POPs Regulation
EU POPs Regulation:
Persistent Organic Pollutants – Obligations, Restrictions & Compliance
Scope of the POPs Regulation and Legal Framework
The Regulation (EU) 2019/1021 (POPs) is a key EU instrument for regulating particularly hazardous persistent organic pollutants (POPs) and applies to all economic operators within the European Union as well as to imports from third countries. It covers substances, mixtures, and articles throughout their entire life cycle—from manufacture and use to placing on the market, as well as waste management and disposal. The objective of the Regulation is to sustainably reduce environmental and human health exposure to long-lasting pollutants and to permanently prevent their uncontrolled release.
EU Regulation & Chemicals Legislation – Implementation of the Stockholm Convention
From a legal perspective, the POPs Regulation is firmly embedded in European chemicals legislation and implements the requirements of the Stockholm Convention. This Convention obliges the Parties to eliminate particularly hazardous pollutants or toxins from material cycles worldwide or to reduce their releases to a minimum. The EU transposes these obligations into directly applicable regulations, thereby ensuring a uniform level of protection across the Member States.
POPs in Substances, Mixtures and Articles – Placing on the Market, Use and Manufacture
The POPs Regulation precisely defines which substances, mixtures, and articles fall within its scope. It regulates not only manufacture, but also any form of use and placing on the market within the EU. It is irrelevant whether POPs have been intentionally added or are present as impurities. This clear delineation of terms is crucial for the legally compliant implementation of the requirements in operational processes.
Annexes of the POPs Regulation and Key Provisions
The key provisions of the POPs Regulation are set out in several annexes, which are directly legally binding and immediately applicable. They specify which substances are classified as POPs, the applicable restrictions, and the conditions under which exemptions may be permitted. As the annexes are regularly updated to reflect new scientific knowledge, continuous monitoring of the Regulation is essential for companies to ensure legal compliance regarding products, articles, and waste.
Annexes I–III: Listed Substances, Restrictions & Provisions
Annexes I to III distinguish between fully prohibited POPs, substances subject to specific exemptions, and those where unintentional releases are the focus. They contain detailed provisions on limit values, permissible residual concentrations, and transitional periods. As such, they form the central basis for compliance assessment and the derivation of concrete operational obligations.
Delegated Acts/Amendments by the Commission – Entry into Force & Versions
Amendments to the POPs Regulation are made regularly through delegated acts of the European Commission. Each amendment may add new substances or tighten existing provisions. For practical purposes, it is crucial to know the date on which a new version becomes legally binding, as transitional periods are limited and violations can entail significant legal consequences.
Listed POP Substances and Substance Groups (Examples)
The POPs Regulation covers a steadily growing number of persistent organic pollutants that have been or are still used in various industrial applications. These substance groups are particularly targeted by authorities and market surveillance due to their environmental and health relevance.
PFOA, PFHxS, Perfluorooctanoic Acid/Perfluorooctanesulfonic Acid (PFAS) – Restrictions & Exemptions
Perfluorooctanoic Acid (PFOA), Perfluorooctanesulfonic Acid, and PFHxS belong to the PFAS substance group and are globally regulated due to their extreme persistence. The POPs Regulation imposes extensive restrictions on manufacture, use, and placing on the market. Only clearly defined exemptions, often time-limited, are still permitted and must be strictly documented.
Example: Hexabromocyclododecane – Use in Articles/Mixtures
Hexabromocyclododecane (HBCDD) is a brominated flame retardant listed in the POPs Regulation due to its toxicological and ecotoxicological properties. The manufacture, use, and placing on the market of HBCDD in new articles and mixtures is generally no longer permitted. In practice, the substance is primarily relevant today in the context of legacy products, construction waste, and recycled materials, which are subject to specific requirements for monitoring, handling, and disposal.
