What are the Proposition 65 regulations?

Prop 65 is a California law that requires a clear and reasonable warning on product labels and product web pages if that product contains chemicals known to the State of California to cause cancer and birth defects (reproductive toxicity). The law has specific requirements on how this warning should be displayed on product labels.

The warnings only apply to products sold in or into the state of California in the United States however other states are looking to adopt similar rules so food and cosmetic companies are preparing to apply this across all their products.

How can Creme Global help

A key element in determining if you require a warning label is the level of human exposure caused by your product to any of the listed chemicals. Creme Global are expert in conducting exposure assessments, providing both access to licenced state-of-the-art software in addition to consultancy services where we perform the exposure assessments for you. Our exposure software is used by many regulators across the globe including the US FDA. 

Read on to learn more. 

Exclusions to prop 65 laws

Small businesses of 10 employees and fewer and government agencies are exempt from Proposition 65’s warning requirements and from discharging any listed chemicals into drinking water sources.

Also excluded or exempt are chemicals and elements in foods that are found to be “naturally occurring” and are present in the “lowest level currently feasible.” These elements are normally a result of their absorption or accumulation in the environment in which it is grown.

If a substance on the Prop 65 list does not exceed the “no significant risk levels” prescribed by law however you must provide documentation as proof that the particular chemical substance is not present or at levels below set limits. 

Does Prop 65 only apply to California?

So far California prop only applies to the state of California in the United States however other states are looking to adopt similar rules so food and cosmetic companies are preparing to apply this across all their products.

In addition to this, industries are looking to avoid the additional costs associated with separate labeling, marketing and supply chains for a single state so they are looking into adopting the same rules across their entire market.

Does California Proposition 65 affect other states?

Not right now. The requirement of a consumer warning applies to any product sold in California. Regardless of whether a business is located in California or out-of-state, as long as its products are sold to individuals in California.

What is included in Prop65?

Proposition 65 does not just apply to products sold but also to environments where consumers may interact with chemicals.

What is a safe harbor limit Prop 65?

A safe harbor level identifies a level of chemical exposure that does not require a Proposition 65 warning. A manufacturer does not need to provide a warning if exposure to a chemical occurs at or below these levels. However, as described above in the exclusions section you must provide documentation as proof that the particular chemical substance is not present or at levels below set limits. 

You can find a list of the Safe Harbour levels here

Which chemicals are on the Proposition 65 List?

The list contains 900+ substances and is updated yearly by the state of California.

A small sample of these 900+ chemicals currently listed under California Proposition 65 identified to cause cancer and reproductive harm are listed here.

Does Prop 65 apply to packaging?

Yes.

A couple of the chemicals listed under Prop65 are vinylidene chloride and diisononyl phthalate (DINP) which are known to cause cancer. DINP is found in many soft plastic and vinyl products, and has even been found in packaging such as gift bags for various products.

In recent years, businesses that use disposable product packaging have seen an increase in Proposition 65 Notices of Violation for the commonly used chemical DEHP. These Notices can result in significant financial penalties. Settlements often require the business to label its products as cancer-causing because of the packaging alone. Which can be alienating to consumers and have a large impact on product sales.

What are the legal requirements of a label?

The California Proposition 65 website has a list of sample warnings for different types of products

Proposition 65 warning label size requirements are as follows:

  • Letters and characters have to be displayed in a minimum 6-point type. It cannot be any smaller than the largest font size utilized in other consumer products.
  • The warning must feature an exclamation point in black outlined by a yellow triangle, and the word “WARNING” must also be featured and printed boldly in capital letters.
  • The warning has to feature the full name of a listed chemical a minimum of one time.

If the warning is included on a product, a short-form warning is allowed and does not need to feature the name of the listed chemical, however, the other requirements must be met.

proposition 65 standard and short-form warning label examples

Any qualifying consumer product made available over the internet has to feature a warning on the associated website that informs the buyer before the purchase. These products should also feature a short-form warning on the product or a long-form warning on the label that adheres to the requirements.

proposition 65 warning label ecommerce

If any of these product labels or packaging provides consumer information in a non-English language, the Prop 65-compliant warning has to be provided in that language, as well as in English.

Wish has a good overview of the Prop 65 label requirements for their online merchants.

How is Proposition 65 Enforced?

Enforcement is carried out through civil lawsuits carried out by the  California Attorney General’s Office (OAG), district attorney and city attorney 

In addition, private parties acting in the public interest may also initiate Proposition 65 lawsuits.

Private parties must first provide at least 60 days’ notice of the alleged violation to the business, as well as to the Attorney General and the appropriate district attorney and city attorney and can proceed if they have not taken action.

If a business is found to be in violation of Proposition 65, a court may order the business to stop committing the violation. The penalties can be as high as US$2,500 per violation per day.

Full list of prop65 regulations

The full details of the Proposition 65 law and regulations can be found on the California State website https://oehha.ca.gov/proposition-65/law/proposition-65-law-and-regulations 

How do you become Prop 65 compliant?

The most direct route for manufacturers to be Proposition 65 compliant is to simply implement Prop 65 labels directly on their products. If you are unclear about exposure levels in your product and what warnings you need to apply Come talk to us. 

California Proposition 65 Testing and Certification

There are a range of independent testing services.

First you need to establish if you might have any prop 65 substances in your product by looking at what you sell, what they are made of, what they are packaged in and other potential sources of exposure in the growing and manufacturing process.

If you suspect you have any listed chemicals you need to get your product tested as a specialist testing laboratory. 

The third stage is to perform an exposure assessment to determine if use of the product results in exposure above the safe harbor limits, triggering a warning. Creme Global can help with these exposure assessments.

 


 

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