pre-conference · consumer products sold in california, including cosmetics and other personal care...

Pre-Conference Wednesday, April 24, 2019Workshops8:30 AM WORKSHOP REGISTRATION & CONTINENTAL BREAKFAST

9:00 AM

WORKSHOP A: A-Z GUIDE—WHAT IT TAKES TO DEVELOP AND MARKET A NATURAL/ORGANIC PRODUCTPersistence Market Research states that the Natural and Organic Beauty Market will reach $22Bn by 2024, with an approximate 8-10% annual growth. With increasing consumer demand for eco-friendly personal care products there is a growing interest for companies to enter into the natural and organic personal care products market, developing new and/or advanced products. Scope: What are the rules, definitions and standards? There are no regulations governing Natural products. Does the USDA Organic Program apply? What is the significance of ISO standards? Attend this workshop to learn key strategies to develop and market a natural/organic product.

Discussion will include:

· Ingredient selection – What are the sleeper rules that affect ingredient selection and importation?

· Gain insight into the rapid analysis and screening tests to insure ingredients are free from restricted elements, toxins, and pesticides

· Learn best practices for developing labeling claims to ensure compliance

· The impact of the 2018 Farm Bill

· How beauty brands can make hemp and/or CBD work for them

· Why securing sustainable, authentic supply chain will become brands’ top priority

Leave this workshop with practical tools and solutions to ensure compliance and successful market entry.

Colleen Quinn, Founder & Director, Lucy Annabella

11:00 AM WORKSHOP REGISTRATION & COFFEE BREAK

www.asdevents.com - www.asdevents.com/event.asp?id=19176

https://cosmeticscompliance.iqpc.com

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Pre-Conference Wednesday, April 24, 2019Workshops

11:30 AM

WORKSHOP B: CHEMICALS OF CONCERNS AND THE ENVIRONMENT - WHAT YOU NEED TO KNOWCosmetic companies can save millions of dollars if they are able to identify what chemicals or ingredients might create issues for them. In this interactive workshop, panelists from different agencies will share key insights to help you understand how to advance your efforts in addressing chemicals that are of consumer concerns.

· The Washington State consumer safety laws that reduce toxic exposure

· The California Safe Consumer Products: The Priority Work Program and what it means to Beauty Products

· The California Consumer Products Rulemaking: Goals, Process and Next Steps

1:30 PM WORKSHOP REGISTRATION & POWER LUNCH

2:00 PM

WORKSHOP C: CREATING A CULTURE OF COMPLIANCE COLLABORATION · Develop a holistic strategy of inter-departmental cooperation to increase cross-functional transparency

· “Engineer for performance” instead of “re-engineering to fit”: involve regulatory affairs and marketing at the early stages of product development to avoid costly and time consuming reformulation

· Craft an agile, lean environment that facilitates timely change adaptation in a timely fashion to meet product launch deadlines

4:00PM END OF WORKSHOP DAY





Conference Thursday, April 25, 2019Day One7:30 AM REGISTRATION & CONTINENTAL BREAKFAST

8:00 AM WELCOME AND OPENING REMARKS FROM CHAIRPERSON

REGULATORY UPDATES TO ENSURE COMPLIANCE

8:15 AM

REGULATORY UPDATE -- CONSUMER PRODUCT AIR QUALITY TRENDS AND POSSIBLE NEW REGULATIONS The California Air Resources Board (CARB) has recently completed its comprehensive three-year survey of over 400 categories of consumer products sold in California, including cosmetics and other personal care products. The survey generated sales and chemical ingredient data for over 300,000 products from about 1,600 manufacturers and provides the technical foundation for new CARB regulations to further reduce smog-forming emissions from consumer products. So, what does this regulatory work mean for you, whether you’re a California-based cosmetics company or not? Come learn the latest regarding sales, chemical formulations, and air quality impacts of consumer products, and how CARB’s new rulemaking could impact your industry.

