{"id":30377,"date":"2025-10-16T14:14:34","date_gmt":"2025-10-16T13:14:34","guid":{"rendered":"https:\/\/www.certifiedcosmetics.com\/product\/nezarazene\/dokumentace-k-kosmetickym-pripravkum-podle-zakona-mocra\/"},"modified":"2025-10-16T14:14:34","modified_gmt":"2025-10-16T13:14:34","slug":"dokumentace-k-kosmetickym-pripravkum-podle-zakona-mocra","status":"publish","type":"product","link":"https:\/\/www.certifiedcosmetics.com\/cs\/product\/oduvodneni-bezpecnosti-kosmetickych-pripravku\/dokumentace-k-kosmetickym-pripravkum-podle-zakona-mocra\/","title":{"rendered":"Dokumentace k kosmetick\u00fdm p\u0159\u00edpravk\u016fm podle z\u00e1kona MoCRA"},"content":{"rendered":"

Z\u00e1kon o modernizaci regulace kosmetick\u00fdch p\u0159\u00edpravk\u016f (MoCRA)<\/strong> zavedl nov\u00e9 pr\u00e1vn\u00ed po\u017eadavky pro v\u00fdrobce kosmetiky a majitele zna\u010dek, kte\u0159\u00ed prod\u00e1vaj\u00ed sv\u00e9 v\u00fdrobky ve Spojen\u00fdch st\u00e1tech.
Ka\u017ed\u00fd kosmetick\u00fd p\u0159\u00edpravek mus\u00ed b\u00fdt nyn\u00ed doprov\u00e1zen jasnou a p\u0159ehlednou dokumentac\u00ed, kter\u00e1 prokazuje ,<\/strong> \u017ee je bezpe\u010dn\u00fd<\/strong> , je spr\u00e1vn\u011b ozna\u010den, byl vyroben v hygienick\u00fdch podm\u00ednk\u00e1ch a spl\u0148uje po\u017eadavky FDA<\/strong>.<\/p>\n

Na\u0161e slu\u017eba zam\u011b\u0159en\u00e1 na sestaven\u00ed dokumentace kosmetick\u00e9ho p\u0159\u00edpravku pro trh v USA<\/strong> zahrnuje v\u0161echny pot\u0159ebn\u00e9 dokumenty, podklady a strukturu, kter\u00e9 pot\u0159ebujete k dodr\u017een\u00ed dokumenta\u010dn\u00edch standard\u016f MoCRA \u2013 podobn\u011b jako v p\u0159\u00edpad\u011b souboru informac\u00ed o v\u00fdrobku (PIF) v EU<\/strong>, av\u0161ak p\u0159izp\u016fsoben\u00e9ho p\u0159edpis\u016fm USA.<\/p>\n

Vytv\u00e1\u0159\u00edme kompletn\u00ed dokumentaci p\u0159ipravenou k auditu, kter\u00e1 zajist\u00ed, \u017ee va\u0161e zna\u010dka bude kdykoli p\u0159ipravena na inspekci nebo ov\u011b\u0159en\u00ed ze strany FDA.<\/p>\n

Co obsahuje produktov\u00e1 dokumentace v USA<\/h2>\n

Ka\u017ed\u00e1 dokumentace je sestavena tak, aby pokr\u00fdvala cel\u00fd rozsah po\u017eadavk\u016f FDA v r\u00e1mci MoCRA:<\/p>\n

1. Administrativn\u00ed \u00fadaje a identifikace v\u00fdrobku<\/strong><\/p>\n

    \n
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    N\u00e1zev produktu, funkce a kategorie<\/p>\n<\/li>\n

  • \n

    \u00dadaje o odpov\u011bdn\u00e9 osob\u011b (v\u00fdrobce, dovozce nebo distributor)<\/p>\n<\/li>\n

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    Posouzen\u00ed ozna\u010den\u00ed v\u00fdrobk\u016f, ilustrac\u00ed a tvrzen\u00ed<\/p>\n<\/li>\n

