{"id":31238,"date":"2025-10-17T11:05:53","date_gmt":"2025-10-17T10:05:53","guid":{"rendered":"https:\/\/www.certifiedcosmetics.com\/product\/nekategorizirano\/storitev-mocra-za-vpis-izdelkov\/"},"modified":"2025-10-17T11:05:53","modified_gmt":"2025-10-17T10:05:53","slug":"storitev-mocra-za-vpis-izdelkov","status":"publish","type":"product","link":"https:\/\/www.certifiedcosmetics.com\/sl\/product\/utemeljitev-varnosti-kozmeticnih-izdelkov\/storitev-mocra-za-vpis-izdelkov\/","title":{"rendered":"Storitev MoCRA za vpis izdelkov"},"content":{"rendered":"<p data-start=\"403\" data-end=\"704\"><strong data-start=\"407\" data-end=\"460\">Zakon o modernizaciji ureditve kozmeti\u010dnih izdelkov (MoCRA)<\/strong> je temeljito spremenil na\u010din urejanja kozmeti\u010dnih izdelkov v ZDA. Od leta 2024\u20132025 naprej mora biti vsak kozmeti\u010dni izdelek, ki se daje na trg v ZDA, ustrezno <strong data-start=\"601\" data-end=\"615\">registriran<\/strong> (objekti) in <strong data-start=\"633\" data-end=\"643\">registriran<\/strong> (izdelki) pri Ameri\u0161ki agenciji za hrano in zdravila (FDA).<\/p>\n<p data-start=\"706\" data-end=\"736\">Neupo\u0161tevanje teh dolo\u010db lahko povzro\u010di:<\/p>\n<ul data-start=\"738\" data-end=\"958\">\n<li data-start=\"738\" data-end=\"803\">\n<p data-start=\"740\" data-end=\"803\"><strong data-start=\"744\" data-end=\"763\">Opozorilna pisma<\/strong>, izvr\u0161ilni ukrepi ali prepovedi uvoza s strani FDA<\/p>\n<\/li>\n<li data-start=\"804\" data-end=\"831\">\n<p data-start=\"806\" data-end=\"831\">Zamude pri dostopu na trg<\/p>\n<\/li>\n<li data-start=\"832\" data-end=\"882\">\n<p data-start=\"834\" data-end=\"882\">Tveganje za ugled pri trgovcih na drobno in potro\u0161nikih<\/p>\n<\/li>\n<li data-start=\"883\" data-end=\"958\">\n<p data-start=\"885\" data-end=\"958\">Motnje v poslovanju v primeru spremembe sestave izdelka ali etikete<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"960\" data-end=\"1100\">Z na\u0161o storitvijo strokovnjaki poskrbijo za celoten postopek, od registracije do letnih posodobitev, medtem ko se vi osredoto\u010dite na svojo blagovno znamko in prodajo.<\/p>\n<h3 data-start=\"1102\" data-end=\"1119\">Na\u0161a ponudba<\/h3>\n<p data-start=\"1121\" data-end=\"1195\">Na\u0161a storitev na osnovi naro\u010dnine vklju\u010duje:<\/p>\n<div class=\"_tableContainer_1rjym_1\">\n<div class=\"group _tableWrapper_1rjym_13 flex w-fit flex-col-reverse\">\n<table class=\"w-fit min-w-(--thread-content-width)\" data-start=\"1197\" data-end=\"2311\">\n<thead data-start=\"1197\" data-end=\"1222\">\n<tr data-start=\"1197\" data-end=\"1222\">\n<th data-start=\"1197\" data-end=\"1207\" data-col-size=\"sm\">Funkcija<\/th>\n<th data-start=\"1207\" data-end=\"1222\" data-col-size=\"lg\">Opis<\/th>\n<\/tr>\n<\/thead>\n<tbody data-start=\"1233\" data-end=\"2311\">\n<tr data-start=\"1390\" data-end=\"1562\">\n<td data-start=\"1390\" data-end=\"1423\" data-col-size=\"sm\"><strong data-start=\"1392\" data-end=\"1422\">Po\u0161lji seznam izdelkov<\/strong><\/td>\n<td data-col-size=\"lg\" data-start=\"1423\" data-end=\"1562\">Prek <strong data-start=\"1532\" data-end=\"1552\">portala Cosmetics Direct<\/strong> ameri\u0161ke agencije za hrano in zdravila (FDA) pripravljamo, oddajamo in upravljamo podatke o va\u0161ih izdelkih (ime, kategorija, sestavine po standardu INCI, etiketa itd.).