Cosmetic compliance 2015

EUROPEAN UNION • PACIFIC ALLIANCE • LATIN AMERICA • BRAZIL • UNITED STATES OF AMERICA • ASIA PACIFIC • CHINA • MIDDLE EAST

APRIL 27-29, 2015 • NEW JERSEY

NEW! Over 12 hours of interactive global focus case studies

Align the similarities of safety reports worldwide and efficiently

tailor them to each market

PRODUCT SAFETY REPORTS

Make an accurate assessment of package and label stability and ensure they uphold compliance

guidelines

PRODUCT PACKAGING & LABELING

Protect your brand! Join our interactive discussions surrounding global criteria of

cosmetic claims:

COMPARITIVE • DRUG • PRODUCT PERFORMANCE

CLAIMS SUBSTANTIATION

Eliminate the confusion, and hear different specifications for a

cosmetic, OTC or drug from region to region globally

GLOBAL DEFINITIONS OF A “COSMETIC”

Stay on top of the latest substances banned around the globe, and quickly source the available alternatives for your

products

RAW MATERIAL REGISTRATION

MEET SOME OF OUR SUBjECT MATTER ExPERTS:

PATRICIA HANSENDeputy Director, Office of Cosmetics and ColorsUNITED STATES FOOD AND DRUG ADMINISTRATION (FDA)

LAURIE PANRegulatory AffairsSALLY BEAUTY COMPANY

PAOLA BECVARSenior Manager, Regulatory Affairs, Latin AmericaENERGIZER PERSONAL CARE

LAURIE WELSHFragrance and Testing, Claims SubstantiationCOTY INC.

IRENA PERICProject Manager, Global Regulatory AffairsYOUNG LIVING ESSENTIAL OILS

Launching a new product? Don’t miss out on our case studies

of realistic timelines for getting your cosmetics on the shelves and

keeping them there

MARKET ENTRY AND POST MARKET

SURVEILLANCE

Register Today: www.CosmeticsCompliance.com • 1-800-882-8684 • [email protected]

SPONSOR:

Welcome to the Global Cosmetic Compliance Summit

We understand that staying up-to-date with ever changing global regulations and guidelines, as well as current and forthcoming standards set forth around the world have many organizations questioning their preparedness for global compliance deadlines in 2015 and beyond.

After holding the Cosmetic Compliance Summit in September of 2014, we received overwhelming feedback and insight surrounding the many challenges that you are facing in understanding regulatory guidelines of some of the leading and emerging personal care and cosmetics markets of the world such as; European Union, Latin America, China, Asia/Pacific, South Africa, and India.

This event is so timely to the industry because it is positioned to not only address where your organization stands in its global compliance journey, but how you are continuing to look at the scope of regulatory affairs that pan across the globe. At the 2015 Summit, we will be posing pivotal questions regarding how strong your organizations efforts are to benchmark globally, and continue to help you either expand into new markets or continue to establish your brands presence. If you can answer yes to any of these questions, you cannot afford to miss out on attending this summit: • Have you considered the future of your organization by building a comprehensive compliance system to be prepared for

global regulatory updates?• Is your organization working towards eliminating variances of your products going into China, as compliance initiatives

continue to mirror the European Union standards?• Have you considered the business benefits behind a successful compliance initiative program that will continue to protect

your consumers?• Would you benefit from hearing first hand accounts of successful product launches in emerging markets such as

Middle East?• Is your company looking to stay up-to-date on the latest “drug” vs “cosmetic” specifications in the United States, in order to

avoid significant claims and labeling errors?• Are you looking for specific guidance on recent Canadian regulations for your products market entry procedures, and post

market surveillance? • Are you interested in hearing over 12 hours of in-depth and candid case studies with a global focus from some of the

leading companies in the industry?

Our goal is to provide you with powerful examples of how industry stakeholders of personal care and cosmetic companies around the world have built existing frameworks for compliance, and are continuing to explore new strategies that will safeguard against market volatility and risk

We encourage you to visit our exhibitors on site who can give you further details of the many ways that can save your organization time, money, and even help to map a timeline of your brands own specific goals for global markets.

