{"id":31325,"date":"2025-10-16T14:14:34","date_gmt":"2025-10-16T13:14:34","guid":{"rendered":"https:\/\/www.certifiedcosmetics.com\/product\/nekategorizirano\/dokumentacija-o-kozmeticnih-izdelkih-v-skladu-z-uredbo-mocra\/"},"modified":"2025-10-16T14:14:34","modified_gmt":"2025-10-16T13:14:34","slug":"dokumentacija-o-kozmeticnih-izdelkih-v-skladu-z-uredbo-mocra","status":"publish","type":"product","link":"https:\/\/www.certifiedcosmetics.com\/sl\/product\/utemeljitev-varnosti-kozmeticnih-izdelkov\/dokumentacija-o-kozmeticnih-izdelkih-v-skladu-z-uredbo-mocra\/","title":{"rendered":"Dokumentacija o kozmeti\u010dnih izdelkih v skladu z uredbo MoCRA"},"content":{"rendered":"<p data-start=\"467\" data-end=\"839\"><strong data-start=\"471\" data-end=\"524\">Zakon o modernizaciji regulacije kozmetike (MoCRA)<\/strong> je uvedel nove zakonske zahteve za proizvajalce kozmetike in lastnike blagovnih znamk, ki prodajajo izdelke v Zdru\u017eenih dr\u017eavah Amerike.<br data-start=\"640\" data-end=\"643\"\/> Vsak kozmeti\u010dni izdelek mora zdaj spremljati jasna in dobro organizirana dokumentacija, ki dokazuje, da je <strong data-start=\"733\" data-end=\"836\">varen<\/strong> <strong data-start=\"733\" data-end=\"836\">, pravilno ozna\u010den, proizveden v higienskih pogojih in izpolnjuje zahteve FDA<\/strong> .<\/p>\n<p data-start=\"841\" data-end=\"1109\">Na\u0161a storitev <strong data-start=\"845\" data-end=\"887\">priprave dokumentacije za kozmeti\u010dni izdelek za trg ZDA<\/strong> vklju\u010duje vse potrebne dokumente, dokazila in strukturo, ki jih potrebujete za izpolnjevanje dokumentacijskih standardov MoCRA \u2013 podobno kot pri <strong data-start=\"1035\" data-end=\"1072\">datoteki s podatki o izdelku (PIF) v EU<\/strong>, vendar prilagojeno predpisom ZDA.<\/p>\n<p data-start=\"1111\" data-end=\"1236\">Pripravimo celovito dokumentacijo, ki je pripravljena za revizijo in zagotavlja, da je va\u0161a blagovna znamka kadarkoli pripravljena na in\u0161pekcijski pregled ali preverjanje s strani FDA.<\/p>\n<h2 data-start=\"1238\" data-end=\"1280\">Kaj vsebuje dokumentacija o izdelku v ZDA<\/h2>\n<p data-start=\"1282\" data-end=\"1365\">Vsak dosje je sestavljen tako, da zajema celoten obseg pri\u010dakovanj agencije FDA v okviru zakona MoCRA:<\/p>\n<p data-start=\"1367\" data-end=\"1417\"><strong data-start=\"1367\" data-end=\"1415\">1. Upravna identifikacija in identifikacija izdelka<\/strong><\/p>\n<ul data-start=\"1418\" data-end=\"1616\">\n<li data-start=\"1418\" data-end=\"1458\">\n<p data-start=\"1420\" data-end=\"1458\">Ime izdelka, funkcija in kategorija<\/p>\n<\/li>\n<li data-start=\"1459\" data-end=\"1530\">\n<p data-start=\"1461\" data-end=\"1530\">Podatki o odgovorni osebi (proizvajalec, uvoznik ali distributer)<\/p>\n<\/li>\n<li data-start=\"1531\" data-end=\"1579\">\n<p data-start=\"1533\" data-end=\"1579\">Ocena ozna\u010devanja izdelkov, ilustracij in trditev<\/p>\n<\/li>\n<li data-start=\"1580\" data-end=\"1616\">\n<p data-start=\"1582\" data-end=\"1616\">Sklici na registracijo objekta<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1618\" data-end=\"1646\"><strong data-start=\"1618\" data-end=\"1644\">2. Sestava izdelka<\/strong><\/p>\n<ul data-start=\"1647\" data-end=\"1874\">\n<li data-start=\"1647\" data-end=\"1706\">\n<p data-start=\"1649\" data-end=\"1706\">Celoten seznam sestavin z imeni INCI in koncentracijami<\/p>\n<\/li>\n<li data-start=\"1707\" data-end=\"1760\">\n<p data-start=\"1709\" data-end=\"1760\">Dokumentacija