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
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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