MONOMER REGISTRATION AND SPECTRAL DATA FOR SUBSTANCES USED IN POLYMER MANUFACTURING UNDER KKDİK

Content addition date : 29-05-2025

Under the KKDİK Regulation, the registration of polymers and monomers requires particular attention to the following aspects:

► Spectral Data and Chromatograms: 

For the registration of polymers and their associated chemicals, the spectral data and chromatograms of the original monomer used in the polymer’s production, as well as other components, must be provided. These data are scientific records that confirm the chemical properties and structure of the polymer’s components. For instance, IR (infrared) spectra, NMR (nuclear magnetic resonance) data, or chromatographic analyses (such as gas chromatography or liquid chromatography) are used to determine the identity and composition of the components.

These data ensure that the polymer’s content accurately reflects the chemical properties of the monomers and other substances used. If these data cannot be provided, the reasons must be clearly stated. For example, in some cases, the exact composition of the monomers used in the polymer’s production may not be determined, or proprietary formulas may be used. In such cases, a scientific explanation is required.


► Unacceptability of Generic Data: 

Generic spectral data or generic chromatograms are not acceptable because they do not accurately reflect the true composition of the monomer or other components used in the polymer’s production. Generic and standardized data cannot capture the unique structure and composition of each polymer or monomer. Polymers can vary widely due to the different chemicals used in their production processes, and it is important to accurately determine the characteristics of each polymer.

Generic data, which are considered valid for all similar compounds, do not accurately reflect the chemical structure of specific components. Therefore, specialized analyses must be conducted to determine the unique structure of each substance. Additionally, if generic data are used, scientific justification must be provided to support their validity and accuracy.


► Scientific Justifications and Explanations: 

If specific spectral data or chromatograms for a substance cannot be provided, a scientific justification must be given. For example:

•    The exact components of the monomer used in the polymer’s production may be proprietary or confidential.
•    It may not be possible to obtain these data due to technical or analytical reasons (e.g., depending on the materials used or production conditions).
•    Alternative test methods or data can be presented, and in this case, explanations supporting the reliability and validity of these alternatives must be provided.

In conclusion, for the registration of polymers and monomers, it is necessary to analyze the substances used in production accurately and provide spectral data and chromatograms for these substances. Generic data cannot be used, and specific data reflecting the true chemical structure of each component must be provided. Otherwise, if data cannot be provided, the scientific reasons for this must be clearly explained.