Coeliac Disease - 20ppm Gluten Directive

[Name Removed] made this Freedom of Information request to Food Standards Agency This request has been closed to new correspondence. Contact us if you think it should be reopened.

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Dear Food Standards Agency,

The UK standard for gluten allowed in foods labelled 'gluten free' is 20ppm.

Approximately 1/3 of all ceoliac sufferers are intolerant even to this level, and require 0ppm to achieve and maintain good health.

The 20ppm is also an EU supported level.

Considering that coeliac disease requires a complete elimination of all gluten, for life, to repair the gut, associated damage and achieve good health, it seems bizarre that the 20ppm is actually allowed by law, and products that still contain up to 20ppm can be labelled as gluten free and suitable for coeliacs.

I am requesting that you disclose all research that:
- You have independently conducted on the suitability of the 20ppm level for coeliac sufferers;
- Any external research you have sourced to assess the suitability of the 20ppm level for coelica sufferers;
- Any other regulatory information on this matter.

Yours faithfully,

[Name Removed]

FoodIntoleranceEnquiries, Food Standards Agency

3 Attachments

Good Morning,


Thank you for your email regarding Gluten free labelling and the
establishment of the 20mg/kg threshold.


You asked about

• Suitability of the 20mg/kg level for those living with coeliac
• External research to assess this level for those with coeliac disease
• Any other regulatory information on this matter.


Labelling for the suitability of foods suitable for those with coeliac
disease is an EU area of competence. To inform risk management discussions
and decisions, scientific opinions will be reviewed.


However, in the case of the standard for gluten free labelling, there was
a Codex Standard on gluten labelling which set the minimum requirements at
a global level. Codex Alimentarius is run by the Food and Agriculture
Organisation of the United Nations and the World Health Organisation.
Their role is to set up and agree international food standards to improve
food safety, quality and fairness of food trade.


For gluten free labelling, the basis of the EU standard was based on the
discussion on the revision of the Codex Standards for Gluten Free Foods
Codex STAN 118-1981 (changing the limit from 200mg/kg to 20mg/kg). This
discussion was held at Codex Committee on Nutrition and Foods for Special
Dietary Uses (CCNFSDU) but also at Codex Committee on Methods, Analysis
and Sampling (CCMAS) to review the method of analysis to enable the
monitoring and enforcement of the 20mg/kg threshold.


The UK provided input to form the EU position and the EU provided a
response to CCNFSDU to proposals to revise Codex STAN 118-1982 and the
ability to detect gluten at the proposed revised threshold. The revision
of the 200mg/kg gluten free threshold to 20mg/kg was adopted in 2008.
Below you will find the relevant documents from CCNFSDU

• [1]
• [2]
• [3]
• [4]
• [5]


To support risk management discussions at an EU level (to amend EU
regulations and to inform Codex discussions) and to form the UK position,
the FSA independently commissioned research on coeliac disease and
published papers which can be found on our website:


In order to amend the UK regulations to reflect changes at the EU level a
public consultation was held covering an explanatory memorandum (including
an impact assessment) on the issue.



Since the regulation was laid, a scientific review was performed by the
European Food Safety Authority in 2014 to provide an overview of the EU
regulatory allergens of public health importance. On page 63, a mini
overview of coeliac disease considers the prevalence, potency, protein
characterisation, effect of processing, detection methods and use of
gluten free claims


Finally, in your email, I would like to seek clarification on what you
mean by “Any other regulatory information on this matter”? Once you have
reviewed the information I have provided you in this email, if you would
provide clarification on what regulatory information you require that
would be helpful.



Best regards,






Amanda Sanderson

Business Support Officer

Food Policy Directorate

Food Standards Agency, York



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