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    Referen\u010dn\u00ed \u00fadaje o registraci za\u0159\u00edzen\u00ed<\/p>\n<\/li>\n<\/ul>\n

    2. Slo\u017een\u00ed v\u00fdrobku<\/strong><\/p>\n

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    • \n

      \u00dapln\u00fd seznam slo\u017eek s n\u00e1zvy podle INCI a koncentracemi<\/p>\n<\/li>\n

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      Dokumentace t\u00fdkaj\u00edc\u00ed se p\u016fvodu surovin a \u00fadaj\u016f o dodavatel\u00edch<\/p>\n<\/li>\n

    • \n

      Omezen\u00ed a regula\u010dn\u00ed opat\u0159en\u00ed pro jednotliv\u00e9 slo\u017eky<\/p>\n<\/li>\n

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      Dokumentace t\u00fdkaj\u00edc\u00ed se aromatick\u00fdch l\u00e1tek a vonn\u00fdch l\u00e1tek, je-li to relevantn\u00ed<\/p>\n<\/li>\n<\/ul>\n

      3. Bezpe\u010dnostn\u00ed list<\/strong><\/p>\n

        \n
      • \n

        Toxikologick\u00fd profil jednotliv\u00fdch slo\u017eek<\/p>\n<\/li>\n

      • \n

        Expozice a posouzen\u00ed rizik<\/p>\n<\/li>\n

      • \n

        V\u00fdpo\u010dty bezpe\u010dnostn\u00edch rezerv (MoS)<\/p>\n<\/li>\n

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        Z\u00e1v\u011bre\u010dn\u00e9 od\u016fvodn\u011bn\u00ed bezpe\u010dnosti<\/p>\n<\/li>\n<\/ul>\n

        4. Informace o v\u00fdrob\u011b a kvalit\u011b<\/strong><\/p>\n

          \n
        • \n

          Popis v\u00fdrobn\u00edho procesu a kontroln\u00edch opat\u0159en\u00ed<\/p>\n<\/li>\n

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          Prohl\u00e1\u0161en\u00ed o dodr\u017eov\u00e1n\u00ed z\u00e1sad GMP (v souladu s po\u017eadavky FDA a z\u00e1sadami normy ISO 22716)<\/p>\n<\/li>\n

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          Mikrobiologick\u00e9 kontroly a sledovatelnost \u0161ar\u017e\u00ed<\/p>\n<\/li>\n

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          \u00dadaje o testov\u00e1n\u00ed kvality a kompatibilit\u011b obal\u016f<\/p>\n<\/li>\n<\/ul>\n

          5. \u00dadaje o stabilit\u011b a dob\u011b pou\u017eitelnosti<\/strong><\/p>\n

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          • \n

            Souhrny zkou\u0161ek stability a skladovatelnosti<\/p>\n<\/li>\n

          • \n

            V\u00fdsledky test\u016f kompatibility obal\u016f<\/p>\n<\/li>\n

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            Doba po otev\u0159en\u00ed (PAO) nebo od\u016fvodn\u011bn\u00ed doby trvanlivosti<\/p>\n<\/li>\n<\/ul>\n

            6. Dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f t\u00fdkaj\u00edc\u00edch se ozna\u010dov\u00e1n\u00ed a uv\u00e1d\u011bn\u00fdch tvrzen\u00ed<\/strong><\/p>\n

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              Ov\u011b\u0159en\u00ed ozna\u010den\u00ed v\u00fdrobku za \u00fa\u010delem zaji\u0161t\u011bn\u00ed souladu s p\u0159edpisy FDA o ozna\u010dov\u00e1n\u00ed kosmetick\u00fdch p\u0159\u00edpravk\u016f (21 CFR 701).<\/p>\n<\/li>\n

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              Ov\u011b\u0159en\u00ed \u00fadaj\u016f o slo\u017een\u00ed, varov\u00e1n\u00ed a toto\u017enosti v\u00fdrobku<\/p>\n<\/li>\n