<\/td>\n<\/tr>\n<tr data-start=\"1563\" data-end=\"1701\">\n<td data-start=\"1563\" data-end=\"1598\" data-col-size=\"sm\"><strong data-start=\"1565\" data-end=\"1597\">Letne posodobitve in vzdr\u017eevanje<\/strong><\/td>\n<td data-col-size=\"lg\" data-start=\"1598\" data-end=\"1701\">Vsako leto preverjamo va\u0161e oglase, jih po potrebi posodobimo in ponovno predlo\u017eimo, da zagotovimo va\u0161o skladnost z zakonskimi zahtevami.<\/td>\n<\/tr>\n<tr data-start=\"1884\" data-end=\"2015\">\n<td data-start=\"1884\" data-end=\"1919\" data-col-size=\"sm\"><strong data-start=\"1886\" data-end=\"1918\">Spremljanje rokov in opozorila<\/strong><\/td>\n<td data-col-size=\"lg\" data-start=\"1919\" data-end=\"2015\">Spremljamo pomembne roke (npr. roke za letno poro\u010danje) in vas o njih vnaprej obvestimo.<\/td>\n<\/tr>\n<tr data-start=\"2160\" data-end=\"2311\">\n<td data-start=\"2160\" data-end=\"2183\" data-col-size=\"sm\"><strong data-start=\"2162\" data-end=\"2182\">Arhiv<\/strong><\/td>\n<td data-start=\"2183\" data-end=\"2311\" data-col-size=\"lg\">Vodimo varen arhiv vseh predlo\u017eenih dokumentov, potrditev in korespondence, tako da imate na voljo jasno revizijsko sled.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<h3 data-start=\"2313\" data-end=\"2331\">Kdo to sploh potrebuje?<\/h3>\n<p data-start=\"2333\" data-end=\"2377\">Na to storitev se morate naro\u010diti, \u010de:<\/p>\n<ul data-start=\"2379\" data-end=\"2676\">\n<li data-start=\"2379\" data-end=\"2442\">\n<p data-start=\"2381\" data-end=\"2442\">Prodajajte kozmetiko ali izdelke za osebno nego na ameri\u0161kem trgu.<\/p>\n<\/li>\n<li data-start=\"2443\" data-end=\"2524\">\n<p data-start=\"2445\" data-end=\"2524\">Ali ste proizvajalec, lastnik blagovne znamke, pakirni podjetnik ali distributer (ali sodelujete z njimi)?<\/p>\n<\/li>\n<li data-start=\"2525\" data-end=\"2609\">\n<p data-start=\"2527\" data-end=\"2609\">\u017delite zagotoviti skladnost z zakonom MoCRA, ne da bi za to porabili notranje regulativne vire?<\/p>\n<\/li>\n<li data-start=\"2610\" data-end=\"2676\">\n<p data-start=\"2612\" data-end=\"2676\">Na\u010drtujte redno prenovo izdelkov, njihovo preimenovanje ali uvedbo novih izdelkov<\/p>\n<\/li>\n<\/ul>\n<h3 data-start=\"2872\" data-end=\"2903\">Kako deluje \u2013 korak za korakom<\/h3>\n<ol data-start=\"2905\" data-end=\"3820\">\n<li data-start=\"2905\" data-end=\"3077\">\n<p data-start=\"2908\" data-end=\"3077\"><strong data-start=\"2908\" data-end=\"2939\">Vklju\u010devanje novih partnerjev in zbiranje informacij<\/strong><br data-start=\"2939\" data-end=\"2942\"\/>Prosimo za podatke o izdelku: ime, namen uporabe (nega ko\u017ee, li\u010dila itd.), popoln seznam sestavin po standardu INCI, slike etikete ter podatke o proizvodnji.<\/p>\n<\/li>\n<li data-start=\"3227\" data-end=\"3396\">\n<p data-start=\"3230\" data-end=\"3396\"><strong data-start=\"3230\" data-end=\"3260\">Po\u0161iljanje seznamov izdelkov<\/strong><br data-start=\"3260\" data-end=\"3263\"\/>Pripravljamo datoteke Structured Product Labeling (SPL) in jih po\u0161iljamo prek Cosmetics Direct, vklju\u010dno z vsemi obveznimi polji in potrditvami. <strong data-start=\"3082\" data-end=\"3107\">Za to je potrebna<\/strong> <strong data-start=\"3082\" data-end=\"3107\">registracija obrata.<\/strong> <\/p>\n<\/li>\n<li data-start=\"3398\" data-end=\"3529\">\n<p data-start=\"3401\" data-end=\"3529\"><strong data-start=\"3401\" data-end=\"3429\">Potrditev in arhiviranje<\/strong><br data-start=\"3429\" data-end=\"3432\"\/>Ko bodo prispevki sprejeti, vam bomo poslali potrditev in datoteke shranili v na\u0161 arhiv.