U.S – The Food and Drug Administration (FDA) has advised producers of plant-based proteins to be aware of the regulations that apply to their products, as a preventative measure for those creating novel plant types with the intention of introducing genes for allergen-causing proteins.

Currently, there are no food products from these types of new plant varieties in the U.S market. However, research is underway hence FDA saw the need to reach out to developers and manufacturers as early as possible.

FDA is only aware of one instance in which a business introduced a gene from a major food allergen into a crop plant—a gene for a Brazil nut protein into a soy variety to enhance its nutritional profile for animal feed—since the publication of its 1992 guideline on food from novel plant varieties.

The creators of the new variety voluntarily stopped work on it after learning that the transferred Brazil nut protein was an allergen due to the potential threat to people who are allergic to Brazil nuts.

“The FDA is reminding the industry of the relevant legal requirements and potential food safety concerns related to producing, processing, packaging, and holding these types of plant varieties and the industry’s responsibility to ensure that they do not become unintended or unexpected allergens in final food products,” the FDA warned.

Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame are among the nine foods on the federal government’s list of major food allergens.

The FDA has urged manufacturers and developers to take risks into account during the early development and management phases due to the safety hazards posed by these allergens.

The FDA advised food producers and developers that undeclared allergy risks to food safety could have effects beyond those affecting consumer health and welfare. Even at low levels, adverse reactions to food allergens can be severe and life-threatening.

It notes that there may be additional repercussions for food producers if unanticipated and undeclared allergens reach the food supply, such as the requirement to recall the impacted products.

“We are specifically reminding those developers who are now exploring the development of these types of plant varieties of their responsibility for food safety. 

“In particular, we are reminding them to consider the allergenicity issues related to their products, and how they would be stewarded from production to manufacturing to consumption so that they do not inadvertently or unexpectedly enter the food supply. We are also reminding them that they need to be properly labeled when intentionally part of the food supply,” said the regulator.

Consequently, the FDA is urging developers and producers to meet with the organization before marketing their products in order to assist them in their endeavors.

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