            • \n

              P\u0159ezkoum\u00e1n\u00ed marketingov\u00fdch tvrzen\u00ed s c\u00edlem zajistit, aby nebyla uv\u00e1d\u011bna \u017e\u00e1dn\u00e1 tvrzen\u00ed p\u0159ipom\u00ednaj\u00edc\u00ed tvrzen\u00ed o l\u00e9\u010divech<\/p>\n<\/li>\n<\/ul>\n

              7. Podp\u016frn\u00e1 dokumentace<\/strong><\/p>\n

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                Analytick\u00e9 certifik\u00e1ty (COA) a bezpe\u010dnostn\u00ed listy (SDS) pro kl\u00ed\u010dov\u00e9 slo\u017eky<\/p>\n<\/li>\n

              • \n

                Dokumentace IFRA, o alergenech nebo o vonn\u00fdch l\u00e1tk\u00e1ch, je-li k dispozici<\/p>\n<\/li>\n

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                Zpr\u00e1vy o zkou\u0161k\u00e1ch bezpe\u010dnosti a v\u00fdkonu (voliteln\u00e9)<\/p>\n<\/li>\n

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                Potvrzen\u00ed o ozn\u00e1men\u00ed FDA (registrace za\u0159\u00edzen\u00ed a za\u0159azen\u00ed v\u00fdrobku do seznamu)<\/p>\n<\/li>\n<\/ul>\n

                Pro\u010d je tato zpr\u00e1va d\u016fle\u017eit\u00e1<\/h2>\n

                Vytvo\u0159en\u00ed strukturovan\u00e9 dokumentace v\u00e1m pom\u016f\u017ee:<\/p>\n

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                  Prok\u00e1zat soulad s p\u0159edpisy MoCRA a FDA<\/p>\n<\/li>\n

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                  Zajist\u011bte transparentnost a sledovatelnost v cel\u00e9m sv\u00e9m dodavatelsk\u00e9m \u0159et\u011bzci<\/p>\n<\/li>\n

                • \n

                  Zajistit okam\u017eit\u00fd p\u0159\u00edstup k dokumentaci v p\u0159\u00edpad\u011b, \u017ee FDA po\u017e\u00e1d\u00e1 o inspekci<\/p>\n<\/li>\n

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                  Chra\u0148te svou zna\u010dku p\u0159ed n\u00e1kladn\u00fdmi donucovac\u00edmi opat\u0159en\u00edmi nebo sta\u017een\u00edm v\u00fdrobk\u016f z trhu<\/p>\n<\/li>\n

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                  Budujte si d\u016fv\u011bryhodnost u partner\u016f, distributor\u016f a maloobchodn\u00edk\u016f<\/p>\n<\/li>\n<\/ul>\n

                  Kompletn\u00ed dokumentace prokazuje, \u017ee va\u0161e spole\u010dnost postupovala s n\u00e1le\u017eitou p\u00e9\u010d\u00ed v oblastech bezpe\u010dnosti, kvality a ozna\u010dov\u00e1n\u00ed, co\u017e je nezbytn\u00e9 pro vstup na americk\u00fd trh.<\/p>\n

                  Kdo tuto slu\u017ebu pot\u0159ebuje<\/h2>\n
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                    Evropsk\u00e9 nebo mezin\u00e1rodn\u00ed zna\u010dky<\/strong>, kter\u00e9 vyv\u00e1\u017eej\u00ed kosmetiku do Spojen\u00fdch st\u00e1t\u016f<\/p>\n<\/li>\n

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                    Ameri\u010dt\u00ed v\u00fdrobci<\/strong> cht\u011bj\u00ed uspo\u0159\u00e1dat a sjednotit dokumentaci t\u00fdkaj\u00edc\u00ed se dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f<\/p>\n<\/li>\n

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                    Spole\u010dnosti provozuj\u00edc\u00ed vlastn\u00ed zna\u010dky a distributo\u0159i<\/strong>, kte\u0159\u00ed spravuj\u00ed v\u00edce produktov\u00fdch \u0159ad v r\u00e1mci jedin\u00e9ho subjektu nesouc\u00edho odpov\u011bdnost<\/p>\n<\/li>\n

