EURÓPSKA LEGISLATÍVA pre kozmetické výrobky
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1 EURÓPSKA LEGISLATÍVA pre kozmetické výrobky Nariadenie Európskeho parlamentu a Rady (ES) č. 1223/2009 o kozmetických výrobkoch - Korigendum k nariadeniu Európskeho parlamentu a Rady (ES) č. 1223/2009 o kozmetických výrobkoch NOVELY nariadenia 1223/2009 Nariadenie Komisie (EÚ) č. 344/ Nariadenie Komisie (EÚ) č. 483/ Nariadenie Komisie (EÚ) č. 655/ Nariadenie Komisie (EÚ) č. 658/ Nariadenie Komisie (EÚ) č. 1197/ Nariadenie Komisie (EÚ) č. 358/ Nariadenie Komisie (EÚ) č. 866/ Korigendum k nariadeniu Komisie (EÚ) č. 866/ SK Korigendum k nariadeniu Komisie (EÚ) č. 866/ Nariadenie Komisie (EÚ) č. 1003/ Nariadenie Komisie (EÚ) č. 1004/ Nariadenie Komisie (EÚ) č. 2015/ Nariadenie Komisie (EÚ) č. 2015/1298/ Nariadenie Komisie (EÚ) č. 2016/314 Nariadenie Komisie (EÚ) č. 2016/621 Nariadenie Komisie (EÚ) č. 2016/622 VYKONÁVACIE PREDPISY k nariadeniu 1223/2009
2 Vykonávacie rozhodnutie Komisie 2013/674/EÚ k usmerneniam k prílohe I k nariadeniu Európskeho parlamentu a Rady (ES) č. 1223/2009http://eur-lex.europa.eu/legalcontent/SK/TXT/PDF/?uri=CELEX:32013D0674&from=SK USMERNENIA k nariadeniu 1223/2009 TVRDENIA Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products HLÁSENIA ZÁVAŽNÝCH NEŽIADUCICH ÚČINKOV Hlásenie závažných nežiaducich účinkov (SUE) - Usmernenie k hláseniam závažných nežiaducich účinkov - Posúdenie kauzality nežiaducich účinkov vyvolaných kozmetickými výrobkami - SUE Form A, B, C (vzory oznámení) - The national contact points in charge of SUE (kontaktné miesta) NOTIFIKÁCIA NA CPNP Príručka na oznamovanie kozmetických výrobkov na Cosmetic Products Notification Portal (CPNP) Article 13 Používateľská príručka na oznamovanie kozmetických výrobkov s obsahom Nanomateriálov Article 16 HRANIČNÉ VÝROBKY Manual on the Scope of Application of the Cosmetic regulation (EC) No 1223/2009 (ART. 2(1)(a))Version 1.0 (November 2013) NORMY pre kozmetické výrobky STN/EN/ISO Kozmetika. Správna výrobná prax. Pokyny na správnu výrobnú prax STN EN ISO Kozmetické výrobky. Mikrobiológia. Dôkaz baktérií Candida albicans STN EN ISO Kozmetické výrobky. Mikrobiológia. Všeobecné pokyny na mikrobiologické skúšanie STN EN ISO Kozmetické výrobky. Mikrobiológia. Dôkaz a stanovenie počtu aeróbnych mezofilných baktérií STN EN ISO Kozmetické výrobky. Mikrobiológia. Stanovenie baktérií Escherichia coli STN EN ISO Kozmetické výrobky. Mikrobiológia. Dôkaz baktérií Pseudomonas aeruginosa STN EN ISO Kozmetické výrobky. Mikrobiológia. Dôkaz baktérií Staphylococcus aureus STN EN ISO Kozmetické výrobky. Mikrobiológia. Pokyny na posudzovanie rizika a identifikáciu výrobkov s nízkym mikrobiologickým rizikom STN EN ISO Kozmetické výrobky. Mikrobiológia. Stanovenie počtu kvasiniek a plesní STN EN ISO Kozmetické výrobky. Mikrobiológia. Dôkaz špecifikovaných a nešpecifikovaných mikroorganizmov STN/EN/ISO Kozmetické výrobky. Mikrobiológia. Hodnotenie antimikrobiálnej ochrany kozmetických výrobkov STN EN ISO Kozmetické výrobky. Mikrobiologické limity