In this newsworthy session, participants will:

· Examine some of the key findings from this three year survey

· Learn about possible regulatory approaches CARB is considering to reduce smog-forming emissions from consumer products

· Identify how to participate in development of CARB’s new air quality regulations slated to kick off in Spring 2019

Josh Berghouse, Air Pollution Specialist, State of California

9:00 AM

FDA AUTHORITY OVER COSMETICS: BEST PRACTICES FOR APPROACHING CURRENT AND FUTURE REGULATIONS Although US FDA does not have extensive lists of restricted ingredients and does not require pre-market approval of cosmetics, the Agency has clear expectations and priorities related to the quality and safety of cosmetic products. This session will reveal those expectations and how FDA communicates those priorities.

· Areas of collaboration with foreign regulatory agencies: assessment of cosmetic ingredient safety; cosmetic product preservation; trace contaminants

· Products and ingredients prioritized for inspection

· Labeling of fragrance allergens

Jennifer R. Martin, Director Regulatory Affairs-North America, The Colgate-Palmolive Company

Darcy Manning, Chief Legal Officer, VP of Finance & Secretary, DHC USA Inc.





Conference Thursday, April 25, 2019Day One9:45 AM NETWORKING REFRESHMENT BREAK

Join your peers to continue the discussion while networking over refreshments

10:15AM

Lacey Act and Supply Chain TransparencyThe Lacey Act is the oldest wildlife protection statute in the United States. It was originally enacted in 1900 to protect animal species. In 1981, Congress expanded the Lacey Act to cover certain plants and plant parts taken in violation of US domestic law, but not foreign law. In 2008, Congress substantially expanded coverage of the Lacey Act to include all types of plant (including lumber, wood and other plant products – including essential oils and other natural products) and animal materials. The 2008 Amendment was the first ban on wood and plant products that sought to target illegal harvest outside the United States, and to provide better transparency into the source and species of plant and wood products being imported into the United States. This session will discuss how this US statute affects industries utilizing plant ingredients in finished products and the push for supply chain transparency.

· Background on the Lacey Act and prohibitions

· Application to natural products industry and due care standards

· Looking ahead

Julie Hunter, Deputy Compliance Officer, Young Living Essential Oils

FEDERAL LEGISLATIVE UPDATES

11:00 AM

COSMETICS MODERNIZATION LEGISLATION: MAKEUP SHAKE UP-- HATCH VS. FEINSTEIN COLLINS · Which bill is fit to finally modernize cosmetic oversight?

· Does cosmetics law need to modernize after 80 years of the status quo?

· Comprehend the gravity of recently proposed legislation on the regulatory landscape and your organization

· Learn the difference between the bills and discuss what is best for the industry

· Discuss complying with the good manufacturing standards under both bills





Conference Thursday, April 25, 2019Day One

11:45 PM

PANEL DISCUSSION: FINDING THE BORDER ON THE BORDERLINE -- DECIDING FACTORS IN REGULATORY CLASSIFICATIONSIs my product a cosmetic, drug, medical device or a dietary supplement? Whether you are veteran or new to the cosmetic landscape, this interactive will answer your pressing questions and provide a clear understanding that will help you in your regulatory classification. Topics covered include:

· What is the border among cosmetics, drugs and medical devices?

· How do you manage “premiums” and “promotions” to cosmetics?

· What claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic?

· What are the differences among the FDA labeling requirements for dietary supplements, drugs and cosmetics, and is it possible to have a single label?

· When must products comply with the requirements for both cosmetics and drugs

Jennifer R. Martin, Director Regulatory Affairs-North America, The Colgate-Palmolive Company

Joseph P. Sarteschi, Director, Regulatory Affairs, StriVectin Operating Company, Inc.

12:30 PM NETWORKING LUNCHJoin us for a Networking Lunch break to grow your industry network and continue discussing today’s hot topics

TECHNOLOGY INNOVATION & SOLUTIONS TO MEET REGULATORY & COMPLIANCE NEEDS

1:30 PM

MODERNIZING YOUR COMPLIANCE PLAYBOOK Collaboration is the “new normal” in cosmetic compliance. New technologies allow small independent companies to scale quicker and abide by compliance changes faster than bigger brands. That is why it is essential that companies explore how to use technology effectively, because there is more need than ever to do more with less -- and in less time.

