The updated Proposition 65 requirements have been one of the most-discussed topics in the natural products industry in 2018. Since you’ve heard about them so much, you probably have them memorized. You know that businesses are required to provide “clear and reasonable” warnings on products that expose consumers to any of the 900 chemicals listed. You’re familiar with the safe harbor levels that the heavy metals must meet to prove “no significant risk level” (if not, check here: Prop 65 levels). But are you aware of the exceptions for naturally occurring chemicals and elements?
Explaining “Naturally Occurring”
Section 25501 of the Proposition 65 regulations specifically relates to foods and dietary supplements. The Office of Environmental Health Hazard Assessment (OEHHA) exempts the exposures of chemicals and elements in foods that are found to be “naturally occurring” and are present in the “lowest level currently feasible.”
“Naturally occurring” chemicals and elements are those that exist in food as a natural component. In other words, their presence in a food or crop is directly a result of its absorption or accumulation in the environment in which it is grown or harvested.
In relation to Prop 65, the “naturally occurring” amount of a chemical or element in that particular food can be subtracted from the total amount of the chemical in the calculation of exposure levels.
However, this is easier said than done.
It is important to understand that a chemical or element is naturally occurring only if it is not generated by any human activity. To prove this, suppliers must show that the existing natural levels of that chemical or element are directly affected by the area in which the food is obtained. This can be done by specific analyses, but depending on the location of where the food is grown, it can be almost impossible to perform. Food providers must also show that the chemical or element will occur naturally in the food, despite their best efforts of safe food practices to avoid them. Quality controls must be used to maintain the “lowest levels feasible” of the listed chemical or element.
Lead: The Leading Culprit
Possibly the most cited element in Prop 65, lead has more violations than any other element listed. This is probably because of the frequency it occurs in nature. Low doses of lead have been found in the soil, plants or water used in food, herbal and dietary supplements production across the industry.
Lead has been named a reproductive toxicant, so Proposition 65 warnings are required on labels for exposures of more than 0.5 μg/day. This safe harbor level of 0.5 μg/day is considered significantly lower than the amount of lead in normal daily serving sizes of fruits, vegetables, and herbs.
This leaves it up to the company supplying the food to demonstrate that the level of the lead is “naturally occurring”. If they can prove this, they are “exempt” and can avoid the warning requirement for levels exceeding 0.5 μg/day for lead.
If you are on the fence about testing your ingredients or food products, it’s better to err on the side of caution and have it tested. SGS is your trusted third party laboratory with over 20 years of experience in the food and dietary supplement industry.
For Prop 65 testing of metals in your product, please contact Chemical Solutions either by calling us at (717) 697 –7536 or submitting a request. Either way, we’ll respond promptly to your inquiry.