Pregled kontaminantov in nedovoljenih snovi v kozmetičnih izdelkih na trgu Evropske unije, prijavljenih v sistem hitrega obveščanja v obdobju 2015-2020

Majdič, Urša (author), Sollner Dolenc, Marija (mentor)

Kozmetični izdelki so v razvitem svetu ena od stvari, s katero se vsakdo sreča skoraj vsakodnevno, naj gre za čiščenje, nego, dekoriranje ali zaščito. Zaradi njene široke uporabe je zelo pomembno, da so izdelki za uporabnike pri normalni in razumni uporabi varni. To področje je v Evropski uniji urejeno z Uredbo (ES) 1223/2009. Število kozmetičnih izdelkov na trgu je visoko in s tem prihaja tudi do pojava neustreznih izdelkov. RAPEX oz. Sistem hitrega obveščanja o nevarnih neživilskih izdelkih je sistem, ki so ga v Evropski uniji (EU) uvedli z namenom hitre izmenjave informacij o neustreznih izdelkih na tržišču, ki predstavljajo resno tveganje za zdravje in varnost potrošnikov med državami članicami. Med njih sodijo tudi kozmetični izdelki. V diplomski nalogi smo proučili neustrezne kozmetične izdelke, ki so jih v sistem prijavili med julijem 2015 in julijem 2020. Pri delu smo si pomagali z Uredbo (ES) 1223/2009 o kozmetičnih izdelkih, Uredbo (ES) št. 1272/2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi ter podatkovno bazo CosIng. V proučevanem obdobju je bilo v sistem prijavljenih 462 kozmetičnih izdelkov. Ugotovili smo, da je bilo največ prijavljenih izdelkov namenjenih negi. Največ izdelkov je v bazo prijavila Nemčija, ki ima med državami prijaviteljicami največji trg. Ugotovili smo, da je izvor kar 10,4 % izdelkov, danih na trg Evropske unije, neznan. 54,1 % izdelkov je v EU uvoženih iz držav, ki niso njene članice, na lastnem trgu pa je proizvedenih 35,5 % izdelkov. V največ (366) primerih je šlo za kemično neustrezne izdelke, sledili so mikrobiološko neustrezni. V treh primerih je šlo za kombinacijo obeh neustreznih kontaminacij. V 14 % izdelkov je šlo za več kot en kontaminant hkrati. Najbolj pogost kontaminant v kozmetičnih izdelkih je zmes metilkloroizotiazolinona in metilizotiazolinona, sledi pa mu hidrokinon. V večini primerov mikrobiološko kontaminiranih izdelkov v sistemu ni bilo točno zavedeno, za kateri kontaminant gre, v 7 primerih izdelkov je šlo za bakteriji Staphylococcus aureus in Pseudomonas aeruginosa. Poleg kemičnih in mikrobioloških kontaminacij je bilo v sistem prijavljenih kar nekaj izdelkov, ki so imeli kot nevarnost klasificirano ostalo. V največ (42) od teh primerov je šlo za izgled izdelka, podoben hrani kar Uredba (ES) o kozmetičnih izdelkih prepoveduje. Zaradi neustreznosti izdelkov so bili sprejeti tako obvezni ukrepi, kot tudi prostovoljni ukrepi s strani proizvajalcev, distributerjev in prodajalcev. V nekaterih primerih prijave je šlo za več ukrepov hkrati. V največ (344) primerih je šlo za odpoklic izdelka s trga ali od kupcev. Nekateri izdelki so za uporabnika predstavljali večjo nevarnost kot drugi. Odkrili smo, da je bilo v sistem zabeleženih celo nekaj izdelkov, ki so vsebovali sestavine uvrščene med CMR- snovi.

• Language: Slovenian
• Keywords: kozmetični izdelki, sistem RAPEX, negovalna kozmetika, kemična kontaminacija, mikrobiološka kontaminacija, ukrepi
• Work type: Bachelor thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-138052
• Publication date in RUL: 08.07.2022

Secondary language

• Language: English
• Title: Review of prohibited substances and contaminants in cosmetics available on the European Union market, reported by rapid alert system during 2015-2020

Abstract

Cosmetic products are part of every person's life in developed countries almost daily. They are used for cleaning purposes, skin and body nourishment, decorating, and protection of skin. These products are widely used, so it is very important that they are safe for users when used under normal and reasonable conditions. Regulation (EC) No. 1223/2009 is the main legislation that the European Union uses to regulate the cosmetics market. The number of cosmetics products is high. There is also a high number of unsuitable products. RAPEX, or Rapid Exchange of Information System, is the European Union's rapid alert system for unsafe consumer products and consumer protection. It was created for the quick exchange of information about unsuitable products on the market of the European Union to protect consumers' health and safety. It includes information about cometic products that do not comply with regulations. The diploma thesis deals with unsuitable products that were logged in the system between July 2015 and July 2020. We have used Regulation (EC) No. 1223/2009, Directive 76/768/EC and CosIng base to deal with the thesis problems. In the inspected time frame, there were 462 cosmetics products logged into the system. Self-care cosmetics were the most frequently logged as unfit. Germany logged the most products as expected, due to its large market. The origin of 10.4% of cosmetics products was unknown. There were 54.1% imported products and 35.5% of products were EU produced. In most cases (366), the products posed a chemical hazard followed by microbiological. There were three cases that posed mix of both dangers. In 14% of products, there was more than one contaminant present. The most common contaminant in cosmetic products was the mix of methylsothiazolinone and methylchloroisothiazolinone, and the second one was hydrokinon. In most microbiologically contaminated cases, it was not exactly stated which micro-organism was present. Seven reported cases contained organisms such as Staphylococcus aureus and Pseudomonas aeruginosa, prohibited by Regulation (EC) No. 1223/2009. In addition to microbiological and chemical hazards, products are also reported to be dangerous when classified as "other." 42 cases were unsuitable because their appearance imitated food, which is prohibited by Regulation (EC) No. 1223/2009. Due to the non-conformity, both mandatory and voluntary measures taken by manufacturers, distributors, and retailers were taken, in some cases, several at the same time. In most (344) cases, the product was recalled from the market or from customers. Some products pose a greater danger to the user than others. Even products containing CMR substances were recorded in the system.

• Keywords: cosmetics products, RAPEX system, care cosmetics, chemical contamination, microbiological contamination, measures