In a 56-page comment responding to the FDA’s proposal to ban PHOs, the ABA says this would have the “unintended consequence” of rendering several technical/functional ingredients that contribute trace amounts of trans fats to finished foods - but are critical to bakers - as illegal.
The law of unintended consequences
For example, some PHOs used to encapsulate bioactives or protect heat sensitive substances contribute “negligible amounts of trans fat to the daily diet” but have “no functionally equivalent replacements”, said SVP government relations & public affairs, Lee Sanders.
Meanwhile, some PHOs are used as starting materials for ingredients such as mono- and di-glycerides, which also contribute only trace amounts of trans fat to finished products, she added.
“Industry has also developed special catalysts that are capable of catalyzing the process of partial hydrogenation to produce stable oils and fats with very low levels of trans fat.”
Similarly, while interesterification (where the structure of oils is chemically or enzymatically re-arranged in order to give it different properties) is often touted as an alternative to partial hydrogenation as a means of making liquid oils more solid, “most people don’t know that the source oils used in the interesterification process are often modified by hydrogenation before the process is performed”, Sanders told FoodNavigator-USA.
The resulting structured fats are not PHOs, but if PHOs used as starting materials are no longer GRAS, ”then industry will not be able to use these to produce these interesterified fats”, she said.
There are no functional alternatives to some PHO-derived emulsifiers
Meanwhile, hydrogenation - both full and partial - is of particular importance to bakers because it is used in the manufacture of emulsifiers such as sodium steroyl lactylate, mono- and di-glycerides, ethoxylated mono- and di-glycerides, distilled diglycerides, and DATEM “for which there are no functional alternatives”, she claimed.
“These ingredients contain some trans fat, but due to the low level at which they are used in manufacturing (less than 0.5% formula basis), their trans fat contribution to finished bakery products is typically well below 0.2g per serving or RACC.”
FDA’s approach is unlawful
The bulk of the ABA’s comment, however, is devoted to arguing that the FDA has failed to prove that the very low levels of trans-fats now consumed by Americans present a safety concern, and pointing out that the agency’s proposals are based on trans fat consumption levels 10 times higher than current levels.
She added: “Because FDA’s data evaluates the safety of trans fat at much higher intake levels than those represented by current US consumption patterns, the Agency has not provided a sufficient basis to conclude that consumption of PHOs - a single source of trans fat that contributes an estimated daily amount of trans fat of 0.5% total energy - presents a safety concern.
“Moreover, FDA’s approach is unlawful because it does not examine the use of each PHO and the probable consumption of each use.”
Finally, the FDA also overstated the contribution PHOs make to trans fat intakes in a 2012 analysis by coding all products making 0g trans-fat claims as containing 0.4g trans fat, when in fact they typically contained just 0.2g, she said.
Meanwhile, many of these products have been reformulated since 2012 meaning levels are now even lower, she claimed.
What should the FDA do instead?
So what should the FDA do instead of banning PHOs? The ABA outlines several alternatives:
1 - Change the ‘rounding rule’ for declaring trans fats on the Nutrition Facts Panel (which allows firms to state ‘0g trans fat’ if a food contains less than 0.5g/serving). Instead, FDA could change the rules such that firms could only make this claim if their products contain less than 0.2g per serving.
2 - Establish nutrient content claims for trans fat and establish disclosure and disqualifying levels for trans fat.
3 - Set specifications for the quantity or percentage of trans fat in the total fat in finished foods or set specifications for the percentage of trans fat allowed in PHOs.
4 - Declare certain uses of PHOs as GRAS, particularly where such uses contribute negligible amounts of trans fat to the diet (e.g., emulsifiers such as mono- and di-glycerides, encapsulates, colors, flavors, spices, processing aids) or because they are in infrequently-consumed foods (e.g., ready-to-use frostings, fillings, coatings).
Click HERE to read what the American Heart Association thinks.
Click HERE to read what the National Association of Margarine Manufacturers thinks.
Click HERE to read all the comments in the docket.