Edit: Washington State officially passed new packaging EPR laws as of May 19, 2025. 

The plastics manufacturing landscape has undergone significant regulatory changes over the past year with more transformative policies on the horizon. For manufacturers supporting pivotal industries like medical devices, research, aerospace, and defense, understanding these regulations is essential, despite those regulations’ shifting landscape. We will examine the most impactful recent and upcoming regulations affecting plastics manufacturing and provide realistic strategies for navigating this evolving regulatory environment.

2025: A Turning Point in Plastics Regulations

The past year has witnessed unprecedented regulatory activity targeting plastic industry operation across state, federal, and international levels. With growing public concerns about plastic pollution, PFAS contamination, and business’s sustainability requirements, these regulations that have worked to address these concerns directly impact plastic manufacturers and their customer base. This holds especially true for those serving specialized industries outside of broader, retail-based plastic products. While there are several influences (both potential and real) that can change these regulations quickly, businesses can prepare for future developments if/when they occur to remain agile and remain competitive in today’s markets.

State-Driven EPR Expansion Defies Federal Inaction

While the current administration has deprioritized federal recycling legislation, Extended Producer Responsibility (EPR) programs continue gaining momentum at the state level with 14 states now implementing or advancing packaging EPR laws as of May 2025. Maryland became the sixth state to enact EPR legislation on May 13, 2025, with Washington State poised to follow as the seventh. These EPR laws build on existing programs in California, Colorado, Maine, Minnesota, and Oregon, which are now entering critical implementation phases. At the time of this writing, these are the most current updates regarding those regulations in those states:

PFAS Regulations: Navigating Uncertainty and Compliance

The EPA's July 2024 Section 21 TSCA petition targeting PFOA, PFNA, and PFDA formation in fluorinated containers now works within an unsettled regulatory landscape. While the petition remains technically active, the Trump administration's May 2025 moves to weaken PFAS drinking water standards and extend compliance timelines to 2031 suggest the potential softening of federal regulations through three factors:

1. Legal Precedent Limitations: The Fifth Circuit's March 2024 ruling against EPA's TSCA Section 5 application creates enforcement hurdles, potentially forcing reliance on Section 6's cost-benefit requirements.
2. Implementation Delays: Mirroring drinking water rule extensions and compliance deadlines for container manufacturers could push beyond 2027 targets.
3. Narrowed Scope: EPA may only focus on enforcing direct food/pharma contact containers rather than all fluorinated applications.
   

In that vein, the EPA’s February 2024 release of a new methodology for detecting PFAS in high-density polyethylene (HDPE) containers (an important tool for quality control in medical, research, and specialty manufacturing) could lose regulatory force if the agency’s enforcement capabilities are diminished. While the methodology itself remains scientifically valid and publicly available, its adoption may become voluntary rather than mandatory. This will then shift the burden of compliance to the industry for self-regulation or to either the states, major customers, or international markets to impose and enforce those requirements.

With this federal step-back, manufacturers then face other pressures from other entities requiring them to meet higher standards. These include:

• 29 states advancing PFAS legislation independent of the federal government
• Major customers like DOD maintaining strict PFAS procurement bans
• EU's PPWR imposing 2030 recyclability mandates on exported containers

These are only the beginning when it comes to these dueling approaches. With federal and some states seeming diametrically opposed on several considerations, this situation can become particularly complicated. To simplify:

Moreover, if the EPA’s authority here is curtailed, manufacturers would indeed experience reduced federal oversight and fewer new operational restrictions. However, that would then lead to an unstandardized and confusing patchwork of state and local regulations, especially for those operating near communities concerned with environmental justice. Manufacturers within those communities can then expect to see increased activism and litigation from non-governmental organizations and affected communities, filling the gap left by federal retreat.

Despite federal rollbacks, many states and major institutional buyers continue to pursue aggressive plastic reduction goals. As a result, manufacturers should adopt modular strategies allowing quick adaptation to meet these goals or risk losing business. This might involve investing in such products as non-fluorinated barrier technologies (e.g. plasma-enhanced chemical vapor deposition (PECVD) coatings) and/or proactive investment in reusable, compostable, or highly recyclable alternative as long-term solutions to accommodate either trajectory. This holds especially true for those with long-term contracts or exposure to environmentally progressive markets, even if federal enforcement wanes. With that in mind, business leadership needs to closely monitor federal policy developments and also prepare for a hodgepodge of requirements across their customer base.

European Union PPWR: Global Impact on Manufacturing Standards

While not a U.S. regulation, the  European Union's Packaging and Packaging Waste Regulation (PPWR)  (EU) 2025/40 (which entered into force on February 11, 2025) will significantly impact global supply chains and manufacturing standards. This regulation replaces the 1994 directive with directly applicable requirements, eliminating variations between EU countries and establishing stricter sustainability targets.

Key provisions with cross-border implications for this regulation include:

• Mandatory recyclability: All packaging must be recyclable by 2030 based on new Design-for-Recycling criteria
• Recycled content requirements: By 2030, plastic packaging must incorporate specific percentages of post-consumer recycled material:
  • 30% for PET-based contact-sensitive packaging
  • 10% for non-PET contact-sensitive plastic packaging
  • 30% for single-use plastic beverage bottles
  • 35% for all other plastic packaging

Industry-Specific Implications

Medical Device Manufacturing

Medical device manufacturers face particularly complex regulatory challenges in balancing patient safety with sustainability requirements. The FDA's ongoing publication of Medical Device Material Safety Summaries highlights the growing attention to materials’ long-term performance in implantable devices as well as their safety to both patient and the planet.