This is your opportunity to come face to face with the largest compliance implementations that this industry has ever faced, and roll out a successful traceability program within your organization. Don’t get left behind in 2015.

I look forward to meeting you in New York City.

Lisa IL Grande Conference Program Director |IQPC

Register Today: www.CosmeticsCompliance.com • 1-800-882-8684 • [email protected] 2

2014 ATTENDING COMPANY SNAPSHOT

• 3E Company• Arbonne International• C B Fleet Company, Inc.• Colgate Palmolive• Cosmetic Laboratories of America• Cover FX• Croda• Dermalogica Inc• DuPont• Elevance• FDA• Fleet Laboratories• Food and Drugs Authority - Ghana• Galante Compliance Services, LLC• Harlan Laboratories• Intercos America Inc• Jafra Cosmetics International, Inc.• Johnson & Johnson Consumer

Group of Companies• Jos. H. Lowenstein• Keratin Complex• Kobo Products• LUSH Handmade Cosmetics Ltd.• Mana Products, Inc.• Mary Kay• MEDISCA• Newhall Laboratories• Petro-Canada Lubricants Inc.• SigmaAldrich• The Estée Lauder Companies Inc• The Humane Society of the United States• TRI-K Industries, Inc.• Vapour Organic Beauty• Waters Corporation• William Sonoma• Young Living Essential Oils• Zotos Intl Inc

NEW FOR 2015

GLOBAL FOCUS CASE STUDIES

• Graphics and copy requirements for cosmetic packaging

• Assessing purity and stability of the final packaging and its components and ensuring they uphold compliance guidelines

• Removal of prohibited substances present in packaging; what are the alternatives available in 2015?

• Animal testing alternatives on the global scale; what are the recent initiatives taken to ensure updates in regulations?

• Understanding the business needs behind successful good manufacturing practices; global compliance outcomes, requirements and expectations

• Designing a good manufacturing practice system that correlates with your organizations existing infrastructure

Packaging and Labelling for the Cosmetics Industry; Latest Trends and Innovations that Correlate with your Organizations Compliance Initiatives

Good Manufacturing Practices and Alternatives to Animal Testing on the Global Scale: Upholding your Companies Compliance Initiative

• Obligation to register chemicals in your product to protect the consumer; what are your organizations responsibilities for 2015?

• Controlling the use of dangerous chemical substances circulated within the common market, and ensuring the adequate replacement of these substances

• What products have the highest concentrations of chemicals and how can that be decreased?

• How to prepare for further requirements to ensure a products compliance and the largest challenges the industry is facing

• Achieving all requirements of your organizations report by working with a technical expert, what are the benefits of understanding each element?

• Industry response to implemented compliance guidelines; what are your organizations priorities for 2015?

Latest list of Exempt Chemical Substances and their Alternatives in 2015?

Production of a Cosmetic Product Safety Report, and Clarification of Global Guidelines

NEW!

NEW!LOOKING FOR MORE WAYS TO NETWORK AMONG YOUR INDUSTRY PEERS?

NETWORKING BRILLIANCE BAR

DEMO DRIVES

INTERACTIVE ROUND TABLES

Join us after the end of Main Conference Day 1 (Monday, April 28th) for an on-site reception where you can continue to network with your industry peers for additional take-away’s from the days’ presentations.

Are you looking for the latest solutions for maintaining, updating and translating your extensive product information files, cosmetic product safety reports and other key compliance documents? Visit our exhibition hall and meet top of the line solution providers who are ready to showcase the latest solutions available for your organization

Don’t miss out on the interactive roundtable discussions surrounding product claims substantiation! • COSMETIC CLAIMS CRITERIA

• SPECIFICATION OF A COSMETIC VS DRUG

• CLINICAL TRIALS TIME FRAMES


PRE CONFERENCE WORKSHOP DAYMONDAY, APRIL 27, 2015

9:30AM- 11:30 AM

WORKSHOP A: European Union – What are the latest Amendments and Additions to EU Regulation 1223/2009 and How Have they Altered your Organizations Compliance Architecture?

