Biorius helps you to make your products compliant with California cosmetic regulations:

Step 1: California Safe Cosmetic Program

 

The state of California regulates cosmetic products differently than other states in the US. To be compliant when selling a cosmetic product in California, the cosmetics brand must consider both national regulations and regulations in California.

In 2005, California created its California Safe Cosmetics Program, becoming the first state in the US to have regulations regarding the safety of cosmetics ingredients. The program was designed to protect consumers and promote the safe manufacture of cosmetics products. In other words, the CSCP was developed to protect consumers while CARB was developed to protect the environment.

This regulation requires identifying cosmetic products containing ingredients that are recognized as potentially hazardous. It also requires the reporting of these ingredients, which must be continuously updated in the event of any changes to the formula composition and any chemical identified as harmful to be disclosed on product labels.

The list of chemical ingredients identifies hazardous and potentially hazardous ingredients, including substances listed under Proposition 65 and those listed by the EPA (Environmental Protection Agency), the CERHR (Center of Evaluation of Risk to Human Reproduction) and the IARC (International Agency for Research on Cancer).

How does it work ?

As explained above, the ‘California Safe Cosmetics Program’ requires that cosmetics brands marketed in California report the presence of potentially hazardous ingredients.

Biorius analyzes the cosmetic products to determine which ingredients are affected by this regulation.

To conduct a California Safe Cosmetics Program evaluation, Biorius’ experts analyze the product composition as well as each raw material in the product, the product category and all specificities to determine if the product contains any hazardous ingredients.

When the product is compliant with the California Safe Cosmetics Program, a certificate of compliance is issued, which highlights the following:

• Applicable legislation
• The concentration of hazardous ingredients
• Expert conclusions and any modifications to be implemented

Step 2: Proposition 65

The state of California has specific regulations for cosmetics products, one of which is Proposition 65. To sell products in California, cosmetics brands must comply with national regulations as well as with state-specific regulations.

California’s Safe Drinking Water and Toxic Enforcement Act (also named Proposition 65) was published for the first time in 1986.

Proposition 65 regulates products intended to be sold in the state of California, including regular cosmetics and OTC’s.

The goal of this legislation is to identify whether a specific product presents any carcinogenic risk according to state limitations. If it does, appropriate warnings must be displayed.

The California Office of Environmental Health Hazard Assessment (OEHHA) updates the Proposition 65 list on a yearly basis, adding substances considered harmful, i.e., suspected of causing cancer. This list currently contains more than 900 chemicals to consider prior to selling cosmetic products in California.

A product containing one of these substances must have “easily understandable, readable and prominently placed” warnings applied on its labeling materials along with a warning symbol.

All persons involved in the cosmetics supply chain must comply with Proposition 65 in order to do business in California.

Biorius reviews the production composition and advises which warning(s) should be added to the labels when necessary.

How does it work?

Two scenarios can occur when reviewing cosmetic products:

The product contains ingredients listed in Proposition 65, for which limitations are provided by law.

The process is then divided in two phases:

• Identification of the Ingredients: Biorius analyzes the cosmetic product formula in order to determine which ingredients are affected by this regulation.
• Conclusion & Warnings: Biorius determines the appropriate warnings based on the limitations provided by Proposition 65.Corrective actions and comments are provided for updating the formula when necessary.The product contains ingredients listed in Proposition 65 but for which no safe harbor levels are provided.

The product contains ingredients listed in Proposition 65 but for which no safe harbor levels are provided.

The process is then divided in three phases:

• Identification of the Ingredients:  Biorius analyses the cosmetic product formula in order to determine which ingredients are affected by this regulation.
• Calculation of Safe Harbor Levels: Biorius conducts a toxicological study to calculate the limits for each ingredient listed. This is done by evaluating published toxicological data and using OEHHA methodology. For cancer, cancer potency and the NSRL (allowable risk of 1:100000) is identified using mathematical models and methodologies accepted by the EPA and OEHHA. For reproductive and developmental toxicity, toxicological data from reliable studies are used to derive an MADL (the maximum dose level having no observable effect divided by one thousand [1,000] to arrive at the maximum allowable dose level).
• Conclusion & Warnings: Biorius determines the appropriate warnings based on the conclusion of the toxicological study. Depending on exposure to the ingredient and its respective safe harbor level, the need for a warning can then be determined. Obviously, having accurate exposures and derived safe harbor levels is extremely important when determining whether warnings are needed or not.Corrective actions and comments are provided for updating the formula when necessary.