                  • \n

                    Poradci v oblasti regulace nebo dovozci<\/strong>, kte\u0159\u00ed vystupuj\u00ed jako odpov\u011bdn\u00e1 osoba podle z\u00e1kona MoCRA<\/p>\n<\/li>\n<\/ul>\n

                    Co obdr\u017e\u00edte<\/h2>\n
                      \n
                    • \n

                      Kompletn\u00ed dokumentace k kosmetick\u00e9mu p\u0159\u00edpravku pro USA<\/strong> v elektronick\u00e9 podob\u011b (PDF nebo Word)<\/p>\n<\/li>\n

                    • \n

                      V\u0161echny dokumenty jsou indexov\u00e1ny, opat\u0159eny k\u0159\u00ed\u017eov\u00fdmi odkazy a ulo\u017eeny v logick\u00e9 struktu\u0159e<\/p>\n<\/li>\n

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                      Voliteln\u00e1 roz\u0161\u00ed\u0159en\u00ed pro p\u0159eklady, aktualizace nebo dal\u0161\u00ed formulace<\/p>\n<\/li>\n

                    • \n

                      Dokumentace p\u0159ipraven\u00e1 pro inspekci FDA a verze pro dlouhodob\u00fd archiv<\/p>\n<\/li>\n<\/ul>\n

                      N\u00e1\u0161 postup<\/h2>\n
                        \n
                      1. \n

                        Sb\u011br dat<\/strong> \u2013 Poskytnete n\u00e1m slo\u017een\u00ed v\u00fdrobk\u016f, etikety a v\u00fdrobn\u00ed \u00fadaje.<\/p>\n<\/li>\n

                      2. \n

                        Kontrola souladu s p\u0159edpisy<\/strong> \u2013 Ov\u011b\u0159ujeme \u00faplnost \u00fadaj\u016f, ozna\u010den\u00ed a soulad s p\u0159edpisy.<\/p>\n<\/li>\n

                      3. \n

                        Sestaven\u00ed dokumentace<\/strong> \u2013 N\u00e1\u0161 t\u00fdm sestav\u00ed kompletn\u00ed dokumentaci a uspo\u0159\u00e1d\u00e1 ji v souladu s po\u017eadavky MoCRA.<\/p>\n<\/li>\n

                      4. \n

                        Kontrola kvality a dod\u00e1n\u00ed<\/strong> \u2013 Obdr\u017e\u00edte kompletn\u00ed soubor p\u0159ipraven\u00fd k odesl\u00e1n\u00ed spolu s p\u0159ehledem v\u00fdsledk\u016f kontroly.<\/p>\n<\/li>\n<\/ol>\n

                        Pro\u010d si vybrat pr\u00e1v\u011b n\u00e1s<\/h2>\n
                          \n
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                          Odborn\u00edci na dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f v oblasti kosmetiky v<\/strong> EU i v USA<\/strong><\/p>\n<\/li>\n

                        • \n

                          D\u016fkladn\u00e1 znalost p\u0159edpisu MoCRA, pravidel FDA pro ozna\u010dov\u00e1n\u00ed a toxikologick\u00e9 dokumentace<\/strong><\/p>\n<\/li>\n

                        • \n

                          Jasn\u00e1 komunikace a transparentn\u00ed postup<\/p>\n<\/li>\n

                        • \n

                          Profesion\u00e1ln\u00ed dokumentace p\u0159ipraven\u00e1 k p\u0159edlo\u017een\u00ed k posouzen\u00ed, vypracovan\u00e1 odborn\u00edky na regula\u010dn\u00ed z\u00e1le\u017eitosti<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

