Introduction to Proposition 65
If you are operating in the state of California or have consumers who use your products in the state of California, you must be aware and comply by the “the Safe Drinking Water and Toxic Enforcement Act of 1986” also commonly known as the Proposition 65 or Prop 65.
1. What is Proposition 65?
According to the Prop 65 regulation:
“Any person doing business in California who knowingly and intentionally exposes California consumers to one of 900 listed chemicals known to cause cancer or reproductive toxicity must give a “clear and reasonable” warning to those consumers.”
Proposition 65 is the set of laws that require businesses to keep Californians aware of the compositions of their products if they contain certain chemicals that are carcinogenic, cause childbirth anomalies or other harms to the reproductive system of the consumers.
The Prop 65 was passed as law in the Californian state by a majority of 63%-37% and actually aimed at keeping the water sources clean from any contamination from the cancer-causing chemicals or other chemicals that can have toxic effects on the reproductive system of the consumers.
As a result of the regulation, now businesses are required to clearly mark their products that contain a certain amount of the specified chemicals with “WARNING” labels.
The entire process of Proposition 65 and its enforcement is monitored by the California Office of Environmental Health Hazard Assessment (OEHHA).
2. What chemicals are on the Proposition 65 list?
For Prop 65 compliance businesses are required to put a clear WARNING label on the products that contain known chemicals that cause cancer or other reproductive anomalies in the consumers.
According to the Proposition 65 regulation, the list of chemicals that are categorized as the “known chemicals for causing birth defects and cancer” is published on the OEHHA website and is required to be updated at least once a year (Health and Safety Code section 25249.8).
The affected chemicals range from a variety of products including natural and synthetic chemicals that are widely used in a number of daily use products. For instance, specific pesticides, food colors, drugs, dyes, and certain solvents are listed on the Proposition 65 list of affected chemicals.
A few of the products that may contain the affected chemicals can be of any of the following categories of products (the list is non-exhaustive):
- Paints and other solvents
- Shoes and other footwear
- Toys and plastic products
- Cosmetics and Beauty products
- Papers, banners and other stationery products
Interestingly, the affected chemicals may not only be directly a part of the product being sold, but it can also be a by-product of the part after a chemical process, for instance, the fumes from the car exhaust that can be containing the affected chemicals.
As such it is extremely important for businesses to know about the affected chemicals on the Prop 65 list and put a clear warning label to make the consumers aware of the harmful effects of the products.
3. What does a Prop 65 warning mean
A Prop 65 warning label on a product indicates that the business manufacturing the product is aware of the harmful chemicals contained in the product or will be released into the environment after a chemical process.
In case the business understands that the level of Prop 65 chemicals in the product are low enough to cause any harm to the consumers then such a label can be avoided (in order to do this a business will have to prove by the Prop testing methods that the current level of chemical in the product will not cause any harm to the consumers as listed in Proposition 65 regulations.)
Also, it is important to note that the warning labels must be “clear and reasonable” and can be posted on the affected product/area of production in multiple ways. The instructions for the warning as available on the p65 warning website are as follows:
- The name of at least one listed chemical that prompted the warning
- The Internet address for OEHHA’s new Proposition 65 warnings website, 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
As a result, you must be aware of the products that your business is producing that contain the chemicals listed in the Proposition 65 list.
4. Does California Proposition 65 Apply to Your Product?
The California proposition 65 requirements apply to all businesses that are either situated and operating in California State OR are supplying products for consumers in the state of California. There are only 3 exceptions to the rule:
- If a business can show that the exposure level due to their product falls at or below the “safe harbor” level. OEHHA has devised the safe harbor levels for the listed chemicals and you will have to prove it to the office of environmental health hazard assessment by Prop 65 testing rules that the affected chemical in your product is below the “safe harbor” level.
- Businesses having 10 or more employees are subject to the regulations (in case you are supplying to a larger group of distributors then even with less than 10 employees your business will have to comply with the Prop 65 compliance)
- Businesses who do not sell products to Californian consumers are also exempted from the Proposition 65 compliance (in case you are supplying products to a distributor that operates in the Californian region then you must also comply with the Prop 65 regulations).
As such it is a complex process for companies to know when they fall under the Prop 65 compliance criteria. This is why Tetra Inspection is here to help you out comply with the Prop 65 regulations because a violation of the rules can lead you into deep trouble.
5. What Are the Consequences of Non-Compliance?
In case a product that you are supplying to Californian consumers fails the Prop 65 testing criteria AND the product does not contain a “clear and reasonable” warning label then your product will be held in violation of the regulations and the associated penalties will apply.
Once a product is found in violation of the Proposition 65 compliance rules the business will be issued a 60-day notice by the Attorney General’s Office. During this period the Attorney General’s office can initiate an action against the manufacturer and if the AG office does not take an action a private party can file a lawsuit after the 60-day notice period.
The penalty for non-violation can rate as high as $ 2,500 per violation per day. An out of court settlement is then solicited that can price as high as $ 60,000 for the medium-sized organizations and $1000, 000 for larger ones.
It has also been discovered that a lot of bounty hunters are in search for the businesses that are non-compliant with the Prop 65 regulations and earn a fortune from them.
6. The Impact of Consumer Product Recalls
Violations of the Prop 65 will not only cost you the various penalties, but it will also damage the reputation of your product in more ways than you can possibly think of.
According to the Consumer Product Safety Improvement Act (CPSIA) of US, all manufacturers are required to comply with the regulations for products that can be hazardous for the general consumers and especially children from the ages of 0-12. Once your product has been found in violation of the Proposition 65 regulations you will have to “call-back” your products.
As a result, consumer confidence in your product will plummet and it might take a lifetime for you to regain the level of market share after the violation.
Also, recalling the products from the market may cost a fortune due to all the transportation costs, investigation costs, customer reimbursements and many more costs that might even send you into bankruptcy.
Once the product has been removed from the market, it will take you a substantial time to reach the same level of market share and penetration as people will not be confident to buy a product that has been found in violation of the regulation.
Competitors will fully capitalize on this and will try their best to push you out of business during your downtime.
7. How Can Tetra Inspection helps you avoid Prop 65 Violations?
Due to all the hassle associated with the Proposition 65 requirements and the potential harm a violation can cause for your product you must solicit the services of an expert quality inspection organization like Tetra Inspection.
Tetra Inspection will not only help you keep clear from harm’s way by pointing out the potential violation of the regulation by your products it will also suggest you ways of improving the product and increasing its quality.
In this regard, we have designed special Initial Product Inspections and During Production Inspections (DUPRO) that enable you to identify the compliance of your end-products with regulations.
As such, you will have substantial time to take the corrective actions and avoid suffering from the product call-backs.
Furthermore, the Proposition 65 chemical list and other associated requirements are updated regularly. As a result, Tetra Inspection will keep you posted on the relevant updates in the regulation and how you should take the necessary changes to avoid any violations and ensure the smooth running of your business with the highest quality of deliverables.