New EU Regulation on Preventing Plastic Pellet Loss: How OCS Certification Supports Compliance

What Does the Regulation on Preventing Plastic Pellet Loss Cover?

The primary goal of the EU’s regulation is to reduce the leakage of plastic pellets into the environment, primarily due to accidental spillage or inadequate handling practices. These incidents typically occur during the production, transportation, processing and recycling stages of the supply chain. While some businesses have already adopted voluntary guidelines, the EU regulation makes consistent, legally enforced standards the norm across all member states.

The regulation on the prevention of plastic pellet loss complements Commission Regulation (EU) 2023/2055: whereas Commission Regulation (EU) 2023/2055 focuses on microplastics that are intentionally added to products, such as cosmetics and detergents, the regulation on plastic pellet loss focuses on the prevention of accidental spills and losses.

Who is affected by the Regulation on preventing plastic pellet losses?

The EU regulation 2025/2365 to prevent plastic pellet loss targets specific companies and activities across the plastics supply chain that handle, transport, or process plastic pellets. The scope is defined broadly to capture all stages where pellet leakage may occur, from production to disposal.

The regulation applies to all economic operators involved in handling plastic pellets in the EU in quantities of 5 tonnes or more in the previous calendar year, as well as economic operators operating installations in the Union for the cleaning of plastic pellet containers and tanks, EU and non-EU carriers transporting plastic pellets in the Union.

The regulation covers the following types of companies and activities:

Pellet production, masterbatching and compounding

Companies involved in the production of plastic pellets are a primary focus of the regulation. This includes polymer manufacturers and other facilities that create pellets as raw materials for further processing. Production sites are critical points for pellet loss due to the high volume of pellets produced and transferred within these facilities, necessitating stringent containment measures.

Plastic Processors and Manufacturers

Facilities that use plastic pellets to manufacture plastic goods, such as packaging, automotive parts, construction materials, and consumer goods, also fall under the regulation. These companies handle large quantities of pellets, which are shaped into finished products. Pellet loss often occurs during transfer from storage to processing equipment, so these companies are required to implement spill prevention and containment measures.

Storage and Handling Facilities

Any facility where plastic pellets are stored before being used or transported—such as warehousing sites, distribution centers, and other intermediary locations—are covered. These facilities must adhere to storage protocols that prevent pellets from spilling and escaping, especially when handling bulk transfers.

Transport and Logistics Companies

Logistics providers involved in transporting plastic pellets are also in scope. Transportation is one of the most common points of pellet loss, especially during loading and unloading. This also includes activities such as tank cleaning. The regulation includes transport by road, rail and waterways. Maritime transport is also included (from 17 December 2028).

Waste Management and Recycling Facilities

Facilities that handle, process, or dispose of plastic pellets or plastic waste are also included. Waste facilities will need to adopt containment practices and enhanced filtration systems to prevent pellets from escaping into the environment.

Subcontractors and Third-Party Service Providers

Companies that provide services related to pellet handling, transport, or processing on behalf of other firms also fall under the scope of the regulation. This includes third-party logistics providers, subcontracted storage facilities, and any other entities that handle plastic pellets as part of their service provision. Subcontractors will be responsible for adhering to the same containment, training, and spill response requirements as the primary entities in the plastics supply chain.

Importantly, the adopted regulation defines “plastic pellets” broadly as a mass of polymer-containing material, regardless of shape, form, or size, that is produced for moulding in plastic product manufacturing operations, irrespective of its actual use. The recitals also clarify that plastic pellet dust, as industrial residue not used in plastic product manufacturing operations, does not fall within the scope of the plastic pellets definition in the Regulation.

However, not all companies are affected in the same way: the regulation provides reduced requirements and adjusted timelines depending on company size.

Key Provisions of the Regulation on Prevention of Plastic Pellet Loss

Companies affected by the regulation 2025/2365 have to meet six key requirements to reduce the risk of pellet loss. These are described primarily in Articles 5, 6, 7, 8 and related annexes.