                          Z\u00e1kon o modernizaci regulace kosmetick\u00fdch p\u0159\u00edpravk\u016f (MoCRA) zavedl nov\u00e9 pr\u00e1vn\u00ed po\u017eadavky pro v\u00fdrobce kosmetiky a majitele zna\u010dek, kte\u0159\u00ed prod\u00e1vaj\u00ed sv\u00e9 v\u00fdrobky ve Spojen\u00fdch st\u00e1tech.Ka\u017ed\u00fd kosmetick\u00fd p\u0159\u00edpravek mus\u00ed b\u00fdt nyn\u00ed doprov\u00e1zen jasnou a p\u0159ehlednou dokumentac\u00ed, kter\u00e1 prokazuje , \u017ee je bezpe\u010dn\u00fd , je spr\u00e1vn\u011b ozna\u010den, byl vyroben v hygienick\u00fdch podm\u00ednk\u00e1ch a spl\u0148uje po\u017eadavky FDA. Na\u0161e slu\u017eba…<\/p>\n","protected":false},"featured_media":30378,"template":"","meta":[],"product_brand":[],"product_cat":[3603],"product_tag":[],"class_list":["post-30377","product","type-product","status-publish","has-post-thumbnail","product_cat-oduvodneni-bezpecnosti-kosmetickych-pripravku","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":"\nDokumentace k kosmetick\u00fdm p\u0159\u00edpravk\u016fm podle z\u00e1kona MoCRA - Certified Cosmetics<\/title>\n<meta name=\"description\" content=\"Na\u0161e slu\u017eba pro vypracov\u00e1n\u00ed dokumentace kosmetick\u00fdch p\u0159\u00edpravk\u016f pro USA poskytuje ve\u0161ker\u00e9 pot\u0159ebn\u00e9 dokumenty, podklady a strukturu, kter\u00e9 pot\u0159ebujete ke spln\u011bn\u00ed dokumenta\u010dn\u00edch standard\u016f z\u00e1kona MoCRA \u2013 koncep\u010dn\u011b se jedn\u00e1 o obdobu souboru informac\u00ed o v\u00fdrobku (PIF) v EU, av\u0161ak p\u0159izp\u016fsoben\u00e9ho p\u0159edpis\u016fm USA.\" \/>\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.certifiedcosmetics.com\/cs\/product\/oduvodneni-bezpecnosti-kosmetickych-pripravku\/dokumentace-k-kosmetickym-pripravkum-podle-zakona-mocra\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dokumentace k kosmetick\u00fdm p\u0159\u00edpravk\u016fm podle z\u00e1kona MoCRA\" \/>\n<meta property=\"og:description\" content=\"Na\u0161e slu\u017eba pro vypracov\u00e1n\u00ed dokumentace kosmetick\u00fdch p\u0159\u00edpravk\u016f pro USA poskytuje ve\u0161ker\u00e9 pot\u0159ebn\u00e9 dokumenty, podklady a strukturu, kter\u00e9 pot\u0159ebujete ke spln\u011bn\u00ed dokumenta\u010dn\u00edch standard\u016f z\u00e1kona MoCRA \u2013 koncep\u010dn\u011b se jedn\u00e1 o obdobu souboru informac\u00ed o v\u00fdrobku (PIF) v EU, av\u0161ak p\u0159izp\u016fsoben\u00e9ho p\u0159edpis\u016fm USA.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.certifiedcosmetics.com\/cs\/product\/oduvodneni-bezpecnosti-kosmetickych-pripravku\/dokumentace-k-kosmetickym-pripravkum-podle-zakona-mocra\/\" \/>\n<meta property=\"og:site_name\" content=\"Certified Cosmetics\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2025\/10\/dossier.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"1024\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Cena\" \/>\n\t<meta name=\"twitter:data1\" content=\"$56.82\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dostupnost\" \/>\n\t<meta name=\"twitter:data2\" content=\"Skladem\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/cs\\\/product\\\/oduvodneni-bezpecnosti-kosmetickych-pripravku\\\/dokumentace-k-kosmetickym-pripravkum-podle-zakona-mocra\\\/\",\"url\":\"https:\\\/\\\/www.certifiedcosmetics.com\\\/cs\\\/product\\\/oduvodneni-bezpecnosti-kosmetickych-pripravku\\\/dokumentace-k-kosmetickym-pripravkum-podle-zakona-mocra\\\/\",\"name\":\"Dokumentace k kosmetick\u00fdm p\u0159\u00edpravk\u016fm podle z\u00e1kona MoCRA - 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