Polymers themselves are generally exempt from registration in KKDIK; However, this exemption does not completely relieve polymer manufacturers from liability.
The critical point is monomers: monomers and reagents that form the polymer and are present in certain proportions may be subject to registration when they are 1 tonne or more per year. In addition, the classification, labeling and SDS obligations of the polymer continue.
Roadmap; Includes monomer inventory, tonnage calculation, monomer registration status and SDS/label compliance. ONAY Mühendislik performs polymer and monomer evaluation.
Separation of Polymer Itself and Monomer
The polymers themselves are exempt from the registration obligation; However, this exemption does not completely exclude the company that produces the polymer. If the monomers and other substance units bound in the polymer exceed certain ratio and tonnage thresholds, it creates a registration obligation. Failure to make this distinction is the most common misconception that causes polymer manufacturers to think they are out of scope.
Threshold Calculation
The calculation is carried out on the weight ratio of the monomer unit in the polymer and the annual polymer production amount. For each monomer above the specified rate, the annual total amount of that monomer is calculated and compared to the registration threshold. If the same monomer is used in more than one polymer, the amounts are added; Skipping this collection process is a common mistake.
Already Registered Monomers
If the monomer is already registered further up the supply chain and the registration covers your use, additional registration may not be required. This must be verified with the registration number and covered uses information obtained from the supplier. For imported monomers, the determining factor is whether the foreign manufacturer can appoint a sole representative.
Additives and Stabilizers
Additives such as stabilizers, plasticizers, flame retardants and pigments used in polymer formulations do not benefit from the polymer exemption. These are considered substances in their own right and give rise to registration obligations based on the tonnage threshold. Keeping the additive inventory separate from the monomer inventory prevents calculation errors.
Steps of the Roadmap
The recommended sequence for polymer manufacturers is: first the full formulation breakdown is produced on a product by product basis, then the proportions of bound monomers are calculated, then the annual quantity for each monomer and additive is totaled, the registration status is verified at the supplier level and a registration schedule is established for items exceeding the threshold. This study needs to be updated as the product portfolio changes.
Additive Inventory for Polymer Manufacturers
Polymer Manufacturers often focus on monomer calculation and overlook additives in the formulation. Stabilizers, plasticizers, flame retardants and pigments do not benefit from the polymer exemption; are considered as substances in themselves. For Polymer Manufacturers, keeping the additive inventory separate from the monomer inventory prevents calculation errors in the first place.
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Official full text of the regulation: KKDIK Regulation - Official Gazette.