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Opis razvoja kozmetičnega izdelka in priprava dokumentacije v skladu z zakonodajo
ID Vrhovec, Anja (Author), ID Gašperlin, Mirjana (Mentor) More about this mentor... This link opens in a new window

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Abstract
Trend v kozmetični industriji narekujejo potrošniki. Zaradi svoje vedno večje ozaveščenosti o varovanju okolja in zdravja, potrošniki vedno bolj posegajo po kozmetiki iz naravnih sestavin (t.j. naravni kozmetiki). Kozmetični trg kljub neugodnim gospodarskim razmeram v preteklih letih še vedno izkazuje dobro rast. Zaradi dobrih ekonomskih kazalcev in povečanega povpraševanja po naravni kozmetiki veliko ljudi vidi v tem zanimivo podjetniško izkušnjo. V zadnjih letih se je tako v Sloveniji razvilo kar nekaj butičnih proizvajalcev naravne kozmetike. V Evropi največji tržni delež predstavljajo kozmetični izdelki za nego kože, kjer med tehnološkimi oblikami prevladuje emulzija. Emulzija je sestavljena iz treh osnovnih komponent – notranje faze, zunanje faze in emulgatorja, vendar to nikakor ni dovolj, da izdelamo varen, učinkovit in stabilen kozmetični izdelek. Za izboljšanje učinka se lahko dodajo kozmetično aktivne sestavine. Pospeševalce penetracije uporabimo za izboljšanje prehoda aktivne kozmetične sestavine v kožo. Fizikalno stabilnost izboljšamo z uporabo zgoščeval. Da bo kozmetični izdelek mikrobiološko neoporečen, moramo obvezno uporabiti ustrezen konzervans. Namen magistrske naloge je opisati postopek načrtovanja izdelave kozmetičnega izdelka ter predstaviti obveznosti in dolžnosti odgovorne osebe (v našem primeru proizvajalca), ki daje izdelek v promet. Izdelali smo kremo za nego kože z učinkom vlaženja (emulzija O/V) in težili k uporabi čim bolj naravnih sestavin. Za zunanjo fazo smo uporabili destilirano vodo, za notranjo fazo pa karitejevo maslo in arganovo olje. Kot emulgator smo uporabili Olivem® 1000, ki tvori tekoče kristale. Glicerol, alantoin in koko kaprilat smo dodali kot vlažila. Alantoin ima poleg svojih vlažilnih lastnosti tudi keratoplastično delovanje (mehča poroženelo plast). Koko kaprilat pa dodatno izboljša tudi mazljivost emulzije. Emulzijo smo mikrobiološko zaščitili s konzervansom Cosgard in kalijevim sorbatom. Mikrobiološko zaščito smo dokazali s testom mikrobiološke kakovosti izdelka in izzivnim preskusom učinkovitosti konzervansa. Za izboljšanje vonja smo uporabili eterično olje pelargonije. Končna formulacija je imela pH v alkalnem območju, zato smo uporabili raztopino citronske kisline in ga znižali na 5,5. Končni izdelek pa mora biti učinkovit in varen za uporabo skozi daljši čas. Varnost kozmetičnega izdelka dokažemo z izdelavo poročila o varnosti. Poročilo je sestavljeno iz dveh delov: A in B. Del A je sestavljen iz 10 točk. Za varnost kozmetičnega izdelka je bistvena točka 8, kjer smo pregledali toksikološke profile za vse uporabljene sestavine in izračunali mejo varne uporabe. Vse uporabljene sestavine so v skladu z Uredbo 1223/2009/ES in so varne oziroma uporabljene v varnih koncentracijah. V drugem delu smo obrazložili svoj zaključek ocene na podlagi informacij iz dela A. Ugotovili smo, da je izdelek varen za zdravje ljudi in ustrezen za prodajo na slovenskem trgu. Poročilo o varnosti kozmetičnega izdelka je del dokumentacije z informacijami o kozmetičnem izdelku, kar mora proizvajalec hraniti še 10 let po tem ko je zadnja serija izdelkov bila dana na trg. Ko imamo urejeno vso dokumentacijo, moramo izdelek še priglasiti na CPNP portalu. To lahko opravimo preko spleta in je brezplačno. Izdelana emulzija je fizikalno stabilna in ustreza mikrobioloških kriterijem. Varnost izdelka smo dokazali z izdelavo poročila o varnosti. Zaključimo lahko, da je izdelek varen za uporabo in se lahko prodaja na slovenskem trgu. Dodatno bi lahko analizirali še učinkovitost kozmetičnega izdelka (izboljšanje hidratacije kože na podlagi kapacitivnosti ali prevodnosti) ter pridobili certifikat za naravno kozmetiko.

