As a professional in an industrial setting, it is likely that you use products that contain chemicals to effectively maintain, protect and sanitize your work environment. Although you want these products to be effective, it is also important that they be safe.

Chemicals known to the state of California to cause cancer, birth defects or other reproductive harm are published on a list as required by the state’s Proposition 65, or the Safe Drinking Water and Toxic Enforcement Act of 1986. California enforces the most stringent requirements on these potentially harmful chemicals—far beyond those of other states. Chemical quantities above extremely strict limits trigger warning disclosures, and a failure to comply can lead to fines and lawsuits.

This white paper gives an overview of Proposition 65 and the process Deb Group went through to reformulate its products to remove all traces of the chemicals in question in the best interest of all of its consumers, regardless of state.

About Proposition 65
The Proposition 65 list is limited to naturally occurring and synthetic chemicals — molds and other such toxins are not included—and to date, more than 850 chemicals are included on the list. Listed chemicals may be used in manufacturing or they may be the result of chemical processes.

The list is monitored by the Office of Environmental Health Hazard Assessment (OEHHA), part of the California Environmental Protection Agency. According to its website, the OEHHA’s mission is to “protect and enhance public health and the environment by scientific evaluation of risks posed by hazardous substances."

The organization also evaluates the available scientific information on substances considered for inclusion in the Proposition 65 list. There are different ways for a chemical to be added to the list:

• Determination by either of the independent committees on the OEHHA’s Science Advisory Board;
• Designation by an “authoritative body” or a state or federal agency such as the U.S. Environmental Protection Agency (U.S. EPA) or U.S. Food and Drug Administration (U.S. FDA); and
• Identification by the California Labor Code.

If a listed chemical is found in a product, manufacturers are required to take action within 12 months either by removing the ingredient(s) or complying with the state’s warning requirement: 

According to the California Health and Safety Code Section 25249.6, no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.

For example, for consumer products that contain a chemical identified to cause cancer, the warning language must include the following message: “WARNING: This product contains a chemical known to the State of California to cause cancer.”

Warnings must be provided for exposures that pose a “significant risk.” According to the OEHHA, “for chemicals that are listed as causing cancer, ‘significant risk’ is defined in regulation to mean one excess cancer for every 100,000 people exposed (assuming exposures occur over a 70-year lifetime). For chemicals listed as causing birth defects or other reproductive harm, the significant risk level is defined as the level at which no observable (adverse) effects are seen divided by 1,000.”

Furthermore, this warning requirement applies to any company employing 10 or more employees who manufactures, distributes or otherwise transfers these products containing these chemicals into the stream of commerce in California; businesses with fewer than 10 employees and government agencies exempt from Proposition 65’s warning requirements.

Proposition 65 and Deb Group
On June 22, 2012, OEHHA added two chemicals to the Proposition 65 list as substances known to the State of California to cause cancer: Titanium Dioxide (as an airborne inhalant) and Cocamide DEA. A third chemical, Triethanolamine (TEA), was also under scrutiny as a possible carcinogen.

Titanium Dioxide is a mineral commonly used as a pigment, UV blocker or thickener in products such as sunscreen and cosmetics. TEA is used as a pH-balancing ingredient or emulsifier in cosmetic products, soaps and household cleansers, and Cocamide DEA is used in the same types of products as a foaming agent. 

For Deb Group, an away-from-home skin care company, the priority was to ensure that their products not only complied with Proposition 65, but were the safest, yet most-effective formulations available.

Deb Group felt that they could eliminate Titanium Dioxide, TEA and Cocamide DEA to guarantee consumer wellbeing without compromising the overall product performance, so they elected to move forward with reformulating all of the affected products.

The Reformulation Process
Titanium Dioxide was added to the Proposition 65 list due to the concern for airborne exposure. Deb Group, however, uses the chemical in a liquid emulsion. If Deb Group’s products were used properly, there was no concern for exposure, but, due to the connotation of being added to the Proposition 65 list, they elected to remove it entirely. The inclusion of Titanium Dioxide in the original formulation served as a whitener to brighten the appearance of the product. Deb Group made some concessions to the appearance of the product — the product is now oatmeal-colored rather than the original grey-white — but the product performance was unchanged.

TEA is not officially included on the Proposition 65 list as a high-concern carcinogen, due to the high levels of exposure required to cause concern. Even so, Deb Group decided to replace TEA with a more inert ingredient. The alternative element serves the same purpose — it acts as an emulsifier, allowing liquids and oils to stay suspended together within a cream.

Although the limit testing was done on Cocamide DEA at full-strength and the Deb Group’s usage of the ingredient was diluted, Cocamide DEA was replaced with a comparable ingredient that functions in the same manner as a foaming agent.

Deb Group completed all of its necessary reformulations within the 12-month time frame, as required by Proposition 65. Due to the diligent work and planning of Deb Group’s research and development team, the first round of formulations was successful—saving the company time, money and resources.
Deb Group distributed a letter to its customers informing them that Titanium Dioxide, TEA and Cocamide DEA has been removed from its products and that those shipping to California are Proposition 65-compliant and require no warnings. The company is extremely pleased with the reformulated products’ performance, feeling they perform as well as the original products that included the chemicals in question.

In contrast to Deb Group’s decision to remove these ingredients entirely, one of the company’s top competitors determined that because “the amounts of [Cocamide DEA] used are sufficiently low to pose no significant risk to human health,” they would not be reformulating their products.

Leading with an abundance of caution and prioritizing customer safety above all else, Deb Group considers the Proposition 65 reformulation project a success story that demonstrates their leadership within the market.

Read the white paper in its entirety, here.