Cosmeticsandtoiletries201705 DL

May 2017
Halal Certifies
Safety and Trust
Zen-like
Attaining
Skin Balance
K-beauty
from A to Z
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Cover Story Contents
May 2017 | Volume 132, number 5
6 Editor’s Note
Little Jars, Big Effects
8 Industry Insight
Don’t Count On Genetics,
Sunscreens are the Best Bet
72 Ad Index
Market Intelligence
54
10 K-beauty: From A to Z
An Interview with Janice M. Kang
by R. Grabenhofer
13 Technology Launches
10 Regulatory
14 Guiding Sunscreen Traffic

Across the Globe
by K. Yarussi-King
22 Cosmetovigilance
and Safety Assessment
In the World of Active Ingredients
by R. Ross-Fichtner, A. Mazza, M.D., and
A. Schwanke
28 Halal Regulations
Where Culture and Cosmetics Meet
14
by L. Rigano, Ph.D.
Research
34 Dermal-epidermal Separation
Part II: Enzymatic Digestion
by Y. Zhou and H.I. Maibach, M.D.
38 The Name’s Bond. H–F Bond.

Cosmetics Can Leverage Divergent
Fluorine Forces
by G. Pantini
2 | www.CosmeticsandToiletries.com Vol. 132, No. 5 | May 2017
CT1705_TOC_Masthead_fcx.indd 2 4/21/17 10:48 AM

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EDITORIAL
Editor’s note | C&T ®
Contents Director Jo-El M. Grossman
Managing Editor Rachel L. Grabenhofer | 1-630-344-6072/rgrabenhofer@allured.com
Assistant Editors Jennifer Novoseletsky | 1-630-344-6045/jnovoseletsky@allured.com
Savannah Saunders | ssaunders@allured.com
Brooke Schleehauf | 630-344-6032/bschleehauf@allured.com
Lisa Schryver | 630-344-6068/lschryver@allured.com
Digital/Social Media Editor Audrey Latimer | 1-630-344-6067/alatimer@allured.com
Research Analyst Nicole Urbanowicz | 1-630-344-6053/nurbanowicz@allured.com
ADVERTISING SALES
Business Development Manager/
C&T Summit Exhibits
& Sponsorships Tom Harris | 1-201-445-4702/tharris@allured.com
Business Development Manager
Fragrance Paige Crist | 1-630-344-6060/pcrist@allured.com
Coordinator Kasia Smialkowski | 1-630-344-6025/ksmialkowski@allured.com
AUDIENCE DEVELOPMENT
Marketing Specialist Marie Galvan
Marketing Specialist Alyssa Derby
64
Customer Service 1-888-355-5962/customerservice@cosmeticsandtoiletries.com
DESIGN
Graphic Design Manager Lisa Hede
Graphic Designer James Fergus
Production Manager Bryan Crowe
EVENTS
Group Show Director Maria Prior | 1-630-344-6065/mprior@allured.com
Show Manager Brittany Peck | 1-630-344-6073/bpeck@allured.com
50 K-beauty: Adopting a Mindset
Eastern Ritual vs. Western Pace CORPORATE
Partner & President Janet Ludwig
by K. Steventon, Ph.D.
Partner & CEO George Fox
Controller Linda Getner
Digital Products Director Rose Southard
Testing Executive Assistant Maria Romero
OTHER ALLURED PRODUCTS

54 Reaching a Zen-like State Alluredbooks
in Skin Allured Business Media Cosmetics & Toiletries Bench Reference
Cosmetics & Toiletries magazine: Portuguese edition
Biomimetic Peptide to Balance Sensitivity 1-630-653-2155 • fax 1-630-653-2192
336 Gundersen Drive, Suite A Cosmetics & Toiletries Summit
by E. Loing, Ph.D. Carol Stream, IL 60188-2403 USA GCI (Global Cosmetic Industry) magazine
www.Allured.com Skin Inc. magazine
Face & Body Midwest Spa Conference and Expo
Face & Body Northern California Spa Conference and Expo
Formulating Face & Body Southeast Spa Conference and Expo

Perfumer & Flavorist magazine
World Perfumery Congress
Flavorcon
64 Make the Color Connection
The Art and Science of Shade-matching Subscriptions: Subscribe online: www.CosmeticsandToiletries.com/subscribe
with Pigments In the US, telephone: 1-888-355-5962; outside the US, telephone: 1-847-559-7558
(8 AM–5 PM Central, Monday–Friday) Fax: 1-847-291-4816
by S. House and E. Bartholomey E-mail: customerservice@cosmeticsandtoiletries.com
Print subscriptions: Available free to qualified individuals located in the United States. All other countries may subscribe to
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70 Skin Cleansing Formulary Change of address: Give both the new and old addresses. Allow two months for a change to become effective.
Missing issues: Claims for missing issues must be made within three months of the date of issue.
Cosmetics & Toiletries® (ISSN 0361-4387CTOIDG) is published ten times per year as Jan., Feb., March, April, May, June,
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Connect with us Address: Cosmetics & Toiletries, 336 Gundersen Drive, Suite A, Carol Stream, IL 60188-2403 |
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Cosmetics & Toiletries and C&T are registered trademarks of Allured Publishing Corporation.
Vol. 132, No. 5 | May 2017
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Editor’s Note | C&T ®
Little Jars, Big Effects

Cosmetic technologies are amazing. They pack big effects into little jars and boxes whose
outer labels don’t (or can’t) do them justice. If they did, nearly every U.S. marketer would be the
recipient of a U.S. Food and Drug Administration (FDA) warning letter—and the industry would
have larger regulatory issues to face.
In a recent example, one company received a letter for its Purifying Facial Cleanser, for
claims of: “stimulating circulation,” “promoting cellular generation,” and helping to “combat
acne, rosacea, eczema…” As the FDA put it, “Your products are not generally recognized as
safe and effective for the above referenced uses and, therefore, are ‘new drugs’...” The duty-free
product catalog, on my recent flight to in-cosmetics London, provided similar examples: an
“ultimate miracle worker” with “multi-rejuvenation patented biretinoid and active plant cells”
and a “cell power creme,” among others.
Then again, not all products are viewed through the FDA’s lens. Sunscreens are a good
example. This category’s very definition, let alone rules, differs per country (see Yarussi on
Page 14). That’s why smart manufacturers keep on top of regional regulatory rules and edge
toward them with caution. How?
First, by investing in skin research (e.g., see Maibach on Page 34), to ensure
product safety and efficacy. Also, taking measures toward cosmetovigilance, as
Ross-Fichtner explains on Page 22. These steps are becoming
more important as the industry stretches into nutrition and
dermatology. The latter is explored here by Loing, on Page 54, to
bring irritated skin back into balance; and Pantini, on Page 38, to
apply the stability and sensory benefits of liquid fluorine chemistry
from pharma in cosmetics.
Finally, trendsetting manufacturers also follow cultural beliefs
and customs, e.g., halal practices (see Rigano on Page 28) and
K-beauty rituals (see Steventon on Page 50), to secure not just Rachel L. Grabenhofer
safety, but genuine consumer trust—perhaps the most important C&T Managing Editor
and unwritten effect a company can pack into a product.
CT1705_Editors_Note_fcx.indd 6 4/20/17 9:54 AM

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Scientific Advisory Industry Insight|C&T ®
Board
Don’t Count On Genetics,

Sunscreens are the Best Bet
Eric Abrutyn
TPC2 Advisors Ltd.
Zoe Diana Draelos, M.D.