11:30 AM- 1:30 PM

WORKSHOP B: Product Registration in the Chinese Market; What is the Timeline for your Products Entry and Approval to be Sold in the Country, and How Can you Proactively Prepare for the Process?

1:30 PM

WORKSHOP C: Latin America – Clarity into the Pacific Alliance; Benchmarking your Organization in the Fastest Growing Markets of the World and Best Practices for Achieving ROI

After the July and November 2013 updates for (EC) 1223/2009, amendments were released in April, September and August 2014 with additional guidelines for the elimination of certain parabins and triclosan specifically.

These Amendments have increased the regulation on nanomaterial in cosmetic products in addition to increased safety assessments. This interactive workshop will walk you through the latest updates to (EC) 1223/2009 and provide further clarity into the European Market.

What you will learn:

• No. 866/2014, 1003/2014 and 104/2014; how is your organization keeping up-to-date with the latest legislation

• Beginning the consumer product safety report, what are the latest requirements?

• Using the CPNP; is your company proactively using this online data base?

According to the SFDA (State Food and Drug Administration of China, “the time required for the approval procedure is set at 3-4 months, but in reality it normally takes about nine months to a year as it involves such processes as inspection, acceptance of application, technical assessment, and granting of approval document for imports.” This workshop will provide a guideline for your organization on Chinese market entry, and what you can do to plan in advance to export your products.


• Definition of cosmetics and beauty products, and the three set standards that influence them

• Categorization of cosmetics products in China “non-special” vs. “special purpose” cosmetics

• Testing times of cosmetic and personal care products, and how to calculate the approximate amount of months your product will under-go this process

Chile, Colombia, Peru and Mexico manufacture high-quality cosmetics and toiletries, thanks to their natural wealth, adaptability to market trends, high production volumes, experience in the development of proprietary brands, and international certification that support their production processes. In this interactive workshop, we will discuss each country within the alliance, and discover why your organization can not afford to miss out on exporting to this market.


• Raw material registration – what are the restricted substances and the alternatives?

• What the specific packaging requirements for the Pacific Alliance are in 2015

• The criteria for cosmetic claims among the alliance, and specific definition of a cosmetic

How you will benefit:

• Discover how use of different materials may effect your cosmetic claims substantiation

• Consumer product safety report and safety data sheets; best practices for compiling an accurate report

• Learn how to use the CPNP to your organizations advantage and stay well informed on the latest regulatory updates

Sandra Schneider President DougMar Consulting


• Obtain an understanding of the exception, rejection or suspension of your products testing procedure

• Cross-check the application documents and the top ten points for a proper application

• Understand the import procedures to avoid your product being denied entry into the country, and barred from sale

Darryl Do Formulator Delbia Do


• Understand the nano-materials that are approved in member countries

• Ensure that you are partnering with a certified vendor who can ensure the use of proper packaging

• Understanding the post-market surveillance procedures within the Alliance

Paola Becvar Senior Regulatory Affairs Specialist Energizer Personal Care


ASIA FOCUS SESSIONSOPENING KEYNOTE

7:30AM Registration and Breakfast

8:45AM Chairmans Welcome and Opening Session

9:00AM EUROPEAN UNION: Improving the Safety of Cosmetics: Update to Cosmetic Regulation (EC) No. 1223/2009• Expanding on the findings of the Scientific Committee on Consumer

Safety (SCCS); adopting measures for consumer safety through restriction of preservatives in cosmetic products

• A proactive approach to limiting the maximum concentration of preservatives (Propylparaben and Butylparaben) for products on shelves after April 16th, 2015 – what is the benefit to the consumer?

• Proper and secure safety assessment of mixture and maximum concentrations of MCI/MI for the reduction of skin allergies; applying these measurements by July 16th, 2015, how can your organization successfully differentiate the measurements for leave-on or wash-off products?

