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The EU Cosmetics Regulation

The EU Cosmetics Regulation. Matthew A. Kopetski Commercial Specialist U.S. Mission to the European Union matthew.kopetski@trade.gov February 21 st , 2013. Agenda. Introduction - Tony Michalski (Commercial Service, Inland Empire U.S. Export Assistance Center)

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The EU Cosmetics Regulation

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

  2. Agenda • 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)

  3. From Cosmetics Directive to Cosmetics Regulation • 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 • 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 • 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 • 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 • 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 • 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 • Responsible Person: EU established entity legally responsible for ensuring that a cosmetic product complies with EU cosmetic legislation • 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 • U.S. Commercial Service • http://export.gov/europeanunion/accessingeumarketsinkeyindustrysectors/eg_eu_044318.asp • European Commission • EU Cosmetics 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 • Scientific Committee for Consumer Safety http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm • 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.gov

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