Dermatology In a podcast with P&G scientists Frauke Neuser, Ph.D. and
Consulting Services
Rosemarie Osborne, Ph.D., Cosmetics & Toiletries learned
Angela R. Eppler, Ph.D. about genetic studies in support of the Olay brand, and
Pfizer Consumer Healthcare
more. Visit CosmeticsandToiletries.com/multimedia/ to
Trefor Evans, Ph.D. hear the full interview.
TA Evans LLC
S. Peter Foltis C&T : Describe how genetics plays a key role in P&G
L’Oréal research and product development.
Mindy Goldstein, Ph.D.

Atlantic Coast Media Group
Neuser: With the multi-decades and ethnicity study
initiated a few years ago,1 we found some women
Shuzo Ishidate, Ph.D. looked more than ten years younger than their real age.
Shiseido Research Center We’ve now continued this research to understand what
makes these women different. To do so, we partnered
Karl Laden, Ph.D.
Alpa Cosmetics with 23andMe to conduct a genome-wide association
study of more than 155,000 participants.
Osborne: In the 10% of women having younger-

Prithwiraj Maitra, Ph.D.
Johnson & Johnson
looking skin, we examined skin samples for molecular

Jennifer Marsh, Ph.D.
Procter & Gamble differences. In these “good agers,” even into their 60s
and 70s, skin was in similar condition to women in
Marc Pissavini, Ph.D. their 20s, 30s and 40s. So we were interested in under-
Coty-Lancaster
standing to what extent it was genetics vs. lifestyle
Luigi Rigano, Ph.D. choices. As it turned out, two unique genetic differences
Industrial Consulting Research in single nucleotide polymorphisms were identified,
both relating to pigmentation. However, these only
Sylvianne Schnebert, M.D. increased the chances of having younger-looking skin
LVMH Recherche
by 12-14%. That made us more curious about the hab-
Ron Sharpe its, lifestyles and skin care practices of these women.
Amway Additional research revealed other factors were far
more impactful than the genetics. The most impactful,
Leslie C. Smith, Ph.D.
Consultant by far, was sunscreen use. Women who used sunscreen
greater than 90% of the time had a 73% greater chance
David C. Steinberg of having younger-looking skin. Also, interestingly, if
Steinberg & Associates they had a positive outlook on life, they had a 30%
greater chance of looking younger. Of course, this could
Peter Tsolis
The Estée Lauder Companies be a case of the chicken-and-egg.
Russel Walters, Ph.D. Neuser: Hand in hand, we introduced

Johnson & Johnson new products that have been re-formulated Frauke Neuser, Ph.D.
based on these insights. Because, really, Principal Scientist, Olay
Claudie Willemin
L’Oréal wouldn’t everyone like their skin to behave
like that of the 10% “exceptional skin Rosemarie Osborne, Ph.D.
Shuliang Zhang, Ph.D. agers?” And this is coming through in new
Unilever
Research Fellow, P&G Beauty
products: Regenerist Total Effects
and Luminous.
1. www.cosmeticsandtoiletries.com/research/ Want More?

biology/Olay-Breakthrough-Identifies-Traits-of- To hear the full podcast, log onto
www.CosmeticsandToiletries.com/multimedia
Ageless-Women-307976221.html
CT1705_Advisor_Insight_fcx.indd 8 4/20/17 3:30 PM

Market Intelligence | C&T ®
KEY POINTS
• Many product categories were invented outside
of Korea but Korean developers boosted their
popularity, making them a “must-have” part of
beauty routines.
• Skin care products in a K-beauty system are

structured to work together both physically
and biologically.
K-beauty From A to Z: An Interview

with Janice M. Kang
Rachel L. Grabenhofer What is K-beauty?

Managing Editor Many have their own view on what K-beauty is, so I’ll describe
Cosmetics & Toiletries what we think it has come to mean. Cleansers, toners, moistur-
izers and more are all established product categories produced by
beauty brands across the world. What K-beauty does is fuse these
existing products for a new take on them.
To those who develop K-beauty products, Korean beauty
generally means two things: 1) beauty products and formulations
developed and manufactured in Korea by Korean beauty compa-
nies; and 2) skin care and color cosmetics inspired by Korea and
its cultural trends.
Reproduction in English or any other language of

10 | www.CosmeticsandToiletries.com all or part of this article is strictly prohibited. Vol. 132, No. 5 | May 2017
© 2017 Allured Business Media.
CT1705_Mrkt_KBeauty_fcx.indd 10 4/20/17 10:03 AM

1. Many product categories were invented Many Korean women see their dermatologists
outside of Korea. However, Korean developers regularly for everything from facials to other
further expanded these innovations with a focus procedures. Korean dermatologists are also
on boosting their popularity; making them able to offer the advances of Western medicine
trendy, “must-have” products that are integral to alongside traditional Korean medicine. This
Korean beauty consumer routines. fuses the best of both worlds. It’s the best of
For example, the very first BB cream was nature and science coming together.
originally a German innovation introduced to
Korea by the Dr. G brand, from Gowoonsesang How do products in a
Cosmetics. Due to its benefits and popularity, it K-beauty regimen interact?
became a staple in the beauty regimes of many
Skin care products in a K-beauty system,
women across the country, and now, the world.
as is common for most beauty products and
2. Skin care in general is also an integral part
brands with solid scientific and R&D strengths,
of daily hygiene rituals for both Korean men and
are structured to work together both physically
women, as it relates to the desire to feel attrac-
and biologically.
tive. In fact, it is as important to regular daily
Biologically: Many K-beauty brands offer
care as brushing your teeth or showering. It
gentle or mild formula options to effectively
generally consists of cleansing, toning, applying
cleanse while minimizing the disruption of
an “essence” and moisturizing.
skin’s natural balance, which later products
Not surprisingly, as these steps became
in the process often aim to replenish. Since
ritualized and standardized, added steps such
cleansers based on some surfactants can
as sheet masks, sleeping packs, etc., and innova-
disrupt skin’s moisture balance and pH levels,
tive product categories, such as “first essences,”
cleansers in a K-beauty system may be offered
emerged as necessary additions to skin
in a low-pH formula, or a more gentle or milder
care regimens.
formulation. This is because skin’s natural pH
Are there major differences usually sits between 4.5–5.5. A good example
of such a cleanser would be Derma Dr. Lab’s
in East vs. West K-beauty? Mild Bubble Foam or Goodal’s Moisture Rich
One thing that makes Korean beauty for- Cleansing Foam.
mulas different from Western beauty products Physically: From a purely physical view,
is the influence of “hanbang,” also known as products are typically applied from the lightest
traditional Korean medicine. Hanbang skin care texture and thinnest viscosity to the heaviest;
is distinctly Korean, as it is formulated with imagine the way oil sits on top of water. Skin is
herbs traditionally used for medicine. Ginseng, an organ with porous and sponge-like proper-
Centella asiatica and chaga mushroom all have ties. Therefore, applying products from the
amazing health and skin care benefits. thinner and less viscous to the heavier, lipid-
Another difference is in color cosmetics, based formulations allows for the most effective
which are heavily focused on socioeconomic absorption of products, so active ingredients hit
history. Korea was built on a strong agricultural their targets, improving their efficacy.
class, i.e., farmers, and the majority of the Another example is with the vastly popular
population spent more time outdoors while the peeling gels. Exfoliation is a vital part of skin
aristocracy stayed indoors. Clearer and paler care and a naturally occurring phenomenon in
complexions were therefore viewed as more skin. When skin cell turnover is disrupted or
noble and beautiful—a sentiment that still exists poor, it leads to the poor absorption of skin care
today. Thus, sunscreens, lighter foundation products, clogged pores and many other imbal-
colors and brighter lip and eyeshadow colors are ances. So, rather than using heavily abrasive
still big in Korea. granular materials such as ground apricot
seeds, or the now-banned polyethylene beads,
What new variations in Korean consumers are using chemical and/or
K-beauty do you predict? mechanical peeling mits and gels.
We expect to see natural ingredients and Mechanical versions of this product usually
formulations continue, in addition to doctor/der- include natural cellulose in their formulations,
matologist-backed formulations and products. and with a gentle massaging action, they help
Vol. 132, No. 5 | May 2017 Cosmetics & Toiletries® | 11

