New, Evolving Coproducts Require Regulatory Due Diligence
by Kurt A. Rosentrator (Distillers Grains Technology Council/Ethanol Producer Magazine) Altered, novel products may require new AAFCO definitions, GRAS affirmations. — … During the past two years, we have reviewed and commented on two key rulings in the Food Safety Modernization Act, including the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (FDA-2011-N-0992), and the Sanitary Transport of Human and Animal Food (FDA-2013-N-0013). FSMA is expanding the scope of the U.S. Food and Drug Administration.
We must, therefore, make sure that we do our due diligence when it comes to the products we make and the processes we use to manufacture them, being cognizant of the relevant regulations.
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Most dry grind ethanol plants produce coproducts meeting these definitions, as do beverage distilleries here in the U.S. If you make traditional distillers coproducts, then more than likely your coproducts are already defined appropriately. But, are you making a new type of coproduct? If so, does it fall in line with one or more of these definitions? If it does not, then you need to develop a new definition. The AAFCO Official Publication is printed annually or you can subscribe to the online publication which is updated continuously.
As an example, in recent years most fuel ethanol plants have implemented oil removal technologies and many in the industry, including the Distillers Grains Technology Council, have worked to establish a legal definition for distillers oil so that it legally can be sold in the U.S.
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But, one thing is certain: if you are developing new coproducts, or are even thinking about it, start your journey toward compliance now.
In order to legally sell a new coproduct, the new feed ingredient must be proven safe for its intended use. There are three mechanisms to gain authorization for a new feed ingredient: the AAFCO definition process, the Food Additive Petition process or the generally regarded as safe (GRAS) determination with voluntary notification. All three of these mechanisms for approval can be very lengthy, ranging from one to three or more years, requiring extensive documentation.
Although it is dependent on the product and company preference as to which path to take, most follow the official AAFCO process to establish the legal identity and get a published definition in the AAFCO official publication. “A Guide to Submitting New Ingredient Definitions to AAFCO” is available on the AAFCO.org website.
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A third approach is to establish the ingredient is safe for the intended use via a GRAS affirmation. READ MORE