{"id":987866,"date":"2026-02-18T23:46:21","date_gmt":"2026-02-18T20:46:21","guid":{"rendered":"https:\/\/www.chemreg.com.tr\/?page_id=987866"},"modified":"2026-02-18T23:46:24","modified_gmt":"2026-02-18T20:46:24","slug":"urun-bilgi-dosyasi-pif-ve-kozmetik-urun-guvenlilik-raporu-kugr-hazirlama","status":"publish","type":"page","link":"https:\/\/www.chemreg.com.tr\/index.php\/urun-bilgi-dosyasi-pif-ve-kozmetik-urun-guvenlilik-raporu-kugr-hazirlama\/","title":{"rendered":"\u00dcr\u00fcn Bilgi Dosyas\u0131 (PIF) ve Kozmetik \u00dcr\u00fcn G\u00fcvenlilik Raporu (K\u00dcGR) Haz\u0131rlama"},"content":{"rendered":"
\n

T\u00fcrkiye’de kozmetik \u00fcr\u00fcn arz\u0131, 5324 Say\u0131l\u0131 Kozmetik Kanunu ve bu kanuna ba\u011fl\u0131 Kozmetik Y\u00f6netmeli\u011fi ile d\u00fczenlenmektedir. T\u00fcrkiye Kozmetik Y\u00f6netmeli\u011fi, AB’nin 1223\/2009 say\u0131l\u0131 t\u00fcz\u00fc\u011f\u00fc ile tam uyumludur.<\/p>\n\n\n\n

Yasal mevzuat gere\u011fi, piyasaya s\u00fcr\u00fclen her bir kozmetik \u00fcr\u00fcn i\u00e7in bir \u00dcr\u00fcn Bilgi Dosyas\u0131 (PIF – Product Information File)<\/strong> haz\u0131rlanmas\u0131 ve bu dosyan\u0131n \u00fcr\u00fcn\u00fcn son serisinin piyasaya arz\u0131ndan itibaren 10 y\u0131l boyunca muhafaza edilmesi zorunludur.<\/p>\n\n\n\n

1. \u00dcr\u00fcn Bilgi Dosyas\u0131 (PIF) Nedir?<\/strong><\/h3>\n\n\n\n

PIF, kozmetik \u00fcr\u00fcn\u00fcn\u00fcz\u00fcn “teknik kimli\u011fi” ve “yasal pasaportudur”. Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 (T\u0130TCK) denetimlerinde yetkililerin ilk talep edece\u011fi, \u00fcr\u00fcn\u00fcn g\u00fcvenli oldu\u011funu ve mevzuata uygun \u00fcretildi\u011fini kan\u0131tlayan, ya\u015fayan bir ar\u015fivdir.<\/p>\n\n\n\n

Sorumlu Ki\u015finin Y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc:<\/strong> T\u00fcrkiye’de yerle\u015fik Sorumlu Ki\u015fi (\u00fcretici veya ithalat\u00e7\u0131), PIF dosyas\u0131n\u0131, \u00fcr\u00fcn\u00fcn ambalaj\u0131 \u00fczerindeki adreste, T\u0130TCK yetkililerinin denetimine her an haz\u0131r bulundurmakla y\u00fck\u00fcml\u00fcd\u00fcr.<\/p>\n\n\n\n

Bir PIF Dosyas\u0131 Neleri \u0130\u00e7ermelidir?<\/strong> <\/p>\n\n\n\n

Y\u00f6netmelik gere\u011fi PIF, standart bir dosyalama sistemi de\u011fil, teknik ispatlar b\u00fct\u00fcn\u00fcd\u00fcr ve \u015funlar\u0131 i\u00e7ermelidir:<\/p>\n\n\n\n