K-beauty fuses existing
product types for a new
take on them.
to remove dead surface cells bound to natural in Korea, so it’s no surprise these formula-
cellulose by pilling or “noodling” them. Some tions, which are often produced with natural
formulas include: natural ingredients known to ingredients, are popular. Hanbang ingredient
minimize the disruption of skin moisture levels; processing methods, such as fermentation, have
vitamins and other ingredients that benefit skin driven their popularity as well.
health; and anti-inflammatories to minimize or
soothe irritation, especially since exfoliation is a How do you see K-beauty
stimulating process. evolving?
Once skin undergoes peeling/exfoliation, it
Rather than new technologies, I see existing
is better prepared to receive or absorb active
technologies and formulas improving. Two of
ingredients so, in turn, they better penetrate
the biggest things happening in Korea now are:
the layers of skin. As an example, a big trend
Anti-pollution/protection and care for
in K-beauty is the all-popular sheet mask, but
skin, with a focus on the external environ-
to achieve the best results, i.e., serum/essence
ment. This is due to current environmental
ampoule absorption rates, it is highly recom-
concerns; i.e., China’s development has resulted
mended to pair the mask with exfoliation/
in increased pollution, which spills over into
peeling prior to application.
Korea. As a result, the air quality is poor
and anti-pollution skin care and benefits
What technologies have are important.
enabled the K-beauty Cosmeceutical/dermaceutical skin care.
trend? Finally, people are interested in effective skin
One of the strongest influencers from care with science at the forefront. Many proven
Korean tradition is the aforementioned han- ingredients and formulations are backed by
bang approach to skin care. It has hundreds scientists and doctors, and consumers are
of years of history and proof of efficacy. Thus, very educated in Korea. We expect to see
utilizing such ingredients in K-beauty formula- formulations backed by nature and skin care
tions has been integral to its success in Korea, ingredients that compliment and boost skin’s
which recently has come to light to the rest of natural functions; think of ceramides, squalane,
the world due to the popularity of K-beauty. nourishing plant extracts, antioxidants and
In addition, Korean consumers have always anti-inflammatories.
held an affinity for nature. The concept of We expect to see big movements toward
well-being and holistic care has strong roots these two categories.

Technology Launches
Pure and Calming Oil Botanical Active Trio
Photo Credit: Botanic Innovations Photo Credit: Lipoid Kosmetik
Botanic Innovations launched NatureFRESH Cold Press Lipoid Kosmetik launched HerbaShield URB (INCI:
Cucumber Seed Oil (INCI: Cucumis Sativus (Cucumber) Maltodextrin (and) Nasturtium Officinale Flower/Leaf/
Seed Oil), a natural solution for skin, hair and scalp care Stem Extract (and) Hydrogenated Lecithin (and) Urtica
formulations. This pure oil is nutritious and can be applied Dioica (Nettle) Leaf Extract (and) Equisetum Arvense
to moisturizers, anti-aging treatments, clarifying therapies Extract (and) Sodium Chloride), a COSMOS-approved
and calming botanical serums. This lipid has calming botanical active. This ingredient is a self-preserving,
and soothing benefits, which can be blended with other three-component system, which provides natural
NatureFRESH Cold Press seed oils for enhanced results. protection for skin based on its anti-pollution and
www.botanicinnovations.com detoxification activities.
www.lipoid-kosmetik.com
Skin Barrier Defender Active to Age Well
Photo Credit: Silab
Silab has launched Wellagyl (INCI: Rosa Damascena

Photo Credit: Sytheon Flower Extract), a cosmetic active designed to help
Sytheon has launched HydraSynol IDL (INCI: Isosorbide women age well. The company tested in vivo how skin’s
Disunflowerseedate), which improves the appearance parameters are involved in healthy aging, then modeled
of skin by building and maintaining a healthy barrier and compared, in vitro, the genetic and functional
function. HydraSynol IDL is a stable version of linoleic profiles of both poorly and well-aged cells and tissue.
acid, which imparts the same benefits in addition to others. From these findings, Wellagyl was designed to provide
The ingredient is a blend of diesters originating from women with healthy, hydrated and relaxed skin, as well
isosorbide—obtained from corn—and fatty acids from as increased firmness, improved micro-relief and a
sunflower seed oil by an environmentally friendly method. restored complexion.
www.sytheonltd.com www.silab.fr
CT1705_Mrkt_Tech_Launches_fcx.indd 13 4/21/17 10:55 AM

Regulatory | C&T ®
KEY POINTS
• Sunscreens are classified and regulated differently
around the world. For instance, the United States
considers sunscreens as OTC products, while
Canada has a two-part classification system; other
places classify sunscreens as cosmetics.
• Labeling and registering differ worldwide as well.
In some cases, labels require certain Drug Facts or
safety registration numbers, among others. This article
reviews these differences.
Guiding Sunscreen
Worldwide Regulations Update
Traffic Across the Globe
Karen Yarussi-King
Global Regulatory
Associates, Inc.,
Raleigh, N.C. USA
S o, you have an SPF product and you want
to sell it overseas. Simple, just ship the
product, right? Wrong. As most formula-
tors are aware, unlike other cosmetics
and personal care products, sunscreens
create unique challenges for brands sell-
ing their products internationally. This article will provide a macro
view of key elements that differ between the United States and other
regulatory schemes in their treatment of sunscreens.

all or part of this article is strictly prohibited. Vol. 132, No. 5 | May 2017
CT1704_Regulatory_Yarussi_fcx.indd 14 4/20/17 10:45 AM

Brains With
Beauty
Discover crucial R&D insights with peer reviewed scientific knowledge, trends,
and news from the trusted voice of the beauty and cosmetic industry.
Subscribe for FREE now!

