Microplastics in Consumer Products: Future Directions of Policy and Regulation
Plastic’s unique strength, durability, versatility, and affordability makes it a practical material for numerous applications, as evidenced by its ubiquitous presence in nearly every global industry. However, plastic’s unrivaled low production cost and versatility has resulted in an overabundance of a material that takes anywhere from 20 to 500 years to decompose (WWF-Australia, 2018). As reported in 2019, the world has produced 8.3 billion metric tons of plastic, of which 6.3 billion tons have become waste (NGS, 2019). Among this waste are microplastics, which are small pieces of plastic less than five millimeters in size. While some microplastics are formed during the breakdown of large plastic into smaller plastic debris, others are intentionally manufactured and added to various industrial and consumer products. Products containing intentionally-added microplastics introduce an estimated 42,000 tons of plastic waste into the environment each year (ECHA, 2021).
Microplastics were first introduced as additives to personal care and cosmetic products approximately 50 years ago, but have recently emerged as an environmental issue (UNEP, 2015). Studies have shown that microplastics have the potential to bio-accumulate in marine life, and can carry hazardous chemicals, although their potential impacts on human health and the environment are largely unknown (Prata et al., 2020; Miller et al., 2020). A water-shed microplastic model has also demonstrated that microplastics originating from terrestrial environments, such as tire and road wear particles, can be transported into aquatic environments (Unice et al., 2019). Because of the uncertain risk that microplastics pose, certain regulatory organizations have proposed regulating microplastics as a precautionary measure.
The U.S. Microbead-Free Waters Act of 2015, for example, prohibits manufacturing, packaging, and distributing rinse-off cosmetics containing plastic microbeads in the United States (FDA, 2020). The Act defines a plastic microbead as “any solid plastic particle, less than five millimeters in size, intended to be used to exfoliate or cleanse the human body or any part thereof” (Public Law 114). Because the Act only applies to rinse-off cosmetic products such as toothpaste, cleansers, or shampoo, other microbead-containing products, such as leave-on cosmetics, sunscreen, and insect repellent (UNEP, 2015), are not affected. As a result, microbeads are still widely used in numerous U.S. consumer products.
In 2017, the European Commission (EC) requested that the European Chemicals Agency (ECHA) assess intentionally-added microplastics for European Union (EU)-level regulatory action (ECHA, 2021). ECHA submitted its proposal to the EC in January, 2019, recommending wide-ranging restrictions on microplastics in products (no greater than 0.01 % w/w) on the EU/European Economic Area market (ECHA, 2021). Over the course of 20 years, the proposal is expected to prevent 500,000 tons of microplastics from entering the environment (ECHA, 2021). Today, the EC is in the process of drafting its official proposal; voting by EU Member States is expected later this year (ECHA, 2021). If the EC restriction is adopted, it may have a serious impact on industries using microplastics in their products.
The proposed EC restriction would apply to consumer and professional use products but, unlike the US regulation, the EC’s proposal would also restrict leave-on cosmetic products, detergents, medical devices, specific fertilizing products, biocides, and certain agricultural/horticultural products (ECHA 2019). A few exemptions do exist; a substance or mixture containing microplastics, for example, may be derogated from the restriction if its polymer undergoes a permanent change in its physical state during product use (e.g., film-forming) or during product formulation (e.g., incinerated or disposed of during product manufacturing). Products that are exempt from the standard may contain microplastics at concentrations greater than 0.01% w/w; however, they may be required to follow certain labeling and reporting obligations (ECHA 2019).
As summarized in ECHA 2019, proposed transition periods for various products include:
- Immediate at entry into force of regulation (EiF): Rinse-off cosmetic products and detergents containing microbeads
- EiF +2 years: Medical devices and in vitro medical devices
- EiF +4 years: Other rinse-off cosmetic products
- EiF +5 years: Detergents containing polymetric fragrance encapsulation, other detergents, waxes and polishes (maintenance products), fertilizing products (that are not EU regulated), other agricultural and horticultural products (including seed treatment and plant protection products), biocides
- EiF +6 years: Leave-on cosmetic products
With the potential EU microplastic restrictions, preparing for product evaluation and/or taking preemptive action to ensure products are compliant in the proposed timeframe is critical. While the EC restriction would affect products on the EU market, regulations in Europe may also impact other countries. Additionally, products that are marketed internationally may be subject to multiple regulations. As of today, Canada, New Zealand, the Republic of Korea, and the United States have some form of a regulatory framework in place for intentionally-added microplastics in consumer products (ECHA 2019). Additionally, California Senate Bill 1263 required a Statewide Microplastics Strategy. In response, a Working Group of scientific experts released a report in April, 2021 providing a precautionary risk assessment framework for assessing the risk of microplastic pollution to the marine environment, and intervention strategies for reducing and preventing further pollution. The Working Group recommended that the risk assessment framework be re-evaluated in five years, at which time microplastics policies could be implemented and evaluated for efficacy (Brander et al., 2021). Given the evaluation and recommendations of the Working Group, California could potentially adopt more stringent regulations on microplastics in the coming years.
Cardno ChemRisk scientists have extensive professional experience serving as an interface between industry and regulators. We have significant familiarity with the kinds of information that regulators use to drive decision making, and can provide guidance through the regulatory process. Our team of scientists have expertise in product testing/analytical chemistry, stability analysis, microbiology, toxicity testing and toxicological evaluation of ingredients, hazard characterization, environmental fate and transport modeling, human health and environmental risk assessments, and assisting with regulatory submissions. If you would like to learn more about our capabilities, or have any questions about this topic, please contact Alice Han, Jordan Kozal, Andrey Massarsky, or Ken Unice.