    \n
  • \u00dcr\u00fcn Tan\u0131mlamas\u0131:<\/strong> \u00dcr\u00fcn\u00fcn tam form\u00fcl\u00fc, ticari ad\u0131 ve kodlar\u0131.<\/li>\n\n\n\n
  • Kozmetik \u00dcr\u00fcn G\u00fcvenlilik Raporu (K\u00dcGR):<\/strong> Dosyan\u0131n en kritik ve bilimsel b\u00f6l\u00fcm\u00fc (A\u015fa\u011f\u0131da detayland\u0131r\u0131lm\u0131\u015ft\u0131r).<\/li>\n\n\n\n
  • GMP (\u0130yi \u00dcretim Uygulamalar\u0131):<\/strong> \u00dcr\u00fcn\u00fcn ISO 22716 standartlar\u0131na uygun \u00fcretildi\u011fine dair belge ve beyanlar.<\/li>\n\n\n\n
  • \u0130ddia Kan\u0131tlar\u0131 (Claims):<\/strong> \u00dcr\u00fcn etiketinde yer alan iddialar\u0131n (\u00f6rn. nemlendirici, ya\u015flanma kar\u015f\u0131t\u0131) bilimsel kan\u0131tlar\u0131.<\/li>\n\n\n\n
  • Hayvan Deneyleri Yasa\u011f\u0131:<\/strong> \u00dcr\u00fcn\u00fcn ve bile\u015fenlerinin hayvanlar \u00fczerinde test edilmedi\u011fine dair beyanlar.<\/li>\n<\/ul>\n\n\n\n
    \n\n\n\n

    2. Dosyan\u0131n Kalbi: Kozmetik \u00dcr\u00fcn G\u00fcvenlilik Raporu (K\u00dcGR)<\/strong><\/h3>\n\n\n\n

    Y\u00f6netmeli\u011fin Ek I’ine uygun olarak haz\u0131rlanan bu rapor, PIF’in en \u00f6nemli k\u0131sm\u0131d\u0131r. T\u00fcrkiye’de bir kozmetik \u00fcr\u00fcn\u00fcn piyasaya s\u00fcr\u00fclebilmesi i\u00e7in, insan sa\u011fl\u0131\u011f\u0131 a\u00e7\u0131s\u0131ndan g\u00fcvenli oldu\u011funun bilimsel olarak kan\u0131tlanmas\u0131<\/strong> gerekir.<\/p>\n\n\n\n

    Kimler Haz\u0131rlayabilir? (Uzmanl\u0131k \u015eart\u0131)<\/strong> Bu rapor, s\u0131radan bir evrak de\u011fildir. T\u00fcrkiye’deki mevzuata g\u00f6re sadece eczac\u0131l\u0131k, toksikoloji, t\u0131p veya ilgili bilim dallar\u0131nda diplomaya sahip, yetkilendirilmi\u015f bir Kozmetik \u00dcr\u00fcn G\u00fcvenlik De\u011ferlendiricisi<\/strong> taraf\u0131ndan haz\u0131rlanabilir ve imzalanabilir.<\/p>\n\n\n\n

    Rapor iki ana b\u00f6l\u00fcmden olu\u015fur:<\/p>\n\n\n\n

    B\u00f6l\u00fcm A: Kozmetik \u00dcr\u00fcn G\u00fcvenlilik Bilgileri (Veri Toplama)<\/strong><\/h4>\n\n\n\n

    Bu b\u00f6l\u00fcmde \u00fcr\u00fcn\u00fcn teknik r\u00f6ntgeni \u00e7ekilir:<\/p>\n\n\n\n

      \n
    • \u00dcr\u00fcn\u00fcn kalitatif ve kantitatif form\u00fcl\u00fc (INCI adlar\u0131 ve y\u00fczdeleri).<\/li>\n\n\n\n
    • Fiziksel\/kimyasal \u00f6zellikler ve stabilite test sonu\u00e7lar\u0131 (Raf \u00f6mr\u00fc tayini).<\/li>\n\n\n\n
    • Mikrobiyolojik kalite ve koruyucu etkinlik (Challenge) test sonu\u00e7lar\u0131.<\/li>\n\n\n\n
    • Safs\u0131zl\u0131klar, kal\u0131nt\u0131lar ve ambalaj materyali ile etkile\u015fim bilgileri.<\/li>\n\n\n\n
    • Normal ve \u00f6ng\u00f6r\u00fclebilir kullan\u0131m ko\u015fullar\u0131.<\/li>\n\n\n\n
    • \u00dcr\u00fcne ve bile\u015fenlerine maruz kalma (Exposure) hesaplamalar\u0131.<\/li>\n\n\n\n
    • Bile\u015fenlerin toksikolojik profilleri (Karsinojenik, Mutajenik, Reprotoksik – CMR risk analizleri).<\/li>\n\n\n\n
    • Varsa, istenmeyen etkilere (SUE) ili\u015fkin veriler.<\/li>\n<\/ul>\n\n\n\n