www.CosmeticsandToiletries.com/BEAUTY
CT17_House_Ad_FP.indd 1 2/20/17 12:53 PM
Except the United States, most markets that
classify sunscreens as drugs—e.g., special
function cosmetics, therapeutic goods or
medicinal products—require the registration
number to be printed on the package.
Classification of Sunscreens least number of approved sunscreen actives,

may drive global formulations. Table 1 also
To begin with, sunscreens are classified
illustrates why certain ingredients are used
differently around the world. The United States
more often than others; for example, octisalate
classifies sunscreens as over-the-counter (OTC)
is permitted in all four of these markets at 5%.
drugs. Canada, which bases much of its system
The process of adding new sunscreen
on that of the United States, has a two-part
ingredients, depending on the country, can be
classification: natural health products and
cumbersome. The large data requirements and
drugs, depending on the sunscreen actives.
associated costs often keep new ingredients
However, in the European Union (EU), Middle
from being introduced in markets that consider
East and ASEAN markets, sunscreens are
sunscreens as drugs.
classified as cosmetics. Korea, China and other
Asian markets consider sunscreens to be special
function cosmetics, similar to OTCs. Australia
Testing a Sunscreen
classifies sunscreens as therapeutic goods The U.S. Food and Drug Administration
unless exempted. As such, the requirements to (FDA) stipulates the testing required to deter-
formulate, test, label and register sunscreens mine the efficacy of a sunscreen. In most other
can vary greatly. regions, with the exception of Australia and
New Zealand, ISO sunscreen test methods
Formulating a Sunscreen are used. While all have similar elements,
SPF test methods differ slightly, for example,
Table 1 shows a comparison of approved
in their determination of SPF or static SPF,
sunscreen ingredients and levels for the United
UVA or broad-spectrum coverage, waterproof
States, Canada, Australia and the EU. While
or water-resistant properties, photostability,
this is only a sampling of countries, it clearly
critical wavelength and stability. Tables 2 and 3
illustrates the difficulty in creating a single
summarize the basic requirements and dif-
global formula. The United States, having the
ferences between test methods for static SPF
and broad-spectrum testing. Table 4 provides
in vivo requirements.
Labeling a Sunscreen
The sun care market is among the smallest The required labeling for sunscreens makes
personal care segments. However, the global it virtually impossible to sell a single global
market is projected to grow 6.4% to nearly product. The United States and Canada require
$10 billion by 2018, between emerging and Drug Facts boxes, which identify the active
mature markets. ingredients, their functions (sunscreen) and the
percentage of the actives in the formula as well
Source: Global Cosmetic Industry as directions, warnings and other FDA require-
(www.GCImagazine.com) ments as established for OTC drug products in
the Sunscreen Monograph.
Since the EU does not consider sunscreens

Table 1. Approved Sunscreen Levels in Four Markets
Sunscreen Active European Union United States Australia Canada

Aminobenzoic Acid (PABA) 5% Up to 15% Up to 15%
Avobenzone (Butyl
5% Up to 3% 5% Up to 3%
Methoxydibenzoylmethane)
Cinoxate Up to 3% 6% Up to 3%
Dioxybenzone (Benzophenone-8) Up to 3% 3% Up to 3%
Homosalate 10% Up to 15% 15% Up to 15%
Meradimate Up to 5% 5% Up to 5%
Octocrylene 10% (as acid) Up to 10% 10% Up to 10%
Octisalate (Etylhexyl Salicylate) 5% Up to 5% 5% Up to 5%
Octinoxate (Ethylhexyl
10% Up to 7.5% 10% Up to 7.5%
Methoxycinnamate)
Oxybenzone (Benzophenone-3) 10% Up to 6% 10% Up to 6%
Padimate O (Ethylhexyl Dimethyl
8% Up to 8% 8% Up to 8%
PABA)
Ensulizole (Phenylbenzimidazole
8% (as acid) Up to 8% 5% Up to 4%
Sulfonic Acid)
Sulisobenzone (Benzophenone-4) 5% (as acid) Up to 10% 10% Up to 10%
Titanium Dioxide 25% Up to 25% 25% Up to 25%
Trolamine Salicylate Up to 12% 12% Up to 12%
Zinc Oxide 25% Up to 25% No Limit Up to 25%
Diethanolamine Methoxycinnamate Up to 10%
Camphor Benzalkonium Methosulfate 6% 6%
Ecamsule (Terephthalylidene
10% (as acid) 10% Up to 10%
Dicamphor Sulfonic Acid)
Benzylidene Camphor Sulfonic Acid 6% (as acid) 6%
Polyacrylamidomethyl Benzylidene
6%
Camphor
PEG-25 PABA 10% 10%
Isoamyl p-Methoxycinnamate 10% 10%
Ethylhexyl Triazone 5% 5%
Drometrizole Trisiloxane 15% 15% Up to 15%
Diethylhexyl Butamido Triazone 10%
Enzacamene (4-Methylbenzylidene
4% 4% Up to 4%
Camphor)
3-Benzylidene Camphor 2%
Benzophenone-5 5% (as acid) 10%
Methylene Bis-Benzotriazolyl
10% 10%
Tetramethylbutylphenol
Disodium Phenyl Dibenzimidazole
10% 10%
Tetraslfonate
Polysilicone-15 10% 10%
Bis-Ethylhexyloxyphenol
10% 10%
Methoxyphenyl Triazine
Diethylamino Hydroxybenoyl Hexyl
10% 10%
Benzoate
Tris-Biphenyl Triazine 10%

Table 2. Static SPF and UVB (290-320 nm) Testing Requirements
Test Type # of Subjects Skin Types # of Exposures SPF Determination
FDA, Final Rule 2011 In vivo 10+ (≥18) I, II, III 5 Calculated
ISO 24444:2010 In vivo 10-20 (18-70 yrs) I, II, III ≥5 Calculated
AS/NZ 2604 = ISO 2444 In vivo 10-20 (18-70 yrs) I, II, III ≥5 Calculated
Table 3. Broad Spectrum (UVA/UVB) (290–400 nm) Testing Requirements
Application Requirement for Number of

Test Type Plate Type of Product to Drying Time Broad Spectrum Transmittance
Plate (UVA Labeling) Measurements
5 measurements
0.75 mg/cm2
FDA Critical Critical of mean
2-7 μm with two
Wavelength, In vitro 15 min Wavelengeth ≥ transmittance
PMMA phase
Final Rule 2011 370 nm on 3 different
spreading
plates
Critical 4 measurements
6 μm Wavelengeth ≥ of mean
ISO
In vitro PMMA 1.3 mg/cm2 ≥ 15 min 370 nm transmittance on
24443:2012
(HD-6) andUVAPF:SPF 4+ different
ratio = 1:3 plates
6 μm Wavelengeth ≥ of mean
AS/NZ =
In vitro PMMA 1.3 mg/cm2 ≥ 15 min 370 nm and transmittance on
ISO 24443
(HD-6) UVAPF:SPF 4+ different
ratio = 1:3 plates
Wavelengeth ≥ of mean
COLIPA 6 μm
In vitro 1.3 mg/cm2 ≥ 15 min 370 nm and transmittance on
(rarely used) PMMA
UVAPF:SPF 4+ different
ratio = 1:3 plates
Table 4. In vivo UVA Testing Requirements
Test Type # of Subjects Skin Types # of Exposures UVA/PF Determination

ISO 24442:2011 (Japan,
In vivo 10-20 (18-70 yrs) I, II, III 6 Calculated
China, Korea)

as drugs, only the labeling requirements established
in EC No. 1223/2009 are required. ASEAN markets
and the Middle East, as well as some South American
countries, generally follow the same requirements as
the EU.
Further, with the exception of the United States,
in most markets that classify sunscreens as drugs—
e.g., special function cosmetics, therapeutic goods or
medicinal products—the registration number must be
printed on the package. In some cases, over-labeling
can be used to satisfy this requirement so long as the
label is permanently affixed. Table 5 (on Page 20)
summarizes basic differences in labeling requirements.
Registering a Sunscreen
Finally, requirements to register sunscreens are
different in most markets, often due to differences in
classifications. Example requirements include: annual
vs. one-time registration; free vs. paid; and registra-
tion vs. notification, in addition to data requirements.
Markets requiring registration will request a combina-
tion of safety testing, efficacy (SPF) testing, certificates
of analysis, stability testing, formulas, specialty testing
of actives, labeling and product samples.
Further, while sunscreens are considered cosmet-
ics in the EU, safety assessments and entry into the
Cosmetic Products Notification Portal are required,
which depending on the company, may incur associ-
ated costs.
Clearly, developing sunscreen products in a global
market poses challenges, but having all the facts in
place and understanding the various requirements
sheds some light on the process to make it much
easier.
Acknowledgements: Tables were created with support from Suncare
Labs, Winston-Salem, NC.
C&T Daily Newsletter
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Table 5. Comparison of Labeling Requirements of Four Markets
Labeling Requirement European Union United States