o izvoru sestavin in podatki o dobaviteljih<\/p>\n<\/li>\n<li data-start=\"1761\" data-end=\"1818\">\n<p data-start=\"1763\" data-end=\"1818\">Omejitve in regulativni nadzor za vsako sestavino<\/p>\n<\/li>\n<li data-start=\"1819\" data-end=\"1874\">\n<p data-start=\"1821\" data-end=\"1874\">Dokumentacija o aromah in di\u0161avah, kjer je to primerno<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1876\" data-end=\"1911\"><strong data-start=\"1876\" data-end=\"1909\">3. Varnostni list<\/strong><\/p>\n<ul data-start=\"1912\" data-end=\"2072\">\n<li data-start=\"1912\" data-end=\"1957\">\n<p data-start=\"1914\" data-end=\"1957\">Toksikolo\u0161ki profil za vsako sestavino<\/p>\n<\/li>\n<li data-start=\"1958\" data-end=\"1990\">\n<p data-start=\"1960\" data-end=\"1990\">Ocena izpostavljenosti in tveganja<\/p>\n<\/li>\n<li data-start=\"1991\" data-end=\"2030\">\n<p data-start=\"1993\" data-end=\"2030\">Izra\u010duni varnostnih rezerv (MoS)<\/p>\n<\/li>\n<li data-start=\"2031\" data-end=\"2072\">\n<p data-start=\"2033\" data-end=\"2072\">Kon\u010dna utemeljitev varnosti<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2074\" data-end=\"2120\"><strong data-start=\"2074\" data-end=\"2118\">4. Podatki o proizvodnji in kakovosti<\/strong><\/p>\n<ul data-start=\"2121\" data-end=\"2375\">\n<li data-start=\"2121\" data-end=\"2174\">\n<p data-start=\"2123\" data-end=\"2174\">Opis proizvodnega procesa in nadzornih ukrepov<\/p>\n<\/li>\n<li data-start=\"2175\" data-end=\"2260\">\n<p data-start=\"2177\" data-end=\"2260\">Izjava o skladnosti z GMP (v skladu z zahtevami FDA in na\u010deli standarda ISO 22716)<\/p>\n<\/li>\n<li data-start=\"2261\" data-end=\"2312\">\n<p data-start=\"2263\" data-end=\"2312\">Mikrobiolo\u0161ki nadzor in sledljivost serij<\/p>\n<\/li>\n<li data-start=\"2313\" data-end=\"2375\">\n<p data-start=\"2315\" data-end=\"2375\">Podatki o preskusih kakovosti in zdru\u017eljivosti embala\u017ee<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2377\" data-end=\"2415\"><strong data-start=\"2377\" data-end=\"2413\">5. Podatki o stabilnosti in roku uporabnosti<\/strong><\/p>\n<ul data-start=\"2416\" data-end=\"2551\">\n<li data-start=\"2416\" data-end=\"2456\">\n<p data-start=\"2418\" data-end=\"2456\">Povzetki preskusov stabilnosti in skladi\u0161\u010denja<\/p>\n<\/li>\n<li data-start=\"2457\" data-end=\"2492\">\n<p data-start=\"2459\" data-end=\"2492\">Rezultati zdru\u017eljivosti embala\u017ee<\/p>\n<\/li>\n<li data-start=\"2493\" data-end=\"2551\">\n<p data-start=\"2495\" data-end=\"2551\">Obrazlo\u017eitev obdobja po odprtju (PAO) ali roka uporabnosti<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2553\" data-end=\"2592\"><strong data-start=\"2553\" data-end=\"2590\">6. Skladnost z ozna\u010devanjem in trditvami<\/strong><\/p>\n<ul data-start=\"2593\" data-end=\"2838\">\n<li data-start=\"2593\" data-end=\"2690\">\n<p data-start=\"2595\" data-end=\"2690\">Preverjanje ozna\u010devanja izdelkov za zagotovitev skladnosti s predpisi FDA o ozna\u010devanju kozmeti\u010dnih izdelkov (21 CFR 701).