In this session, participants will:

· Evaluate how the most agile companies are using technology to meet compliance and regulatory needs

· Explore how to modernize collaboration during the audit process

· Examine how individuals in multiple locations are working together to deal with testing and auditing





Conference Thursday, April 25, 2019Day OneCLAIMS SUBSTANTION TO ENSURE COMPLIANCE AND MEET REGULATORY STANDARDS

2:15 PM

INDIE BEAUTY CLAIMS STRATEGYIndie beauty brands often create products that offer curated, tailor-made solutions to unique consumer concerns. These curated solutions are presented to consumers as cosmetic claims. In the increasingly competitive beauty industry, cosmetic claims are key to the marketing strategy of an indie beauty company. As indie beauty brands continue to grow, how do they navigate the challenging and expensive testing environment for product marketing claims? How do they maintain authenticity with their consumers while staying compliant with US compliance and regulatory standards?

Discussion points will include:

· Cosmetic claims throughout history: from ancient to modern times

· US FDA and FTC definition and regulations of claims

· Identification of common skincare and cosmetic claims

· How/when to utilize product testing within the product development process

· Validating ingredient-based claims with product performance testing

Qareena Ahsan, Regulatory Manager – New Product Development, Tarte

3:00 PM AFTERNOON REFRESHMENT BREAK Join your peers to continue the discussion while networking over refreshments

LABELING COMPLIANCE TO AVOID COSTLY MISTAKES

3:30 PM

STRATEGIES FOR IDENTIFYING, AVOIDING AND RESOLVING LABELING MISTAKESLabeling has never been stricter, nor have consumers ever been so knowledgeable about ingredients or keener to know what is in the products they are consuming. This means companies need to be more aware of how their products are marketed to ensure compliance.


· Hear how to implement mandatory labeling changes effectively and quickly and how to fix labeling errors

· Examine how marketing can help during the labeling process

Holly C. Young, President, H&Y Regulatory Graphics Consultants





Conference Thursday, April 25, 2019Day OneREGULATORY COMPLIANCE TO ENSURE THE SAFETY AND EFFICACY OF YOUR COSMETIC PRODUCTS

4:15 PM

CASE STUDY: BUILDING UP YOUR REGULATORY PROGRAMS As an independent brand it is essential to be able to scale your regulatory department quickly and effectively or the competition will pass you by and you’ll be buried in legal. However, it is possible to scale into international markets quickly if you do it right. You just need to know how to work inside regulatory boundaries, and you find that you can comply faster than the bigger brands.


· Examine the key areas where independent brands struggle when launching their regulatory programs

· Outline strategies to quickly and effectively scale your regulatory program

· Dissect core processes that need to be in place to overcome issues before they happen

Danah Mims, Director of Regulatory Compliance, Macadamia Beauty

5:00 PM

CHANCE OR CHALLENGE? DEEP DECODING LATEST CHINESE COSMETIC REGULATION: FILING POLICY AND CSAR · Review the new CSAR

· Discuss the filing policy, including difference with registration and requirements about documents and procedure

· Understand the influence on cosmetic companies and the cosmetic industry

Dawa Liu, Business Development Manager, ChemLinked, Reach24h Consulting Group

5:45 PMEND OF MAIN CONFERENCE DAY ONE

NETWORKING DRINKS RECEPTION IN EXHIBIT HALLAfter a long day of intense learning, join your colleagues for drinks and create valuable discussions and connections





Conference Friday, April 26, 2019Day Two7:30 AM REGISTRATION & NETWORKING BREAKFAST

8:00 AM WELCOME AND OPENING REMARKS FROM CHAIRPERSON

REGULATORY COMPLIANCE TO ENSURE THE SAFETY AND EFFICACY OF YOUR COSMETIC PRODUCTS

8:10 AM

NAVIGATING THE WATERS OF COMPLIANCE DURING MERGERS AND ACQUISITIONS It’s often said that big brands can’t understand independent brands and vice versa. However, when the two come together via a merger or acquisition there needs to be some common understanding- otherwise, both brands can be damaged.