Other Persistent Organic Pollutants – Environment & Health, Minimizing Releases
In addition to PFAS and HBCDD, the POPs Regulation covers other persistent organic pollutants whose releases pose significant risks to the environment and human health. The aim of the provisions is to permanently reduce both direct emissions and indirect inputs via waste or recycling processes.
Obligations for Companies, Manufacturers, Importers & Users
The POPs Regulation establishes comprehensive legal obligations for manufacturers, importers, downstream users, and distributors. Companies are required to ensure compliance with all provisions on their own responsibility and to implement appropriate measures for the identification, assessment, and control of relevant substances. Violations of the POPs Regulation can result in marketing bans, product recalls, and regulatory sanctions.
Labeling/Information in the Supply Chain, Monitoring by Authorities/Environmental Agency
The transfer of relevant information on POP-containing chemicals and products is mandatory. Monitoring is carried out by national authorities, in particular the Environmental Agency, which works closely with market surveillance bodies.
Demonstration of Compliance When Placing Products & Articles on the Market
When placing products and articles on the market, companies must be able to demonstrate that they comply with the applicable limit values of the POPs Regulation. Analytical testing is a key tool for verifying compliance with the legal requirements.
Handling of Restrictions, Exemptions, and Time-Limited Uses
Proper assessment of restrictions and exemptions requires thorough knowledge of the current version of the Regulation. Time-limited uses must be actively monitored and terminated in a timely manner.
POPs in Waste and Disposal
The POPs Regulation includes specific requirements for handling POPs in waste, as these can be a significant source of uncontrolled pollutant releases. The aim is safe and environmentally sound disposal outside the material cycle.
Circular Economy: Limit Values, Disposal, Recovery – Preventing Uncontrolled Releases
Waste containing persistent organic pollutants is subject to specific limit values under the POPs Regulation. If a defined threshold is exceeded, recovery is prohibited and safe disposal is required. These provisions are intended to prevent POPs from re-entering the material cycle through waste streams or recycling processes and causing uncontrolled releases into the environment.
Practical Requirements for Collection, Treatment, and Documented Disposal
Companies must document the collection, treatment, and disposal of POP-containing waste in a traceable manner. These records are part of regulatory oversight and internal compliance.
Testing and Documentation Reference (Our Services for POP Compliance)
Analytical testing is an indispensable tool for ensuring compliance with the POPs Regulation. It is the only reliable way to prevent significant economic losses when placing products on the market, such as production stoppages or product recalls.
Analysis of PFAS (e.g., PFOA/PFHxS) in Products/Articles (LC-MS)
The detection of PFOA, PFHxS, and other PFAS can be carried out using sensitive LC-MS analysis in products and articles, depending on the specific application.
Detection of Brominated Flame Retardants (e.g., HBCDD) in Mixtures/Articles (GC-MS)
For brominated pollutants such as HBCDD, established GC-MS methods are used, enabling reliable assessment of mixtures. In addition to the brominated example HBCDD, other polyhalogenated organic compounds are listed in the annexes, whose detection is also feasible using GC-ECD techniques.
Screening & Confirmation Tests, Limit Value Checks per Annex, Compliance Reporting
Screening analyses, confirmation tests, and limit value checks per annex form the basis for legally compliant reporting and are offered by SAS Hagmann as part of their service portfolio.
Conventions & International Regulations
The POPs Regulation is part of a global framework for controlling persistent pollutants and does not exist in isolation alongside other environmental and chemicals legislation, but plays a central role within it. Its importance is further underscored by its referenced application under the Supply Chain Due Diligence Act. Within the framework of so-called “extended producer responsibility” (EPR), the POP Regulation, alongside social regulations, is a key component of modern, responsible business practices.
Stockholm Convention – Implementation through EU Regulations/Directives
The Stockholm Convention provides the international legal basis for EU-wide regulations on the control of POPs and ensures global harmonization.
Interfaces with Other Chemicals Regulations and National Legislation
In addition to the POPs Regulation, there are close interfaces with other EU and national chemicals and environmental regulations, which must be considered together.