Risk assessment / risk management plan: companies need to establish a risk management plan for each affected installation, taking into account the nature and size of the installation as well as the scale of its operations. They need to take the corresponding preventive measures following from the risk management plan, and notify the relevant authorities of the plan together with a self-declaration of conformity, unless certification, permit-based compliance, or a qualifying management-system route applies. The requirements for the risk management plan are listed in Annex I of the Regulation.

Staff training: companies in scope of the regulation need to ensure their staff is trained on the relevant procedures to prevent pellet loss, or to handle any spills when they occur.

Record keeping: companies need to keep records of the risk management plan, the actions taken, the estimated quantities of losses and the total volume of pellets handled.

Corrective actions: take corrective actions for any incidents where the measures to prevent, contain or clean up a loss of pellets turn out to be ineffective.

Conduct a yearly internal review of the state of compliance with the risk management plan: this annual internal assessment applies to medium-sized and large enterprises operating installations where plastic pellets in quantities equal to or above 1 500 tonnes have been handled in the previous calendar year.

Certification: certain companies in scope of the regulation have to obtain third-party certification from an accredited certifier to demonstrate compliance with the requirements. We will take a closer look at this requirement in the next section.

EU Regulation 2025/2365: Which Companies Require Certification?  

Whether a company is required to obtain certification depends both on its size and whether it operates installations handling 1,500 tonnes or more of plastic pellets per year. Microenterprises and all enterprises below this threshold are not subject to certification but must submit a risk management plan and a self-declaration of conformity, to be renewed every five years.

For installations at or above the 1,500-tonne threshold, certification becomes mandatory:

• large enterprises must obtain certification by 17 December 2027 and renew it every three years; 
• medium-sized enterprises by 17 December 2028, with renewal every four years; and
• small enterprises by 17 December 2030, with certificates valid for five years.

A commonly misunderstood point is the certification period: while the Regulation mentions certification intervals of three, four and five years, this should not be confused with the auditing frequency, as most certification schemes require yearly surveillance audits in between the certification and recertification audits.

Operation Clean Sweep (OCS) Certification and the New EU Regulation: A Close Connection

The EU’s proposal built on the principles established by Operation Clean Sweep (OCS) and the OCS Europe Standard, a voluntary certification standard developed by industry associations Plastics Europe and EuPC to minimize pellet loss. The adopted regulation still reflects that background. In its recitals, it notes that since 2015 the European plastic manufacturing industry has progressively adopted the international Operation Clean Sweep® programme as a voluntary pledge, but also that those practices have not been comprehensively implemented and that uptake remains low.

OCS provides a set of guidelines, training resources, and tools to help companies manage and contain plastic pellets effectively. The EU regulation makes key pellet-loss-prevention principles legally binding, extending beyond voluntary efforts by making standards uniform across the industry. Many elements of the OCS framework are reflected in the regulation’s requirements on risk assessment, prevention, containment, clean-up, training and monitoring.

This alignment between OCS principles and regulatory measures underscores the EU’s commitment to reducing pellet pollution. At the same time, it is important to formulate the point carefully: the regulation does not say that OCS Europe certification is automatically the certification required under Article 6. What it does do is create a certification requirement for certain installations and a detailed compliance framework that aligns strongly with the OCS Europe standard. For that reason, obtaining OCS certification to the OCS Europe Standard can be a highly relevant and practical way for companies to prepare for and support compliance.

The OCS Europe standard and the corresponding certification are not to be confused with the OCS Pledge: whereas the pledge is a voluntary commitment without external validation, the OCS Europe certification is based on an independent third-party audit to verify compliance with the requirements of the OCS Europe Standard.

