The nano form of a substance is treated specially in the legislation because it may have different properties even though it is chemically the same.
Within the scope of KKDIK and REACH, separate substance identity information, characterization data and additional safety assessment may be requested for nanoforms when necessary. Companies that produce or import nanoforms may have additional obligations to standard registration information.
ONAY Mühendislik provides support in the characterization of nanoforms and evaluation of registration requirements.
Nano Form Definition and Registration Difference
Nano form is a form of matter whose size distribution is within a certain range and is defined in terms of surface functionality, shape or specific surface area. Each nanoform that has the same chemical identity but carries a different size distribution or different surface coating must be characterized individually in the registration file. An aggregate nano declaration is not considered sufficient because the forms behave differently from each other.
Characterization Data Requirements
For nanoforms, size distribution, shape and aspect ratio, specific surface area, surface functionality and crystal structure information are expected in the file. These data should be presented using standard analytical methods and specifying measurement uncertainty. If the size distribution varies between production batches, the range declared in the file must be defined to cover all batches.
Transferability of Toxicological Data
Toxicological data generated for the bulk form of a substance cannot be directly transferred to its nano form. Nanoforms vary in their solubility, bioaccessibility and respiratory behavior. Therefore, if the read-across approach is to be used, the justification for similarity must be established through nano-specific parameters and the adequacy of the data must be clearly defended.
Exposure Control and Labeling
Preventing dust formation in areas where nanoforms are worked, using a closed system and ventilation with appropriate filter class are the priority control measures. Clearly stating in the safety data sheet that it is a nanoform and specific protective measures is the only way for the downstream user to take correct precautions. In cosmetic products, the phrase nano is also mandatory in the ingredients list.
Practical Roadmap for Companies
First of all, it should be clarified with the supplier declaration and analysis data whether the substances produced or imported contain nanoforms. If there is a nano form, it is checked whether the current registration file contains this form. If it is not covered, a file update is planned. Incorporating this determination into the annual review process avoids the cost of subsequent extensive revisions.
How to Request a Supplier Declaration for Nano Forms?
Whether your product contains Nano Forms can often only be determined by the supplier's declaration. The document to be requested; It is a report that gives size distribution, specific surface area and surface functionality values together with the measurement method. An unjustified statement that does not contain Nano Forms and does not specify a method will not be accepted as evidence in the audit.
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Official full text of the regulation: KKDIK Regulation - Official Gazette.