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Bioengineered labelling


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#1 moskito

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Posted 11 September 2020 - 10:14 AM

Dear all,

 

following the discussions on BE labelling (NBFDS) in the US there are still some questions for me related to the requirement of labelling in the context of enzymes.

To my understanding the use of enzymes in the manufacturing of ingredients (glucose syrup from non-GMO corn with enzymes produced with an engineered microorganism (e.g. amylase from Bacillus) does not require a labelling of BE on the finished product (e.g. a biscuit), when this ingredient is used.

1) But unclear for me is what is requirement for an enzyme produced in the same manner, but used as processing aid for manufacturing e.g. a biscuit? 

2) In the EU we have the definition of self-cloning which to my knowledge does not exist in the US. Self-cloned organisms (only rDNA from the organism itself -> e.g. multi-copy) are not GMO in the EU (rational: can happen in nature).

Does it make a difference in BE labelling if the enzyme is produced with the aim of an self-cloned micro?

 

Rgds

moskito



#2 Bo16

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Posted 16 September 2020 - 02:35 PM

 Enzymes used as processing aids are out of the scope since they are not required to be on the label.

The amended Act limits the disclosure to (1) food that is subject to the labeling requirements of the FDCA; or (2) food that is subject to the requirements of the three FSIS statutes previously mentioned, with certain exceptions. See 7 U.S.C. 1639a. As for the FDCA, which is under FDA jurisdiction, the NBFDS applies to all foods subject to its labeling requirements, including but not limited to raw produce, seafood, dietary supplements, and most prepared foods, such as breads, cereals, non-meat canned and frozen foods, snacks, desserts, and drinks. Distilled spirits, wines, or malt beverages as defined by the Federal Alcohol Administration Act (FAA Act) are foods under the FDCA but are not subject to the NBFDS because they are subject to the labeling provisions of the FAA Act rather than the labeling requirements of the FDCA. Alcoholic beverages not subject to the labeling provisions of the FAA Act, such as wines with less than seven percent alcohol by volume and beers brewed without malted barley and hops, Start Printed Page 65816would be subject to the NBFDS. The amended Act also specifies that the NBFDS only applies to foods subject to the labeling requirements of the three FSIS statutes if the most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA; or if the most predominant ingredient of the food is broth, stock, water, or a similar solution and the second-most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA. See 7 U.S.C. 1639a©(2).

 

Also, it is out of scope if no genetic material is in the product. Most enzymes remove the source organism during the purification process, therefore having no genetic material left in the product.






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