Proposition 65 Safety Dossier

Home Page

CALIFORNIA’S PROPOSITION 65
REGULATION CHANGES FOR 2018
Frequently Asked Questions & Services

[1] What is Proposition 65

“In 1986, California voters approved Proposition 65, an initiative to address their growing concerns about exposure to toxic chemicals. That initiative is officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986.” [1] The Act requires companies offering products or services that are sold in or used in California to give the public a Notice if any product involved contains chemical substances “known to the State of California” to be carcinogenic (cancer-causing) or to be involved in birth defects or other reproductive harm. The list of covered chemical substances has grown from several hundred to over 900. To make matters more complex, there are “safe harbor” levels for several hundred of the listed chemicals.

[2] What Prop 65 Changes are Coming in 2018?

Starting for any product manufactured after August, 2018 revisions to the Regulations under the Act will impose a significant increase in the burden on any business that offers products or services that are bought or used in California.

The State of California explains the changes this way:

“Since the original warning requirements took effect in 1988, most Proposition 65 warnings simply state that a chemical is present that causes cancer or reproductive harm, but they do not identify the chemical or provide specific information about how a person may be exposed or ways to reduce or eliminate exposure to it.

New OEHHA regulations, adopted in August 2016 and that will take full effect in August 2018, change the safe harbor warnings which are deemed to comply with the law in several important ways. For example, the new warnings for consumer products will say the product “can expose you to” a Proposition 65 chemical rather than saying the product “contains” the chemical. They will also include:

The name of at least one listed chemical that prompted the warning
The Internet address for OEHHA’s new Proposition 65 warnings website, www.P65Warnings.ca.gov, which includes additional information on the health effects of listed chemicals and ways to reduce or eliminate exposure to them
A triangular yellow warning symbol on most warnings.”

Therefore, it is no longer legally sufficient to merely include a generic “prophylactic” warning on labels. Companies doing business in California, which means most companies in the United States that are not strictly local businesses, will need to know whether they must include the required warning.

Failure to do so subjects the company to enforcement action by the State, or by private persons who are authorized by the Act to sue on behalf of the public. There is quite a “business” which has developed in California of environmental activists and lawyers who seek out companies that may be in violation. The fines and required legal fees can be substantial.

It is, to repeat, urgent for each business to determine their liability under the new Prop 65 Regulations.

[3] How Does the Prop 65 Dossier Service Work?

The Proposition 65 Dossier Service has established a web site to help companies learn what they must do to be in compliance with the Act and new Regulations.

Here is how it works:

USE OUR CONTACT FORM TO START. TELL US ABOUT YOUR PRODUCTS AND WE WILL REPLY.
Once you have contacted us, you will receive an email for the initial search fee, allowing you to privately enter the ingredients. Your ingredient list will be held in strictest confidence by us. We will compare your list to the Prop 65 List and let you know if there are any matches. Your ingredients must be provided as directed to return meaningful search results.
If there are no matches, you can obtain and download a Search Certification from us documenting that lack of matches. Please be advised the Prop 65 List changes regularly and the accuracy of your search will depend on accurate entry of scientific chemical names. Prop 65 Dossier Service does not accept any liability for changes in the List.
If there are any matches, you will be contacted to decide your next step.
1. You can decide to do nothing and take your chance that no one will notice. This is not advisable since there are many Californians who are aware of the private party enforcement system and are happy to receive the reward for your error.
2. You can continue to work with Prop 65 Dossier Services.
  1. We will conduct a professional search of the Prop 65 List to confirm whether your product has covered ingredients.
  2. We will search the “safe harbor” list to determine if your covered ingredients have a “safe harbor” level. We will need your proprietary and confidential ingredient formulation for this stage.
  3. At this stage we can provide you with an Initial Prop 65 Report.
3. There are two further steps after receiving the Initial Report:
  1. We can work with you to determine if your product contains less than the “safe harbor” amount of the ingredient and certify that fact to you, by Safe Harbor Certification, allowing you to avoid giving the Notice.
  2. If there is no “safe harbor” level, nonetheless, you may be qualified to receive our Prop 65 Safety Dossier attesting that the amount of the ingredient in the product is below the generally recognized “no adverse reaction” level, thereby permitting you to avoid giving the Notice.

[4] What Reports Does Prop 65 Dossier Services Offer?

We offer the following report services:

Our Initial Search per product. $ 50.00
Our Search Certification per product $100.00
The Initial Prop 65 Report detailing the covered ingredients. $250.00
The Safe Harbor Certification, per covered ingredient. $200.00
The Prop 65 Safety Dossier for the allowed levels that your product meets. $500.00 per covered ingredient
[Does not include the cost of chemical analysis testing.]

[1] https://www.p65warnings.ca.gov/new-proposition-65-warnings