20.500.12556/RUL-182473 Pregled prisotnosti nedovoljenih snovi in kontaminantov v negovalnih kozmetičnih izdelkih v obdobju 2022-2025 na trgu Evropske unije s Sistemom hitrega obveščanja o nevarnih izdelkih Overview of prohibited substances and contaminants in personal care cosmetics on the European Union market during 2022-2025 through the Rapid alert system for dangerous products Kozmetični izdelki zaradi neposrednega in pogosto dolgotrajnega stika s kožo ter sluznicami predstavljajo pomemben vir potencialne izpostavljenosti kemičnim in mikrobiološkim tveganjem, zato je zagotavljanje njihove varnosti ključnega pomena za varovanje zdravja potrošnikov. Namen diplomske naloge je bil analizirati prisotnost prepovedanih snovi in različnih kontaminantov v negovalnih kozmetičnih izdelkih na trgu Evropske unije v obdobju 2022–2025 na podlagi podatkov iz sistema hitrega obveščanja Safety Gate ter ovrednotiti uporabnost tega sistema pri nadzoru varnosti. V analizo je bilo vključenih 1631 prijavljenih kozmetičnih izdelkov, razvrščenih glede na skupino izdelka, državo izvora, državo prijave, vrsto tveganja ter vrsto kontaminanta. Največ prijav se je nanašalo na kozmetične izdelke za čiščenje (630), sledili so izdelki za nego kože (471) ter deodoranti in antiperspiranti (283), kar kaže na večje tveganje pri izdelkih z visoko pogostostjo uporabe. Rezultati so pokazali, da je večina neskladnosti povezana s kemičnimi kontaminanti (96 %), medtem je bila mikrobiološka kontaminacija ugotovljena v manjšem deležu primerov (3 %). V preostalem 1 % so bila zabeležena druga tveganja, kot so zdravstvena tveganja, dušenje ali ureznine. Med kemičnimi snovmi so prevladovale prepovedane snovi iz Priloge II Uredbe (ES) št. 1223/2009 ter snovi z razvrstitvijo CMR. Najpogosteje zaznana snov je bila 3-(4-terc-butilfenil)-2-metilpropanal (BMHCA), ki je bila po 1. marcu 2022 zaradi reproduktivne toksičnosti uvrščena med prepovedane snovi. Pogosto so bile zaznane tudi težke kovine (arzen, kadmij, svinec, živo srebro), 1,4-dioksan ter alergene dišavne sestavine, kot sta linalol in limonen. Mikrobiološke neskladnosti so vključevale prisotnost potencialno patogenih mikroorganizmov, kot sta Pseudomonas aeruginosa in Staphylococcus aureus, ki lahko predstavljajo večje tveganje predvsem za ranljive skupine uporabnikov. Analiza je pokazala tudi, da največ neskladnih izdelkov izvira iz Evrope (1361), pri čemer je prevladovala Italija (826), ki je tudi podala največ prijav v sistem (1112). Rezultati kažejo, da sistem Safety Gate predstavlja pomemben mehanizem za zgodnje prepoznavanje nevarnih kozmetičnih izdelkov ter omogoča hitro izmenjavo informacij in usklajeno ukrepanje med državami članicami Evropske unije. Due to their direct and often prolonged contact with the skin and mucous membranes, cosmetic products represent an important source of potential exposure to chemical and microbiological risks. Ensuring their safety is therefore essential for the protection of consumer health. The aim of this thesis was to analyse the presence of prohibited substances and various contaminants in cosmetic products intended for personal care on the European Union market in the period from 2022 to 2025 using data from the Safety Gate rapid alert system, and to evaluate the usefulness of this system in monitoring product safety. A total of 1631 reported cosmetic products were included in the analysis. The products were classified according to product category, country of origin, reporting country, type of risk and type of contaminant. Most notifications referred to cleansing cosmetic products (630 cases), followed by skin care products (471) and deodorants and antiperspirants (283), indicating increased risk and regulatory attention for products with high frequency of use. The results showed that the majority of non-compliances were associated with chemical contaminants (96 %), while microbiological contamination was detected in a smaller proportion of cases (3 %). The remaining 1 % involved other types of risk, such as health hazards, choking hazards or cuts. Among chemical substances, prohibited substances listed in Annex II of Regulation (EC) No. 1223/2009 and substances classified as CMR predominated. The most frequently detected substance was 3-(4-tert-butylphenyl)-2-methylpropanal, which was classified as a prohibited substance after 1 March 2022 due to its reproductive toxicity. Other frequently detected contaminants included heavy metals (arsenic, cadmium, lead and mercury), 1,4-dioxane and allergenic fragrance substances such as linalol and limonene. Microbiological non-compliances included the presence of potentially pathogenic microorganisms such as Pseudomonas aeruginosa and Staphylococcus aureus, which may represent an increased risk particularly for vulnerable groups of users. The analysis also showed that most non-compliant products originated from European countries (1361), with Italy accounting for the largest share (826). Italy also submitted the highest number of notifications to the system (1112). The results indicate that the Safety Gate system represents an mechanism for the early identification of hazardous cosmetic products and enables rapid information exchange and coordinated action among European Union Member States. kemična kontaminacija mikrobiološka kontaminacija negovalni kozmetični izdelki sistem hitrega obveščanja varstvo potrošnikov chemical contaminants consumer safety microbiological contaminants personal care cosmetic products rapid alert sistem true false false [N. Drobnič] Slovenski jezik Angleški jezik Diplomsko delo 2026-05-13 08:45:09 2026-05-13 08:45:28 2026-05-15 04:06:38 0000-00-00 00:00:00 2026 0 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 1970-01-01 579.66:661.58(4-67EU)(043.2) 125328 278148867 31943.pdf 31943.pdf 1 279FD40CE499B4BAD089922887244588 9450bed6ec375f5196d7c6bf73a137ebe29f3d44092ebba0147c9490d2dd2cd1 0edbad84-4e97-11f1-b0ab-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=233773 31944.pdf 31944.pdf 1 846490829CA2AF90EE67F2837D36916E 086c0d12c66b94ba666da5184e6020ebea0f0bd575818f565be0b3113221ace1 0ee124b7-4e97-11f1-b0ab-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=233774 Fakulteta za farmacijo 0 0 0