<\/p>\n<\/li>\n<li data-start=\"3531\" data-end=\"3653\">\n<p data-start=\"3534\" data-end=\"3653\"><strong data-start=\"3534\" data-end=\"3557\">Letni cikel posodabljanja<\/strong><br data-start=\"3557\" data-end=\"3560\"\/>Vsako leto pregledamo va\u0161e sezname, preverimo podatke ter jih ponovno predlo\u017eimo ali potrdimo pri FDA.<\/p>\n<\/li>\n<li data-start=\"3655\" data-end=\"3820\">\n<p data-start=\"3658\" data-end=\"3820\"><strong data-start=\"3658\" data-end=\"3691\">Upravljanje sprememb (\u010de je potrebno)<\/strong><br data-start=\"3691\" data-end=\"3694\"\/>\u010ce spremenite sestavo izdelka, prenovite embala\u017eo ali zamenjate proizvodne obrate, moramo v 120 dneh predlo\u017eiti posodobljene podatke, da ohranimo skladnost z zakonodajo.<\/p>\n<\/li>\n<\/ol>\n<h3 data-start=\"3822\" data-end=\"3859\">Roki in skladnost<\/h3>\n<ul data-start=\"3861\" data-end=\"4124\">\n<li data-start=\"3861\" data-end=\"3934\">\n<p data-start=\"3863\" data-end=\"3934\"><strong data-start=\"3863\" data-end=\"3913\">Rok za vpis obstoje\u010dih izdelkov<\/strong>: 29. december 2023<\/p>\n<\/li>\n<li data-start=\"3935\" data-end=\"3989\">\n<p data-start=\"3937\" data-end=\"3989\"><strong data-start=\"3937\" data-end=\"3971\">Rok za vpis v program<\/strong>: 29. marec 2024<\/p>\n<\/li>\n<li data-start=\"3990\" data-end=\"4058\">\n<p data-start=\"3992\" data-end=\"4058\"><strong data-start=\"3992\" data-end=\"4010\">Letne posodobitve<\/strong>: potrebne za ohranjanje to\u010dnosti in skladnosti<\/p>\n<\/li>\n<li data-start=\"4059\" data-end=\"4124\">\n<p data-start=\"4061\" data-end=\"4124\"><strong data-start=\"4061\" data-end=\"4080\">120-dnevna poro\u010dila<\/strong>: obvezna v primeru bistvenih sprememb<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"4126\" data-end=\"4220\">Neupo\u0161tevanje rokov lahko povzro\u010di regulativne posledice, zadr\u017eanje uvoza ali opomine.<\/p>\n<h3 data-start=\"4222\" data-end=\"4239\">Zakaj izbrati nas<\/h3>\n<ul data-start=\"4241\" data-end=\"4846\">\n<li data-start=\"4241\" data-end=\"4362\">\n<p data-start=\"4243\" data-end=\"4362\"><strong data-start=\"4243\" data-end=\"4270\">Strokovnost in zanesljivost<\/strong><br data-start=\"4270\" data-end=\"4273\"\/>Na\u0161a ekipa odli\u010dno pozna zakon MoCRA; redno se seznanjamo z najnovej\u0161imi smernicami FDA in spremembami politike.<\/p>\n<\/li>\n<li data-start=\"4364\" data-end=\"4499\">\n<p data-start=\"4366\" data-end=\"4499\"><strong data-start=\"4366\" data-end=\"4390\">Ugodna cena, velika vrednost<\/strong><br data-start=\"4390\" data-end=\"4393\"\/>S to naro\u010dnino vam ni treba zaposlovati redno zaposlenega osebja za regulativne zadeve niti pla\u010devati dragih pravnih stro\u0161kov.<\/p>\n<\/li>\n<li data-start=\"4501\" data-end=\"4607\">\n<p data-start=\"4503\" data-end=\"4607\"><strong data-start=\"4503\" data-end=\"4526\">Pregleden postopek<\/strong><br data-start=\"4526\" data-end=\"4529\"\/>Imate popoln vpogled v oddane vloge, potrditve in spremembe statusa.<\/p>\n<\/li>\n<li data-start=\"4609\" data-end=\"4735\">\n<p data-start=\"4611\" data-end=\"4735\"><strong data-start=\"4611\" data-end=\"4634\">Prilagodljiva in raz\u0161irljiva<\/strong> re\u0161itev \u00bb<br data-start=\"4634\" data-end=\"4637\"\/>\u00ab \u2013 ne glede na to, ali imate 1 izdelek ali 100, se lahko prilagodimo vsakemu obsegu. Ko se va\u0161a ponudba \u0161iri ali spreminja, se temu prilagodimo.   <\/p>\n<\/li>\n<li data-start=\"4737\" data-end=\"4846\">\n<p data-start=\"4739\" data-end=\"4846\"><strong data-start=\"4739\" data-end=\"4757\">Zmanj\u0161evanje tveganj<\/strong><br data-start=\"4757\" data-end=\"4760\"\/>S pravilnim upo\u0161tevanjem predpisov zmanj\u0161ate tveganje izvr\u0161ilnih ukrepov, glob ali motenj na trgu.