Page 45 - Demo

raf%u0131na kadar t%u00fcm kullan%u0131m a%u015famalar%u0131nda insan sa%u011fl%u0131%u011f%u0131 ve %u00e7evrenin y%u00fcksek d%u00fczeyde korunmas%u0131n%u0131 sa%u011flamak i%u00e7in kimyasallar%u0131n kayd%u0131, de%u011ferlendirilmesi, izni ve k%u0131s%u0131tlamas%u0131na ili%u015fkin idari ve teknik usul ve esaslar%u0131 d%u00fczenler. Ayr%u0131ca maddelerin i%u00e7sel %u00f6zelliklerinin (fiziko-kimyasal, toksikolojik ve eko-toksikolojik) %u00fcretilmesine y%u00f6nelik alternatif y%u00f6ntemleri, yani hayvanlar%u0131n kullan%u0131lmad%u0131%u011f%u0131 y%u00f6ntemleri, te%u015fvik etmeyi ama%u00e7lar.Bu y%u00f6netmelik insan sa%u011fl%u0131%u011f%u0131 ve %u00e7evreyi imal edilen, piyasaya arz edilen veya kullan%u0131lan kimyasallar%u0131n olumsuz etkilerinden koruma sorumlulu%u011funu imalat%u00e7%u0131lara, ithalat%u00e7%u0131lara ve alt kullan%u0131c%u0131lara y%u00fcklemektedir. Dolay%u0131s%u0131yla kay%u0131t y%u00fck%u00fcml%u00fcl%u00fc%u011f%u00fc de imalat%u00e7%u0131lara ve ithalat%u00e7%u0131lara aittir. Bu kapsamda imal veya ithal ettikleri maddelere ili%u015fkin veri %u00fcretmeleri; bu verileri risk de%u011ferlendirmesi i%u00e7in kullanmalar%u0131 ve uygun risk y%u00f6netim %u00f6nlemleri geli%u015ftirip bunlar%u0131 tavsiye etmeleri gerekmektedir. S%u00f6z konusu y%u00fck%u00fcml%u00fcl%u00fckleri fiilen yerine getirdiklerinden emin olunmas%u0131 ve %u015feffafl%u0131%u011f%u0131n sa%u011flanmas%u0131 i%u00e7in kay%u0131t dosyas%u0131 haz%u0131rlanmal%u0131 ve Kimyasal Kay%u0131t Sistemi (KKS) arac%u0131l%u0131%u011f%u0131yla Bakanl%u0131%u011fa sunulmal%u0131d%u0131r.Maddenin birden %u00e7ok firma taraf%u0131ndan imal veya ithal edildi%u011fi ya da imal veya ithal edilmesinin planland%u0131%u011f%u0131 durumlarda, baz%u0131 bilgilerin birlikte sunulmas%u0131 Y%u00f6netmelik taraf%u0131ndan te%u015fvik edilmektedir. Verilerin bu %u015fekilde ortak sunumu b%u00fct%u00fcn maddeler i%u00e7in ge%u00e7erlidir. Bu kapsamda kay%u0131t ettirenlerin, maddenin i%u00e7sel %u00f6zellikleri ve s%u0131n%u0131fland%u0131rma ve etiketlendirme bilgileri ile, e%u011fer anla%u015fmaya var%u0131rlarsa, Kimyasal G%u00fcvenlik Raporunu (KGR) ve g%u00fcvenli kullan%u0131m rehberini de birlikte sunmalar%u0131 gerekmektedir. Bu yakla%u015f%u0131m%u0131n amac%u0131 i%u015f birli%u011fini te%u015fvik ederek, kay%u0131t ettirenlerin dosyan%u0131n haz%u0131rlan%u0131%u015f%u0131nda i%u015f g%u00fcc%u00fcnden tasarruf etmelerini, %u00f6zellikle omurgal%u0131 hayvanlara ili%u015fkin test yapma ihtiya%u00e7lar%u0131n%u0131n ve maliyetin azalt%u0131lmas%u0131n%u0131 sa%u011flamakt%u0131r. KKD%u0130K Kapsam%u0131nda Kay%u0131t, De%u011ferlendirme, Kimyasal G%u00fcvenlik Raporu ve Bakanl%u0131k S%u00fcre%u00e7leriKimyasallar%u0131n riski maddenin miktar%u0131 ile do%u011fru orant%u0131l%u0131 olarak artt%u0131%u011f%u0131ndan, KKD%u0130K Y%u00f6netmeli%u011fi, y%u0131ll%u0131k 10 ton ve %u00fczeri miktarda imal edilen ya da ithal edilen maddeler i%u00e7in Kimyasal G%u00fcvenlik Raporu haz%u0131rlanmas%u0131 ve ilgili kay%u0131t dosyas%u0131n%u0131n bir par%u00e7as%u0131 olarak sunulmas%u0131 zorunlulu%u011funu getirmi%u015ftir. Bu s%u00fcre%u00e7te yap%u0131lan Kimyasal G%u00fcvenlik De%u011ferlendirmesinin (KGD) amac%u0131 bir maddenin; imalat%u0131, form%u00fclasyonu ve son kullan%u0131m%u0131ndaki t%u00fcm kullan%u0131m ve kullan%u0131m ko%u015fullar%u0131nda g%u00fcvenli kullan%u0131m%u0131n%u0131 temin etmektir.dures and principles for the registration, evaluation, authorisation and restriction of chemicals, with the aim of ensuring a high level of protection for human health and the environment throughout all stages of a substance%u2019s lifecycle%u2014from manufacture to disposal. It also aims to promote alternative methods for generating information on the intrinsic properties of substances (physicochemical, toxicological and ecotoxicological), namely methods that do not involve the use of animals.This Regulation places on manufacturers, importers and downstream users the responsibility of protecting human health and the environment from the adverse effects of chemicals that are manufactured, placed on the market or used. Accordingly, the obligation to register also lies with manufacturers and importers. They must generate the necessary data for the substances they manufacture or import; use this data for risk assessment; and develop and recommend appropriate risk management measures. To ensure that these obligations are effectively fulfilled and to provide transparency, a registration dossier must be prepared and submitted to the Ministry via the Chemical Registration System (KKS).Where a substance is manufactured or imported by more than one company or is planned to be manufactured or imported by more than one company, the Regulation encourages certain information to be submitted jointly. Joint submission applies to all substances. In this context, registrants must jointly submit information on the intrinsic properties of the substance and on classification and labelling, and%u2014if they agree%u2014also jointly submit the Chemical Safety Report (CSR) and the guidance on safe use. The aim of this approach is to encourage cooperation, enabling registrants to reduce workload in dossier preparation, particularly reducing the need for and cost of testing related to vertebrate animals.Registration, Evaluation, Chemical Safety Report and Ministry Procedures Under KKDIKSince the risk of chemicals increases proportionally with the quantity placed on the market, the KKDIK Regulation requires a Chemical Safety Report (CSR) to be prepared for all substances manufactured or imported at ten tonnes per year or more, and to be submitted as part of the registration dossier. The purpose of the Chemical Safety Assessment (CSA) conducted in this process is to ensure the safe use of a substance across all uses and conditions of use throughout its lifecycle, including manufacture, formulation and end use.43Uzman G%u00f6r%u00fc%u015f%u00fc / Expert OpinionTURKCOAT Aral%u0131k / December - Ocak / January 2026