California Proposition 65 FAQ
What is this warning?
You may have seen the following warning label associated with our products, as well as on many other products purchased from other manufacturers:
WARNING: This product can expose you to chemicals including DI(2-ETHYLHEXYL) PHTHALATE (DEHP), which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
The warning does not mean our products will necessarily cause cancer or other harm. Moreover, a Proposition 65 warning does not mean a product is in violation of any product-safety standards or requirements. In fact, the California government has clarified that “the fact that a product bears a Proposition 65 warning does not mean by itself that the product is unsafe.” The government has also explained, “You could think of Proposition 65 more as a ‘right to know’ law than a pure product safety law.”
While we believe our products are not harmful when used as designed, we choose to provide the warning as a result of this California law.
What is Proposition 65?
Proposition 65 is a broad law that applies to any company operating in California, selling products in California, or manufacturing products that may be sold in, or brought into, California. Proposition 65 mandates that the Governor of California maintain and publish a list of chemicals that are known to cause cancer, birth defects and/or other reproductive harm. The list, which must be updated annually, includes a wide variety of chemicals that can be found in many everyday items, such as dyes, solvents, drugs, food-additives, by-products of certain processes, pesticides, and tobacco products.
The purpose of Proposition 65 is to ensure that people are informed about exposure to these chemicals. Proposition 65 also requires warnings to be placed on any product, product packaging, or literature accompanying a product that contains or may contain any of the more than 800 chemicals that the California Air Resources Board considers harmful. As noted above, many of the elements listed under Proposition 65 have been routinely used in everyday consumer items for years without documented harm.
A warning must be given if the listed chemical is merely present in a product unless a business demonstrates that the exposure it causes poses "no significant risk". With respect to carcinogens, the "no significant risk" level is defined as the level that is calculated to result in not more than one excess case of cancer in 100,000 individuals exposed over a 70-year lifetime. In other words, if you are exposed to the chemical in question at this level every day for 70 years, theoretically, it will increase your chances of getting cancer by no more than 1 case in 100,000 individuals so exposed. With respect to reproductive toxins, the "no significant risk" level is defined as the level of exposure that, even if multiplied by 1,000, will not produce birth defects or other reproductive harm. In other words, the level of exposure is below the "no observable effect level," divided by 1,000. (The "no observable effect level" is the highest dose level that has not been associated with observable reproductive harm in humans or test animals.)
A Proposition 65 warning generally means one of two things: (1) the business has evaluated the exposure and has concluded that it exceeds the "no significant risk level"; or (2) the business has chosen to provide a warning simply based on it’s knowledge about the presence of a listed chemical without attempting to evaluate the exposure.
AliMed has chosen to provide a warning based on it’s knowledge about the presence of one or more listed chemicals without attempting to evaluate the level of exposure, as not all of the listed chemicals provide exposure limit requirements. With AliMed products, the exposure may be negligible or well within the “no significant risk” range. However, out of an abundance of caution, AliMed has elected to provide the Proposition 65 warnings.
Why does AliMed include this warning?
The penalties for not complying with Proposition 65 are high. As a result of the potential penalties, and because there is no penalty for providing an unnecessary warning, AliMed, as well as many other manufacturers, have elected to provide the Proposition 65 notice on all of our products out of an abundance of caution in order to avoid the potential for liability. I purchased this product outside of California; why is it included? AliMed products are sold nationwide. It would be extremely difficult and costly to determine which products will be ultimately sold or brought into California. Therefore, to ensure compliance with Proposition 65 requirements, AliMed has decided to include these warnings on all of our products, regardless of origin.
For more information about Proposition 65 please visit: https://www.p65warnings.ca.gov/.