To conduct a Proposition 65 assessment, Biorius’ experts analyze the product composition and each raw material in the product along with the product category and all specificities.

When the product is deemed as compliant with Proposition 65, a compliance certificate is issued, which highlights the following:

• Applicable legislation
• Concentration of ingredients
• Expert conclusions and any warnings to be displayed

Additional toxicological studies must be performed in addition to the above process. In this case, Biorius delivers a complete report which includes the toxicological studies in order to justify the presence or absence of warnings on the labeling materials.

Step 3: CARB: California Air Resources Board

The CARB (California Air Resource Board) is in charge of protecting people against air pollution and its dangerous effects. It also oversees the development of programs to combat climate change.

Through CARB, California regulates the Clean Air Act differently than the rest of the United States. To sell a cosmetic product in California, cosmetics brands must comply with state regulations as well as with  federal regulations.

In 1967, the state of California established CARB regulations which limit the presence of substances contributing to air pollution in cosmetics products in order to reduce environmental pollution.

Air pollution created by cosmetics products is an important issue related to Volatile Organic Compounds emissions reduction. Limitations have been set by the state of California per product category (hairsprays, fragrances, nail care, etc.) in order to mitigate this concern.

Biorius helps cosmetics brands determine the presence of limited or banned substances in cosmetics products based on this norm, and determines whether the results are acceptable or not. In the latter case, our experts will suggest the corrective actions to be taken.

How does it work?

Biorius’ process consists of two phases: the determination of the total concentration of CARB concentration and the conclusion.

1. Determination of the Total CARB Concentration: Biorius analyzes the formula in order to determine the percentage of substances in each ingredient and then calculates the total percentage in the final product.
2. Conclusion & Recommendation(s): Biorius determines the substances’ compliance for the specific product category according to the legislation. Any corrective actions and remarks are provided for updating the formula when necessary.

In order to proceed with the CARB determination, Biorius’ experts analyze the product composition and each raw material in the product along with the product category and all characteristics.

When the product is compliant with the CARB regulations, a compliance certificate is issued, which highlight the following elements:

• Applicable legislation
• The concentration of CARB per ingredient
• Expert conclusions and any modifications to be implemented.

Step 4: Volatile Organic Compounds

As stated by Tox Town, Volatile Organic Compounds “are compounds found in consumer products that easily become vapors or gases. They commonly enter the body through inhalation or skin contact.”  Many substances classified as VOCs can be found in our daily lives: in the home, in the office and in personal care products.

Breathing them for long periods of time, even in low quantities, may increase certain health problems. Studies have shown that exposure can lead to the worsening of asthma and its symptoms, headaches and even cancer or central nervous system damage in situations of chronic exposure.

To better protect public health, Volatile Organic Compounds and their percentages in products need to be specific and in the USA, are limited in cosmetic products, depending on the product category.

US Federal Legislation (e.g., the Federal Clean Air Act and the EPA) is applicable at the federal level while Californian Legislation (CARB) applies specifically to California.

Biorius can analyze VOCs and determine whether the results are acceptable or not. If not acceptable, our experts will suggest corrective actions to be taken.

How does it work?

BIORIUS’ process is divided into two phases: the determination of the total concentration of VOCs and the conclusion.

1. Determination of the Total VOC Concentration: Biorius analyzes the formula in order to determine the percentage of VOCs in each ingredient and calculate the total percentage in the finished product.
2. Conclusion & Recommendation(s): Biorius determines compliance according to the legislation for the specific product category.  Corrective actions are provided for updating the formula when necessary.

To determine the VOC concentration, experts at Biorius analyze the product composition along with each raw material contained within it in addition to the product category and all specificities.

As soon as the product is determined to be compliant with the Volatile Organic Compounds legislation, a compliance certificate is issued, which highlights the following:

• Applicable legislation
• The concentration of VOC per ingredient
• Expert conclusions and any modifications to be implemented