SPF Number Required Required
Approved SPF Numbers ≥6 N/A
Registration Number No No
Drug Facts Box No Yes
Identification of Actives In the body of the IL Actives called out separately
Declare Percentage of Actives No Yes
• For external use only.
• Do not use on damaged or broken skin.
• Stop use and ask a doctor if rash occurs.
• When using this product keep out of
eyes. Rinse with water to remove.
• Do not stay too long in the sun, even • Keep out of reach of children. If
while using a sunscreen product. swallowed, get medical help or
• Keep babies and young children out contact a Poison Control Center
of direct sunlight. right away.
Required Warnings • Over-exposure to the sun is a serious • For sunscreen products that are not
health threat. broad-spectrum or are broad-spectrum
• Reducing the quantity of sunscreen with an SPF < 15:
product applied will lower the level Skin Cancer/Skin Aging Alert: Spending
of protection significantly. time in the sun increases your risk of
skin cancer and early skin aging.
This product has been shown only
to help prevent sunburn, not
[in bold font] skin cancer or early
skin aging.
• Non-Water Resistant Product:

-Apply liberally 15 minutes before
sun exposure.
-Use a water resistant sunscreen
if swimming or sweating.
-Reapply at least every 2 hours.
• Apply sunscreen products before sun
-Children under 6 months: Ask a doctor.
exposure.
• Apply generously.
Required Directions • Water Resistant Product:
• Reapply frequently to maintain
-Apply liberally 15 minutes before
protection, and especially after
sun exposure.
perspiring, swimming or toweling.
Reapply:
-After 40 [or 80] minutes of swimming
or sweating
-Immediately after towel drying
-At least every 2 hours
-Children under 6 months: Ask a doctor.
• For sunscreens with Broad Spectrum

SPF ≥ 15:
-Sun Protection Measures:
Spending time in the sun increases
your risk of skin cancer and early
skin aging. To decrease this risk,
regularly use a sunscreen with a
Sun Alert Statement N/A
Broad Spectrum SPF value of 15
or higher and other sun protection
measures, including:
-Limiting time in the sun, especially
from 10:00 a.m.–2:00 p.m.
-Wearing long-sleeved shirts,
pants, hats and sunglasses

Australia Canada
Required Required
4 N/A
Yes Yes (DIN or NPN)
No Yes
Actives called out Actives called out separately
Yes Yes
• Warning statements to the effect that the product

should be kept out of the eyes and should not be used • For external use only.
on broken, damaged or diseased skin • Do not use on damaged or broken skin.
• Spray sunscreens should also include a warning not to • If rash occurs, discontinue use and consult a health care
inhale the product practitioner.
• Primarily therapeutic (but not secondary) sunscreen • When using this product keep out of the eyes. Rinse with water
products should also include warning statements to to remove.
the effect that prolonged exposure to the sun should • Keep out of reach of children. If swallowed, get medical help or
be avoided, and it is important to wear protective contact a Poison Control Center right away.
clothing, hats and eyewear when exposed to the sun
• Apply liberally/generously (and evenly) 15 minutes before

For a primary therapeutic sunscreen:
sun exposure.
• The product should be applied to the skin in generous
• Reapply at least every 2 hours.
amounts over all of the exposed areas 20 minutes
• For use on children less than 6 months of age, consult a health
before sun exposure.
care practitioner.
• Product should be reapplied every 2 hours or more
often when sweating, and should be reapplied after
Depending on water-resistance:
swimming or toweling.
• Use a water resistant sunscreen if swimming or sweating.
• Skin Cancer/Skin Aging Alert: Spending time in the sun increases

your risk of skin cancer and early skin aging. This product has
N/A
been shown only to help prevent sunburn, not skin cancer or early
skin aging.

Regulatory | C&T ®
KEY POINTS
• It can be deduced from today's scientific
literature that countless ingredients have been
developed with the intent to alter the structure
and function of human skin.
• This raises important questions in terms of

how these products should be regulated and
what types of safety standards they should
be held to.
North American Regulatory Review
Cosmetovigilance
and Safety Assessment
S
In the World of Active Ingredients
Robert Ross-Fichtner,
Angela Mazza, MD, and
Anna Schwanke
Focal Point Research Inc., canning U.S. Food and Drug Administration (FDA) warning
Mississauga, Ontario letters to cosmetic companies, it is clear that cosmetics are
being formulated with the intent of altering the structure
or function of human skin. Historically, we considered
these kinds of claims as extreme marketing, in an effort
to convince consumers that a product provided real and

CT1705_Regulatory_Fichtner_fcx.indd 22 4/20/17 10:35 AM

Unlike drugs—where monographs dictate
what actives can be used and regulatory
processes control what actives make it
to market—no such barriers exist for
cosmetic actives.
long-lasting benefits. Twenty-five years ago, the drugs. A good example is sunscreens, which
industry had very few tools to actually make in the North American cosmetics market, are
such changes to skin. "Active" ingredients were regulated as drug products. In conjunction, new
typically included in products at infinitesimally sunscreen actives are classified as new drugs,
small quantities, in order to make a label mandating the same extensive safety, efficacy
claim. The challenge for formulators then was and quality assurance testing and oversight
to develop products with excellent aesthetics as drugs. This classification also requires
whose effects were much shorter-lived. Such mandatory reporting of serious Adverse Drug
products truly met the intended definition for Reactions (ADRs) to regulatory authorities
a "cosmetic." and the practice of pharmacovigilance, which
It can be deduced from today’s scientific involves the detailed analysis and reporting of
literature that countless ingredients have been adverse events from drugs.
developed with the intent to alter the structure The basic elements of pharmacovigilance
and function of human skin; and by extrapola- include:1
tion, that the finished products they are used • A summary of ongoing safety issues.
in are intended to do so as well. These bring This includes important identified risks,
truly exciting and innovative possibilities for potential risks and missing information.
the cosmetics industry. At the same time, this • Routine pharmacovigilance practices.
raises important questions in terms of how These are the systems and processes that
these products should be regulated, what types ensure information on all reported suspected
of safety standards they should be held to, and adverse reactions is collected in an accessible
how consumer complaints and adverse reac- manner. It also includes the preparation of
tions should be monitored. reports for regulatory authorities and the
continuous monitoring of the safety profile of
Pharmacovigilance in Action approved products.
Today, there is a stark contrast in the • An action plan for safety issues.
requirements between cosmetics and true If a safety issue is identified, it should be
specified. Also, proposed actions, their objec-
tives and rationale should be documented.
Monitoring by the sponsor for safety issues
and proposed actions must be carried out, and
Zion Market Research reports the anti- milestones for evaluation and reporting set.
aging market will be worth US $216.52 • Summary of actions to be completed.
billion by 2021, expanding at a CAGR of The summary should consider when
7.5% between 2016 and 2021. exposure to the product will have reached
sufficient levels to allow for the identification
and characterization of ADRs and when the
Source: Global Cosmetic Industry results of ongoing or proposed safety studies
(www.GCImagazine.com) are expected to be available.