· Examine the key hurdles companies can run in to when going through a merger or acquisition

· Outline opportunities that can exist as a result of M&A – including ramping up improved compliance measures

· Identify ways to communicate effectively to ensure that nothing is missed during audits

Andra Dallas, Legal, Compliance & Acquisitions, Pulp Riot and Research and Innovation, L’Oreal

9:00 AM

COSMETIC CLAIMS: A EUROPEAN PERSPECTIVEIn Europe, cosmetic claims are covered by Article 20 of the Cosmetic Products Regulation (EC) No. 1223/2009 (CPR) and Regulation (EU) No. 655/2013 - Common Criteria for Justification of Claims. The six Common Criteria for claims are Legal Compliance, Truthfulness, Evidential Support, Honesty, Fairness, and Informed Decision-Making. The European Commission’s Technical Document on Cosmetic Claims is a collection of best practices and provides guidance for the case-by-case application of the Common Criteria. Some member states have expressed an intention to enforce the Technical Document after July 2019, and this will have a large impact on “free-from” and hypoallergenic claims in these markets. This session will also explore developing claim trends in an EU regulatory context.

Jonathan Reynolds, Head of Regulatory & Compliance, Charlotte Tilbury Beauty





Conference Friday, April 26, 2019Day TwoBOTANICALS, NATURAL & ORGANIC INGREDIENTS – STANDARDS & GUIDELINES TO OPTIMIZE COMPLIANCE

9:40 AM

ORGANIC AND NATURAL INGREDIENTS: MAKING YOUR CLAIM AND PAYING THE PRICEConsumers are constantly navigating a cosmetic market in which companies routinely claim their products are “natural” or free from particular ingredients. All too often, these claims are contested, and cosmetic companies spend millions of dollars every year on defensive litigation. It is important to know and understand the standards, guidelines and issues surrounding claims.


· Discuss the standards, guidelines and confusion behind the claims

· Examine what claims are trending and how cosmetic marketers are using them to boost their brands

· Explore current case law surrounding marketing claims on products

· Review best practices for making claims and where most companies experience hurdles

10:20 AM MORNING NETWORKING BREAK

11:00AM

A HEALTHY FOCUS ON ORGANIC AND NATURAL PRODUCTSThe natural and organic industry is booming. Consumers want products that are ‘from the earth’. However, many organic products can be toxic or allergenic, and some – like CBD – can’t be shipped across state or international borders.


· Evaluate how ‘natural’ and ‘organic’ are being defined at the federal level

· Examine FDA and USDA areas of concern related to ‘natural’ and ‘organic’ products

· Explore new regulations around ‘natural’ and ‘organic’ products

· Dissect how a leading cosmetic company is navigating successfully through compliance

Darryl Do, Perfumer, Delbia Do Company





Conference Friday, April 26, 2019Day Two

11:40AM

SHADES OF GREEN: THE GRADIENT WHICH DIVERSIFIES THE NATURAL AND ORGANICS SECTOR · Discuss how perceptions of ingredients have altered the natural and organics space and how these perceptions will develop in the future

· Examine how 3rd-party verification is becoming fundamentally important to proving claims in the natural and organic space

· Evaluate your brand’s presentation from the consumer point of view and discover ways to minimize risk by controlling your supply and distribution chain

Kristin Adams, Founder & CEO, Afterglow Cosmetics

12:15PM

INTERACTIVE GROUP DISCUSSIONS (IDGs)Our facilitated, Interactive Discussion Groups (IDGs) optimize peer-to-peer learning by crowdsourcing solutions to common challenges surrounding your compliance issues. The connections you make through the IDGs will likely be amongst your most valuable takeaways. You will have the opportunity to sit in on two 30-minutes sessions.

INDEPENDENT COSMETIC COMPANIES BIG BRAND COSMETIC COMPANIES

IDG 1: SCALING YOUR COSMETIC COMPLIANCE PROGRAM QUICKLY AND EFFECTIVELYWith many independent brands growing very rapidly:

· How are they scaling their cosmetic compliance programs?

· How are they finding manufacturing locations that meet FDA rules and regulations?

· How are they navigating the claims that can help them grow their brand?

IDG 1: BEING AN AGILE LARGE SCALE BRANDWith technology being so important in the world today:

· How are large-scale brands becoming more agile and meeting compliance requirements with the use of technology?

· How are large-scale brands learning from smaller brands?

· What is the next big trend that larger scale brands need to wrap their heads around or risk being left behind?





Conference Friday, April 26, 2019Day TwoIDG 2: MAKING SURE YOU’RE MARKETING REALITY, NOT MYTHSWith it being important to differentiate yourself in the market:

· How are independent brands ensuring they can follow through with their marketing promises?

