A new methodology from the science-based nonprofit ChemFORWARD will enable consistency and comparability between traditional ingredients and botanical alternatives. Driven by surging consumer interest in “clean” and “natural” ingredients, the use of new plant-derived substances in beauty and personal care is growing much faster than the industry’s capacity to fully understand the impact these can have on the health and safety of workers, consumers, and the natural environment.

Consumers and producers often assume that “natural” means “safe,” sometimes without adequate information to determine what hazards an ingredient may truly present. Is it possible to develop an effective, standardized methodology to screen and compare the safety of natural botanical ingredients used in cosmetics and personal care products?

A science-based, NGO-industry collaboration thinks so.

Most countries currently place the onus on manufacturers to substantiate the safety of cosmetic products on the market. Since no standard methodology exists, many businesses are assessing the safety of botanical ingredients in their own way. This is problematic since botanical materials are complex mixtures that present challenges in assessing in a similar manner to traditional chemicals. For the benefit of human health and the environment, there is a great need for standardized, efficient, and comprehensive ways to conduct assessment of botanical ingredients.

A standardized approach to assessing botanical materials that is comparable to how traditional chemicals are assessed is imperative. With a lack of data available for many botanicals, the potential for regrettable substitution is high. To further research these issues, we created a broad-spectrum stakeholder roundtable that included manufacturers of cosmetic products and ingredients, retailers, consultants, regulators, public-interest groups, and a naturopathic practitioner. This roundtable met again in May after a kickoff meeting last summer. The goal of the meeting was to hear progress and discuss continuing challenges and potential solutions.

Participants acknowledged there are gaps in safety data on botanicals that need to be addressed as well as a need to develop a way to compare the safety of botanicals with alternative ingredients, including synthetic ones. Based on these illuminating conversations, we are now refining, testing, and further developing a v1 Botanicals Assessment Methodology.

Here are the key points raised in the roundtable discussion that we are addressing in the forthcoming methodology:

Determine botanical composition prior to the safety assessment

Botanicals are actually complex mixtures. They can range in known constituents from several chemicals to dozens of chemicals. Further, the composition of a botanical can vary depending on many factors, including plant species and part, where and when it was grown, and how it was produced, processed, and stored. Composition must be defined clearly to ensure accurate and comparable results.

Require consistent characterization of botanicals

To address the lack of consistency between botanicals of the same name, minimum requirements for characterizing product composition will be defined. Constituency analysis and/or quality control could play a role, noting that extraction solvent impurities are part of the variability. Where information on the hazard of an endpoint for a botanical ingredient is limited, assessors need to determine how to make the hazard classification—identifying the constituents and their hazard classifications as an assessor would with a mixture is one approach to filling gaps.

Establish best practice for applying History of Safe Use (HSU)

Many decisions relating to the safety of botanicals are based on existing knowledge about impacts of exposure by referring to HSU data (usually from food/dietary exposures), rather than knowledge of the hazard properties of constituent ingredients—as is the case for synthetic ingredients. This is a challenge for companies trying to compare the safety of botanicals with synthetic ingredients. HSU could be applied for specified exposure routes and doses relevant to the use. For example, if an ingredient is a food product, history of safe use could be applied to oral toxicity hazard endpoints. If empirical data on the botanical material exists, it should be used for endpoints that it is applicable to; however, most botanical materials do not have traditional toxicology data. Any endpoints with data gaps could be supplemented with clear rationales on any additional constituent analysis and best practice rules on mixture assessment.

Customize thresholds for botanicals

A common threshold for traditional chemicals is 100 ppm, a concentration at which most hazard endpoints would not be classified via GHS regardless of the toxicity of the material. Some botanicals are phototoxic at 1 ppm—leading to the conclusion that hazards assessment of constituents need customized thresholds. Identifying and accounting for these constituents of concerns that have activity below 100 ppm will be critical to the assessment process. One approach would be to set safe use limits that would limit constituents of concern concentrations in the final formulation.  Details like these will be explained in a summary accompanying the assessment.

Hazard first

For comparability with traditional ingredients, the method will take a hazard-first approach. This approach will clearly identify in the assessment summary report the constituents present and how they were identified, along with the part of plant and other sourcing information. We acknowledge that there is a concern that a lot of botanicals will be classified as hazardous on paper but actually won’t be hazardous in use. Some botanicals, such as rosemary extract, display carcinogenic and anti-carcinogenic properties. Assessments are complex, and there are gaps in knowledge, but our approach to classifying hazards for botanicals will assist assessors in properly characterizing potential risks.

The v1 Botanical Hazard Assessment Methodology will be released later this year following a peer review and comment period. The pilot botanical assessments will be posted on the ChemFORWARD Chemical Optimization Platform, available through subscription. Work will continue with brand and retailer partners in the coming months to establish a minimum dataset for botanicals.

Future developments

We are working to integrate the methodology for botanicals into a broader decision-making framework to enable consistency and comparability between traditional synthetic chemicals and botanicals assessments. This allows the identification of safer chemical ingredients by trade name.

The roundtable participants acknowledged that the European Chemicals Agency is planning to look at the hazards posed by use of botanicals as it takes on more work in the field of cosmetics regulation. This is likely to turn the spotlight on botanicals used in these applications. This  methodology, pilot, and repository of botanical ingredients by INCI and trade name can serve as a resource for companies preparing for these changes. We invite botanical suppliers, formulators, and brands interested in establishing a minimum dataset for botanicals to join the roundtable by reaching out to lead toxicologist Dr. Chris Bartlett.