December 22, 2024

Global Regulatory Status: Precision Fermentation/Synbio Technology: GMO or GMO free?

In the domain of precision fermentation, a noticeable asymmetry exists between U.S. and European start-ups. The United States outpaces Europe in efficiently bringing innovative microorganism-derived alternatives to conventional animal products to market. This is particularly pertinent as “animal-free” dairy proteins, often unlabeled and unregulated GMOs, gain widespread incorporation into consumables. A contemporary surge in plant-based products through synthetic biology, termed “synbio,” and falling under precision fermentation, is evident in online and physical marketplaces, reflecting a growing trend in both regions.

What is precision fermentation?

Synthetic biology, known as synbio, employs genetic engineering to modify microbes like yeast, algae, or bacteria, creating innovative products through techniques like CRISPR, gene editing, or cloning. Marketed as “precision fermentation” in biotechnology, it enhances natural processes by programming microbes to produce sellable materials, such as edible fats or proteins resembling animal products. Despite sounding like an improved natural process, precision fermentation is essentially a form of genetic engineering. Notably, it involves genetically modified organisms (GMOs), where common microbes are reengineered to produce proteins identical to those in items like eggs or dairy when fermented, emphasizing the intersection of biotechnology and food production.

Official declarations from diverse organizations regarding ingredients manufactured through precision fermentation

Non-GMO project

The Non-GMO Project, a nonprofit, focuses on promoting non-GMO products. It recently examined precision fermentation-derived dairy, referred to as “synbio dairy.” Expressing concerns about uncertainties in manufacturing processes, the organization highlights potential risks to consumers, the environment, and small-scale, non-GMO dairy farms, taking a distinctive approach within the biotech and pharmaceutical industries.

GFI

The Good Food Institute (GFI) is a non-profit organization promoting alternative proteins and innovative technologies in the food industry. GFI defines precision fermentation as a biotechnological process modifying microbes, like yeast, to produce proteins akin to those in eggs, dairy, or sweeteners during fermentation. Precision fermentation, characterized by GFI as creating “cell factories,” enables the substantial production of novel substances.

The National Bioengineered Food Disclosure Standard

The U.S. National Bioengineered Food Disclosure Standard (NBFDS) mandates labeling for genetically modified foods. It defines bioengineered foods as those with detectable genetic material modified through specific laboratory techniques, not achievable through conventional breeding or natural processes, ensuring clear disclosure of such ingredients in food products.

FDA

The FDA’s recent National Bioengineered Food Disclosure Standard doesn’t require labeling for precision fermentation-produced foods as GMOs, as they don’t contain the modified organisms but are created by them. Hence, they don’t qualify for Non-GMO Project Verification. The United States is advancing in regulating precision fermentation-derived foods, surpassing the European Commission, which is yet to approve its first such product, highlighting a notable disparity in regulatory progress between the U.S. and Europe.

European Commission

In Europe, widespread public concern about genetically engineered food has led many Member States to ban GMO crop cultivation. The European Commission has yet to approve any precision fermentation-derived food products, categorizing fermentation products obtained through GMOs under Regulation (EC) No 1829/2003 on genetically modified food and feed if recombinant DNA is present. This classification holds regardless of the quantity of recombinant DNA traces. The European Food Safety Authority (EFSA) recognizes the longstanding use of precision fermentation in producing medicines and food enzymes. The evolving science of precision fermentation opens up new potential applications in food. Major players in precision fermentation have established Food Fermentation Europe (FFE) to advocate for regulations supporting sustainable, animal-free foods and ingredients in the European market, contributing to a resilient and sustainable food system.

Summary

In summary, precision fermentation, while appearing as an improved natural process, is fundamentally genetic engineering. Despite claims that synbio ingredients aren’t GMOs, the Non-GMO Project classifies them as genetic engineering products. Although precision fermentation involves GMOs, the end product often claims to be GM-free. This complexity prompts ongoing debate, and regulations differ by country. To address GMO concerns, consumers are advised to examine food labels and research the producing companies for transparency and informed decision-making.

Is precision fermentation genetically engineered (GMO) or not (GMO-Free)?

Yes the end products such as lactoferrin, alpha-lactalbumin, milk proteins, etc are produced in genetically modified organism (GMO), therefore it is the process which involves genetically engineering its main step without this step it doesn’t exist.

Does end product of precision fermentation have GMO or Non-GMO? According to top maufacturers in the domain their end products are free from any kind of GMOs, therefore they label their products as GMO-free. It means that they utilized the genetic engineering but the product produced by the genetically modified organism doesn’t contains the remains of the GMO.

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