1. The EU Cosmetics Regulation Matthew A. Kopetski Commercial Specialist U.S. Mission to the European Union matthew.kopetski@trade.gov February 21 st, 2013

2. Agenda 1.Introduction - Tony Michalski (Commercial Service, Inland Empire U.S. Export Assistance Center) 2. Overview of EU Cosmetics Legislation - Matthew Kopetski (Commercial Service, U.S. Mission to the European Union) 3. Main Presentation - Doram Elkayam (Obelis) 2

3. From Cosmetics Directive to Cosmetics Regulation 3 1.EU Legislation: Directives and Regulations Directive: (i) Instruction to Members States to adopt measures targeted at achieving a common outcome; (ii) Requires Member State transposition Regulation: (i) Provisions have binding legal effect throughout the European Union; (ii) No Member State transposition required; (iii) Supersedes pre-existing national legislation 2.Change = Greater Clarity and Harmonization Clarified definition cosmetic products Formalized contents of the Product Information File (PIF) Specific requirements for nanomaterials European Commission can amend annexes

4. Current Issues 4 1.Animal Test Ban: More stringent requirements to enter into force on March 11, 2013 Art. 18 of the Cosmetics Regulation set to enter into force Commission is expected to publish guidance on how this provision will be implemented 2.Fragrances: European Commission may propose restrictions on use later this year June 2012 SCCS adopted opinion recommending that the EC impose restrictions on 82 fragrance ingredients because of allergenic properties Opinion under review for possible legislative response

5. Key Definitions and Terminology 5 1.Cosmetic Products Any substance or preparation intended to be placed in contact with the external parts of the human body, teeth or mucous membranes; AND, With a view exclusively or mainly to cleaning, perfuming, changing appearance and/or protecting or keeping in good condition 2.Distinction between the importer and distributor Importer: The entity that places a product from a third country on the EU market Distributor: Makes the product available in the EU and is not the manufacturer or importer 3.Responsible Person: EU established entity legally responsible for ensuring that a cosmetic product complies with EU cosmetic legislation 4.Nanomaterials: An insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm

6. Resources 6 1.U.S. Commercial Service http://export.gov/europeanunion/accessingeumarketsinkeyindustrysectors/eg_eu_044318.a sphttp://export.gov/europeanunion/accessingeumarketsinkeyindustrysectors/eg_eu_044318.a sp 2.European Commission EU Cosmetics Directive http://ec.europa.eu/consumers/sectors/cosmetics/documents/directive/ http://ec.europa.eu/consumers/sectors/cosmetics/documents/directive/ EU Cosmetics Regulation http://ec.europa.eu/consumers/sectors/cosmetics/documents/revision/index_en.htm http://ec.europa.eu/consumers/sectors/cosmetics/documents/revision/index_en.htm Scientific Committee for Consumer Safety http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm 3.Industry Associations Cosmetics Europe https://www.cosmeticseurope.eu Independent Cosmetic Manufacturers and Distributors (ICMAD) http://www.icmad.org Personal Care Products Council (PCPC) http://www.personalcarecouncil.org

7. THANK YOU!!! Questions and further information contact: Matthew A. Kopetski Commercial Specialist U.S. Mission to the European Union Tel: +32 2 811 5684 Email: matthew.kopetski@trade.govmatthew.kopetski@trade.gov 7