{"id":30375,"date":"2025-10-16T14:14:34","date_gmt":"2025-10-16T13:14:34","guid":{"rendered":"https:\/\/www.certifiedcosmetics.com\/product\/nekategorizirano\/dosje-kozmetickog-proizvoda-mocra\/"},"modified":"2025-10-16T14:14:34","modified_gmt":"2025-10-16T13:14:34","slug":"dosje-kozmetickog-proizvoda-mocra","status":"publish","type":"product","link":"https:\/\/www.certifiedcosmetics.com\/hr\/product\/potvrdivanje-kozmeticke-sigurnosti\/dosje-kozmetickog-proizvoda-mocra\/","title":{"rendered":"Dosje kozmeti\u010dkog proizvoda MoCRA"},"content":{"rendered":"

Zakon o modernizaciji regulacije kozmetike (MoCRA)<\/strong> uveo je nove zakonske zahtjeve za proizvo\u0111a\u010de kozmetike i vlasnike robnih marki koji prodaju proizvode u Sjedinjenim Dr\u017eavama.
Svaki kozmeti\u010dki proizvod sada mora biti popra\u0107en jasnom, dobro organiziranom dokumentacijom koja dokazuje da je siguran<\/strong> , pravilno ozna\u010den, proizveden u higijenskim uvjetima i ispunjava zahtjeve FDA<\/strong> .<\/p>\n

Na\u0161a usluga sastavljanja dosjea kozmeti\u010dkog proizvoda za SAD<\/strong> pru\u017ea sve potrebne dokumente, dokaze i strukturu koja vam je potrebna za uskla\u0111enost sa standardima dokumentacije MoCRA-e, sli\u010dnim konceptu Datoteke s informacijama o proizvodu EU (PIF)<\/strong> , ali prilago\u0111ene ameri\u010dkim propisima.<\/p>\n

Izra\u0111ujemo cjelovitu dokumentaciju spremnu za reviziju koja osigurava da je va\u0161 brend u bilo kojem trenutku spreman za FDA inspekciju ili provjeru.<\/p>\n

\u0160to sadr\u017ei ameri\u010dka dokumentacija o proizvodu<\/h2>\n

Svaki dosje je strukturiran tako da pokriva puni opseg o\u010dekivanja FDA-e prema MoCRA-i:<\/p>\n

1. Administrativna i proizvodna identifikacija<\/strong><\/p>\n

    \n
  • \n

    Naziv proizvoda, funkcija i kategorija<\/p>\n<\/li>\n

  • \n

    Podaci o odgovornoj osobi (proizvo\u0111a\u010d, uvoznik ili distributer)<\/p>\n<\/li>\n

  • \n

    Procjena ozna\u010davanja proizvoda, ilustracija i tvrdnji<\/p>\n<\/li>\n

  • \n

    Reference za registraciju objekta<\/p>\n<\/li>\n<\/ul>\n

    2. Sastav proizvoda<\/strong><\/p>\n

      \n
    • \n

      Potpuni popis sastojaka s INCI nazivima i koncentracijama<\/p>\n<\/li>\n

    • \n

      Dokumentacija o izvoru sastojaka i podacima o dobavlja\u010dima<\/p>\n<\/li>\n

    • \n

      Ograni\u010denja i regulatorne kontrole za svaku komponentu<\/p>\n<\/li>\n

    • \n

      Dokumentacija o aromama i mirisima gdje je primjenjivo<\/p>\n<\/li>\n<\/ul>\n

      3. Sigurnosno-tehni\u010dki list<\/strong><\/p>\n

        \n
      • \n

        Toksikolo\u0161ki profil za svaki sastojak<\/p>\n<\/li>\n

      • \n

        Izlo\u017eenost i procjena rizika<\/p>\n<\/li>\n

      • \n

        Izra\u010duni margina sigurnosti (MoS)<\/p>\n<\/li>\n

      • \n

        Kona\u010dno sigurnosno opravdanje<\/p>\n<\/li>\n<\/ul>\n

        4. Informacije o proizvodnji i kvaliteti<\/strong><\/p>\n

          \n
        • \n

          Opis proizvodnog procesa i kontrola<\/p>\n<\/li>\n

        • \n

          Izjava o sukladnosti s GMP-om (uskla\u0111ena s o\u010dekivanjima FDA-e i na\u010delima norme ISO 22716)<\/p>\n<\/li>\n

