by Doug Schoon
The California cosmetics industry will soon undergo some very big changes. The California Green Chemistry Initiative (CGCI) officially came into existence in 2008 when then Gov. Schwarzenegger signed two pieces of legislation that established an advisory panel of scientists, known as the Green Ribbon Science Panel. After a series of public meetings to gather input from stakeholders, the science panel was charged with the task of determining how manufacturers could be required to adopt what has been termed a “cradle-to-cradle” approach.
Cosmetic, beauty and personal care products are specifically included under the proposed regulations and several trade associations and other stakeholders are currently negotiating on behalf of the industry to help ensure the final regulations are reasonable and fair.
According to this legislation, manufacturers will be required to evaluate “chemicals of concern” – substances that demonstrate an “ability to contribute to or caused adverse impacts” - that may be found in their products or used in manufacturing processes and to seek suitable, less potentially toxic replacements. The legislation also requires the establishment of a “toxic information clearinghouse,” which will be maintained by the California Department of Toxic Substances Control (DTSC) and used to increase knowledge on hazards associated with chemicals of concern. The goal of this initiative is to improve environmental protection and to create regulation that covers all chemical substances used by any industry in California. Cosmetic, beauty and personal care products are specifically included under the proposed regulations and several trade associations and other stakeholders are currently negotiating on behalf of the industry to help ensure the final regulations are reasonable and fair.
California’s Green Chemistry Initiative regulations were to go into effect on January 11, 2012; however, this initiative has been postponed until the end of the year to allow further discussion by stakeholders. Present concerns are many, but the implementation delay is centered around an important controversy over how potentially harmful chemicals are to be listed and regulated by the DTSC. Non-government environmental pressure groups (NGO) are attempting to force the DTSC to use the “Precautionary Principle” which would regulate substances even though there is no scientific evidence to show they should be regulated. The DTSC proposes to only regulate substances with evidence demonstrating that they may be potentially harmful; a far more realistic approach.
The hope is that this initiative will spur the creation of new materials and products that are less hazardous to human health or the environment by encouraging innovation at the product design and manufacturing level.
Traditionally, environmental laws have been based on a model called “cradle-to-grave”, which requires manufacturers to assess the life cycle of products from raw materials, through manufacturing, product distribution, consumer use and disposal. The Green Chemistry Initiative’s “cradle-to-cradle” approach requires manufacturers to consider eventual chemical exposure from products while they are still in product development and manufacturing, as well as throughout a products’ useful life and after disposal. The intent is to encourage manufacturing of safer products and improve end-of-life cycle reuse and recycling. The hope is that this initiative will spur the creation of new materials and products that are less hazardous to human health or the environment by encouraging innovation at the product design and manufacturing level. The DTSC also hopes the proposed regulations will set the stage for a “national model” aimed at chemical policy reform.
The proposed regulation is still under development, but is expected to require:
1. Establishment of a list of chemicals of concern, which will initially contain approximately 1200 chemicals, but is likely to expand over time.
2. The DTSC will evaluate and prioritize these chemicals of concerns and the types of products which contain them to create what is called a “Priority Products” list.
3. The DTSC will require manufacturers to conduct a detailed analysis to determine if there are any suitable alternative substances to replace the chemicals of concern.
4. Manufacturers, retailers, resellers and importers of products which contain chemicals of concern will be required to notify the DTSC of their intent to perform an alternatives analysis: a structured, comprehensive analysis designed to explore the potential for safer alternative substitutions for chemicals of concern and/or to limit exposures to minimize adverse impacts on the environment or public health.
5. The DTSC will monitor manufacturers’ responses and ensure compliance.
6. Regulations will provide for education and training, research and technology transfer, where applicable. For instance, one of the expressed goals is to provide information needed to train a new generation of chemists, engineers and other technical workers so they can develop and produce safer products in the future. The regulations also require specific education experience for certified safety assessors responsible for carrying out alternatives assessments.