Viny Srinivasan Assistant Vice President L’Oreal

9:45AM LATIN AMERICA – Emerging and Established Markets: Proper Registration and Certification Standards Across the Continent• Definition of cosmetic in Latin America – Comitment to transparency

and regulatory cooperation among Latin America in the areas of: - Raw material registration - Post-market surveillance - Labelling and claims

• Analyzing the Pacific Alliance (Alianza del Pacífico); Chile, Colombia, Mexico, and Peru: What are the technical standards set forth in 2015 to ensure proper certification and registration of cosmetic products?

• Measuring successful trade in Latin America: Reduce time and costs of exporting and importing cosmetics through the interoperability of single windows within the Alliance

Paola Becvar Senior Regulatory Specialist; Latin America Energizer Personal Care

10:30AM Morning Networking Break – BUSINESS CARD CHALLENGE! How many business cards can you exchange between now and the end of

the afternoon networking break? Collect as many as you can! The winner will be e-mailed an e-gift card here on site!

11:15AM ASIA: Spotlight on China and CFDA and SFDA Directives for Product Registration; Conducting Successful Trade Operations with Updated Raw Material Registration and Substantiated Claims• Testing and raw-material requirements; what are the current banned

chemicals in China, and how does your organization manage working with alternatives?

• Putting an end to variance of cosmetics for Chinese market; the benefit of certifying a product in multiple global markets before entering China

• Cosmetic claims in China: an in-depth description of the difference between product claims in the Chinese market vs. other top sectors of the world

Victor Mencarelli Senior Manager, Regulatory Affairs Hain-Celestial Group

12:00PM ASIA PACIFIC: Product Registration and Compliance Standards for ASEAN Member States • Registration and business operation within the member countries; what

are the supporting documents that must be submitted with a product notification?

• Notifying your product to an ASEAN member country; informing each regulatory authority of your products marketing, and examples of timelines for approval

• From pre-market approval system, to a post-marketing surveillance system; the details of the ASEAN Cosmetic Directive that monitor your products

Irena Peric Project Manager, Global Regulatory Affiars Young Living Essentials


MAIN CONFERENCE DAY 1TUESDAY, APRIL 28, 2015

NORTH AMERICA FOCUS SESSIONS

MAIN CONFERENCE DAY 1 Continued

12:45PM Networking Lunch Break

1:45PM UNITED STATES OF AMERICA: Monitoring Compliance and Product Information - Standards for Market Entry, Approval, and Post-market Surveillance• Proper distinction between a “cosmetic” and a “drug” – best practices

for avoiding mislabelling and improper marketing of your product• Allowing data to have a voice; analysis of findings from the cosmetic

industry as well as a track record of product recall and outcomes of inspections

• Cosmetic ingredients that are certified for use in the USA; how can we continue evaluate the safety of cosmetic ingredients into 2015?

Dr. Patricia Hansen Deputy Director, Office of Cosmetics and Colors United States Food and Drug Administration

2:30PM PANEL DISCUSSION: Canadian Regulations Proper product registration in the Canadian market can only occur after

manufacturers and importers notify Health Canada within 30 days after first selling a cosmetic in the country.

You expressed your top challenges with Canadian regulations to us, and we will be discussing the top three common themes within this panel:

Vasanti Raman Senior Manager, Regulatory Affairs MURAD

THEME #1 THEME #2 THEME #3

Products that full under the SPF

category – what are the most up-to-date

requirements for chemical

Regulatory information regarding hair-dye-

important safety and label information

required for product

Security packaging requirements within the regulation- what specific products in your inventory must

have protective packaging ?

THEME #1 THEME #2 THEME #3

What are the criteria’s for

Cosmetic Claims throughout the world and how do they affect

your organizations product

development strategy?

Specification between a cosmetic

and a drug, what is the fine line between the

two, and how do you ensure your

organization does not cross it?

Backing cosmetic claims with clinical

trials; what is the time frame for this process to be complete, and how does it

correlate with the expectations of your

company?

3:15PM Afternoon coffee break Take time to reflect on the afternoons session with today’s speakers and

visit our sponsor booths! Don’t forget to keep collecting business cards!

