Microplastics: an increased focus on product stewardship and safety

Microplastics – solid, synthetic polymer particles smaller than 5 millimeters in size – are considered contaminants of emerging concern. Some microplastics, called primary sources, are intentionally added to end-use products such as personal care products, coatings, and detergents. Other microplastics arise from the fragmentation of larger pieces of plastics, called secondary sources.

The widespread use of microplastics in industrial and consumer products and their ubiquitous presence in the environment have led to growing concerns globally about the safety of microplastics in human health and the environment. The growing body of science around exposure to microplastics and the safety of these materials are expected to drive regulatory actions and therefore increase the need for product stewardship around this emerging category of contaminants. 

Potential sources of microplastics: regulatory drivers and research interests

Microplastics can originate from various industrial and consumer products, including cosmetics, medicines, food and beverage products, household and commercial products such as carpeting, furniture, clothing, and building materials, electric vehicles, and geotextiles. Concerns and potential regulatory drivers depend on the category of products.  

Cosmetic products

For example, cosmetic products such as soaps and scrubs may contain synthetic, solid, plastic particles (microbeads) that are used for exfoliating and cleansing. Microplastics serve multiple critical functions in medicinal products, such as taste-masking elements, excipients, or active pharmaceutical ingredients (API) (e.g., non-absorbed polymer drugs). The concern is that microplastics in these products will be washed down the sink after consumer use and released to wastewater treatment plants and subsequently to the aquatic environment via effluent discharge, and to the terrestrial environment via biosolids application.  

Food products

Food products, particularly seafood products, are drawing the attention of regulatory authorities. Microplastics are mostly present in the stomach and intestine of aquatic organisms, which are usually removed during food preparation, and therefore significant exposures are not expected by consumers. However, microplastics may enter the human body through consumption of crabs, shrimp, and other aquatic organisms consumed whole or with their gastrointestinal tract still intact.  

The US Food and Drug Administration (FDA) and European Food Safety Authority (EFSA) found that substantial data gaps exist with respect to the occurrence, fate, exposure, and toxicity of microplastics in food and beverages, and full human health risk assessments cannot be performed.  

Indoor dust

Microplastics are also found in indoor dust shed from carpeting, furniture, clothing, and building materials. Since people spend most of their time in indoor environments, they can be exposed to microplastics through incidental ingestion of, inhalation of resuspended particles from, and dermal contact with indoor dust. The most common types of microplastics found in indoor dust are polyethylene terephthalate, polypropylene, and polycarbonate.  

Consistently, polypropylene and polyethylene terephthalate are the most abundant microplastics found in human lung tissue samples. Indoor dust is not yet a regulatory driver for microplastics, but it is an area of research interest. 

Electric vehicles 

Tire wear and non-exhaust emission particles from electric vehicles (EVs) are potential sources of microplastics. EVs’ heavier weight due to battery packs and regenerative braking systems influence tire wear patterns differently from internal combustion engines (ICE) in traditional vehicles. Consequently, tire wear particles, encompassing both microplastics and chemical compounds, are released into the environment throughout the lifespan of EV tires. 

Geotextiles 

Geotextiles are synthetic or natural polymeric textile materials used in geotechnical and civil engineering applications to provide drainage, separation, filtration, or reinforcement functions. Geotextiles usually undergo strength and weathering testing to fulfill performance requirements. However, these tests do not evaluate whether and to what extent microfibers are released from geotextiles.  

A majority of geotextiles are manufactured from nonwoven polypropylene which is sensitive to deterioration from ultraviolet (UV) exposure. If geotextiles are not covered according to the manufacturer’s instructions, they could lose strength and become more prone to disintegrate. Abrasion, heat, and chemical degradation also influence the degradation of geotextiles. Their use in hydraulic applications has been identified as having a high risk for microplastic release due to water and material movement as well as possible UV exposure.  

There are still lots of uncertainties regarding the formation and release of microplastics from geotextiles, as well as potential risks to human health and the environment.

Regulatory landscape

There are currently a limited number of regulations specific to microplastics, and we expect that number to increase in the next few years.  Laws and regulations targeting single-use plastics, including consumer products such as plastic bags, disposable utensils, and beverage containers, have been enacted in many countries. These are not specific to microplastics but could help reduce the secondary sources of microplastics.

Regulations in the US

To date, the only US federal regulation targeting microplastics in consumer products is the Microbead-Free Waters Act, which amended the Federal Food, Drug, and Cosmetic Act in 2015. This act prohibits the manufacture, packaging, and distribution of rise-off cosmetics and non-prescription (also called over-the-counter or OTC) drugs containing intentionally added plastic microbeads. Several states, including California, Colorado, Connecticut, Illinois, Indiana, Maine, Maryland, New Jersey, and Wisconsin, have passed their own bills banning personal care products containing microbeads.

