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

The U.S.’ Top 15 Trading Partners in 2011 (in Goods)

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)

Country Exports Imports Total Trade Trade Balance

Canada 280.9 316.5 597.4 -35.6

China 103.9 399.3 503.2 -295.4

Mexico 197.5 263.1 460.6 -65.6

Japan 66.2 128.8 195 -62.6

Germany 49.1 98.4 147.5 -49.3

United Kingdom 56 51.2 107.1 4.8

South Korea 43.5 56.6 100.1 -13.1

Brazil 42.9 31.4 74.3 11.5

France 27.8 40 67.8 -12.2

Taiwan 25.9 41.3 67.2 -15.4

Netherlands 42.8 23.5 66.3 19.3

Saudi Arabia 13.8 47.5 61.3 -33.7

India 21.6 36.2 57.8 -14.6

Venezuela 12.4 43.3 55.6 -30.9

Singapore 31.4 19.1 50.5 12.3

* United States Census Bureau - http://www.census.gov/foreign-trade/statistics/highlights/top/top1112yr.html

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 - http://pm.gc.ca/eng/media.asp?id=3935

Canada / U.S. Trade in Perspective

Growing Integration

• Supply Chains

• Manufacturing

• Distribution Channels

• Retailing (direct sellers, retailers, internet sales, etc.)

Regulation (Aligned or Harmonized)?

• 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”

Regulatory Cooperation Council

• 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

Industry Participation

• 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

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)

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

Joint Action Plan

• 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!

RCC Opportunity

RCC Summit

CCTFA will be hosting a

Canada-U.S. Regulatory Cooperation Council Summit

as part of CCTFA’s Annual Conference Friday, September 14th, 2012

Niagara-on-the-Lake, Ontario

ICCR International Cooperation

on Cosmetic Regulation

Regulatory Alignment

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

ICCR - Issues for Consideration

• Alternatives to Animal Testing

• Nanotechnology

• Trace Materials

• Safety Assessment Approaches

• Cosmetic Labelling

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

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

ICCR-4 (Toronto) Official Photo ICCR-4 (Toronto) Official Photo

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)

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

Challenge

• To make it happen!