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Priprava poročila o varnosti kozmetičnega izdelka za izbrani balzam za lase
ID Škufca, Petja (Author), ID Jakopin, Žiga (Mentor) More about this mentor... This link opens in a new window

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Abstract
Balzami za lase predstavljajo nepogrešljiv del kozmetične nege, namenjene izboljšanju strukture, videza in zdravja las. Njihova primarna funkcija je zagotavljanje ustrezne hidracije, zmanjševanje poškodb, ki nastanejo zaradi mehanskih in kemičnih vplivov, ter olajšanje česanja. Z naraščajočim zanimanjem za nego las in razvojem inovativnih formulacij so balzami postali ključni izdelek v vsakodnevni rutini mnogih posameznikov. V magistrski nalogi je predstavljena toksikološka ocena varnosti kozmetičnega izdelka – balzama za lase, v skladu z Uredbo (ES) št. 1223/2009 in smernicami Znanstvenega odbora za varnost potrošnikov (SCCS). Osrednji cilj raziskave je bil ovrednotiti varnost posameznih sestavin izdelka ob upoštevanju njihove koncentracije v formulaciji, ocenjene dermalne absorpcije, sistemski izpostavljenosti (SED) in razpoložljivih podatkov o najvišjih odmerkih, pri katerih še ni bilo opaženih neželenih učinkov (NOAEL). V nalogi so predstavljeni tudi osnovni principi toksikološke ocene, struktura poročila o varnosti kozmetičnega izdelka in zakonodajni okvir. Naloga tako nudi celovit vpogled v praktično izvedbo ocene varnosti ter vlogo strokovno usposobljene osebe pri zagotavljanju skladnosti izdelkov na trgu. Za vse sestavine smo iz znanstvene literature ter regulatornih virov zbrali temeljne fizikalno-kemijske lastnosti, toksikološke profile in ostale ustrezne podatke (podatke o dermalni absorpciji in vrednostih NOAEL). Za oceno tveganja smo uporabili pristop MoS (meja varne uporabe) in ugotovili, da vse sestavine, vključene v formulacijo, presegajo varnostni prag MoS ≥ 100, kar pomeni, da je izdelek varen za uporabo v predvidenih pogojih. Izvedeni preračuni potrjujejo, da je obravnavani balzam za lase varen za potrošnike pri predvideni uporabi ter v celoti skladen z zahtevami veljavne evropske kozmetične zakonodaje.

Language:Slovenian
Keywords:kozmetični izdelek, poročilo o varnosti kozmetičnega izdelka, kozmetična zakonodaja.
Work type:Master's thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2025
PID:20.500.12556/RUL-171760 This link opens in a new window
Publication date in RUL:02.09.2025
Views:192
Downloads:0
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Secondary language

Language:English
Title:Preparation of a cosmetic product safety report for a selected hair conditioner
Abstract:
Hair conditioners represent an indispensable part of cosmetic care aimed at improving the structure, appearance, and health of the hair. Their primary function is to provide adequate hydration, reduce damage caused by mechanical and chemical influences, and facilitate combing. With growing interest in hair care and the development of innovative formulations, conditioners have become a key product in the daily routine of many individuals. This Master's thesis presents a toxicological safety assessment of a cosmetic product – a hair conditioner – in accordance with Regulation (EC) No. 1223/2009 and the guidelines of the Scientific Committee on Consumer Safety (SCCS). The main objective of the research was to evaluate the safety of individual ingredients in the product, taking into account their concentration in the formulation, estimated dermal absorption, systemic exposure dose (SED), and available data on the No Observed Adverse Effect Level (NOAEL). The thesis also outlines the basic principles of toxicological assessment, the structure of the cosmetic product safety report, and the legislative framework. Thus, it provides a comprehensive insight into the practical implementation of safety assessment and the role of the qualified safety assessor in ensuring product compliance on the market. For all ingredients, basic physicochemical properties, toxicological profiles, and other relevant data (including dermal absorption and NOAEL values) were collected from scientific literature and regulatory sources. The Margin of Safety (MoS) approach was used for risk assessment, and it was determined that all ingredients included in the formulation exceed the safety threshold of MoS ≥ 100, indicating that the product is safe for use under the intended conditions. The calculations performed confirm that the hair conditioner under consideration is safe for consumers when used as intended and is fully compliant with the requirements of current European cosmetic legislation.

Keywords:cosmetic product, cosmetic product safety report, cosmetic legislation.

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