KKDIK and Product Safety in Polyurethanes

Polyurethanes rank among polymer systems used in numerous applications, particularly in the footwear sector, owing to their characteristics such as lightweight, durability and versatility. Shoe sole systems, elastomer structures, foam applications, adhesives, coating systems, sealing materials and various technical components clearly demonstrate how widespread polyurethane use is across different sectors. This broad application scope makes polyurethanes a subject that must be carefully addressed not only in terms of technical performance, but also with regard to chemical content, product safety and increasingly prominent sustainability expectations.

This article addresses how different use forms of polyurethanes affect regulatory assessment, which key obligations under KKDIK stand out, why the product safety approach extends beyond chemical compliance limits, and how current expectations for the European Union market are reflected in the sector.

Different use forms of polyurethanes and their impact on regulatory assessment
The basic framework governing chemical management in Turkey has been established through the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK). Matters such as product market placement, economic operator responsibilities, market surveillance and corrective measures are addressed under product safety legislation. In Turkey, the general framework for product safety has been shaped by Law No. 7223 on Product Safety and Technical Regulations, with the general product safety approach supported by relevant secondary regulations. For companies operating in the European Union market, product safety and sustainable product approaches open a broader evaluation field than chemical compliance.

Different use forms of polyurethanes make it difficult to address these materials in a single regulatory structure. The main reason for this is the ability to develop systems within the same material family that respond to different performance needs. In the footwear sector, sole systems, elastomer structures and comfort-purpose foam applications stand out, while in other fields, adhesives, coatings, sealing materials and elastomer applications also attract attention. This diversity makes it necessary to evaluate polyurethanes as a complete system designed according to different purposes of use.

Particularly from the footwear sector perspective, regulatory assessment often presents a more complex picture than examining a single material. The main reason is that a shoe is a multi-component product. Polyurethane sole systems, foam structures, adhesives, coatings and various auxiliary materials come together within the same product; this moves both chemical content management and product safety assessment to a more layered structure. Therefore, when evaluating the suitability of a polyurethane-based component in the footwear sector, the material's own characteristics, its function within the product, its relationship with other components and final use conditions must be considered together.

The key point that emerges here is that the broad application scope of polyurethanes directly affects regulatory assessment. A product from the same material family can be placed on the market as a mixture in one case, while becoming a component of an article in another. Particularly in multi-component products reaching consumers directly, correct positioning of polyurethane-based materials within the appropriate regulatory framework gains even greater importance. Therefore, the first fundamental step for companies operating in polyurethane systems is the correct definition of each product in their portfolio within its intended use and presentation form.

Evaluation of polyurethanes under KKDIK
When evaluating polyurethane products under KKDIK, it is not sufficient to approach the subject solely through the "polymer" definition. KKDIK is the fundamental regulation governing registration, evaluation, authorisation and restriction procedures for chemical substances. Within this framework, in polyurethane systems, not only the technical characteristics of the material but also how the components it contains are positioned from a regulatory perspective must be considered.

Under this scope, polymers are not directly subject to registration obligations. However, registration obligations may arise under certain conditions for monomers not previously registered by an actor in the supply chain and other substances chemically bound to the polymer. A registration obligation may arise if the polymer contains such substances by weight at 2% or more, and the total quantity of these substances amounts to 1 ton or more annually. This scenario shows that polyurethane systems must be evaluated together with component composition and tonnage information, not merely by product name.

This point carries particular importance for the polyurethane sector; because in practice, the term "polymer" is sometimes interpreted as having no obligations. However, although registration provisions do not apply to the polymers themselves, the registration approach remains important for monomers that constitute polymers and meet relevant conditions, as well as for other substances chemically bound to the polymer. Therefore, the technical functions of components used in polyurethane systems must be evaluated separately alongside their regulatory status.

