Introduction
The push for use of safer chemicals in commercial products is increasing on a global basis. In addition to complying with the regulatory restrictions, individual companies have started to select less hazardous chemicals for their products as an integral part of their sustainability programs. At the same time, the extent of restrictions on or outright bans of chemicals by various governments through the world is continuously growing and thus driving chemical substitution.
The replacement of these chemicals of concern is not a simple process and a full evaluation and characterization must be conducted so as not to cause to unintended consequences. A prime example of this scenario is when a chemical of concern is substituted with a poorly characterized substance that results in the product having a more toxic hazard profile than the original chemical. The use of a specific evaluation process such as the alternatives assessment process allows companies to identify, evaluate and select safer chemicals for product reformulation to have safer, more sustainable solutions.
What is an Alternatives Assessment?
An alternatives assessment is a systematic process used to identify and compare alternative chemicals intended to replace a chemical of concern and select those substances that have a safer or reduced hazard profile. A full characterization of the health and environmental hazards of these substances as well as their functionality and performance within the product is conducted as part of the assessment. The economic viability of the alternatives may also be evaluated. The end result provides an informed analysis of the potential alternatives to a chemical of concern, identifying safer chemicals that may be substituted while retaining the performance needed in the product.
As this process has become more refined over the years, several tools and protocols have been developed to evaluate the health and environmental hazards, performance, and economic viability needed to complete an alternatives assessment. In general, these methodologies provide a specific approach with stepwise set of assessment criteria to serve as the basis for conducting such an evaluation. The figure below provides a general outline of the alternatives assessment process.
https://www.kemi.se/en/guidance-for-companies/substitution-of-hazardous-substances
Why are Alternatives Assessments important?
A key driver for this type of evaluation is the potential of unintended consequences or “regrettable substitutions “as described above. Since the initial reason for concern was not resolved, a new alternative must be found, leading to increased time, cost, resource use and potentially bad publicity. The goal of an alternatives assessment is to avoid such scenarios by completing a more comprehensive evaluation and using this information to undertake the necessary actions.
A second factor in the use of alternatives assessment is the growing regulatory movement to have less toxic or safer ingredients in products. This can be seen in the US and the EU. In the US, chemical substitution activity is controlled at the federal level with the EPA’s Design for the Environment and Safer Choice programs with several ongoing programs in several U.S. states. In the EU, a number of regulations support the Safe-and-Sustainable-by-Design approach that drives chemical substitution in consumer products. In addition, EU REACH regulation restrictions and authorization now require manufacturers and suppliers to phase out chemicals of concern and replace them with safer alternatives. Having a well-defined and characterized alternatives assessment provides a detailed explanation that allows companies to comply with these regulations and also ensure their products are safe and sustainable.
Conclusion
The ultimate goal of an alternatives assessment is to manage the risk involved in marketing a product while remaining compliant with the regulations in each specific region. This evaluation allows consideration of each potential alternative solution based all available data, leading to a more informed substitution process that supports a transition to safer alternatives.
Potential business impacts
Some issues to consider:
- Do you have the technical expertise and capability to complete an Alternatives Assessment to maintain compliance with an existing or proposed regulation?
- Do you have any substances of concern in your products?
- Do you have any plans for addressing this use of these chemicals, including replacing them with safer alternatives?
Published April 24, 2025
This article was generated with the assistance of Artificial Intelligence.