CRN's vice president of scientific and international affairs, John Hathcock, is speaking to attendees today on risk assessment for functional food ingredients and is proposing the use of new methodology to set fortification upper limits. There are currently no labeling requirements for upper limits in the US. According to Hathcock, consumers are generally more aware of the amount of supplements they are ingesting, but perhaps not as aware of the nutrient content of fortified products. "A supplement is a thing people are more likely to take deliberately," Hathcock told NutraIngredients-USA. "They are less likely to pay attention to the cumulative aspects of functional foods." The risk is not so much that consumers will take in too much of one nutrient, but rather that they are simply not aware of the doses, said Hathcock. "I want to provide advice to manufacturers to be reasonable and not to put in too much," said Hathcock. "I want them to put in as much as they think is useful while being safe." And, in the absence of upper limits, there is also leeway for governments to set their own standards without scientific basis - thereby possibly restricting fortification. "In the absence of an appropriate number, I'm worried that governments around the world will set arbitrary upper limits," said Hathcock. "So, a lot of what I do is stakeout a rational approach to regulatory policy so that this is not arbitrary." In the US, the Food & Nutrition Board sets upper limits for nutrients with known toxicity by dividing dosing by an uncertainty factor. CRN has been compiling risk assessments on nutrients and calculating upper limits using its own methodology. As such, while the Food & Nutrition Board has set the upper limit for vitamin D at 6,000 UI, the trade association says it should be 10,000 UI. CRN's take on uncertainty adjustment is to look at case studies and select downward in the clinical trial data until they find a dosing in which they have a high confidence. Hathcock is proposing a twofold approach to improving the safety of supplementation and fortification through standardized dosing. This includes: - Setting the upper limits for materials with no known toxicity; - Using better methodology for taking uncertainty into account. So far, CRN has applied its risk assessment methodology to chondroitin sulfate, glucosamine, Coenzyme Q10, creatine, carnitine and lycopene. It also has three other risk assessments currently submitted for publication - these are for the amino acids argenine, L-glutamine and taurine.