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On November 18, 2015, the United States Food and Drug Administration (US FDA) published a proposed rule which will provide an alternate method to verify the compliance of fermented, hydrolyzed and distilled foods that are labeled as Gluten-Free.[1] The final gluten-free rule published August 5, 2013 identified uncertainty with the compliance methods for these products.

SAFEGUARDS | Food NO. 213/15

This alternative method to verify compliance will provide the public with more verified Gluten-Free products and allows the industry producing these items to voluntary label the products as gluten-free.

All of the requirements in this rule will apply to fermented, hydrolyzed or ingredients voluntarily labeled as gluten-free. The manufacturers of these products will have to make and keep records to show the following:

  • The food meets the US FDA definition of gluten-free, including that the food had less than 20 mg/kg of gluten before the fermentation or hydrolysis process
  • The manufacturer must evaluate the process for any potential gluten cross-contamination
  • If there is potential for cross-contamination the manufacturer would implement measures to prevent this

These records are to be kept for at least 2 years from the date on which the product is placed into interstate commerce. It must also be made available to the US FDA on request.

For distilled foods and ingredients, the US FDA proposes that the manufacturer uses a scientific method to verify that no detectable level of protein is in the food. The method sensitivity shall have a limit of detection as close to zero as possible. Records of this testing will need to be retained for at least 2 years from the product’s entry into interstate commerce. It must also be made available to the US FDA on request.

The comment period for this proposal ends February 16, 2016.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website. www.foodsafety.sgs.com.

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager
t: +01 973 461 1493

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