Pregled odpoklicev kozmetičnih izdelkov v sistemu RAPEX

Zupančič, Nika (author), Gašperlin, Mirjana (mentor)

Dandanes je kozmetika nepogrešljiv del našega življenja, zato je njena varnost izrednega pomena. Regulirana je z Uredbo (ES) 1223/2009 o kozmetičnih izdelkih, ki veleva, da morajo vsi kozmetični izdelki biti varni za zdravje ljudi pod normalnimi in razumno predvidljivimi pogoji uporabe. Zavoljo učinkovitega nadzora nad evropskim trgom je bil leta 2004 ustanovljen informacijski sistem RAPEX (angl. Rapid alert system for dangerous non-food products). Ta skrbi za hitro in učinkovito medsebojno obveščanje držav članic o izdelkih na trgu, ki pomenijo resno tveganje za zdravje in varnost potrošnikov – vključujoč kozmetične izdelke. Magistrska naloga zajema pregled kozmetičnih izdelkov, prijavljenih v bazo RAPEX na podlagi resnega kemijskega tveganja, v časovnem obdobju 2018 – 2022. Resno tveganje je opredeljeno kot tveganje, ki zahteva hitro posredovanje pristojnih organov, tudi takrat ko učinki tveganja niso takojšnji. V bazo je bilo prijavljenih 450 takih kozmetičnih izdelkov, ki so bili razvrščeni v skupine po namembnosti. Snovi, odgovorne za neskladnost, so bile vrednotene glede na trenutno veljavno Uredbo (ES) 1223/2009. Dano petletno obdobje zajema pandemijo Covid-19, katere vpliv se je pokazal za znatnega z upadom števila prijav izdelkov za dobrih 50 % glede na predpandemično povprečje. Največ izdelkov je v sistem hitrega obveščanja prijavila Švedska. Nemčija, ki ima največji kozmetični trg v Evropi, je bila na 4. mestu po številu prijav. Po izvoru je največ izdelkov neznanega porekla. Temu je sledila Kitajska, ki po teh podatkih sodeč še vedno, kljub prizadevanju evropskih organov, ne dosega evropskih predpisov glede varnosti potrošniških izdelkov. Tudi sicer je Azija tista, iz koder je izviralo največ neskladnih kozmetičnih izdelkov, in sicer 35,6 %. Z 31,6 % ji je sledila Evropa. Dobro polovico vseh prijavljenih neskladnih kozmetičnih izdelkov predstavljajo izdelki za posvetlitev kože, parfum, ter kreme, geli in losjoni za telo. Te skupine so v nalogi podrobneje analizirane. Snovi, odgovorne za neskladnost izdelkov za posvetlitev kože, so bile najpogosteje hidrokinon, živo srebro in klobetazol propionat. Pri parfumih je z izjemo vsebnosti metil alkohola v enem izdelku šlo za prekoračene koncentracije dišav. 58,3 % neskladnih krem, gelov in losjonov za telo je vsebovalo preseženo koncentracijo mešanice konzervansov metilizotiazolinona in metilkloroizotiazolinona. Skupno je bilo kar 72,2 % izdelkov v tej skupini neskladnih zaradi presežene koncentracije konzervansov.

• Language: Slovenian
• Keywords: RAPEX, kozmetični izdelki, odpoklic, varnost potrošnikov, resno kemijsko tveganje
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2023
• PID: 20.500.12556/RUL-153001
• Publication date in RUL: 14.12.2023

Secondary language

• Language: English
• Title: Overview of cosmetic product recalls in RAPEX system

Abstract

Nowadays, cosmetics are an indispensable part of our lives, so their safety is of paramount importance. It is regulated by Regulation (EC) 1223/2009 on cosmetic products, which states that all cosmetic products must be safe for human health under normal and reasonably foreseeable conditions of use. In order to effectively control the European market, the RAPEX (Rapid alert system for dangerous non-food products) information system was set up in 2004 to ensure that Member States can quickly and efficiently inform each other about products on the market that pose a serious risk to the health and safety of consumers - including cosmetic products. The MSc thesis reviews the cosmetic products notified to RAPEX on the basis of serious chemical risk over the time period 2018-2022. A serious risk is defined as a risk that requires rapid intervention by the competent authorities, even when the effects of the risk are not immediate. 450 such cosmetic products were notified to RAPEX and classified into groups according to their intended use. The substances responsible for the non-compliance have been evaluated against the currently applicable Regulation (EC) 1223/2009. The five-year period covers the Covid-19 pandemic, the impact of which has been shown to be significant, with a drop in the number of product notifications of more than 50% compared to the pre-pandemic average. Sweden has notified the highest number of products to the Rapid Alert System. Germany, which has the largest cosmetics market in Europe, ranked 4th in the number of notifications. By origin, most products are of unknown origin. This was followed by China, which, according to these data, is still not complying with European rules on consumer product safety, despite the efforts of the European authorities. Asia was also the source of the highest number of non-compliant cosmetic products, accounting for 35.6%, followed by Europe with 31.6%. Skin lighteners, perfumes, and body creams, gels and lotions accounted for a good half of all non-compliant cosmetic products reported. These groups are analysed in more detail in the thesis. The substances responsible for the non-compliance of skin lightening products were most frequently hydroquinone, mercury and clobetasol propionate. For perfumes, with the exception of methanol in one product, the fragrance concentrations were exceeded. 58.3% of the non-compliant body creams, gels and lotions contained an exceeded concentration of a mixture of preservatives methylisothiazolinone and methylchloroisothiazolinone. Overall, 72.2% of the products in this group were non-compliant due to an excess concentration of preservatives.

• Keywords: RAPEX, cosmetic products, recalls, consumer safety, serious chemical risk