Alternatives to OCS Certification: Compliance through Environmental Management Systems

Are there alternatives to Operation Clean Sweep certification? Yes – these are described in Article 8 of the Regulation. Sites which are participating in the EMAS scheme can be exempted from the certification requirement, if the EMAS auditor verifies that the requirements of EU 2025/2365 have been implemented as part of the environmental management system.

In addition, the regulation enables Member States to waive the certification requirement for sites that have a certified management system, if a number of conditions have been met:

• The member state in which the site is located has decided to accept EMS certificates
• The site needs to have an accredited third-party certificate (e.g. ISO 14001)
• The certification audit needs to be extended to include the requirements of EU

2025/2365, Annex I and should include spot checks of the surrounding areas to evaluate the effectiveness of pellet loss prevention.

This is the opening under which certificates such as ISO 14001 may become relevant in some Member States. However, as matters stand, Member States have not yet defined how these options will be implemented in practice. For affected companies, it would therefore be risky to wait for possible national recognition of ISO 14001-based approaches rather than preparing now for the regulation’s direct requirements. Companies that already hold ISO 14001 certification should also bear in mind that the regulation creates obligations at the installation level: each site must have its own risk management plan and demonstrate compliance at that site, which is a different logic from the multi-site sampling approach often used in ISO 14001 certification programmes.

EU Regulation on Plastic Pellet Loss: Timeline and Deadlines for Companies

The proposal from the European Commission was published on 16 October 2023. The European Parliament adopted its position on 23 April 2024. The final Regulation (EU) 2025/2365 was adopted on 12 November 2025 and published in the Official Journal on 26 November 2025. The regulation on preventing plastic pellet loss entered into force on the twentieth day following publication and applies from 17 December 2027. However, Article 3(1), Article 5(6), second subparagraph, Article 16, Article 17(1) and Article 18(2) and (3) apply from 16 December 2025. For shippers and operators, agents and masters of seagoing vessels, the relevant provisions apply from 17 December 2028.

However, for the implementation of certain requirements, such as the completion of third-party certification, the regulation specifies different timelines:

• large enterprises: by 17 December 2027, and every three years thereafter;
• medium-sized enterprises: by 17 December 2028, and every four years thereafter;
• small enterprises operating installations at or above the 1 500-tonne threshold: by 17 December 2030, with a certificate valid for five years.

EU Aims to Reduce Microplastic Pollution

The EU estimates that the loss of plastic pellets into the environment ranges between 52,000 and 184,000 metric tons annually in the EU, contributing significantly to plastic pollution in European waters and beyond. By reducing this loss, the EU aims to decrease overall microplastic pollution, protect marine biodiversity, and reduce contamination in food sources.

Pellet Loss Prevention with DQS Certification

The EU’s regulation represents a vital step toward reducing plastic pollution at its source, strengthening the voluntary standards of Operation Clean Sweep into enforceable regulations that set uniform standards across the industry.

Given the complexity of the new requirements, many companies will need to systematically review their existing processes and systems. An independent certification body can here provide clear guidance on requirements and evidence. As one of the first global certification bodies to be approved for Operation Clean Sweep (OCS) certification, DQS has the knowhow to help you meet compliance with the pellet loss prevention certification requirement. In addition to certification audits, we can help you with gap assessments and training.

DQS – the right partner from the very beginning

DQS has stood for in-depth expertise, international recognition, and the highest audit quality since 1985. As the first German certification body and with its founding partners DGQ and DIN at our side, we combine standards expertise, practical experience, and a modern approach to auditing. Our auditors are experienced professionals who don’t just want to inspect – they want to understand – and provide you with valuable insights for continuous improvement your management system.

Our audit philosophy is based on going far beyond simply working through checklists: We ask the right questions, identify opportunities for improvement, and create value through independent, accredited procedures, we ensure globally valid comparability and build trust. A DQS certificate stands for quality, efficiency, and a genuine commitment to customer focus – and is thus a strong sign of trust, both within your organization and toward your stakeholders. Take us at our word! We look forward to hearing from with you.