Beyond these basics are various pharmacovigi-
lance requirements for the different entities involved
in the production and marketing of drug products,
described as follows.2
Manufacturer Requirements
• Report all information relating to serious
adverse drug reactions within 15 days after receiving
or becoming aware of them.
• Prepare an annual summary report of all
information relating to adverse drug reactions and
serious adverse drug reactions.
• Maintain records of the reports and
case reports.
• Retain each record for 25 years, beginning the
day after each is created.
Requirements for
Product License Holders
Author's note: Examples include Drug Identifica-
tion Number [DIN] holders or Market Authorization
Holders [MAHs].
• Complaints procedure
• ADR procedures
• Receipt of ADR data
• Evaluation of ADR data
• Reporting of ADR data to Health Canada
• Literature search
• Contractual agreement
• Validation of computerized systems
• Preparation of annual summary report
• Preparation of an issue-related summary report
• Maintenance of records
• Receipt and reporting of unusual failure in
efficacy for new drugs
Requirements for Importers

• Complaints procedure
• ADR procedures
• Receipt of ADR data
• Contractual agreement
• Validation of computerized systems
• Maintenance of records
• Receipt of unusual failure in efficacy for
new drugs
Cosmetovigilance Applied
The parallel term to pharmacovigilance in the
world of cosmetics is cosmetovigilance. Relatively
new, it was first introduced in a 1997 French pub-
lication in the context of “monitoring cosmetic
product safety.”3 Several European countries experi-
mented with cosmetovigilance systems between

The industry must embrace cosmetovigilance
as a priority for products whose benefits
extend beyond short-term 'cosmetic' effects.
1989 and 2005, with varying degrees of success. Pre-clinical: Prior to testing the drug in
One of these trials resulted in the August 2004 humans, it must be investigated for toxicity, i.e.,
Public Health Law, which is the foundation for its potential to cause harm. This is carried out
cosmetovigilance in France today. through either in vitro or in vivo research.5
This system has led to the detection of Phase I: A several-months-long study is
emerging allergen and sensitizing ingredients conducted on 20–100 otherwise healthy people
such as vitamin K, paraphenylenediamine with the condition of interest to evaluate the
(PPD) and octocrylene. Following the Coun- safety and dosage of the drug. Approximately
cil of Europe Resolution ResAP (2006), 70% of drugs move to Phase II.6
Belgium, Denmark, Germany, Italy, Norway Phase II: Several hundred people with the
and Sweden implemented cosmetovigilance condition participate in a study lasting from
systems, in which cases reported by health several months to two years to investigate the
care professionals were collected. In a two- efficacy and side effects of the drug. Approxi-
year pilot study, more than 1,600 undesirable mately 33% of drugs move to Phase III.
effects were reported, of which up to 64 were Phase III: This larger-scale study of the
deemed serious. drug’s efficacy involves monitoring 300–3,000
volunteers having the condition for adverse
Allergy, Irritation and reactions over a 1–4 year trial period. Only
Beyond: Safety in Phases after a drug passes the pre-clinical trial and
first three clinical phases can it be submitted
Family doctors, allergists, dermatologists
to a regulatory agency for review and approval.
and immunologists manage all skin conditions
Approximately 25–30% of drugs move to
related to irritants. Patients typically present
Phase IV.
with two types of reactions: contact dermatitis
Phase IV: This phase represents post-market
and allergic dermatitis. Some patients experi-
safety monitoring once a drug is on market.
ence a combination of both.
These lengthy and costly studies and analy-
Contact dermatitis is a direct injury to
ses examine safety implications beyond allergy
layers of the skin; allergic reaction involves
and irritation. They are intended to examine
the immune system, where antibodies are
the systemic and long-term effects of new drug
formed to attack the antigen, e.g., the cosmetic
products. While such a discussion might seem
ingredient. This skin reaction can manifest with
out of place in the context of cosmetics, entre-
varying degrees of redness, superficial and deep
preneurial efforts in the industry are showing
swelling, blisters and hives; it occurs through
tremendous promise for creating molecules that
direct or airborne contact. In review of the
could have profound implications on skin aging
literature, the incidence of dermatitis due to
and skin restoration. Yet, unlike drug products,
cosmetics is between 2% and 8%.3, 4
where monographs dictate what actives can be
In contrast with cosmetics, drugs developed
used for common drugs, complex regulatory
for topical or oral use must consider safety
processes control what new active ingredients
beyond allergy and irritation. New drugs are
make it to market, no such barriers exist for
developed in a series of stages or phases that
cosmetic actives.
begin with preclinical animal models and
In the United States, action is being taken
progress through a series of human studies with
to shift to a similar cosmetovigilance frame-
increasing numbers of clinical subjects. A typi-
work as that adopted by European countries.
cal new drug development pathway is described
The proposed 2015 Cosmetic Modernization
as follows.

Prior to testing a drug in humans, it must be investigated for toxicity.
Amendments and 2016 Personal Care Products effects intended for cosmetics. This should
Safety Act have been drafted, and require that include a stronger effort to monitor and
cosmetics companies report any serious adverse characterize adverse reactions and share them
health events associated with their products globally, with responsibility shared by both
to the FDA.7, 8 And most likely, any reactions ingredient suppliers and brand owners.
reported would be topical in nature and not As an industry, added regulation and proce-
systemic. The measures in these bills would dures are rarely welcomed. However, this is a
provide an excellent start. critical insurance policy we must implement to
protect our companies, brands and the indus-
Conclusion try’s reputation. This will allow our innovation
For cosmetic scientists, this is an exciting programs to proceed safely and successfully.
and profound time, where we can look forward
to making real differences in skin aging and References
other disorders. But there are questions we All websites accessed April 10, 2017.
must face with eyes wide open: What are these 1. https://www.fda.gov/downloads/drugs/guidancecomplian-
products we are making? If, for example, we ceregulatoryinformation/guidances/ucm073107.pdf
can incorporate an active into a wrinkle cream 2. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-
that can repair DNA, what standards must we bpf/docs/gui-0102_gvp-eng.php
hold such a product to? We, as an industry, 3. http://www.jle.com/en/revues/ejd/e-docs/cosmetovigi-

lance_definition_regulation_and_use_in_practice_303725/
must ensure this technology can be used safely article.phtml?tab=texte
without the same routine preclinical testing as 4. https://www.ncbi.nlm.nih.gov/pubmed/19808005
required for drug products, and we must put 5. https://www.fda.gov/ForPatients/Approvals/Drugs/
plans into place for the responsibility of safety ucm405658.htm
assessments for new molecules incorporated 6. https://www.fda.gov/ForPatients/Approvals/Drugs/
ucm405622.htm
into cosmetic products.
7. https://www.congress.gov/bill/114th-congress/
While there is no easy answer to these
house-bill/4075/all-info
questions, the industry must broadly embrace
8. https://www.congress.gov/bill/114th-congress/
cosmetovigilance as a priority for products senate-bill/1014
whose benefits extend beyond the short-term

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Regulatory | C&T ®
KEY POINTS
• For Muslims, additional rules for cosmetics are
mandated by a unique source, the Quran, which
implies further safety considerations related to
the specific care of one's body.
• Halal certification, outlined here, is essentially

a synonym for the careful supervision over
all formula and production details, and
its guarantee has gained interest from an
increasing number of consumers.
Formulator's Forum
Halal Regulations
Where Culture and Cosmetics Meet
Luigi Rigano, Ph.D.