For medical manufacturers, these regulatory developments entail:

• Increased vigilance in material selection and testing
• Enhanced documentation of material safety profiles
• Investment in alternative materials that maintain biocompatibility while meeting sustainability requirements
• Developing recyclable alternatives for traditionally single-use components

With more states establishing higher standards and goals for plastic usage, medical manufacturers will have to consider several operational factors that could affect their budget. They will then need to determine how to accommodate while still remaining profitable.

Aerospace & Defense Applications

The White House’s previous strategy to phase out single-use plastics in federal operations by 2035 would have significantly impacted aerospace and defense manufacturers reliant on specialized plastic components. For aerospace and defense suppliers, this means:

• The urgency to accelerate R&D into durable and reusable alternatives from single-use plastic components has diminished at the federal level as immediate regulatory pressure is easing.
• Likely delays, weakening, or replacing federal mandates with voluntary guidelines for take-back programs and specialized recycling processes for plastics used in government contracts.
• Relaxed lifecycle analysis and sustainability reporting requirements for federal procurement and shifting focus back to cost and performance rather than environmental criteria.

However, manufacturers should remain aware of a few key factors:

• State and international regulations may still require investment in sustainable alternatives, especially for exports or operations in states with stricter plastic policies.
• The plastics industry is lobbying for deregulatory measures and increased support for advanced recycling methods, which could provide new opportunities for cost reduction and compliance flexibility if adopted.
• Long-term contracts and customer expectations (especially for global defense and aerospace supply chains) may still prioritize sustainability, even as federal enforcement slackens.

In this evolving landscape, aerospace and defense manufacturers should monitor both federal rollbacks and emerging state or international requirements. They should also maintain adaptable strategies that can pivot as regulatory conditions will continue to change.

Research, Diagnostics, and Specialty Electronics 

For manufacturers serving research, diagnostics, and specialty electronics markets, PFAS regulations present particular challenges. These sectors often require high-performance containers and components historically dependent on fluorinated plastics for chemical resistance and durability. However, with EPA's detection methodology for PFAS in plastic containers (combined with the previous petition to regulate PFAS formed during container fluorination) signals some intensifying scrutiny of these materials, no matter the entity or business. 

To remain broadly compliant. manufacturers in these industries need to consider:

• Implementing comprehensive testing protocols using the EPA methodology established in 2024
• Developing non-fluorinated alternatives for high-performance applications
  
• Establishing clear communication channels with customers about material changes
• Investing in R&D for innovative barrier technologies that don't generate PFAS

Incorporating these strategies will likely decrease the chances of noncompliance and their resulting consequences. 

Smart Compliance: Cost-Effective Strategies for 2025 and Beyond

But what can you or your manufacturer do to ensure compliance without breaking the budget? We have detailed below our recommendations on potential strategies you can use.

Audit Your Supply Chain and Materials

Conduct a comprehensive audit of your current materials, focusing on the following:

• Identifying materials potentially containing PFAS
• Assessing the recyclability of current materials against upcoming standards
• Evaluating supplier sustainability practices
• Documenting the percentage of recycled content in current materials

This baseline assessment will identify high-risk materials and higher-priority processes.

Invest in Sustainable Design

Rather than making incremental adjustments to existing products, invest in comprehensive redesigns that:

• Eliminate problematic materials from the outset
• Incorporate reusability and recyclability as core design principles
• Reduce material complexity to enhance recyclability
• Standardize materials across product lines to achieve economies of scale

Develop Internal Expertise

Create a dedicated regulatory compliance team with specialized knowledge of plastics regulations. This investment typically pays for itself by:

• Preventing costly compliance violations from local, state, or even international authorities
• Identifying strategic opportunities in regulatory trends
• Enabling proactive rather than reactive compliance approaches
• Providing competitive intelligence on industry adaptations

Collaborate Across the Value Chain

Form strategic partnerships with:

• Raw material suppliers to develop compliant alternatives
• Customers to align expectations and development timelines
• Industry associations to share compliance costs and research
• Recyclers to develop take-back programs for specialty materials

Collaborative approaches distribute costs while accelerating innovation.

Document and Communicate Compliance

Implement robust documentation systems that:

• Track material composition through the manufacturing process
• Validate compliance with current and anticipated regulations
• Provide transparent information to customers
• Support environmental claims with verifiable data

Effective communication about compliance efforts can transform regulatory burdens into marketing advantages, particularly in B2B relationships where customers face their own downstream compliance requirements.

Transforming Regulatory Challenges Into Competitive Advantages

The wave of plastics regulations enacted over the past year represents both significant challenges and strategic opportunities for specialized plastics manufacturers and their customer base. By focusing on sustainable innovation, material science advancement, and transparent customer communication, innovative manufacturers can transform regulatory compliance from a cost center into a competitive advantage. The transition to more sustainable plastics manufacturing isn't just about avoiding penalties. It's about securing your company's position in the evolving industrial landscape where environmental performance increasingly determines market success. Those who adapt survive.