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FDA Gets Specific on Partially Hydrogenated Oils (PHO's)




Effective 22nd December 2023, the US FDA is explicitly banning PHO's by removing them from the GRAS (Generally Recognised as Safe) lists for canned tuna, peanut butter and other products and further defining the requirements. But what are PHO's and why is this new announcement important?


What are PHO's? Partially hydrogenated oils (PHOs) are a type of oil that has undergone a process called partial hydrogenation. This process involves a chemical process like adding hydrogen to liquid oils, typically vegetable oils, under high pressure and temperature in the presence of a catalyst. Partial hydrogenation converts some of the unsaturated fats in the oil into saturated fats and also creates trans fats.


Here are some key points about partially hydrogenated oils:


1. Trans Fats: The primary reason for partially hydrogenating oils is to convert liquid oils into solid or semi-solid fats. This makes the oils more stable and suitable for use in various food products, such as baked goods, fried foods, and margarine. However, during the partial hydrogenation process, some of the unsaturated fats can become trans fats.


2. Trans Fat Health Concerns: Trans fats are known to have detrimental health effects. They raise levels of LDL (low-density lipoprotein) cholesterol (commonly referred to as "bad" cholesterol) and lower levels of HDL (high-density lipoprotein) cholesterol ("good" cholesterol). Consuming trans fats is associated with an increased risk of heart disease, stroke, and other cardiovascular health issues.


3. Regulation: Due to the health risks associated with trans fats, the Food and Drug Administration (FDA) in the United States has taken steps to restrict their use in food products. In 2015, the FDA determined that partially hydrogenated oils are no longer considered "generally recognized as safe" (GRAS) for use in human food. As a result, food manufacturers were required to remove partially hydrogenated oils from their products by June 18, 2018.


4. Alternative Oils: Food manufacturers have since turned to alternative fats and oils, such as fully hydrogenated oils, palm oil, and various liquid oils that are low in saturated and trans fats, to replace partially hydrogenated oils in their products.


5. Labeling: Food products in the US are required to include trans fat information on their nutrition labels. If a product contains less than 0.5 grams of trans fat per serving, it can be labeled as having "0 grams" of trans fat. However, it's important to check ingredient lists for partially hydrogenated oils, as even small amounts can contribute to trans fat intake.


6. Health Recommendations: In line with the FDA's actions, health experts recommend minimizing the consumption of trans fats by choosing foods that do not contain partially hydrogenated oils. This can help reduce the risk of cardiovascular disease and promote overall health.


In summary, partially hydrogenated oils are oils that have undergone a chemical process to make them more stable and suitable for use in food products. However, this process can create trans fats, which have been linked to health risks. Due to these health concerns, there has been a significant reduction in the use of partially hydrogenated oils in the food industry, and they have been largely phased out in the US. This action looks to be the final stage in that journey.


On the 8th of September 2023, FDA announced the following:


"The Food and Drug Administration (FDA or we) is amending our regulations that provide for the use of partially hydrogenated oils (PHOs) in food in light of our determination that PHOs are no longer generally recognized as safe (GRAS).


The rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna. It revises FDA's regulations affirming food substances as GRAS pertaining to menhaden oil and rapeseed oil to no longer include partially hydrogenated forms of these oils, and deletes the regulation affirming hydrogenated fish oil as GRAS as an indirect food substance.


We are also revoking prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health.


We are issuing these amendments directly as a final rule because they are noncontroversial given the public health risks associated with PHOs and the increasing use of PHO alternatives, and we anticipate no significant adverse comments because PHOs were declared no longer GRAS for any use in human food in 2015."


Unpacking the above it is clear that FDA wishes to ensure there are no loopholes left of PHO's so be aware that if you make, import, or sell products, in the US with PHO's you are at one second to midnight. It's time to reformulate and make your products safe, legal and compliant.


If you require a GRAS review of your ingredients why not contact us to find out how we can help.

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