Macro Regulation of Microplastics: New EU Initiatives and Their Global Business Impact

Introduction

As part of its broader zero-pollution action plan, and in response to microplastics’ recognised long-term negative impacts on ecosystems, the European Union has recently announced several proposals to reduce microplastics pollution from different sources: plastic waste and litter; accidental and unintentional releases (e.g., plastic pellet loss, tyre degradation, or release from clothing); and intentional use in products. These regulatory measures will impact the use of microplastics in cosmetics and medicines, among other products. The proposals come on the heels of other global regulatory developments involving microplastics, as well as bans on other components in drugs and cosmetics that may be harmful to human health. Collectively, these proposals indicate a potential increased regulatory focus on holding industry financially responsible for potentially harmful components in their products and packaging. The proposals rely on the well-established ‘polluter pays’ principle, under which those who produce pollution bear the costs of managing such pollution to prevent damage to human health or the environment.

This alert explores the new EU initiatives on microplastics, their potential impact on industry, and relevant global regulatory trends.

Microplastics and Human Health

The European Commission has defined microplastics as ‘synthetic polymer particles below five millimetres that are organic, insoluble and resist degradation’. Microplastics are often added to products such as the granular infill material used on artificial sport surfaces, as well as cosmetics, medicines, and detergents; they are also used in packaging. Microplastics can pass unchanged through waterways into the ocean.

Although microplastics are ubiquitous, their impact on human health, as well as animal health and ecosystems, is still the subject of ongoing research. However, research has found that microplastics may affect the human body by stimulating the release of endocrine disruptors and can carry other toxic chemicals such as heavy metals and organic pollutants, which can adversely affect the human body.

Due to microplastics’ potential impact on human and environmental health, certain key jurisdictions have begun taking action to reduce the use of microplastics. The Netherlands, for example, was the first country to introduce a ban on microbeads in cosmetic products in 2014, which was followed later that year by a joint statement from Austria, Luxembourg, Belgium, and Sweden calling for an EU-wide microplastics ban. Shortly thereafter, the United States enacted the Microbead-Free Waters Act of 2015, under which the manufacture of ‘rinse-off’ cosmetic products containing plastic microbeads was prohibited in 2017, and retail sales of such products were prohibited in 2018. Following the Netherlands’ and the United States’ microbead bans, a number of jurisdictions, including Korea, the United Kingdom, Australia, and New Zealand, have followed suit with similar regulations. The European Union’s action is consistent with the global trend of recognising microplastics pollution as one of the most pervasive emerging environmental issues, raising concerns for the associated environmental and human impacts that will require concerted regulatory interventions.

EU Microplastics Proposal

The European Union’s zero-pollution action plan, which set a target to reduce microplastics pollution by 30% by 2030, includes several proposals intended to reduce human exposure to microplastics. On 25 September 2023, the European Commission adopted measures that restrict microplastics intentionally added to products such as cosmetics, detergents, medicines, and medical devices. The first measures, including a ban on loose glitter and microbeads, went into effect in October 2023.

Most recently, on 29 January 2024, the European Council and European Parliament reached a provisional political agreement on a proposal to remove microplastics and other micropollutants out of urban wastewater. Under this proposal, at least 80% of the costs needed to remove pollutants in the sewage treatment process would be covered by pharmaceutical and cosmetic producers, in line with the ‘polluter pays’ principle. By 2045, the provisional agreement would require EU member states to remove a broad spectrum of micropollutants from urban wastewater before releasing it into the environment.

This provisional political agreement would have a significant financial impact on producers of cosmetics, chemicals, and medicines in the European Union. Under the proposal:

• companies would have to cover the costs of gathering and verifying data on how their products impact wastewater;
• there would be potential cost implications arising from product reformulation to meet the proposed environmental risk minimisation requirements; and
• new product formulations would be subject to regulatory scrutiny by medicines regulatory authorities, to ensure compatibility with the new requirements without adversely affecting the safety, quality, and efficacy of the reformulated products.

As a next step, the provisional agreement will be submitted to the EU members’ representatives with the European Council and to the European Parliament’s environment committee. Then, if formally adopted by both institutions, the directive will be published in the European Union’s Official Journal.