Language:Slovenian
Keywords:kozmetičen izdelek, formulacija, dokumentacija z informacijami o kozmetičnem izdelku, poročilo o varnosti kozmetičnega izdelka
Work type:Master's thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2019
PID:20.500.12556/RUL-110778 This link opens in a new window
Publication date in RUL:19.09.2019
Views:2801
Downloads:529
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Secondary language

Language:English
Title:Description of cosmetic product development and preparation of documentation in accordance with the legislation
Abstract:
The trend in the cosmetics industry is dictated by consumers themselves. Due to the increasing consumer awareness of environmental and health protection, consumers are increasingly resorting to cosmetics made from natural ingredients (i.e. natural cosmetics). Despite the adverse economic conditions, the cosmetic market is still showing strong growth in recent years. Due to good economic indicators and increased demand for natural cosmetics, many people see this as an interesting entrepreneurial experience. In recent years Slovenia got quite a few boutique manufacturers of natural cosmetic. Skin care products have the largest European market share, where emulsion is the dominant technological form. The emulsion is made up of three basic components - the inner phase, the outer phase and the emulsifier, but this is by no means sufficient to produce a safe, effective and stable cosmetic product. Cosmetically active ingredients may be added to enhance the effect of cosmetic product. Penetration enhancers are used to enhance the penetration of the active cosmetic ingredient and improve skin feel. Stability is improved by using thickeners. Cosmetic product must be microbiologically safe, so the appropriate preservative must be used. In our formulation of moisturizing skin care cream (O / V emulsion), we tended to use as many natural ingredients as possible. Distilled water was used for the outer phase and shea butter and argan oil for the inner phase. Olivem® 1000 was used as the emulsifier. Glycerol, allantoin and coco caprylate were used as moisturizers. In addition to its moisturizing properties, allantoin has also a keratoplastic action (softens the stratum corneum). In addition to the moisturizing effect, coco caprylate also improves the lubricity of the emulsion. The emulsion was microbiologically protected with Cosgard preservative and potassium sorbate. Microbiological protection was proven by testing the microbiological quality and challenge test. Pelargonium essential oil was used to improve the smell. The final formulation had a pH in the alkaline range, so a citric acid solution was used and reduced its pH to 5.5. However, the finished product must be effective and safe to use over time. The safety of a cosmetic product is proven by safety report of cosmetic product. The report consists of two parts: A and B. Part A consists of 10 points. The point 8 is essential for the safety of the cosmetic product, where we have examined the toxicological profiles for all ingredients used and calculated the margin of safety. All ingredients used are in accordance with Regulation 1223/2009 / EC and are safe or used in safe concentrations. The calculated margin of safety of each ingredient was above 100, which is sufficient to ensure that the ingredient is safe. In the second part, we explain our conclusion of the assessment based on the information in part A. We have determined that the product is safe for human health and suitable for sale on the Slovenian market. The cosmetic product safety report is part of the cosmetic product information file and must be retained by the manufacturer for 10 years after the last batch of products has been placed on the market. Once we have all the documentation in order, we have to notify the product on the cosmetic product notification portal. This can be done online and is free of charge. The emulsion produced is physically stable and meets microbiological criteria. Product safety was proven by making a safety report. We can conclude that the product is safe to use and can be sold on the Slovenian market. We could further analyze the effectiveness of the cosmetic product (improving skin hydration based on capacitance or conductivity) and obtain certification for natural cosmetics.

Keywords:Key words: cosmetic product, formulation, product information file, cosmetic product safety report

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