<\/p>\n<\/li>\n<\/ul>\n<h3 data-start=\"4848\" data-end=\"4867\">Cene in pogoji<\/h3>\n<ul data-start=\"4869\" data-end=\"5276\">\n<li data-start=\"4869\" data-end=\"4916\">\n<p data-start=\"4871\" data-end=\"4916\"><strong data-start=\"4871\" data-end=\"4892\">Cena naro\u010dnine<\/strong>: na izdelek \/ leto<\/p>\n<\/li>\n<li data-start=\"4917\" data-end=\"4951\">\n<p data-start=\"4919\" data-end=\"4951\"><strong data-start=\"4919\" data-end=\"4930\">Zara\u010dunavanje<\/strong>: letno vnaprej<\/p>\n<\/li>\n<li data-start=\"4952\" data-end=\"5070\">\n<p data-start=\"4954\" data-end=\"5070\"><strong data-start=\"4954\" data-end=\"4976\">Vklju\u010dene posodobitve<\/strong>: Letna posodobitev potrditve registracije<\/p>\n<\/li>\n<li data-start=\"5071\" data-end=\"5181\">\n<p data-start=\"5073\" data-end=\"5181\"><strong data-start=\"5073\" data-end=\"5089\">Preklic<\/strong>: Naro\u010dilo lahko prekli\u010dete ob koncu leta; izdelki, ki jih boste umaknili s seznama, bodo odstranjeni v skladu z va\u0161imi navodili.<\/p>\n<\/li>\n<\/ul>\n<h3 data-start=\"5278\" data-end=\"5286\">Pogosta vpra\u0161anja<\/h3>\n<p data-start=\"5288\" data-end=\"5586\"><strong data-start=\"5288\" data-end=\"5361\">V: Ali to potrebujem, \u010de \u017ee izpolnjujem predpise EU (npr. PIF, CPSR)?<\/strong><br data-start=\"5361\" data-end=\"5364\">O: Da. Program EU PIF je dragocena podlaga, vendar zakon MoCRA zahteva lo\u010deno strukturo za predlo\u017eitev podatkov v ZDA (registracija obrata, seznam izdelkov, datoteke SPL). Kadar je to mogo\u010de, uporabljamo va\u0161e obstoje\u010de podatke, da poenostavimo postopek.    <\/p>\n<p data-start=\"5588\" data-end=\"5792\"><strong data-start=\"5588\" data-end=\"5626\">V: Kaj pa, \u010de spremenim sestavo izdelka sredi leta?<\/strong><br data-start=\"5626\" data-end=\"5629\">O: Zahtevano 120-dnevno poro\u010dilo bomo vlo\u017eili v va\u0161em imenu, vendar lahko ve\u010dje spremembe, na katere nimamo vpliva (npr. nove surovine, ki zahtevajo nove varnostne ocene), povzro\u010dijo dodatne stro\u0161ke.<\/p>\n<p data-start=\"5794\" data-end=\"5985\"><strong data-start=\"5794\" data-end=\"5841\">V: Ali morajo biti vsi kozmeti\u010dni izdelki na seznamu?<\/strong><br data-start=\"5841\" data-end=\"5844\">O: Ve\u010dina jih mora. Izjeme so izdelki, ki so uvr\u0161\u010deni med pravo milo (ne kozmeti\u010dno milo), ali nekatera majhna podjetja, ki izpolnjujejo pogoje za izvzetje.   <\/p>\n<p data-start=\"5987\" data-end=\"6137\"><strong data-start=\"5987\" data-end=\"6021\">V: Ali lahko dostopam do portala FDA?<\/strong><br data-start=\"6021\" data-end=\"6024\">O: Da. Uporabljamo vmesnik Cosmetics Direct in vas obve\u0161\u010damo o tem, kaj v va\u0161em imenu po\u0161iljamo.   <\/p>\n<p data-start=\"6139\" data-end=\"6279\"><strong data-start=\"6139\" data-end=\"6181\">V: Kaj \u010de FDA zavrne mojo prijavo?<\/strong><br data-start=\"6181\" data-end=\"6184\">O: Pomagamo pri odpravljanju pomanjkljivosti, ponovni vlo\u017eitvi vloge in ohranjanju stika z FDA, da se te\u017eave odpravijo.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Zakon o modernizaciji ureditve kozmeti\u010dnih izdelkov (MoCRA) je temeljito spremenil na\u010din urejanja kozmeti\u010dnih izdelkov v ZDA. Od leta 2024\u20132025 naprej mora biti vsak kozmeti\u010dni izdelek, ki se daje na trg v ZDA, ustrezno registriran (objekti) in registriran (izdelki) pri Ameri\u0161ki agenciji za hrano in zdravila (FDA). 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