Managing the Regulatory Environment

By Melissa Meisel, Associate Editor | May 3, 2013

NYSCC looks at global regulations.

Regulations shape the household and personal care industry every day. Just look at recent rulings for indoor tanning beds in New Jersey, the ongoing debate about the safety of triclosan in hand soap or the ban on animal testing in Europe. As a result, the New York chapter of the Society of Cosmetic Chemists (NYSCC) hosted its annual Regulatory Seminar on April 10 at Seasons in Washington Township, NJ.

According to event co-chair Adrienne Nagy of CCA Industries, the regulatory field is so fluid and complex that no curriculum exists to explain how cosmetic companies manage to sort through it all. Therefore, the only way to learn about this topic is from leading experts and colleagues in the business itself, as companies are required to comply with global regulations and product safety assessments.

Industry experts such as Dr. Yan Qi of Johnson & Johnson Consumer Companies, Craig Weiss of Consumer Product Testing Company and Annie Ugurlayan of National Advertising Division (NAD) - Better Business Bureau spoke at the event. Topics included: The EU’s Legislation on Cosmetic Products; Canadian Cosmetic Regulations; The Regulatory Environment Today in China; Cosmetic Regulation in China - One of Many; Safety Testing for Emerging Technology; Cosmetic Efficacy Claims Support; The Advertising Self Regulatory Forum & Anti-Aging Claims – an Overview of the Forum, a Review of Recent NAD Cases and Practical Advice for Claim Substantiation.

The EU Outlook
The conference opened with Dr. Annelie Struessman of CONUSBAT, a provider of internationalization services for the household and personal care industry. Her presentation, “The European Union’s Legislation on Cosmetic Products,” focused on the new requirements of the Cosmetic Products Regulation (CPR) in Europe. She also touched on Scientific Committee on Consumer Safety (SCCS) activities such as the recent attention given to fragrance allergens.

According to Struessman, the goal of the new CPR is to establish “rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.” A July 2013 deadline has been set for this guideline.

A paramount issue in the CPR regulations is the labeling of nanomaterials.

“All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients,” emphasized Struessman. “The name of such ingredients shall be followed by the word ‘nano’ in brackets.”

Other relevant topics in her presentation include a “free of claims” discussion and the recent animal testing ban.

“Canadian Cosmetic Regulations” followed Struessman’s presentation. Karl Popp of KPopp Consulting LLC offered insight on all things “north of the US” by way of personal care manufacturing. His slideshow touched on everything from cosmetic classifications to GMPs. According to Popp, Health Canada’s particularities include non-disinfectant soaps in the definition of cosmetics, defines antiperspirant containing aluminum or zirconium salt as cosmetics and requires that a product be either a drug or a cosmetic—it cannot be both.

“Classification as a cosmetic or drug is dependent upon its ingredients and claims,” noted Popp. “Drug claims are not permitted for cosmetic products.”

He cited examples such as a face cream with SPF 15, a drug because it protects the skin from sun damage; massage oil, a cosmetic because it lubricates and maintains the integrity of the skin (provided no claims on its effects on muscles are made); and toothpaste, a cosmetic when claim is to clean or whiten teeth or a drug when claim is to prevent tooth decay.

Labeling items in both English and French with a listing of ingredients in INCI format are also important, noted Popp in his presentation.

The Rules in China
China was the next stop on the global journey with Dr. Yan Qi, global regulatory affairs director at Johnson & Johnson. She is also an active member in external organizations including the China Association of Fragrance Flavor and Cosmetic Industries (CAFFCI) and Cosmetics Working Group in European Chamber of Commerce in China (EUCCC).

She noted that China, with its huge population and fast growing consumption of cosmetics, is one of the most important markets for J&J.

“The cosmetics industry is booming there,” said Qi.

However, the comprehensive regulatory and governmental strategies are “very crucial to business,” added Qi. She told the crowd, “There is a unique regulatory environment in China, as the government’s policies change very fast and the regulatory requirements are overlapped.”

She shared a slide showcasing the different Chinese agencies involved in cosmetics, including the State Food and Drug Administration and Ministry of Health (SFDA/MOH), General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), State Administration for Industry and Commerce (SAIC) and Ministry of Environmental Protection (MEP).

Current concerns regarding the cosmetics industry are the revision of the Cosmetics Hygienic Management Rules (CHMR), the pre-market registration for all important and special products (as imported products cannot be launched simultaneously in China with the rest of the world) and new ingredient registration.

“We need to make efforts all together,” concluded Qi. “It involves three words: Understand. Respect. Influence.”

Lucille Van Baaren, vice president of global regulatory affairs at Estée Lauder, also discussed the region with her presentation entitled “Cosmetic Regulation in China: One of Many.”

“There are so many emerging markets with challenges, the regulatory landscape isn’t getting easier,” she said.

Van Baaren’s slides featured the comparisons of major regulatory models for cosmetics (in-market control vs. pre-registration) and also compared China registration requirements before and after April 1, 2010; for example, documents must be provided on vendor letterhead with original signature and information must align with finished product registration formula.

“We need to make a mark with regulatory reform,” she said.

Put to the Test
Testing was also a hot topic at the April 10 seminar. Craig Weiss of Consumer Product Testing Company offered two presentations, “Safety Testing for Emerging Technology” and “Cosmetic Efficacy Claims Support.” He reviewed the history of safety testing and touched on nanomaterials and other new standards. For example, the Human Repeated Insult Patch Test (HRIPT) is the most popular safety test today, as the strength of this study is its ability to predict irritation and the product’s ability to induce an allergic response.

“Products to be used around the eye need special consideration,” noted Weiss. “Children’s products also need additional testing.”
According to Weiss, the FDA Draft Guidance for Industry in regard to nanomaterials is a hot topic right now in regulations, as well as The Safe Cosmetic Act, The Cosmetic Safety Enhancement Act and the Safe Cosmetic Alliance Bill Cosmetic Safety Amendments.

“All three bills have different priorities and standards, but none have any testing requirements,” noted Weiss.

As for claims support, the goals should be to “inform the consumer and stay competitive,” he added.

Annie Ugurlayan, senior staff attorney for NAD, concluded the event with a look at “The Advertising Self Regulatory Forum and Anti-Aging Claims,” which offered an overview of recent NAD cases regarding L’Oréal USA (Visible Lift Smooth Absolute Foundation), Maybelline New York (Instant Age Rewind Eraser Treatment) and Procter & Gamble (CoverGirl NatureLuxe Mousse Mascara). 

NYSCC’s US-China Cosmetic  Regulatory Symposium is May 16

• China has become one of the largest markets for cosmetic products as well as one of the largest manufacturing regions in the world. SFDA officials from China, industrial regulatory experts and US government officials will present the latest information about regulations in China on May 16 at Renaissance Hotel in Woodbridge, NJ.

Organized by the NYSCC, the event’s keynote speaker is Jon Huntsman, who served as ambassador to China from 2009 through April 2011 when he stepped down to run for the 2012 Republican nomination for president.

The NYSCC has benefitted greatly from the cooperation of the Chinese-American Cosmetic Professional Association in organizing this seminar.

More info: www.nyscc.org  
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