countries. It is essential that the international definition of gluten free is both achievable in commercial food manufacturing processes but it also needs to be safe for those with celiac disease.  It is also essential that the term gluten free is synonymous throughout the medical profession worldwide when discussing the treatment for celiac disease. The internationally accepted level of 20 ppm will achieve all these goals.

Australia and NZ food manufacturers are currently disadvantaged by these laws. It is just not the added cost of compliance, but if they export overseas they have to change the labeling on their products to meet international regulations. It makes sense that the gluten free standard in Australia and NZ should be the same as the widely accepted international standard of less than 20 ppm (parts per million) which has been adopted by the UK, Southern Europe, the USA and Canada; 20 ppm of gluten is a tiny amount equivalent to 0.002% of gluten in a product.


These countries adopted this standard after lengthy and rigorous scientific assessment which took into account the weight of scientific evidence, clinical observation and international expert medical opinion which all supported 20 ppm as a safe threshold for people with celiac disease. If it is not addressed soon, testing methods may become so sophisticated and sensitive to the detection of gluten that the gluten free food space in Australia and NZ could soon become near impossible for manufacturers to compete in. 

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