Another critical issue in evaluating polyurethane products is correctly determining whether the product is placed on the market as a mixture or article. In practice, two-component polyurethane systems, prepolymer-based formulations, adhesives or coating systems are often treated as mixtures; while shoe soles, foam pieces, panels or similar final products may qualify as articles. This distinction does not merely create a terminological difference; the obligations to be applied also vary depending on how the product is placed on the market. For products qualifying as articles, certain tonnage and registration conditions may require additional evaluation for substances designed to release under normal or reasonably foreseeable use conditions. Therefore, the first step for companies operating in the polyurethane field is the correct definition of each product in their portfolio within its use purpose and presentation form.

In summary, KKDIK assessment for polyurethane products should be conducted taking into account the product's composition, market placement form, intended use and position in the supply chain together. In this respect, regulatory compliance in polyurethane systems stands out as one of the fundamental subjects that must be considered together with technical performance assessment.

Information management, supply chain and registration approach
Regulatory compliance in polyurethane products cannot be viewed as a matter limited to registration obligations; information management and supply chain communication occupy the centre of this process. Information management plays a decisive role in ensuring chemical safety. Safety Data Sheets rank among the basic information sources for the safe use of chemicals and mixtures, and therefore their preparation in a correct, current and regulatory-compliant manner is of great importance. According to Ministry announcements, following 31 December 2023, SDS are prepared under KKDIK by Chemical Assessment Specialists certified according to Annex 18. This situation makes the availability of current and regulatory-compliant SDS in polyurethane-based substances and mixtures one of the fundamental elements of proper information flow throughout the supply chain.

Information management in the polyurethane sector is a subject extending beyond documentation. It is also directly related to preservation of data quality throughout the supply chain. In systems containing numerous inputs such as polyols, isocyanates, additives, catalysts, chain extenders, solvents and other auxiliary components, correct communication of regulatory information for each component carries particular significance. Composition information received from suppliers, classification data, restriction status, safe use conditions and documentation currency; all affect the process extending from initial supply through to market placement of the final product. Therefore, regulatory compliance in the polyurethane field requires technical formulation management and regulatory information to be conducted together and in a coordinated manner.

The direction of the registration process in practice raises the need for companies to evaluate together the product portfolio with component information in the polyurethane sector. Companies must examine substances in their portfolios for registration obligations alongside their technical functions. Considering different supply structures, import scenarios and use forms, it is clear that the same registration method will not be appropriate for each substance. Therefore, the registration process must be addressed together with data management and supply chain communication. Such an approach will facilitate companies operating in the polyurethane sector to shape their registration strategy on a substance basis and within their own commercial structures.

Product safety framework and expectations for the EU market
Compliance assessment for polyurethane products must be addressed alongside the product safety dimension as well as chemical safety. The basic framework in the product safety field in Turkey has been established through Law No. 7223 on Product Safety and Technical Regulations. The purpose of this Law is to ensure products are safe and comply with relevant technical regulations; to establish the principles of market surveillance and inspection and the duties of competent authorities and obligations of economic operators. This structure clearly shows that polyurethane-containing consumer products create two interrelated separate evaluation areas: chemical compliance and product safety.

This framework carries importance for products placed on both the domestic market and those subject to foreign trade in the polyurethane sector. The Regulation on Technical Regulations in Foreign Trade covers the technical regulations to which products subject to foreign trade will be subject, import and export inspections, the duties and responsibilities of authorities conducting inspections, the responsibilities of importers and exporters, the measures to be taken and applicable sanctions. Therefore, product safety should not be viewed by exporting companies as a subject limited to compliance with regulations in the target market. Compliance assessment in the export process from Turkey is also part of this whole.

TAREKS, the Risk-Based Control System in Foreign Trade, forms the infrastructure for conducting inspection, compliance and authorisation procedures according to product safety regulations and technical regulations electronically and on a risk basis. Particularly in shoes and similar final consumer products, this structure clearly shows that the product safety approach is not limited to chemical components used in formulation. Documentation, traceability, compliance information and, where necessary, capacity to take corrective measures also occupy the same evaluation area.

