MINISTRY of HEALTH TURKISH MEDICINES AND MEDICAL DEVICES AGENCY Evren ALĞIN YAPAR Pharm MSc PhD Head of Department of Cosmetics Coordination

NATIONAL LEGISLATION  Cosmetics Law, No  Law of Preparation and Implementation of the Technical Legislation on Products, No  Regulation on Cosmetics  Notifications  Guidelines

AMENDMENTS  Amendments to the Annexes on Cosmetic Regulations No , 18 August 2012 dated NEW  Amending the Regulation on Cosmetics (April, 2013) NEW

NOTIFICATIONS  7 Notifications on Methods of Analysis Required for the Control of Combinations of Cosmetic Products  Issued in 2005: İEG-2005/1, İEG-2005/2, İEG-2005/3, İEG-2005/4, İEG-2005/5, İEG-2005/6, İEG-2005/7

GUIDELINES  Guideline of Good Manufacturing Practices on Cosmetics  Guideline on Safety Assessment of Cosmetics (June, 2012) (NEW)  Guideline on Sunscreen Products (August, 2012) (NEW)  Guideline on Advertising of Cosmetics ( August, 2012) (NEW)

GUIDELINES  Guideline on Undesirable Effect Notifications of Cosmetics (September, 2012) (NEW)  Guideline on Cosmetics in Services Sector (September, 2012) (NEW)  Guideline on Notification of Cosmetics to NPIC (National Poisons Information Center) (October, 2012) (NEW)  Guideline on Claims of Organic and Natural Cosmetics (October, 2012) (NEW)

GUIDELINES  Guideline on Cosmetotextile Products (November, 2012) (NEW)  Consumer Information Guideline for Cosmetics (December, 2012) (NEW)  Guideline on Cosmetics for Professional Use (April, 2013) (NEW)

GUIDELINES  Guideline on Electronic Notification of Cosmetics (August, 2012) (NEW)  Guideline on Electronic Applications of Cosmetic Activities (October, 2012) (NEW)  Guideline on Electronic Applications of Cosmetic Activities Version 1.0 (March, 2013) (NEW)

 Adaptation of Regulation (EC) no 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products  New National Cosmetics Law  Other Guidance Studies such as on Nanomaterials, GMP, Test methods etc. ONGOING REGULATORY ISSUES

ADAPTATION PROCESS  Technical translation of Regulation (EC) no 1223/2009 is completed.  National Legislations on Cosmetics and Legislations Related with Cosmetics are under viewed in terms of implementation.  It is expected to Regulation (EC) no 1223/2009 is come into force at the same time in Turkey with the EU.

MAIN ISSUES AND PROBLEMS  Permitting process for cosmetics containing nanomaterials,  Harmonized standard for the GMP  Animal testing

NOTIFICATION AFTER ADAPTATION  Notifications will be done to Turkish Medicines and Medical Devices Agency within the scope of the principles and procedures of Ministry of Health of Turkey.

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