        • \n

          Mikrobiolo\u0161ke kontrole i sljedivost serije<\/p>\n<\/li>\n

        • \n

          Podaci o ispitivanju kvalitete i kompatibilnosti pakiranja<\/p>\n<\/li>\n<\/ul>\n

          5. Podaci o stabilnosti i roku trajanja<\/strong><\/p>\n

            \n
          • \n

            Sa\u017eeci testova stabilnosti i skladi\u0161tenja<\/p>\n<\/li>\n

          • \n

            Rezultati kompatibilnosti pakiranja<\/p>\n<\/li>\n

          • \n

            Razdoblje nakon otvaranja (PAO) ili obrazlo\u017eenje roka trajanja<\/p>\n<\/li>\n<\/ul>\n

            6. Uskla\u0111enost s ozna\u010davanjem i tvrdnjama<\/strong><\/p>\n

              \n
            • \n

              Provjera ozna\u010davanja proizvoda kako bi se osigurala uskla\u0111enost s propisima FDA o ozna\u010davanju kozmeti\u010dkih proizvoda (21 CFR 701).<\/p>\n<\/li>\n

            • \n

              Provjera deklaracija sastojaka, upozorenja i identiteta proizvoda<\/p>\n<\/li>\n

            • \n

              Pregled marketin\u0161kih tvrdnji kako bi se osiguralo da se ne iznose tvrdnje sli\u010dne lijekovima<\/p>\n<\/li>\n<\/ul>\n

              7. Popratna dokumentacija<\/strong><\/p>\n

                \n
              • \n

                Potvrde o analizi (COA) i sigurnosno-tehni\u010dki listovi (SDS) za klju\u010dne sastojke<\/p>\n<\/li>\n

              • \n

                Dokumentacija o IFRA-i, alergenima ili mirisima, ako je dostupna<\/p>\n<\/li>\n

              • \n

                Izvje\u0161\u0107a o ispitivanju sigurnosti i performansi (nije obavezno)<\/p>\n<\/li>\n

              • \n

                Potvrde o obavijestima FDA-e (registracija objekta i popis proizvoda)<\/p>\n<\/li>\n<\/ul>\n

                Za\u0161to je ovaj dosje va\u017ean<\/h2>\n

                Izrada strukturiranog dosjea poma\u017ee vam:<\/p>\n

                  \n
                • \n

                  Doka\u017eite uskla\u0111enost s propisima MoCRA-e i FDA-e<\/p>\n<\/li>\n

                • \n

                  Odr\u017eavajte transparentnost i sljedivost u cijelom lancu opskrbe<\/p>\n<\/li>\n

                • \n

                  Omogu\u0107ite trenutni pristup dokumentaciji kada FDA zatra\u017ei inspekciju<\/p>\n<\/li>\n

                • \n

                  Za\u0161titite svoj brend od skupih mjera provedbe zakona ili opoziva<\/p>\n<\/li>\n

                • \n

                  Izgradite kredibilitet kod partnera, distributera i trgovaca<\/p>\n<\/li>\n<\/ul>\n

                  Potpuna dokumentacija pokazuje da je va\u0161a tvrtka provela du\u017enu pa\u017enju u podru\u010djima sigurnosti, kvalitete i ozna\u010davanja, \u0161to je bitno za pristup ameri\u010dkom tr\u017ei\u0161tu.<\/p>\n

                  Kome treba ova usluga<\/h2>\n
                    \n
                  • \n

                    Europske ili me\u0111unarodne marke<\/strong> koje izvoze kozmetiku u Sjedinjene Dr\u017eave<\/p>\n<\/li>\n

                  • \n

                    Ameri\u010dki proizvo\u0111a\u010di<\/strong> \u017eele organizirati i standardizirati dokumentaciju o uskla\u0111enosti<\/p>\n<\/li>\n