GLOBAL FOCUS: PRODUCT CLAIMS4:00PM Roundtable Session Over the course of one hour, there will be three themed round-table

discussions. The facilitator of each discussion will sit at a table, and every 20 minutes, they will rotate to a new table and discuss their topic. After all discussions are complete, there will be a 15 minute de-brief of the findings that each facilitator has gathered from all three tables.

TOPIC: CLAIM SUBSTANTIATION

5:00PM End of Main Conference Day 1


Sandra Schneider President DougMar

Consultants

Suzanne Roberta Co-Founder and

Managing Partner Adesse Global

Cosmetics

Laurie Welsh Director, Coty

Testing Institute and Fragrance Science

COTY

GROWING MARKET FOCUS SESSION

MAIN CONFERENCE DAY 2WEDNESDAY, APRIL 1 , 2015

7:30AM Registration and Breakfast

8:45AM Chairpersons Welcome and Opening Statements

9:00AM EuroPEaN uNIoN: Designation and Introduction of the Notion for a Responsible Person and Accurate reporting of Serious Undesirable Effects (SUE)• Notifying SUEs to the correct competent authorities of the member

state and corrective measures taken by the Responsible Person or Distributor

• Correct addition of data on SUE as well as any other effects as part of the Cosmetic s Product Safety Report (CPSR)

• Enabling a structure and harmonization for submission of all important factors that are related to the SUE; best practices for organization of your materials

9:45AM UNITED STATES OF AMERICA: Case Study - Conducting Clinical Evaluations of Skin/Sun Care Products

Join this in-depth assessment of the trials that successfully bring a product to the market, and discover the many differences and factors that effect product diversity.

Peter Foltis Director, Scientific Affairs, Skin/Sun Care L’Oreal

10:30AM Morning Networking and Refreshment Break

11:00AM MIDDLE EAST – Entry Procedures for the Cosmetic Market; Timelines for Approval, and Successfully Navigating the Regulatory Guidelines

This case study will provide an in-depth break down of the 10 month timeline that Adesse Global Cosmetics worked with to launch their product line in the Middle East! This presentation will including the step-by-step process behind innovative products that correlate directly with the culture!

Suzanne Roberta Co-Founder and Managing Partner Adesse Global Cosmetics

11:45AM BRAZIL: Case Study - Beyond UV Protection – Effects of Visible Light in Light and Dark Skin Color

The research presented in this session will lead into discussion of what is needed, and what could lead to a future adjustment in product development of sunscreens:

• Sunscreens: Not effective protecting skin against Visible Light - induced effects in skin

• Darker Skin Color will Pigment more easily with Visible Light - what does this mean for sunscreen?

• Investigating why blue-green part of the spectrum of visible light seems to induce most pigment changes

Eduardo Ruvolo Senior Research Fellow Avon

12:45PM Networking Lunch Break


KEYNOTE

MAIN CONFERENCE DAY 2 Continued

1:30PM GLOBAL FOCUS CASE STUDY: Packaging and Labelling for the Cosmetics Industry; Latest Trends and Innovations that Correlate with your Organizations Compliance Initiatives • Graphics and copy requirements for cosmetic packaging; compliance

with the most recent implementations, without sacrificing product identity

• Characteristics packaging material; assessing purity and stability of the final packaging and its components and ensuring they uphold compliance guidelines

• Removal of prohibited substances present in packaging; what are the alternatives available to the industry in 2015?

2:15PM GLOBAL FOCUS CASE STUDY: A Proactive Approach to REACH (Registration, Evaluation, Authorization and Restriction) of Chemicals; What is the Latest list of Exempt Chemical Substances and their Alternatives in 2015?• Understanding your brands obligation to register chemicals in your

product to protect the consumer; what are your organizations responsibilities for 2015?

• Controlling the use of dangerous chemical substances circulated within the common market, and ensuring the adequate replacement of these substances

• Chemical substances manufactured for cosmetic/personal care products; what products have the highest concentrations of chemicals and how can that be decreased?