ISPE srl, Milan, Italy
M any restrictive norms are applied

to cosmetic formulations all over
the world, prohibiting or limiting
the use of certain ingredients. For
example, general good manufac-
turing practices and guidelines
indicate the best procedures for safe manufacturing and filling.
These limitations are usually based on safety considerations,

CT1705_Regulatory_Rigano_fcx.indd 28 4/20/17 10:52 AM

Islam-compliant consumption is
giving rise to the search for
products that meet halal standards.
especially the allergenic or irritant potential of behave accordingly is a sin for strict believers.
ingredients and their combinations. Moreover, Halal rules identify, in detail, the environ-
potential side effects, the toxicological profile of ment of compliant cosmetic products. For
the formula, the sensitivity of the skin applica- example, alcohol (more precisely, ethanol) is
tion site and the consumer’s age are carefully considered a toxic substance in general, not
considered. In addition, ingredients from only when ingested. The reasons for its prohibi-
animal sources, the purity profiles of raw mate- tion are ancient and trace back to the effects
rials and their blends, the frequency of use and of drinking alcohol in hot regions where Islam
duration on the skin, and impurities content are was born and first developed.
taken into account to establish a product's com- Moreover, alcohol can penetrate the skin
pliance to the principles of consumer safety. and exert toxic effects. Therefore, to comply
In most cases, restrictions combine com- with halal rules, cosmetics must not come into
mercial elements with physiological innocuity contact with alcohol. Similarly, ethanol should
requirements, and should be accompanied by be avoided in the chemical extraction and
specially designed warnings on product labels. synthesis of raw materials. Another limitation,
Updates of these norms are regularly carried which rarely affects cosmetics, is pork and its
out following new scientific discoveries and the derivatives such as gelatin. This ban is based
evolution of society. on the ease with which pork decomposes
in hot climates and the high levels of envi-
Halal Fundamentals ronmental pollution pork farming causes in
For Muslims, additional rules for cosmetics desert regions.1
are mandated from a unique source, the Quran,
and imply further safety considerations that are The Potential Market
different from those described above. Cosmetics The world's Muslim population accounts
are important in the Muslim world, especially for approximately two billion people and is
for women. Certain groups believe a body is expected to grow to about 26% of the total
given to each person as a gift from god, who left world's population by 2020. Within these
that body in the person’s care. Therefore, taking figures, the younger (< 30 years) segment makes
care of the body in the right way through the up the majority (~67%).2
application of the correct products is necessary, A rough estimate of personal care and
provided that modesty is preserved. Not to cosmetic purchases in the Asia-Pacific region
is around US $70 billion, of which about 5–6%
are halal-certified. Purchasing of halal-certified
cosmetics is currently concentrated in countries
having a prevailing Muslim faith, including:
The global halal cosmetics market was Indonesia, Pakistan, Turkey, Iran, Saudi Arabia,
valued at $23.4 billion in 2015 and is Malaysia, Gulf Emirates, etc. These countries,
together with Egypt and Algeria, house an
expected expand at a CAGR of 14.5% to
Islamic population of more than 800 million.
reach $45 billion by 2020.
The number of Muslims in other major
nations, including China, Russia and the United
Source: Technavio States, is also substantial; more than 200 mil-
lion. Furthermore, almost 15 million Muslims
live in the main four European countries.

In order to be accepted by Islam followers, halal cosmetics must pass a
rigorous certification procedure.
Beyond the statistics, however, halal- process. These religious sentiments play an
certified products are not only meant for important role in product choices.
Muslim buyers. Currently, they stand out in Most Muslim consumers buy non-halal
the market as healthy, safe and appreciated by certified products only when they cannot
Islamic and non-Islamic consumers, in light of find alternatives. And until recently, given the
the complexity and reliability of controls for the historically limited number of halal-certified
certification process. cosmetic products, consumers were obliged to
Customs laws and rules are also affecting accept non-halal alternatives. Today's habits are
these figures. The Indonesian market of more fast-changing, however, and Islam-compliant
than 200 million Muslim consumers is under consumption is giving rise to a growing search
the “Halal Product Guarantee Law.” Issued in for products that comply with halal standards.
2014, this law will be effective by the end of
2019 and requires that all products, cosmetics Ingredient Considerations
or not, are labeled halal or non-halal. Malaysia, In cosmetics, for halal cosmetics, special
Thailand, the Philippines and other Asian attention should be paid to the origin and
countries are about to pass similar regulations. processing of collagen, keratin, hyaluronic acid,
amino acids and hydrolyzed animal protein.
Halal vs. Haram Additional restrictions concern blood and its
The term allowed in Arabic translates as derivatives, insects and their derivatives—
halal, indicating what is permitted under e.g., cochineal extract or carmine, CI 75470,
Islamic rules. Halal concerns food, drinks, extracted from Dactylopius coccus—and
cosmetics or other common objects and mat- drugs or ethyl alcohol, which are considered
ters of daily life. In contrast, all that is clearly intoxicants, even if simply being used to clean
forbidden is haram. A product is considered equipment in the production facility or to
haram if it contains or comes into contact with develop extracts. In particular, nutmeg, Asa-
forbidden materials during the manufacturing foetida, vanilla extract and gelatin (especially

from pork) are forbidden either due to being intoxicants themselves or
containing certain percentages of other intoxicating substances.
In general, much like overall cosmetic regulatory restrictions, all
substances that are harmful to human health are prohibited from halal
products. GMO ingredients, for example, are an area of concern, as some
question whether they could damage human health.3
Halal Compliance
In many countries, compliance to the norms described here, in the
introduction, are verified only in case of inspections and controls by
authorities in the marketplace, on rare occasions at the production sites,
or when official dossiers are registered at centralized sites. However,
halal compliance is verified as a part of all general procedures, which is
assured through halal certification.
The reason for such a different approach is that control over the
compliance of products with Muslim rules is not based on investiga-
tions carried out a posteriori, with modern analytical instruments,
but in a preliminary manner that ensures any contact with forbidden
ingredients, even superficial, is avoided during the whole production and
distribution process.
Islam prescribes detailed behavioral rules to its believers. Such rules
restrict or prohibit any contact with products that are inconsistent with
its laws. In relation, halal certification attests to a product's conformity
during its whole production cycle to the rules of Islam. Any cosmetic, in
order to be accepted by Islam followers, must pass a rigorous certifica-
tion procedure, provided after a detailed approval path; it should be
noted that Islam is not only a religion but also a civil code for believers.
Four Steps to Certification

Halal certification is a procedure identifying the halal compliance of
a product, service or whole manufacturing process. It certifies a prod-
uct does not contain haram substances and that there are not risks of
contamination in the production process. Upon concluding the certifica-
tion process, a product may be attributed with a logo designating the
identification of compliant products.
The certification procedure consists of four main steps, in order to
guarantee the implementation of the halal quality system in the produc-
tion chain.
1. Administrative/documentation. An interested firm should first
contact the certification agency or a designated company to express
interest in starting the certification process and/or receive more informa-
tion. A budget is then issued and, upon acceptance, a contract is signed.
The certifying agency provides documents describing, in a detail, the
manufacturing processes and products profile. All documents are then
examined by the agency's or a designated party's technical staff.
2. Halal Quality System (HQS) implementation. This is the most
demanding phase of the certification procedure, even if it is similar to
other systems currently in use, such as ISO 9001:2008. Its main steps are
as follows.
a) An internal HQS coordinating team of employees should be cre-
ated. This group manages all parties involved in HQS implementation
throughout the whole production cycle, and ideally should be composed
of one member of each department/function in the company. Each team

