1. SEMINAR /WORKSHOP ON INTRODUCTION OF EU LEGISLATION ON COSMETIC PRODUCTS TAIEX Serbia 22-23.02.2016 MSc Ivona Vidić Štrac, Biol.Sci-Toxicology Head of Department of Objects of Common Use Croatian Institute of Public Health Voditeljica Odjela za predmete opće uporabe Voditeljica Odsjeka za predmete široke potrošnje i praćenje sigurnosti kozmetičkih proizvoda, Hrvatski zavod za javno zdravstvo

2. REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products Preambula 20 To ensure the uniform application and control of the restrictions for substances, sampling and analysis should be carried out in a reproducible and standardised manner.

3. CHAPTER VII MARKET SURVEILLANCE Article 22 In-market control Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.

4. PEMSAC EU countries are responsible for the surveillance of their own markets for cosmetics. In order to ensure a coherent approach to consumer products issues, the market surveillance authorities of all EU countries established the Platform of European Market Surveillance Authorities for Cosmetics PEMSAC Sub-group ANALYTICAL METHODS

5. Analytical methods http://ec.europa.eu/growth/sectors/cosmetics/assessment/index_en.htm

6. EU Book shop

7. https://www.edqm.eu/en/cosmetics-testing Council of Europe - European Directorate for Quality of Medicines and Healthcare - EDQM

8. EDQM - OCCL Official Cosmetics Control Laboratories (OCCLs) check the quality of cosmetic products on the market and support market surveillance activities of the competent authorities. By alerting authorities to products that do not comply with national and European regulations for cosmetic products, OCCLs contribute to consumer health protection.European regulations for cosmetic products

9. EDQM - OCCL The European Network of national OCCLs was set up on a voluntary basis; more than 30 OCCLs participate in regular network activities, including laboratories in 19 Member States of the European Union. An OCCL is a public institution with a mandate to perform laboratory testing of cosmetic and other products as appropriate, for the purpose of market surveillance.

10. http://publications.jrc.ec.europa.eu/repository/bitstream/JRC960 82/15.06.18_eur27284_jrc-report-cosmetics%20final.pdf Cooperation PEMSAC+EDQM-OCCL + CEN TC 392Cosmetics

11. Common approach In order to ensure that testing results related to official controls are sufficiently robust and reliable, the analysis should be performed in accordance with the principles laid down in ISO 17025:2005 – General requirements for the competence of testing and calibration laboratories

12. Selection of the method based on its validation status 1-Community method 2-CEN European standard (EN) or ISO/CEN standard (EN ISO) 3-Other internationally harmonised protocols (e.g. OCCL harmonised and validated methods11; CEN Technical Specifications (CEN/TS)); 4-Ring-trial validated method; 5-Single-laboratory validated method; this method should be applied to perform the analysis.

13. CEN /ISO Cosmetics- Analytical methods, at 11-February 2016 Nitrosamines: Detection and determination of N- nitrosodiethanolamine (NDELA) in cosmetics by HPLC, post-column photolysis and derivatisation (ISO 10130:2009) Nitrosamines: Detection and determination of N- nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS (ISO 15819:2014) Quantitative determination of zinc pyrithione, piroctone olamine and climbazole in surfactant containing cosmetic anti-dandruff products (EN 16342:2013) Determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic preparations, LC-MS methods (EN 16343:2013) Screening for UV-filters in cosmetic products and quantitative determination of 10 UV-filters by HPLC (EN 16344:2013) GC/MS method for the identification and assay of 12 phthalates in cosmetic samples ready for analytical injection (EN 16521:2014)

14. CEN /ISO Sun protection test methods at 11-February 2016 In vivo determination of sunscreen UVA protection (ISO 24442:2011; EN ISO 24442:2011) Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2012; EN ISO 24443:2012) Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2010; EN ISO 24444:2010) Review and evaluation of methods to assess the photoprotection of sun protection products (ISO/TR 26369:2009; CEN ISO/TR 26369:2009) 9 analytical methods and review

15. CEN/ISO Cosmetics – Microbiology, at 11-February 2016 Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930:2012; EN ISO 11930:2012) Enumeration of yeast and mould (ISO 16212:2008; EN ISO 16212:2011) Microbiological limits (ISO 17516:2014; EN ISO 17516:2014) Detection of specified and non-specified microorganisms (ISO 18415:2007; EN ISO 18415:2011) Detection of Candida albicans (ISO 18416:2007; EN ISO 18416:2009) Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010; EN ISO 29621:2011)

16. CEN/ISO Cosmetics - Microbiology, 11-February 2016, General instructions for microbiological examination (ISO 21148:2005; EN ISO 21148:2009) Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2006; EN ISO 21149:2009) Detection of Escherichia coli (ISO 21150:2006; EN ISO 21150:2009) Detection of Pseudomonas aeruginosa (ISO 22717:2006; EN ISO 22717:2009) Detection of Staphylococcus aureus (ISO 22718:2006; EN ISO 22718:2009) 8 microbiological methods with guidelines and instruction

17. At the end, standards for manufacturers Cosmetics -- Packaging and labelling (ISO 22715:2006) Cosmetics -- Good Manufacturing Practices (GMP) -- Guidelines on Good Manufacturing Practices (ISO 22716:2007; EN ISO 22716:2007) Cosmetics -- Good Manufacturing Practices -- General training document (ISO/TR 24475:2010; CEN ISO/TR 24475:2013) 3 general standards

18. Thank you for your attention!