3 INÉ PREDPISY, DOKMENTY A USMERNENIA pre kozmetické výrobky bezpečnosť The SCCS'S Notes of Guidance for the Testing of Cosmetics Ingredients and Their Safety Evaluation, 8 th Revision Resolution CM/ResAP(2012)1 on safety criteria for cosmetic products intended for infants 1 Scientific Committee on Cosmetic Products and Non-food products intended for Consumers (SCCS) opinoins Rozhodnutie Komisie č. 2004/905/ES, ktorým sa ustanovujú zásady oznamovania nebezpečných spotrebiteľských výrobkov príslušným orgánom členských štátov výrobcami a distribútormi v súlade s článkom 5 odsek 3 smernice 2001/95/ES Usmernenie O oznamovaní nebezpečných spotrebiteľských výrobkov príslušným orgánom členských štátov výrobcami a distribútormi v súlade s článkom 5 odsek 3 smernice 2001/95/ES Usmernenie Postup výrobcov a distribútorov pri prijatí nápravných opatrení pri zistení že ich výrobky sú nebezpečné pre zdravie ľudí. (pozri českú verziu, slovenská zatiaľ chýba) obaly a označovanie Rozhodnutie Komisie č. (ES) č. 2006/257/ES, ktoré dopĺňa rozhodnutie Komisie č. 96/335/ES, ktorým sa ustanovuje súpis a spoločná nomenklatúra zloženia kozmetických výrobkov. - Oznámenie Komisie 2007/C 10/07 o dátume povinného uplatňovania aktualizácie súpisu a spoločnej nomenklatúry prísad používaných v kozmetických výrobkoch (1) - CosIng - Databáza zložiek pridávaných do kozmetických výrobkov Odporúčanie Komisie 2006/406/ES o účinnosti opaľovacích prípravkov a o nich súvisiacich údajoch Council Directive 76/211/EEC relating to the making-up by weight or by volume of certain prepackaged products.
4 Council Directive 80/232/EEC relating to the ranges of nominal quantities and nominal capacities permitted for certain prepackaged products. Council Directive 75/324/EEC relating to aerosol dispensers and Commission Directive 94/1/EC adapting some technicalities of Council Directive 75/324/EEC on aerosol dispensers. European Parliament and Council Directive 94/62/EC on packaging and packaging waste Nariadenie Európskeho parlamentu a Rady (ES) č. 1980/2000 o zrevidovanom systéme (schéme) udeľovania environmentálnej značky spoločenstva - Rozhodnutie Komisie 2007/506/ES z 21. júna 2007, ktorým sa stanovujú ekologické kritériá na udelenie environmentálnej značky Spoločenstva mydlám, šampónom a vlasovým kondicionérom testy na zvieratách Správa Európskej komisie Rade a Európskemu parlamentu Správa o vývoji, overovaní a právnom prijímaní alternatívnych metód týkajúcich sa testov na zvieratách v oblasti kozmetiky (2004) Timetables for the phasing-out of animal testing in the framework of the 7th Amendment to the Cosmetics Directive (Council Directive 76/768/EEC) For an overview on the different activities to elaborate alternative testing methods USMERNENIA Európskej komisie k nariadeniu ES č. 1223/2009 o kozmetických výrobkoch Borderline products: Guidance Document on the Relationship Between the General Product Safety Directive (GPSD) and Certain Sector Directives with Provisions on Product Safety Guidance Document agreed between the Commission services and the competent authorities of Member States for the biocidal products Directive 98/8/EC and for the cosmetic products Directive 76/768/EEC borderline between Directive 98/8/EC concerning the placing on the market of biocidal products and Directive 76/76876/768/EEC concerning cosmetic products Manual of decisions for implementation of Directive 98/8/EC concerning the placing on the market of biocidal products Guidance Document on the demarcation between the Cosmetic Products Directive 76/768 and the Medicinal Products Directive 2001/83 as agreed between the Commission services and the competent authorities of Member States Manual on the scope of application of the cosmetics directive 76/768/EEC, version 9.0 Guidelines to Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products
5 Helena Kohútová, ÚVZ SR Bratislava
EURÓPSKA LEGISLATÍVA pre kozmetické výrobky
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