Canadian Cosmetic, Toiletry and Fragrance Association

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1 Leading Canadian Trade Association for the Personal Care Products Industry Canadian Cosmetic, Toiletry and Fragrance Association May 9, 2012 PCPC Legal & Regulatory Conference 2012 Darren Praznik, President & CEO

2 The U.S. Top 15 Trading Partners in 2011 (in Goods) Country Exports Imports Total Trade Trade Balance Canada China Mexico Japan Germany United Kingdom South Korea Brazil France Taiwan Netherlands Saudi Arabia India Venezuela Singapore * United States Census Bureau - This list does not include the European Union which is the largest trading partner of the US (totalling approximately $636.4 billion in total trade)

3 Canada / U.S. Trade in Perspective Total including goods, services and investment: < $1 Trillion in 2011 ($1.6 Billion worth of goods and services cross the Canada/U.S. border each and every day) Relative populations Canada 34 Million - U.S. 313 Million *Office of the Prime Minister Canada/U.S. Trade and Investment -

4 Canada / U.S. Trade in Perspective Growing Integration Supply Chains Manufacturing Distribution Channels Retailing (direct sellers, retailers, internet sales, etc.) Regulation (Aligned or Harmonized)?

5 Regulatory Cooperation Council Created on February 4, 2011 by Canadian Prime Minister Stephen Harper and United States President Barack Obama Objectives: to better align the two countries regulatory approaches, where possible reduce red tape by making regulations in a range of sectors more compatible and less burdensome in both countries facilitate crossing the border

6 Industry Participation CCTFA submitted joint comments with the U.S. Personal Care Products Council and Mexico's CANIPEC - April 29, 2011 CCTFA and PCPC represented at consultations in Washington, D.C. Jan 30-31, 2012 CCTFA and the U.S. Personal Care Products Council submitted joint paper supporting the work of the RCC February 13, 2012

7 Joint Action Plan Released on December 7, 2012 Nanotechnology: Share information Develop joint approaches on regulatory aspects of nanomaterials, including terminology and nomenclature, as well as risk assessment and management

8 Joint Action Plan Health and Personal Care Products: Implement a Common Electronic Submission Gateway to allow submission of documents simultaneously to Health Canada and the U.S. FDA and increase review and collaboration on these products between the two regulatory agencies Develop and adopt common monographs for routine over-the-counter drugs (opportunity for further alignment for cosmetic-like drugs, i.e. sunscreens)

9 Joint Action Plan Health and Personal Care Products (continued): Enhance collaboration on enforcement and compliance by increasing mutual reliance on each other's routine surveillance of good manufacturing practices (GMP) inspection reports of manufacturing facilities for drugs and personal products, rather than having to conduct unnecessarily duplicative inspections in the other country

10 RCC Opportunity Driving RCC Agenda could create opportunity for significant alignment of personal care products regulated as drugs (in Canada) Major source of unnecessary regulatory roadblocks Invitation from RCC Secretariat Opportunity to put forward Industry s cross border narrative!

11 RCC Summit CCTFA will be hosting a Canada-U.S. Regulatory Cooperation Council Summit as part of CCTFA s Annual Conference Friday, September 14 th, 2012 Niagara-on-the-Lake, Ontario

12 Regulatory Alignment ICCR International Cooperation on Cosmetic Regulation

13 What is ICCR? A voluntary international group of cosmetics regulatory authorities from the US, Japan, the EU and Canada (invited as observers for 2012, China, Korea, Saudi Arabia, Israel, Brazil, Australia) Meets on an annual basis to discuss common issues on cosmetics safety and regulation, and to enter into a constructive dialogue with the relevant cosmetics industry trade associations Objective: to maintain the highest level of global consumer protection, while minimizing barriers to international trade

14 ICCR - Issues for Consideration Alternatives to Animal Testing Nanotechnology Trace Materials Safety Assessment Approaches Cosmetic Labelling

15 ICCR Successes Joint Industry-Regulator Working Groups Unprecedented regulator engagement Publication of results on regulator s websites or common website (potential to become international standard) 3 key technical advancements: Nano definition Nano criteria General safety assessment principles

16 Defining Long Term Success Broad International Participation of Regulators Use of Joint Regulatory-Industry Working Groups on Specific Issues (Gathering of Experts) Acceptance for Publication by Regulators (de facto international standard) Over time, can lead to greater alignment and harmonization of regulatory requirements thereby facilitating trade

17 ICCR-4 (Toronto) Official Photo

18 International Industry Collaboration One day meeting in Toronto following ICCR Four industry associations (COLIPA, PCPC, JCIA, CCTFA) plus senior international company representatives Opportunity for discussions on international issues, common approaches and the sharing of resources Follow up meeting held in Paris, 2011 (following ICCR-5)

19 Global Industry Cooperation Need Regulatory alignment/harmonization (ensure consumer safety, enhance benefits of trade, open new markets, greater consumer choice) Chemical/Ingredient reviews for health and the environment (REACH in Europe, CMP in Canada, etc.) Best use of Industry s Resources To make it happen! Challenge