You may see the following warning statement included in the user instructions accompanying some of our products:
This warning statement is a requirement under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 or "Proposition 65" as it is more commonly known.
Please note that this warning does not mean that any particular product is unsafe or in violation of any product safety standards or requirements. The design and manufacture of Fisher & Paykel Healthcare products are subjected to our ISO 13485 certified quality system and comply with relevant internationally recognised product standards.
Some frequently asked questions in relation to Proposition 65 are set out below.
Proposition 65 was enacted almost 30 years ago to address the concerns of California citizens about exposure to toxic chemicals. The purpose of Proposition 65 is to notify consumers that they are being exposed to chemicals known to the state to cause cancer or reproductive toxicity. Proposition 65 requires the State of California to publish a list of such chemicals. This list, which must be updated at least once a year, has grown to include more than 800 chemicals since it was first published. Manufacturers, distributors, and retailers who manufacture, distribute or sell consumer products in California are subject to Proposition 65, whether located in California or not. Proposition 65 applies to a very wide range of consumer products.
Proposition 65 requires that businesses provide a clear and reasonable warning to consumers if a product contains any of the listed chemicals, unless the exposure to the chemical that is likely to result from the use of the product is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. By providing this information, Californians are able to make informed decisions when deciding whether or not to use a product.
For chemicals listed as causing cancer, the State has defined the "no significant risk level” as the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime. In other words, a person exposed to the chemical at the “no significant risk level” for 70 years would not have more than a “one in 100,000” chance of developing cancer as a result of that exposure.
For chemicals that are listed as causing birth defects or reproductive harm, the State determines the “no observable effect level” by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals. Proposition 65 then requires this “no observable effect level” to be divided by 1,000 in order to provide an ample margin of safety. Businesses subject to Proposition 65 are required to provide a warning if they cause exposures to chemicals listed as causing birth defects or reproductive harm that exceed 1/1000th of the “no observable effect level.”
As noted above, it is important to remember that the inclusion of a Proposition 65 warning with some of our products does not mean that a product is unsafe or in violation of any product safety standards or requirements.
The following factors are relevant to the decision of many businesses to include a Proposition 65 warning with their products:
As a global manufacturer of medical devices, we distribute and sell products internationally. Although Proposition 65 only applies in California, it is difficult to determine whether any particular product will ultimately be distributed or used in California.
For more information about Proposition 65 please go to: http://oehha.ca.gov/prop65.html
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