1. OUTLINE OF KEY PROVISIONS IN THE EU REGULATION (1223/2009) ON COSMETIC PRODUCTS INT MARKT 52089 Turkey, Ankara 2013 István Murányi KOZMOS, secretary-general

2. Where did we start? 76/768/EEC Directive Main features: - directive, to be implemented in Member States legislation, led to diverse interpretations and systems, although main core is the same - 7 main amendments, several ATPs – always problems with interpretation, delays and diversification at implementation Decision: no 8th Amend., make Regulation instead

3. The 1223/2009/EC Regulation General remarks  It is a regulation (issued in all languages, no need to implement, immidiate utilization, scope the whole Community market and players, very limited national diversification is permitted.)  Main core is basically the same to the directive, however small, but dramatic changes occurred.  2009-2013 preparation period, everything must be ready by 11 July 2013. Loads of work!

4. The legal preparation process First - simplification Main goal was to simplify the administrative processes and make the systems easier to understand. Second - Recast Having discussed it, it became more evident that it is more than just simplification + EU trend. Outcome No more directive, instead issue of a regulation

5. The main chapters CHAPTER I - SCOPE, DEFINITIONS (Responsible person, who is who, what is what) CHAPTER II - SAFETY, RESPONSIBILITY, FREE MOVEMENT (GMP + ISO standard) CHAPTER III - SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION (Annex I, notification) CHAPTER IV - RESTRICTIONS FOR CERTAIN SUBSTANCES (nano) CHAPTER V - ANIMAL TESTING (new era) CHAPTER VI – CONSUMER INFORMATION (RP+ hour glass, claims) CHAPTER VII - MARKET SURVEILLANCE (undesirable effect) CHAPTER VIII - NON-COMPLIANCE, SAFEGUARD CLAUSE CHAPTER IX - ADMINISTRATIVE COOPERATION (comitology) CHAPTER X - IMPLEMENTING MEASURES, FINAL PROVISIONS (shift)

6. The annexes ANNEX I COSMETIC PRODUCT SAFETY REPORT ANNEX II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS ANNEX III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN ANNEX IV LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS ANNEX V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS

7. The annexes ANNEX VI LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS ANNEX VII SYMBOLS USED ON PACKAGING/CONTAINER ANNEX VIII LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING ANNEX IX PART A Repealed Directive with its successive amendments (referred to in Article 33) PART B List of time-limits for transposition into national law and application ANNEX X CORRELATION TABLE

8. The shift from directive to regulation December 1January 11July 11 2010 2012 2011 20142013 CMR 1, 2, 3 2009 6 months prior January 11 1223/2009/EC CMR 1A, 1B, 2 Local MS notifications 1223/2009/EC EU notification Cosmetics with nanomaterials If on market January 11 76/768/EEC No, if nano in Annex III

9. New definitions - players  ‘manufacturer’ means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;  ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;  ‘importer’ means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;

10. New definitions – the Responsible Person „There can be only one!” Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. As a start, the responsible person is:  manufacturer established within the Community  Importer (established within the Community) The manufacturer/importer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.

11. New definitions - players Cosmetic Company in Istanbul -nor EU based manufacturer -neither EU based importer -cannot be responsible person It needs a partner established in EU to represent it as a responsible person.

12. Responsibilities of the Responsible Person  Product safety (+ label, warnings, usage instructions)  GMP  Safety assessment, PID  Quality assurance, keeping restriction rules  CMR, Nano, traces  Animal tests  Label, claims  Public information  (serious) Undesirable effects  Information on certain substances

13. Responsibilities of the Distributor Before selling the product distributors shall verify that:  the labelling information is present,  the language requirements are fulfilled,  the date of minimum durability, if needed, has not passed. Where distributors consider or have reason to believe that:  a cosmetic product is not in conformity with the requirements doesn’t sell it until everything is OK, or withdraw it or recall it  If there’s a risk to human health, distributors shall immediately inform the responsible person and the competent national authority. Distributors shall ensure storage and transport conditions Distributors shall cooperate with competent authorities.