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Blog: Informational Resource about Food Industry

FSMA Update – FDA submits final preventive controls rules to the Federal Register

The FSMA Human Food and Animal Food Preventive Control Rules were officially completed on Monday, August 31st to meet the court-mandated deadline.  However, due to the size of these rules, these regulations will not be published in the Federal Register until possibly mid-September. 

Documents submitted to the Federal Register can publish several days after they are submitted, with larger documents taking longer to process and display. The FDA will share information about the final rules and how food facilities can comply as soon as they are able to do so.  

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2015-09-01 20:41:46
 

Gluten Free - Inside the Regulation

 

LABELING REQUIREMENTS

(21 CFR 101.91 Gluten free labeling of food - final rule)

FDA allows manufacturers to label a food "gluten-free" if the food does not contain any of the following:

  • an ingredient that is a gluten-containing grain (wheat, barley, rye or cross-breeds of these grains)
  • an ingredient that is derived from these grains and that has not been processed to remove gluten (e.g. wheat flour)
  • an ingredient that is derived from these grains and that has been processed to remove gluten (e.g. wheat starch) if it still results in the food containing 20 ppm or more gluten


Foods that are naturally gluten-free may not use the claim if they become contaminated with levels above 20 ppm as a result of cross-contact with gluten containing foods.

An estimated 3 million people in the United States have celiac disease. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Last year FDA issued a rule on food labeling to improve life for people with celiac disease. The rule ensures that voluntary “gluten-free” claims on food packages are reliable and consistent. It provides a clear definition of the term so that all packaged food products bearing the claim “gluten-free” contain less than 20 parts per million (ppm) of the protein.

As of August 5, 2014, this rule is now in effect and manufacturers using a gluten-free label on their packaging must comply with the FDA’s labeling rule.

The gluten limit of less than 20 ppm applies to foods that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” and means that that to be labeled as free of gluten, each kilogram of the product must contain less than 20 milligrams (mg) of the protein. This is consistent with the threshold established by other countries and international bodies that set food safety standards.

In addition, participation in third-party gluten-free certification programs requires that manufacturers go beyond the FDA's standards for gluten-free products. These certification programs require validated gluten-free management systems that set a limit at less than 10 ppm and lower if possible.

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2015-03-25 16:05:35
 

Food Safety Modernization Act

 

Focus On Environmental Control And Monitoring Programs

The Food Safety Modernization Act (FSMA), signed into law by to identify their potential hazards and confirm adequate preventive controls of those hazards. 

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2015-03-25 16:02:29
 

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