      B\u00f6l\u00fcm B: Kozmetik \u00dcr\u00fcn G\u00fcvenlilik De\u011ferlendirmesi (Uzman G\u00f6r\u00fc\u015f\u00fc)<\/strong><\/h4>\n\n\n\n

      Bu b\u00f6l\u00fcm, toplanan verilerin uzman taraf\u0131ndan analiz edildi\u011fi sonu\u00e7 k\u0131sm\u0131d\u0131r:<\/p>\n\n\n\n

        \n
      • De\u011ferlendiricinin, verileri baz alarak yapt\u0131\u011f\u0131 bilimsel yorum.<\/li>\n\n\n\n
      • \u00dcr\u00fcn etiketinde yer almas\u0131 gereken \u00f6zel uyar\u0131lar ve kullan\u0131m talimatlar\u0131.<\/li>\n\n\n\n
      • Nihai Sonu\u00e7:<\/strong> Uzman\u0131n, “Bu \u00fcr\u00fcn normal kullan\u0131m ko\u015fullar\u0131nda insan sa\u011fl\u0131\u011f\u0131 i\u00e7in g\u00fcvenlidir” onay\u0131n\u0131 i\u00e7eren \u0131slak imzas\u0131 ve diploma bilgileri.<\/li>\n<\/ul>\n\n\n\n

        Bizimle \u00c7al\u0131\u015fman\u0131n Fark\u0131:<\/strong> Biz sadece evrak toplam\u0131yoruz. Uzman ekibimiz (KDU ve G\u00fcvenlik De\u011ferlendiricileri) ile \u00fcr\u00fcn\u00fcn\u00fcz\u00fcn toksikolojik risk analizlerini yap\u0131yor, T\u0130TCK denetimlerine haz\u0131r, eksiksiz bir teknik dosya sunuyoruz.<\/p>\n\n\n\n

        \"\"<\/figure>\n<\/div>","protected":false},"excerpt":{"rendered":"

        T\u00fcrkiye’de kozmetik \u00fcr\u00fcn arz\u0131, 5324 Say\u0131l\u0131 Kozmetik Kanunu ve bu kanuna ba\u011fl\u0131 Kozmetik Y\u00f6netmeli\u011fi ile d\u00fczenlenmektedir. T\u00fcrkiye Kozmetik Y\u00f6netmeli\u011fi, AB’nin 1223\/2009 say\u0131l\u0131 t\u00fcz\u00fc\u011f\u00fc ile tam uyumludur. Yasal mevzuat gere\u011fi, piyasaya…<\/p>\n","protected":false},"author":1,"featured_media":987867,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":""},"class_list":["post-987866","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\n\u00dcr\u00fcn Bilgi Dosyas\u0131 (PIF) ve Kozmetik \u00dcr\u00fcn G\u00fcvenlilik Raporu (K\u00dcGR) Haz\u0131rlama - CHEMREG<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.chemreg.com.tr\/index.php\/urun-bilgi-dosyasi-pif-ve-kozmetik-urun-guvenlilik-raporu-kugr-hazirlama\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00dcr\u00fcn Bilgi Dosyas\u0131 (PIF) ve Kozmetik \u00dcr\u00fcn G\u00fcvenlilik Raporu (K\u00dcGR) Haz\u0131rlama - CHEMREG\" \/>\n<meta property=\"og:description\" content=\"T\u00fcrkiye’de kozmetik \u00fcr\u00fcn arz\u0131, 5324 Say\u0131l\u0131 Kozmetik Kanunu ve bu kanuna ba\u011fl\u0131 Kozmetik Y\u00f6netmeli\u011fi ile d\u00fczenlenmektedir. 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