Laurie Pan Senior Director, Product Safety, Regulatory Affairs Sally Beauty Company

3:00PM Afternoon Networking Break

3:30 GLOBAL FOCUS CASE STUDY: Good Manufacturing Practices and Alternatives to Animal Testing on the Global Scale: Upholding your Companies Compliance Initiative• Animal testing alternatives on the global scale; what are the recent

initiatives taken to ensure updates in regulations?

• Understanding the business needs behind successful good manufacturing practices; global compliance outcomes, requirements and expectations

• Designing a good manufacturing practice system that correlates with your organizations infrastructure; ensuring the ability to have a global outreach

Dr. Pascaline Clerc The Humane Society – United States of America

4:15 GLOBAL FOCUS CASE STUDY: Production of a Cosmetic Product Safety Report, and Clarification of Global Guidelines• Deliberating strategies for creating a thorough report; how to prepare

for further requirements to ensure a products compliance and the largest challenges the industry is facing

• Achieving all requirements of your organizations report by working with a technical expert, what are the benefits of understanding each element?

• Industry response to implemented compliance guidelines; what are your organizations priorities for 2015?

Victoria Tu Senior Director, Global Product Safety, Regulatory, & Microbiology Revlon

5:00 End of Main Conference Day 2

The remainder of the afternoon will be dedicated to interactive case studies, addressing common challenges in the industry, and their direct effect on the global cosmetics supply chain. Engage in the conversation, and leave with best practices for your company.


Team Discounts

PRIMARY: Cosmetics Companies, Brand Owners, Pharmaceutical, & Cosmetic Import

Vendors: Consultants & Solution Providers

EASY WAYS TO REGISTER

Package Register By 2/27/2015

Standard Pricing

Main Conference $1,499 Save $500 $1,999

All Access: Main Conference + All 3 Workshops $2,199 Save $400 $2,599

Individual Workshop $499

Package Register By 2/27/2015

Standard Pricing

Main Conference $2,695 Save $300 $2,995

All Access: Main Conference + All 3 Workshops $4,045 Save $300 $4,345

Individual Workshop $549

5

Send: Save:

Groups of 3 10%off

Groups of 4 to 5 15%off

Groups of 6 or more 20% off

*IQPC reserves the right to determine who is considered an End-User or a Vendor upon registration for an event. Those who are determined a vendor will be denied access to End-User pricing. These prices are featured as a limited time only promotion. IQPC reserves the right to increase these prices at its discretion.

Please note multiple discounts cannot be combined. A $99 processing charge will be assessed to all registrations not accompanied by credit card payment at the time of registration.

MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC

*CT residents or people employed in the state of CT must add 6.35% sales tax.

Team Discounts: For information on team discounts, please contact IQPC Customer Service at 1-800-882-8684. Only one discount may be applied per registrant.

Special Discounts Available: A limited number of discounts are available for the non-profit sector, government organizations and academia. For more information, please contact customer service at 1-800-882-8684.

Details for making payment via EFT or wire transfer: JPMorgan Chase - Penton Learning Systems LLC dba IQPC: 937332641 ABA/Routing #: 021000021 Reference: 23502.002

Payment Policy: Payment is due in full at the time of registration and includes lunches and refreshment. Your registration will not be confirmed until payment is received and may be subject to cancellation.

For IQPC’s Cancellation, Postponement and Substitution Policy, please visit www.iqpc.com/cancellation

Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1-800-882-8684 to discuss your specific needs.

©2014 IQPC. All Rights Reserved. The format, design, content and arrangement of this brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable under the Lanham Act and common law principles.

Metrics and Performance management are initiatives that require buy-in across the IT leadership team to ensure effectiveness. In order to maximize business results generated by your IT organization, take advantage of our group discounts by attending with your entire IT leadership team.

*Discounts apply to registrations submitted together, at the same time. Cannot be combined with any other discount


PRICING & REGISTRATION

www.CosmeticsCompliance.com

1-800-882-8684

[email protected]

212-973-1042

IQPC 535 Fifth Avenue, 8th Floor NY, NY 100017

Business

Cosmetic compliance 2015