· When do independent brands can get into trouble?

· What opportunities do independent brands have versus bigger brands in today’s market?

IDG 2: NAVIGATING RETAILING IN MULTIPLE LOCATIONSWith retail being the bread and butter for major brands:

· How are these brands navigating rules and regulations on products?

· Where do these brands commonly trip up?

· What is the biggest concern that these brands have in a more online economy?

1:15 PM NETWORKING LUNCHJoin us for a delicious lunch and make new contacts at your table.

2:15 PM

COSMETICS CHEMICAL CONCERN—PUTTING IT IN PERSPECTIVEEuropean Commission, EU REACH, the EU Cosmetics Regulation, CIR, TSCA, Green Chemistry, International Fragrance Association, are just some of the evaluators of cosmetic products, but there are many, many more that need to be navigated. Cosmetic companies can save millions of dollars, if they are able to identify what chemicals or ingredients might create issues for them.


· Outline product contamination or concerns

· Dissect how companies are doing multiple product testing to ensure product meet standards

· Identify what overseas regulatory differences – like animal testing with chemicals – might effect their brand

· Explore what other ingredients can be used as an alternative to banned products

· Examine what ingredients consumers are (or are not) looking for in their products

Shawn Blythe, VP, Global Regulatory Affairs, International Flavors & Fragrances





Conference Friday, April 26, 2019Day TwoCANNABIS/ CABBABIODIOL

3:00 PM

PANEL: CBD — RISKS AND REWARD A lot of consumers are starting to view CBD more like a vitamin, because it has been said to contain many vitamins and fatty acids and even possess anti-inflammation properties. However, it is still a relatively unexplored market in cosmetics.


· Examine how states are navigating compliance as it relates to the massively scaling CBD industry

· Explore why many cosmetic companies are and should be interested in the use of CBD in their products

· Examine current case law related to the manufacturing and distribution of CBD

Kristin Adams, Founder & CEO, Afterglow Cosmetics

3:45PM AFTERNOON REFRESHMENT BREAK

4:15 PM

CRYSTAL BALL KEYNOTE – WHAT’S NEXT FOR COMPLIANCE STAKEHOLDERS?Whether you are a brand strategist, toxicologist, perfumer, marketer, regulatory specialist, or any other type of cosmetic leader - you have skin in the game when it comes to cosmetic compliance. So, if you had a crystal ball, what would you see happening in the market in the next few years? Growth is still very possible in the industry, so it’s important to consider what might happen next and ready your brand for it.


· Reflect on the changes that have happened recently and think strategically about how to prepare for what’s coming down the pike · Use an active learning model to learn from each other at the conclusion of the program · Hear predictions from influencers in cosmetic compliance · Outline ways to prepare for what’s coming next





Conference Friday, April 26, 2019Day Two

5:00 PM

STREAMLINE YOUR OPERATIONS TO ENSURE COMPLIANCE AROUND THE WORLD - INTERACTIVE COUNTRY SPECIFIC DISCUSSION GROUP Join your peers as we navigate around challenging international regulations through interactive sessions led by industry leaders. Choose one of the below.

IDG 1: Asia – Ensure Compliance in Asia · What regulations are the

biggest challenges to navigate in Asia?

· How has going direct-to-consumer helped or hindered the process of staying compliant?

· How do you guide your company towards compliance in a cost-effective manner?

IDG 2: United States – Ensure Compliance in the United States · How do you consider other

international markets when making US labels?

· In the States, what are the most challenging issues you face?

· What checks-and-balances best practices do you have in place to ensure compliance?

IDG 3: Europe – Ensure Compliance in Europe · What are the largest

hurdles you run into when maintaining compliance in Europe?

· What trends to you worry about coming down the pike?

· How are you changing your regulatory architecture in response to Brexit?

Jonathan Reynold, Head of Regulatory & Technology, Charlotte Tilbury Beauty

IDG 4: Latin America – Ensure Compliance in Latin America · What is the biggest

concern you have in helping your consumer to navigate your brand?

· What gaps do you think still need to be closed in LATAM when it comes to compliance?

· How are you ensuring that you meet the product & labeling guidelines?

5:45 PM CLOSE OF CONFERENCE





pre-conference · consumer products sold in california, including cosmetics and other personal care...

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