<\/p>\n<\/li>\n<li data-start=\"2691\" data-end=\"2766\">\n<p data-start=\"2693\" data-end=\"2766\">Preverjanje navedb sestavin, opozoril in identitete izdelka<\/p>\n<\/li>\n<li data-start=\"2767\" data-end=\"2838\">\n<p data-start=\"2769\" data-end=\"2838\">Pregled tr\u017enih trditev, da se zagotovi, da se ne navajajo trditve, podobne trditvam o zdravilih<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2840\" data-end=\"2873\"><strong data-start=\"2840\" data-end=\"2871\">7. Prilo\u017eena dokumentacija<\/strong><\/p>\n<ul data-start=\"2874\" data-end=\"3124\">\n<li data-start=\"2874\" data-end=\"2936\">\n<p data-start=\"2876\" data-end=\"2936\">Analiti\u010dni certifikati (COA) in varnostni listi (SDS) za klju\u010dne sestavine<\/p>\n<\/li>\n<li data-start=\"2937\" data-end=\"2996\">\n<p data-start=\"2939\" data-end=\"2996\">Dokumentacija o IFRA, alergenih ali di\u0161avah, \u010de je na voljo<\/p>\n<\/li>\n<li data-start=\"2997\" data-end=\"3047\">\n<p data-start=\"2999\" data-end=\"3047\">Poro\u010dila o preskusih varnosti in zmogljivosti (neobvezno)<\/p>\n<\/li>\n<li data-start=\"3048\" data-end=\"3124\">\n<p data-start=\"3050\" data-end=\"3124\">Potrditve obvestil FDA (registracija obrata in vpis izdelka)<\/p>\n<\/li>\n<\/ul>\n<h2 data-start=\"3126\" data-end=\"3159\">Zakaj je ta dosje pomemben<\/h2>\n<p data-start=\"3161\" data-end=\"3203\">Priprava strukturirane dokumentacije vam pomaga:<\/p>\n<ul data-start=\"3204\" data-end=\"3538\">\n<li data-start=\"3204\" data-end=\"3261\">\n<p data-start=\"3206\" data-end=\"3261\">Dokazati skladnost s predpisi MoCRA in FDA<\/p>\n<\/li>\n<li data-start=\"3262\" data-end=\"3329\">\n<p data-start=\"3264\" data-end=\"3329\">Zagotovite preglednost in sledljivost v celotni dobavni verigi<\/p>\n<\/li>\n<li data-start=\"3330\" data-end=\"3402\">\n<p data-start=\"3332\" data-end=\"3402\">Zagotovite takoj\u0161en dostop do dokumentacije, ko FDA zahteva in\u0161pekcijski pregled<\/p>\n<\/li>\n<li data-start=\"3403\" data-end=\"3468\">\n<p data-start=\"3405\" data-end=\"3468\">Za\u0161\u010ditite svojo blagovno znamko pred dragimi izvr\u0161ilnimi ukrepi ali odpoklici izdelkov<\/p>\n<\/li>\n<li data-start=\"3469\" data-end=\"3538\">\n<p data-start=\"3471\" data-end=\"3538\">Zgradite zaupanje pri partnerjih, distributerjih in trgovcih na drobno<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"3540\" data-end=\"3681\">Celovita dokumentacija dokazuje, da je va\u0161e podjetje ravnalo s potrebno skrbnostjo na podro\u010djih varnosti, kakovosti in ozna\u010devanja, kar je bistveno za dostop na ameri\u0161ki trg.<\/p>\n<h2 data-start=\"3683\" data-end=\"3709\">Kdo potrebuje to storitev<\/h2>\n<ul data-start=\"3711\" data-end=\"4072\">\n<li data-start=\"3711\" data-end=\"3792\">\n<p data-start=\"3713\" data-end=\"3792\"><strong data-start=\"3713\" data-end=\"3749\">Evropske ali mednarodne blagovne znamke<\/strong>, ki izva\u017eajo kozmetiko v Zdru\u017eene dr\u017eave Amerike<\/p>\n<\/li>\n<li data-start=\"3793\" data-end=\"3880\">\n<p data-start=\"3795\" data-end=\"3880\"><strong data-start=\"3795\" data-end=\"3817\">Ameri\u0161ki proizvajalci<\/strong> \u017eelijo urediti in poenotiti dokumentacijo o skladnosti<\/p>\n<\/li>\n<li data-start=\"3881\" data-end=\"3983\">\n<p data-start=\"3883\" data-end=\"3983\"><strong data-start=\"3883\" data-end=\"3920\">Proizvajalci pod lastno blagovno znamko in distributerji<\/strong>, ki upravljajo ve\u010d proizvodnih linij v okviru enega samega odgovornega subjekta<\/p>\n<\/li>\n<li data-start=\"3984\" data-end=\"4072\">\n<p data-start=\"3986\" data-end=\"4072\"><strong data-start=\"3986\" data-end=\"4025\">Svetovalci za regulativne zadeve ali uvozniki<\/strong>, ki delujejo kot odgovorne osebe v skladu z MoCRA<\/p>\n<\/li>\n<\/ul>\n<h2 data-start=\"4074\" data-end=\"4094\">Kaj prejmete<\/h2>\n<ul data-start=\"4096\" data-end=\"4395\">\n<li