Persistent, Bioaccumulative and Toxic (PBT) Substances: Legislative Framework and Industrial Implications

Persistent, Bioaccumulative and Toxic (PBT) Substances: Legislative Framework and Industrial Implications | ChemRAS

Persistent, Bioaccumulative and Toxic (PBT) Substances: Legislative Framework and Industrial Implications

Persistent, Bioaccumulative and Toxic substances (PBTs) are chemicals that remain in the environment for extended periods, accumulate in living organisms, and exert toxic effects. Due to these characteristics, they pose serious threats to both human health and ecological balance. Regulations such as the EU’s REACH and CLP and Türkiye’s KKDIK and SEA frameworks aim to ensure controlled use and/or reduction of these substances through robust legislative measures.


Regulatory Perspective: PBT Classification Criteria and Legal Framework

Under Türkiye’s KKDIK Regulation and the EU’s REACH Regulation, a substance is classified as PBT if it meets the following three key criteria:

These substances are considered “Substances of Very High Concern” (SVHC) and may be listed on the Candidate List published by the European Chemicals Agency (ECHA). The KKDIK Regulation in Türkiye aligns with REACH and governs the registration, evaluation, authorization, and restriction of PBT substances. Regarding labeling, the EU’s CLP Regulation mandates that the risks of such substances be clearly indicated using appropriate GHS pictograms, signal words, EUH phrases, and precautionary statements. However, as these specific label elements have not yet been officially published in Türkiye’s Official Gazette, they are not legally enforced at present.


Industrial Use and Challenges: The Complexity of Seeking Alternatives

PBT substances may be found in various products and applications such as pesticides, certain plasticizers (e.g., phthalates), flame retardants, and industrial solvents. Historically, they were favored for their low cost and high performance. However, considering their long-term adverse environmental and health impacts, these advantages are now seriously questioned. Once released into the environment, the persistence and widespread distribution of PBT substances lead to environmental problems that are difficult to reverse.

In industry, replacing PBTs with safer alternatives is strongly encouraged through the "green chemistry" approach. Nevertheless, this transition is complex—requiring a meticulous evaluation of factors such as the technical equivalence of alternatives, their cost, and their market feasibility. Potential performance loss or increased costs can pose significant challenges for companies during this transition.


Human Health and Environmental Effects: Hidden and Widespread Threats

Human Health

Environment


Conclusion: Shared Responsibility and a Forward-Looking Approach in PBT Management

PBT substances are subject to strict regulatory control and must be handled cautiously in industrial practice. Minimizing the use of such chemicals, promoting safer alternative solutions, and enhancing effective risk communication are critical to protecting both human health and ecosystems. Regulatory frameworks should be continuously updated in light of scientific advancements, prioritizing the protection of the environment and human health. This is not merely a legal obligation but a shared responsibility to ensure a cleaner and healthier planet for future generations.

Illustration showing the environmental persistence and bioaccumulation of PBT substances