Page 46 - Demo

Y%u00f6netmelik kimyasal g%u00fcvenlik de%u011ferlendirmesinin a%u015fa%u011f%u0131da belirtilen t%u00fcm a%u015famalar%u0131n%u0131 d%u00fczenler.%u2022 Zararl%u0131l%u0131k De%u011ferlendirmesiMadde, zararl%u0131l%u0131k de%u011ferlendirmesi sonucunda Maddelerin S%u0131n%u0131fland%u0131r%u0131lmas%u0131, Etiketlenmesi ve Ambalajlanmas%u0131 (SEA) Hakk%u0131nda Y%u00f6netmelik kapsam%u0131nda zararl%u0131 olarak s%u0131n%u0131fland%u0131r%u0131l%u0131r ise ve/veya KKD%u0130K Y%u00f6netmeli%u011finin Ek-13 kriterlerine g%u00f6re PBT/vPvB %u00f6zelli%u011fi g%u00f6sterirse KGD a%u015famalar%u0131na devam edilir. %u0130nsan sa%u011fl%u0131%u011f%u0131 zararl%u0131l%u0131k de%u011ferlendirmesinde %u00e7al%u0131%u015fanlar ve t%u00fcketicilerin maddeye maruz kalabilece%u011fi en y%u00fcksek seviye olan T%u00fcretilmi%u015f Etki G%u00f6zlemlenmeyen Seviye (DNEL) veya T%u00fcretilmi%u015f Minimum Etki Seviyesi (DMEL) belirlenir. DNEL%u2019in alt%u0131nda maruz kal%u0131nmas%u0131 durumunda insanlarda risk olu%u015fmaz. %u00c7evresel zararl%u0131l%u0131k de%u011ferlendirmesinde ise %u00e7evresel ortamlarda ya%u015fayan canl%u0131lar%u0131n maruz kalabilece%u011fi tolere edilebilir seviye olan %u00d6ng%u00f6r%u00fclen Etki G%u00f6zlemlenmeyen Konsantrasyon (PNEC) belirlenir.%u2022 Maruz Kalma De%u011ferlendirmesiMaruz kalma de%u011ferlendirmesi ile, insanlar%u0131n ve %u00e7evrenin maddeye maruz kald%u0131%u011f%u0131 veya kalabilece%u011fi doz ve konsantrasyonlar nicel ya da nitel olarak belirlenir. Maruz kalma senaryosu, bir maddenin ya%u015fam d%u00f6ng%u00fcs%u00fc boyunca nas%u0131l kullan%u0131ld%u0131%u011f%u0131n%u0131; imalat%u00e7%u0131n%u0131n, ithalat%u00e7%u0131n%u0131n veya alt kullan%u0131c%u0131n%u0131n, insanlar%u0131n veya %u00e7evrenin maruz kalmas%u0131n%u0131 nas%u0131l kontrol etti%u011fini veya nas%u0131l kontrol edilmesini tavsiye etti%u011fini a%u00e7%u0131klar. Do%u011fru %u015fekilde uyguland%u0131%u011f%u0131nda, maddenin kullan%u0131m%u0131ndan ileri gelen risklerin yeterli %u00f6l%u00e7%u00fcde kontrol alt%u0131nda tutuldu%u011funu sa%u011flayan %u00e7al%u0131%u015fma %u015fartlar%u0131 ile uygun risk y%u00f6netim %u00f6nlemlerini de i%u00e7erir. %u2022 Risk KarakterizasyonuRisk karakterizasyonu, maddenin ya%u015fam d%u00f6ng%u00fcs%u00fc boyunca t%u00fcm kullan%u0131m ve kullan%u0131m ko%u015fullar%u0131nda risklerin yeterli %u00f6l%u00e7%u00fcde kontrol alt%u0131nda tutulup tutulmad%u0131%u011f%u0131n%u0131n kontrol edildi%u011fi kimyasal g%u00fcvenlik de%u011ferlendirmesinin son a%u015famas%u0131d%u0131r. Kay%u0131t ettiren ki%u015fi, DNEL ve PNEC ile s%u0131ras%u0131yla insan ve %u00e7evreye y%u00f6nelik hesaplanm%u0131%u015f maruz kalma konsantrasyonlar%u0131n%u0131 kar%u015f%u0131la%u015ft%u0131r%u0131r. Tan%u0131ml%u0131 bir toksikolojik veya eko-toksikolojik zarar i%u00e7in s%u00f6z konusu de%u011ferlerin mevcut olmad%u0131%u011f%u0131 durumlarda nitel veya yar%u0131-nicel risk de%u011ferlendirmesi yap%u0131l%u0131r. Risk karakterizasyonu hem insan hem %u00e7evreye y%u00f6nelik maruz kalma senaryolar%u0131n%u0131n her biri i%u00e7in ger%u00e7ekle%u015ftirilir. Sonu%u00e7lar ve a%u00e7%u0131klamalar ise KGR%u2019de rapor edilir. Kay%u0131t ettiren t%u00fcm kullan%u0131mlarda risklerin yeterli %u015fekilde kontrol alt%u0131nda tutuldu%u011funu kan%u0131tlamal%u0131d%u0131r. Riskin kontrol alt%u0131na al%u0131namad%u0131%u011f%u0131 kullan%u0131mlar KGR%u2019de %u201cTasviye Edilmeyen Kullan%u0131mlar%u201d olarak belirtilir.The Regulation defines all stages of chemical safety assessment as follows:%u2022 Hazard AssessmentIf a substance is classified as hazardous under the Regulation on Classification, Labelling and Packaging of Substances and Mixtures (SEA) and/or identified as PBT or vPvB according to Annex 13 criteria of KKDIK, the CSA proceeds. In human health hazard assessments, the Derived No-Effect Level (DNEL) or Derived Minimum Effect Level (DMEL) is determined, which is the highest level at which workers and consumers may be exposed to the substance. When exposure remains below the DNEL, there is no risk to humans. For environmental hazard assessment, the Predicted No-Effect Concentration (PNEC) is determined as the tolerable exposure concentration for organisms in environmental compartments.%u2022 Exposure AssessmentExposure assessment quantitatively or qualitatively identifies the dose and concentrations to which humans and the environment are or may be exposed. An exposure scenario describes how a substance is used throughout its lifecycle and how exposure is controlled or recommended to be controlled by the manufacturer, importer or downstream user. When implemented properly, it includes operational conditions and risk management measures that ensure the risks arising from the substance%u2019s use are adequately controlled.%u2022 Risk CharacterisationRisk characterisation is the final stage of the chemical safety assessment, where it is assessed whether risks are adequately controlled across all uses and conditions of use throughout the substance%u2019s lifecycle. The registrant compares the calculated exposure levels with the DNEL and PNEC for human health and the environment, respectively. In cases where the relevant values are not available for a defined toxicological or ecotoxicological hazard, a qualitative or semi-quantitative risk assessment is performed. Risk characterisation is performed for each exposure scenario affecting both humans and the environment. Results and explanations are documented in the CSR. The registrant must demonstrate that risks are adequately controlled for all uses. Any uses for which risks cannot be controlled are listed as %u201cUses Advised Against%u201d in the CSR.To ensure correct implementation of the registration process, proper chemical safety assessment, and strengthened technical capacity, the Regulation intro44Uzman G%u00f6r%u00fc%u015f%u00fc / Expert OpinionTURKCOAT Aral%u0131k / December - Ocak / January 2026