data-start=\"4096\" data-end=\"4173\">\n<p data-start=\"4098\" data-end=\"4173\">Popolna <strong data-start=\"4103\" data-end=\"4136\">dokumentacija o kozmeti\u010dnem izdelku za ZDA<\/strong> v elektronski obliki (PDF ali Word)<\/p>\n<\/li>\n<li data-start=\"4174\" data-end=\"4250\">\n<p data-start=\"4176\" data-end=\"4250\">Vsi dokumenti so indeksirani, opremljeni s sklicevanji in shranjeni v logi\u010dni strukturi<\/p>\n<\/li>\n<li data-start=\"4251\" data-end=\"4325\">\n<p data-start=\"4253\" data-end=\"4325\">Izbirne raz\u0161iritve za prevode, posodobitve ali dodatne formulacije<\/p>\n<\/li>\n<li data-start=\"4326\" data-end=\"4395\">\n<p data-start=\"4328\" data-end=\"4395\">Dokumentacija, pripravljena za in\u0161pekcijo FDA, in razli\u010dica za dolgoro\u010dno arhiviranje<\/p>\n<\/li>\n<\/ul>\n<h2 data-start=\"4397\" data-end=\"4412\">Na\u0161 postopek<\/h2>\n<ol data-start=\"4414\" data-end=\"4832\">\n<li data-start=\"4414\" data-end=\"4507\">\n<p data-start=\"4417\" data-end=\"4507\"><strong data-start=\"4417\" data-end=\"4436\">Zbiranje podatkov<\/strong> \u2013 Vi nam posredujete sestavine izdelkov, etikete in podatke o proizvodnji.<\/p>\n<\/li>\n<li data-start=\"4508\" data-end=\"4602\">\n<p data-start=\"4511\" data-end=\"4602\"><strong data-start=\"4511\" data-end=\"4532\">Pregled skladnosti<\/strong> \u2013 Preverjamo popolnost podatkov, ozna\u010devanje in skladnost z zakonodajo.<\/p>\n<\/li>\n<li data-start=\"4603\" data-end=\"4716\">\n<p data-start=\"4606\" data-end=\"4716\"><strong data-start=\"4606\" data-end=\"4629\">Priprava dokumentacije<\/strong> \u2013 Na\u0161a ekipa pripravi celotno dokumentacijo in jo strukturira v skladu z zahtevami MoCRA.<\/p>\n<\/li>\n<li data-start=\"4717\" data-end=\"4832\">\n<p data-start=\"4720\" data-end=\"4832\"><strong data-start=\"4720\" data-end=\"4748\">Kontrola kakovosti in dostava<\/strong> \u2013 prejeli boste popolno datoteko, pripravljeno za oddajo, skupaj s povzetkom preverjanja.<\/p>\n<\/li>\n<\/ol>\n<h2 data-start=\"4834\" data-end=\"4851\">Zakaj izbrati nas<\/h2>\n<ul data-start=\"4853\" data-end=\"5124\">\n<li data-start=\"4853\" data-end=\"4908\">\n<p data-start=\"4855\" data-end=\"4908\">Strokovnjaki za <strong data-start=\"4871\" data-end=\"4906\">skladnost kozmeti\u010dnih izdelkov v<\/strong> <strong data-start=\"4871\" data-end=\"4906\">EU in ZDA<\/strong><\/p>\n<\/li>\n<li data-start=\"4909\" data-end=\"4997\">\n<p data-start=\"4911\" data-end=\"4997\">Poglobljeno poznavanje zakona <strong data-start=\"4933\" data-end=\"4995\">MoCRA, pravil FDA o ozna\u010devanju ter toksikolo\u0161ke dokumentacije<\/strong><\/p>\n<\/li>\n<li data-start=\"4998\" data-end=\"5045\">\n<p data-start=\"5000\" data-end=\"5045\">Jasna komunikacija in pregleden postopek<\/p>\n<\/li>\n<li data-start=\"5046\" data-end=\"5124\">\n<p data-start=\"5048\" data-end=\"5124\">Strokovno pripravljene dokumentacije, pripravljene za pregled, ki so jih sestavili strokovnjaki za regulativne zadeve<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Zakon o modernizaciji regulacije kozmetike (MoCRA) je uvedel nove zakonske zahteve za proizvajalce kozmetike in lastnike blagovnih znamk, ki prodajajo izdelke v Zdru\u017eenih dr\u017eavah Amerike. Vsak kozmeti\u010dni izdelek mora zdaj spremljati jasna in dobro organizirana dokumentacija, ki dokazuje, da je varen , pravilno ozna\u010den, proizveden v higienskih pogojih in izpolnjuje zahteve FDA . 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