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 re-
quirements are overlapped.”
She shared a slide showcasing the different Chinese agen-
cies 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,” con-
cluded Qi. “It involves three words: Understand.
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.
Event co-chair Adrienne Nagy
• 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.
NYSCC’S US-CHINA COSMETIC
REGULATORY SYMPOSIUM IS MAY 16
More info: www.nyscc.org
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 consider-
ation,” noted Weiss. “Children’s products also need additional
According to Weiss, the FDA Draft Guidance for Industry
in regard to nanomaterials is a hot topic right now in regula-
tions, as well as The Safe Cosmetic Act, The Cosmetic Safety
Enhancement Act and the Safe Cosmetic Alliance Bill Cosmetic
“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). •