“Chemicals of Concern” (COC) are listed when they exhibit a hazardous trait or toxicity identified by the state of California AND are listed by one of the authoritative bodies that are specified in the regulations. New substances can be added to the list at any time if they can be shown to impact the public’s health, the environment, or if they are harmful to sensitive sub-populations, e.g. children. Both the household presence of the product and disposal methods will also come into consideration when the DTSC evaluates products for their potential adverse impacts.
A “Priority Product” (PP) designation would attract increased attention from the DTSC, since these are defined as products containing a chemical of concern that possess a “significant ability for the public and/or aquatic, avian, or terrestrial animals or plant organisms to be exposed to the COCs in the product in quantities that would contribute to or cause adverse public health or environmental impacts, which may include consideration of how widely the product is distributed in commerce and how widely the product is used by consumers.” The DTSC has determined that initially, until 2016, both of the following criteria must be met before a product or product type may be added to the Priority Product list; a), determined to cause carcinogenicity, reproductive toxicity, mutagenicity, developmental toxicity, endocrine disruption, neurotoxicity, or demonstrates persistent bioaccumulative toxicity AND b). The chemical of concern is already found on any chemical lists identified in the regulations for air/water quality or is currently part of the California biomonitoring program.
The DTSC has already held several alternatives analysis symposiums and is in the process of developing guidelines for conducting these analysis. The purposes of the alternative analysis as defined in the original assembly bill (AB1879) is to, “…establish a process for evaluating chemicals of concern in consumer products, and the potential alternatives, to determine how best to limit exposure or to reduce the level of hazard posed by a chemical of concern…” AND “to establish a process that includes an evaluation of the availability of potential alternatives and potential hazards posed by those alternatives, as well as an evaluation of critical exposure pathways…”
To achieve these goals, the alternatives assessment must take into consideration a wide range of factors some of which are; product function or performance, useful life, water quality impacts, greenhouse gas or other air emissions, costs, worker safety, material/resources consumption, waste generation and product disposal, energy efficiency during production or while in use, as well as the impact to the environment, economics and public health. Two years after the effective date of the final regulation, all current and future alternative analysis must be prepared by or under the “responsible charge” of a certified assessor, however, this work can be performed in conjunction with a trade association or a consortium may be formed. If a manufacturer of a product of concern finds a suitable replacement or discontinues sale, no alternative analysis is required. If the chemical of concern falls below the concentration threshold level to be established by the DTSC, then a threshold exemption notification may be filed, no alternatives analysis will be required. The DTSC will post alternatives analysis guidance on its website, and intends to also post alternative analysis that are already a part of the public domain. The DTSC believes this will aid small businesses that may not presently possess the capacity or expertise needed to comply with the regulations.
At the discretion of the DTSC, up to three years may be allowed for completion of the alternatives analysis; however, a preliminary alternatives analysis report is due within 180 days after the Priority Products are listed. Therefore, once the regulations are finalized, which is expected by the end of 2012, the chemicals of concern list will be immediately published and within 180 days the DTSC will release a list of Priority Products. At this point, it then becomes the responsibility of manufacturers, importers into the U.S. and retailers to notify the DTSC within 60 days that they have a product on the Priority list and that it is their intent to either develop an alternatives analysis, file a notification of COC removal or cease selling/importing the product. If the DTSC finds that the requirements have not been fulfilled, the department will issue a “Notice of Noncompliance” and if no remedy is found, the offending product and company information will be posted to a publicly viewed online “Failure to Comply” list.
The DTSC is currently accepting public comments until September 11, 2012. Send your comments to firstname.lastname@example.org.
About the Author
Doug Schoon is president of Schoon Scientific + Regulatory Consulting, LLC. He has more than 30 years experience as a research scientist, international lecturer, author and educator. Doug is a leading authority in the cosmetic, beauty and personal care industry. Doug has a wide range of experience, including 19 years as Vice President of Research and Development for Creative Nail Design. He is a strong advocate for salon product safety, often representing the entire industry on scientific and technical issues in Canada, Europe, Australia and the United States as co-chair of the Nail Manufacturer’s Council (NMC) for the Professional Beauty Association. Contact Doug directly at DSchoon@SchoonScientific.com.