1. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 1– Free movement of goods Bilateral screening: Chapter1 Brussels, 6 March 2013

2. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working group for Chapter 1 – Free movement of goods Bilateral Screening : Chapter 1 Presentation of Montenegro Brussels 6 March 2013 Chapter 1: xxxxxxx

3. Chapter 25: Science and Research Poglavlje 25 Nauka i istraživanje Chapter 20: xxxxxxx M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Cosmetic products Zora Šćepanović Inspection Directorate Ministry of Health zrscepanovic@gmail.com

4. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 2 0 : xxxxxxx Content Legal framework Institutional framework Harmonization

5. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx Chapter 2 0 : EU legislation Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

6. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 25: Science and Research Chapter 20: xxxxxxx NATIONAL LEGISLATION Law on health safety of food staples and items for general use (Official Gazette of RoM, No. 53/91, 37/02), Law on General Product Safety (Official Gazette of Montenegro, No.48/08) Law on Inspection Control (Official Gazette of RoM, No.39/03 and Official Gazette of Montenegro, No. 76/09, 53/11) Rulebook on conditions related to the health safety of general use items which can be put into circulation (Official Gazette of SFRY, No. 26/83, 18/91);

7. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 25: Science and Research Chapter 20: xxxxxxx Legal framework In accordance with the Rulebooks, cosmetic products are divided into following groups: Items coming into contact with mucous membranes (items from Group A); Items that remain on the skin for a long time (items from group V); Items that after a short time are removed from the skin or are used for the treatment and dyeing of hair or nails (items from group S).

8. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 25: Science and Research Chapter 20: xxxxxxx Legal framework Cosmetic products may be marketed only in the original wrapping of manufacturers, in a packaging that enables proper use and protects the hygienic quality of individual products. Cosmetic products must contain declaration, if their effect depends on the proper application and instructions for use, and for some products also the way and manner of use and the test on sensitivity. Cosmetic products must not, in common usage, adversely affect health.

9. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 25: Science and Research Chapter 20: xxxxxxx Legal framework The Ordinance contains textual part and Annexes: List I - Preservatives List II – Antioxidants List III – Colours

10. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 25: Science and Research Chapter 20: xxxxxxx Institutional framework Ministry of Health Adoption of regulations in the field of cosmetic products is under the competence of the Ministry of Health Inspection Directorate Department of Health - Sanitary Inspection supervises the production, import and trade of cosmetic products under the competences prescribed by the Law. In Montenegro, two laboratories perform the jobs in the field of laboratory quality control and health safety, namely: Institute of Public Health of Montenegro, Podgorica (microbiological, physical and chemical testing) Center for Eco-Toxicological Research, Podgorica (physical and chemical testing)

11. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 25: Science and Research Chapter 1: xxxxxxx Institutional framework Supervision of cosmetic products in the production, imports, and the domestic market is performed ​​by sanitary inspectors. Market surveillance is carried out in accordance with the Market Surveillance Plan. In addition to the control of cosmetic products, inspectors oversee other areas of their competences: safety of toys, food, etc.

12. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 25: Science and Research Chapter 1: xxxxxxx HARMONIZATION The current legislation is not in line with EU regulations on cosmetic products The Ministry of Health began preparations for the harmonization of national legislation on cosmetic products with EU regulations. Harmonization of legislation has been recognized as necessary to enable the free circulation of cosmetic products that are safe, as well as effective supervision to protect consumer health.

13. Thank you for your attention! QUESTIONS