For polyurethane-based products placed on the European Union market, the general product safety approach provides a more visible and more comprehensive framework. The General Product Safety Regulation (GPSR) applied in the European Union has updated the general safety framework for non-food products intended for consumers. With this regulation, traceability, visibility of product safety information in online sales channels, economic operator responsibilities and corrective measures and recall procedures for dangerous products have become more prominent. Thus, assessment for polyurethane-containing consumer products has extended from the chemical content level to a broader area; the accessibility of product information, supply chain responsibility and post-market monitoring procedures have come more prominently to the fore.

Another important subject within the product safety framework is market surveillance and corrective measure procedures. When unsafe products are detected in the market, only technical non-conformities are at issue; important consequences may also arise regarding distribution chain management and commercial continuity. Therefore, compliance with regulations for polyurethane-containing consumer products should not be viewed as an inspection process completed at market placement; it should be addressed as an area of responsibility monitored throughout the product lifecycle. The Safety Gate system in the EU also serves to rapidly share measures taken regarding dangerous non-food products among competent authorities and demonstrates how visible product safety risks have become.

Sustainability, data transparency and overall assessment
The sustainability and data transparency dimension is increasingly shaping new generation compliance expectations in products containing polyurethane. The Ecodesign for Sustainable Products Regulation (ESPR) has established a broader framework for products in the EU. The Regulation creates the legal basis for determining ecodesign requirements for sustainable products; it highlights subjects such as durability, reuse, repairability, recyclability, resource efficiency and information transparency. In this respect, ESPR extends beyond material selection for polyurethane-containing products and also affects expectations related to product design and product information management.

The important point here is not to read ESPR from today as a single text bringing the same technical obligations for each product. The Regulation does not present equally detailed ready rules for all product groups; it establishes the framework where product-specific requirements will be shaped by regulations to be issued later. Therefore, for polyurethane-containing products, ESPR should not be viewed as a completed single list of obligations; it should be read as a regulatory orientation that in the near term raises expectations regarding data transparency, design approach and traceability.

The digital product passport is also one of the notable elements of this structure; however, which information will be included in which product groups will become clearer with subsequent product-specific regulations. In this respect, the digital product passport, while opening a new information area for companies, stands out as a preparation subject requiring product data to be maintained in a more orderly, traceable and current manner. Therefore, in the near term, improving data quality, product information and traceability infrastructure is becoming a more visible need for polyurethane-containing products.

In conclusion, regulatory compliance in the polyurethane sector now emerges as a multi-layered evaluation area.

In evaluating polyurethane products, in addition to chemical composition, the product's market placement form, intended use, position in the supply chain and target market must all be considered together. Registration obligations under KKDIK, the mixture-article distinction and requirements regarding Safety Data Sheets form the foundation of this process, while the product safety framework in Turkey, technical regulations in foreign trade and expectations arising from GPSR and ESPR for products targeting the EU market are becoming increasingly determining. This situation transforms regulatory compliance for companies operating in the polyurethane sector into a strategic subject regarding product management, export continuity and market access.

Within this framework, it is important for companies to evaluate their polyurethane systems alongside performance criteria in terms of regulatory obligations. Conducting correct component-level analysis, timely determination of registration approach, sound management of information flow throughout the supply chain, consideration of product safety expectations and strengthening of traceability infrastructure will become even more determining in the period ahead. Safe and sustainable production requires the joint consideration of chemical regulations, product safety, foreign trade compliance and ecodesign approach.

References
Ministry of Environment, Urbanization and Climate Change. Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK). Official Gazette, 23 December 2017, No: 30279 (Repeated).
Ministry of Environment, Urbanization and Climate Change, Chemicals Helpdesk. Announcement on Safety Data Sheets.
Republic of Turkey. Law No. 7223 on Product Safety and Technical Regulations. Official Gazette, 12 March 2020, No: 31066.
Republic of Turkey. General Product Safety Regulation. Official Gazette, 11 March 2021, No: 31420.

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