REGULATION & COMPLIANCE sampling strategies and validated analytical methods.
Determining insolubility and nondegradability further necessitates reference to standardised test methods and interpretive guidance. Importantly, natural polymers, soluble polymers and demonstrably biodegradable polymers are excluded, reflecting a risk-based prioritisation based on environmental persistence.
Fate & hazard
The restriction of intentionally added SPMs is grounded in the precautionary principle and in the risk assessment framework established under Article 68 of REACH. Following evaluation by ECHA’ s Committees for Risk Assessment and Socio- Economic Analysis( RAC, SEAC), the EC concluded that the widespread and diffuse release of persistent polymer particles to the environment constitutes an unacceptable risk requiring EU-wide risk management.
Microplastics have been detected across marine, freshwater, terrestrial and atmospheric compartments, demonstrating environmental persistence and broad distribution. Ingestion by aquatic and terrestrial organisms has been documented extensively. While the scientific community continues to investigate potential human health implications, environmental persistence and accumulation were central considerations in the regulatory determination.
From a regulatory toxicology perspective, microplastics challenge conventional hazard paradigms traditionally focused on chemical substances and intrinsic molecular toxicity. The behaviour and impact of polymeric particles depend on size, morphology, surface chemistry, additive composition and environmental ageing processes. Consequently, the regulatory intervention reflects not only intrinsic toxicity but also persistence, accumulation potential and the inevitability of diffuse emissions throughout product lifecycles.
Entry 78 therefore represents a significant development: it extends regulatory control beyond molecular hazard classification to address material form and long-term environmental persistence. This approach signals a broader evolution in regulatory science, where particle characteristics and environmental fate are increasingly integrated into risk management decision-making.
Entry 78 obligations
Entry 78 introduces both restriction and information obligations across the supply chain. The placing on the market of products containing intentionally-added SPMs is restricted, subject to transitional periods and specified derogations. Exempted uses include medicinal products, food additives, in vitro diagnostic devices, EU fertilising products, and food and feed, reflecting sector-specific risk management frameworks and essential societal functions.
In addition, manufacturers, importers and downstream users will also be subject to reporting obligations to ECHA. Annual reporting requires the disclosure of intended uses, generic polymer identity information and estimated emissions to the environment. The phased implementation of this( commencing from 2026 and 2027, depending on use category) reflects a pragmatic recognition of the need for data generation and internal compliance system development.
Importantly, distributors are not subject to reporting obligations, although they remain subject to communication duties under REACH. The regulatory architecture thus reinforces upstream responsibility for polymer identity and emission estimation, while preserving downstream traceability.
UK REACH
The UK has indicated its intention to consider regulatory measures addressing intentionally added microplastics under UK REACH. The Health & Safety Executive( HSE), acting as the UK REACH agency, has undertaken evidence gathering and scientific scoping to evaluate the environmental risks associated with SPMs.
At the time of writing, no formal restriction equivalent to EU REACH Annex XVII Entry 78 has been adopted into UK REACH. Any future UK restriction would require development of a regulatory management options analysis( RMOA), followed by public consultation and ministerial decision by the secretary of state and devolved authorities.
While early policy signals suggest technical alignment with the EU approach may be likely, divergence remains possible. Differences could arise in definitional scope, transitional periods, reporting obligations and / or enforcement mechanisms. In particular, the UK may adopt a proportionate model tailored to the structure of the domestic industry and environmental policy priorities.
For operators active in both jurisdictions, this regulatory asymmetry introduces interim complexity in compliance. Companies must therefore monitor UK policy development closely and avoid assuming automatic replication
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