California released a Statewide Microplastics Strategy in February 2022 which focused on early actionable solutions for managing microplastic pollution. Source reduction and product stewardship techniques were proposed, including the elimination of products that are among the highest contributors as well as engagement with industries to identify alternative material sources and product designs. Other California legislative activities include the proposed California Assembly Bill AB-2787 which would expand the existing Microbeads Nuisance Prevention Law to ban all rinse-off cosmetics, waxes and polishes, and leave-on cosmetics containing intentionally added microplastics at ≥ 0.01% w/w.

On April 27, 2023, the California Department of Toxic Substances Control (DTSC) Safer Consumer Products (SCP) Program proposed the addition of microplastics to its Candidate Chemicals List (CCL), which could lead to increased scrutiny on microplastics in consumer products, a requirement of alternative analysis, and regulatory responses such as product labeling, use restriction, and product sales prohibition for any manufacturer, importer, assembler, or retailer selling products containing microplastics in California.

Connecticut has also been active in research into the consumer product contribution to microplastic pollution and established a Microfiber Pollution Working Group under Public Act 18-181 in February 2018. This working group consists of representatives from both the retail and apparel industry and the environmental community. Their objective is to present information regarding synthetic microfibers in clothing to the public through the development of consumer awareness and education programs. A report prepared by the working group was submitted to the state legislature in January 2020.  

Regulations in Europe

EU REACH regulations around microplastics

On August 30, 2022, the European Chemicals Agency (ECHA) published its long-awaited proposal to restrict certain consumer and professional use products with intentionally added microplastics (≥ 0.01% w/w) from placing on the market. This proposed restriction, to be adopted under the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, applies to both producers and suppliers of products containing microplastics and applies to certain conditions of use, labeling and disposal requirements, and reporting obligations.

The restriction will affect the intentional use of microplastics in a range of products, including fragrances, cosmetics, certain fertilizers, plant protection products, and biocidal products. Only certain types of polymers (e.g., degradable polymers) are excluded from the definition of microplastics. The restriction proposal focuses on mitigating ecological risks by controlling product use and the environmental release of microplastics. It is not based on human health concerns, primarily due to the lack of toxicological studies on human health to assess the range of observed human exposures in the environment.  

Update October 2023: The restriction proposal was adopted and published at the end of September 2023 and enters into force on 17 October, 2023. Transition periods of four-12 years (depending on product types) will be provided to affected stakeholders to comply with the restriction and transition to suitable alternatives, such as degradable polymers. The EU microplastic restriction is expected to drive similar microplastic-focused regulations all over the world.

Avoiding double regulations

Certain microplastic-containing products are regulated under separate legislations, and to avoid being double regulated, several derogations are proposed in the draft restriction. For example, the EU microplastic restriction shall not apply to substances used in food or feeding stuffs that are regulated under Regulation (EC) No. 178/2002, including food additives intended for human consumption, flavoring agents in foodstuffs, and additives in feeding stuffs for use in animal nutrition. However, the use of microplastics as food contact materials is within the scope of the proposed EU microplastic restriction. When producing over 10 tonnes or more per year, the registrant of the food contact material is required to submit a chemical safety report, but potential human health risks resulting from microplastics in the food contact material should be addressed within the scope of Regulation (EC) No. 1935/2004.

Another critical derogation is the use of microplastics as medicines in the EU. Both prescription medicines and OTC medications are regulated under Regulation (EC) No. 726/2004 and Directive 2001/83/EC. To reduce water pollution from the pharmaceutical industry and prevent adverse effects of APIs on the environment, the EU microplastic restriction proposes to implement reporting and labelling requirements for medicines containing microplastics, rather than restricting or banning these products, given the increased benefits and societal values of medicines. Instructions for the safe disposal of any unused medicines can also be included as part of the labeling. Such requirements may change in the future depending on the effectiveness of safety measures in place through other regulations or strategies. Therefore, placing of medicines containing microplastics on the market would need to be carefully evaluated to address any labeling requirement.

Regarding cosmetics, in 2015 the European trade association Cosmetics Europe recommended microplastics that are not biodegradable should be discontinued by 2020. Many cosmetic producers opted to take voluntary actions to reduce the use of microplastics in rinse-off cosmetic products in line with the recommendation from Cosmetics Europe and sought biodegradable alternatives such as those made from natural compounds.

In 2018, a Cosmetics Europe survey showed that 97.6% of plastic microbeads used in rinse-off cosmetic and personal care products were already phased out by its members. More broadly, a few European countries also took actions to limit or ban microplastics in cosmetic products. For example, France prohibited placing rinse-off cosmetic products containing plastic microbeads on the market beginning January 1, 2018. England, Wales, Scotland, and Sweden enforced similar prohibitions in summer 2018, and Northern Ireland followed in early 2019.

If the EU microplastic restriction proposal is implemented, it will completely prohibit the intentional use of microplastics in all cosmetics in the EU, including a restriction on leave-on cosmetics such as skincare products, perfume, and lip care products.