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Bezbednost kozmetičkih proizvoda u svetlu evropskih propisa - kozmetička uredba 1223/2009

dc.creatorSavić, Snežana
dc.creatorPaunović, Jelica
dc.date.accessioned2019-09-02T12:04:53Z
dc.date.available2019-09-02T12:04:53Z
dc.date.issued2018
dc.identifier.issn0004-1963
dc.identifier.urihttps://farfar.pharmacy.bg.ac.rs/handle/123456789/3103
dc.description.abstractAfter several accidental situations in the cosmetics industry which led to fatal outcomes, the reappeared a need to regulate cosmetics manufacturing. On July 1976 Cosmetic Directive 76/768/EEC came into force with the aim to define the safety criteria to which cosmetic products must conform and to prescribe rules for their labelling and packaging. The Directive has been widened by seven amendments and numerous technical adaptations that led to some confusion. On 30 November 2009 the new document came into force that consolidated all additions and changes: Regulation (EC) No 1223/2009 Of The European Parliament And Of The Council of 30 November 2009 on cosmetic products, known as Cosmetic Regulation The main driver for new legal framework has been simplification of procedures and the streamlining of terminology, achieving an unobstructed traffic of cosmetic products across the EU market. The main aim of The Regulation 1223/2009 is to ensure that a cosmetic product is of high-quality, efficient and safe for human health under normal or reasonably foreseeable conditions of use. The most significant changes introduced by the Cosmetics Regulation 1223/2009 include: strengthened safety requirements for cosmetic products; introduction of the notion of 'responsible person'; centralised notification of all cosmetic products placed on the EU market; introduction of the reporting of serious undesirable effects (SUE); new rules for the use of nanomaterials in cosmetic product. One of the most important duty of the responsible person is preparing a Product Information File (PIF). It is a mandatory document for each cosmetic product that is placed on the market in the Europe Union.en
dc.description.abstractNakon nekoliko ekscesnih situacija u kozmetičkoj industriji koje su se završile smrtnim ishodom, javila se potreba za pravnim regulisanjem kozmetičke proizvodnje. Jula 1976. na snagu je stupila Kozmetička direktiva 76/768/EEZ, čiji je cilj bio da se definišu bezbednosni kriterijumi kojima se moraju prilagoditi kozmetički proizvodi i propišu pravila za njihovo obeležavanje i pakovanje. Osnovni tekst Direktive vremenom je proširivan, donošenjem sedam amandmana/dopuna i velikog broja adaptacija, što je stvorilo konfuziju. Stoga je 30.11.2009. donet novi zakonski propis, koji je na jednom mestu objedinio sve dotadašnje izmene i dopune: Kozmetička uredba Evropske komisije (EC) 1223/2009 o kozmetičkim proizvodima (engl. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products). Ideja vodilja za donošenje novog pravnog okvira je bila pojednostavljivanje procedura i ujednačavanje terminologije, što bi omogućilo nesmetan promet dobara kroz jedinstveno tržište Evropske unije (EU). Osnovni cilj Kozmetičke uredbe 1223/2009 je da osigura da kozmetički proizvod bude kvalitetan, efikasan i bezbedan u uslovima normalne i razumno predvidive upotrebe. Najznačajnije promene predstavljene u okviru Uredbe 1223/2009 su: pojačani bezbednosni zahtevi za kozmetičke proizvode; uvođenje pojma 'odgovorne osobe'; centralizovana evidencija svih kozmetičkih proizvoda stavljenih na tržište EU; uvođenje izveštavanja o ozbiljnim neželjenim efektima; nova pravila za upotrebu nanomaterijala u kozmetičkim proizvodima. Jedna od glavnih obaveza odgovorne osobe je izrada Dosijea sa informacijama o kozmetičkom proizvodu. On predstavlja prateći dokument za svaki kozmetički proizvod koji je dostupan na tržištu.sr
dc.publisherSavez farmaceutskih udruženja Srbije, Beograd
dc.rightsopenAccess
dc.rights.urihttps://creativecommons.org/licenses/by-sa/4.0/
dc.sourceArhiv za farmaciju
dc.subjectRegulation (EC) No 1223/2009 on Cosmetic Producten
dc.subjectResponsible Personen
dc.subjectProduct Information File (PIF)en
dc.subjectCosmetic product safety reporten
dc.subjectCosmetic product safety assessmenten
dc.subjectCosmetovigilanceen
dc.subjectUredba EC 1223/2009 o kozmetičkim proizvodimasr
dc.subjectOdgovorna osobasr
dc.subjectDosije sa informacijama o kozmetičkom proizvodusr
dc.subjectIzveštaj o bezbednosti kozmetičkog proizvodasr
dc.subjectProcena bezbednosti kozmetičkog proizvodasr
dc.subjectKozmetovigilancasr
dc.titleSafety of cosmetic products in the light of European legislation: Cosmetic Regulation (EC) No 1223/2009en
dc.titleBezbednost kozmetičkih proizvoda u svetlu evropskih propisa - kozmetička uredba 1223/2009sr
dc.typearticle
dc.rights.licenseBY-SA
dcterms.abstractСавић, Снежана; Пауновић, Јелица; Безбедност козметичких производа у светлу европских прописа - козметичка уредба 1223/2009; Безбедност козметичких производа у светлу европских прописа - козметичка уредба 1223/2009;
dc.citation.volume68
dc.citation.issue5
dc.citation.spage911
dc.citation.epage933
dc.citation.other68(5): 911-933
dc.citation.rankM52
dc.identifier.doi10.5937/ArhFarm1805911S
dc.identifier.scopus2-s2.0-85064606688
dc.identifier.fulltexthttps://farfar.pharmacy.bg.ac.rs//bitstream/id/1699/3101.pdf
dc.type.versionpublishedVersion


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