                  • \n

                    Privatni trgovci robnim markama i distributeri<\/strong> koji upravljaju vi\u0161e linija proizvoda pod jednim odgovornim subjektom<\/p>\n<\/li>\n

                  • \n

                    Regulatorni konzultanti ili uvoznici<\/strong> koji djeluju kao odgovorna osoba prema MoCRA-i<\/p>\n<\/li>\n<\/ul>\n

                    \u0160to primate<\/h2>\n
                      \n
                    • \n

                      Potpuni dosje za kozmeti\u010dki proizvod u SAD-<\/strong> u u elektroni\u010dkom formatu (PDF ili Word)<\/p>\n<\/li>\n

                    • \n

                      Svi dokumenti indeksirani, me\u0111usobno povezani i pohranjeni u logi\u010dkoj strukturi<\/p>\n<\/li>\n

                    • \n

                      Neobavezna pro\u0161irenja za prijevode, a\u017euriranja ili dodatne formulacije<\/p>\n<\/li>\n

                    • \n

                      Dokumentacija spremna za FDA inspekciju i verzija za dugoro\u010dnu arhivu<\/p>\n<\/li>\n<\/ul>\n

                      Na\u0161 proces<\/h2>\n
                        \n
                      1. \n

                        Prikupljanje podataka<\/strong> – Vi dajete formule proizvoda, oznake i podatke o proizvodnji.<\/p>\n<\/li>\n

                      2. \n

                        Pregled uskla\u0111enosti<\/strong> – Provjeravamo potpunost podataka, ozna\u010davanje i uskla\u0111enost s propisima.<\/p>\n<\/li>\n

                      3. \n

                        Sastavljanje dosjea<\/strong> – Na\u0161 tim sastavlja kompletan dosje i strukturira ga prema zahtjevima MoCRA-e.<\/p>\n<\/li>\n

                      4. \n

                        Kontrola kvalitete i isporuka<\/strong> – Primit \u0107ete potpunu datoteku spremnu za predaju, zajedno sa sa\u017eetkom provjere.<\/p>\n<\/li>\n<\/ol>\n

                        Za\u0161to odabrati nas<\/h2>\n
                          \n
                        • \n

                          Stru\u010dnjaci za uskla\u0111enost kozmetike u<\/strong> EU i SAD-u<\/strong><\/p>\n<\/li>\n

                        • \n

                          Dubinsko poznavanje pravila ozna\u010davanja MoCRA-e, FDA-e i toksikolo\u0161ke dokumentacije<\/strong><\/p>\n<\/li>\n

                        • \n

                          Jasna komunikacija i transparentan proces<\/p>\n<\/li>\n

                        • \n

                          Profesionalni dosjei spremni za inspekciju koje pripremaju regulatorni stru\u010dnjaci<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

                          Zakon o modernizaciji regulacije kozmetike (MoCRA) uveo je nove zakonske zahtjeve za proizvo\u0111a\u010de kozmetike i vlasnike robnih marki koji prodaju proizvode u Sjedinjenim Dr\u017eavama. Svaki kozmeti\u010dki proizvod sada mora biti popra\u0107en jasnom, dobro organiziranom dokumentacijom koja dokazuje da je siguran , pravilno ozna\u010den, proizveden u higijenskim uvjetima i ispunjava zahtjeve FDA . Na\u0161a usluga sastavljanja…<\/p>\n","protected":false},"featured_media":30376,"template":"","meta":[],"product_brand":[],"product_cat":[3602],"product_tag":[],"class_list":["post-30375","product","type-product","status-publish","has-post-thumbnail","product_cat-potvrdivanje-kozmeticke-sigurnosti","first","instock","virtual","taxable","purchasable","product-type-simple"],"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"exclude_global_add_ons":[],"addons":[],"yoast_head":"\nDosje kozmeti\u010dkog proizvoda MoCRA - Certified Cosmetics<\/title>\n<meta name=\"description\" content=\"Na\u0161a usluga izrade dosjea za kozmeti\u010dke proizvode u SAD-u pru\u017ea sve potrebne dokumente, dokaze i strukturu potrebnu za ispunjavanje standarda dokumentacije MoCRA-e - 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