According to Islam, taking care of the body by
applying the correct products is necessary.
Not doing so is a sin for
dedicated practitioners.
member's duties in relation to halal should be Manufacturing should set up dedicated or

outlined in a manual for relevant procedures separated production lines for halal-certified
and to implement periodic training of all products. Segregation or separation areas
involved personnel. should be foreseen but this also involves tools,
b) Each department should contribute clothes and utensils. After certification, all
to the success of the certification procedure. packaging, flow charts and technical data
For example: sheets must bear the identification for the Halal
Purchasing should buy only ingredients International Authority (HIA), an HIA code and
devoid of haram substances, produced by either the wording HIA approved.
certified suppliers or attesting to the lack of for- 3. Audit. The certification agency will visit
bidden components in the production process. the site and audit the documentation in order to
The R&D Laboratory must formulate in assess the truthfulness of what is reported and
accordance with halal standards, checked by to make sure there are no contamination risks.
the agency or the delegate. The laboratory 4. Certification issued. Having received
approves the conformity of all raw materi- the delegate’s opinion and carried out all
als and lack of cross-contamination with assessments with positive findings, the halal
haram substances. certificate and logo to be placed on the
Transportation should perform checks product's label are released. The certification
for possible contamination with prohibited procedure also includes installing a quality
substances during product transports. Vehicles system with detailed operational standards.
must not have been used for transporting pork A final certificate is awarded by appointed
and its by-products. On the contrary, a detailed certification agencies, e.g., one or more inter-
in-depth purification procedure is necessary. national accreditation authorities who are
Storage and handling must ensure no authorized to release halal certificates in their
cross-contamination occurs between halal and operating countries. Agencies establish and
other materials during the in-house storage and certify that products and services they scruti-
handling. Appropriate "traffic light" signals may nized are in accordance with international halal
be used to mark the areas of segregation where standards. These documents are recognized in
haram materials are located. Such indicators relevant regions under the competence of the
and labelling are useful for identifying storage accreditation authorities.
areas, refrigeration rooms and utensils.
Thus, "green light" labels identify those Authorized Institutes
exclusively used for halal products. Yellow The World Halal Authority (WHA)4 names
labels apply to materials used both for halal and authorizes institutes for assisting com-
and non-halal products. These require santiza- panies with the halal-certification procedure.
tion before use in halal production. Red labels These institutes assist applicants with all the
identify materials and rooms not to be used for steps heading to certification and give support
halal products. to the Halal Management Team during imple-

mentation of the HQS and during the certification
agency audits.
Extreme care should be applied to the selection of
these institutions, as some cases of non-acceptance
and poor quality activities have led to the loss of time
and money for some companies.
Conclusion
Even if halal rules are applied in different countries
at varying levels, halal-certified cosmetics represent a
fast-growing market with nearly two billion potential
consumers. The era of consumers selecting products
based merely on esthetics is over; today’s consumers
make choices based on ingredient content or omission,
and on certification and compliance to recognized and
specialized rationales.5
Product quality also has grown in importance to
consumers, while control over impurities is, more
than ever, a key for safety. Halal certification is essen-
tially a synonym for the careful supervision over all
formula and production details, from cradle to grave,
and its guarantee is growing for a wider number
of consumers.
References
1. M Harris, Good to Eat: Riddles of Food and Culture, Waveland Press
Inc, 50047 (1998)
2. Thomson Reuters, State of the Global Islamic Economy 2013 Report
(2013)
3. www.kosmeticanews.it/halal-e-haram/ (Accessed Apr 18, 2017)
4. www.whad-it.com
5. M Colombini, Cosmesi Halal, Un mercato in crescita, Kosmetica (2)3
26-30 (2016)
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Research | C&T ®
KEY POINTS
• Readers have expressed interest in
understanding the most efficient and reliable
methods to separate the epidermis and dermis
as an important technique for basic
skin investigation.
• This second installment in a three-part series

reviews separation via enzyme digestion.
Dermal-epidermal
A Dermatological View
Separation
Part II: Enzymatic Digestion*
*This article has been adapted with permission from Arch Derm Res (in review).
T
Ying Zou
Shanghai Skin Disease Hospital, Shanghai
and University of California, San Francisco
Howard I. Maibach, M.D. he first column in this skin care and
University of California, San Francisco cosmetic research series on dermal-
epidermal separation methods
reviewed advantages and disadvan-
tages of acid, alkalis and neutral salts
for this purpose. This second column
reviews optimum dermal-epidermal separation methods
utilizing enzyme digestion options.

CT1705_Research_Maibach_fcx.indd 34 4/20/17 11:03 AM

Thermolysin caused detachment in
the basal membrane zone while trypsin
caused chaotic segmentation and
digestion of the keratinocytes.
Enzymatic Digestion tions of trypsinization can also separate the

suprabasal layer.
Several enzymes can separate the epidermis
Pancreatin: Becker et al.11 described the
from the dermis (see Table 2). They do so at
pancreatic enzyme method; results resembled
the dermal-epidermal junction (DEJ) by digest-
those of Medawer7 obtained with trypsin.
ing specific structures.
Fan,12 however, showed crystalline and puri-
Trypsin: Basement membrane elastic
fied trypsin-separated epidermis using equal
fibers play an important part in anchoring the
or smaller amounts than pancreatin. Purified
epidermis to the underlying tissue. Medawer7
trypsin freed the epidermis the most efficiently.
observed human skin incubated in trypsin and
Pronase: Einbinde et al.13 compared
found it possible to disengage the epidermis
pronase, a broad-spectrum proteinase, and the
in the form of an intact sheet. Klein8 also
relative digestive action with five other proteo-
separated mouse epidermis using trypsin
lytic enzymes: trypsin, collagenase, pancreatic
and elastase.
elastase, fungal elastase and keratinase (see
Shorter incubation was required for elastase
Table 2). The endpoint of digestion was
than trypsin, and the ease or difficulty of sepa-
similar. Optimal enzyme concentration, pH and
ration was directly related to the total amount
time varied.
and dimensions of skin samples incubated.
Pronase was extremely active although its
Trypsin separation remains widely used and is
proteolytic and elastolytic activity was not sig-
reported to be less damaging to keratinocytes
nificantly different from the others. Separation
than other physical and chemical procedures.9
at the DEJ was followed by acantholysis and
Separation predominantly occurs between
subsequently, the loss of dermal appendages
basal and suprabasal cells by disruption of
and fibrous elements. Mature keratin structures
desmosomes, which may cause basal cells
or basement membrane structures did not
to remain loosely attached to the basement
appear altered.
membrane.10 Trypsinization causes loosening
Dispase: Dispase is a bacterial neutral pro-
of the keratinocytes intercellular connections,
tease obtained from Bacillus polymyxa culture
and vigorous washing of the isolated epidermal
filtrate, whose cytotoxicity is low. Kitano et
sheet removes contaminating dermal fibroblasts
al. isolated epidermal sheets in vivo without
and dissociates keratinocytes. Slight modifica-
dissociating cells.14 After 24 hr, epidermal sheets
from human skin treated with 500 and 1,000 U/
mL of dispase were easily peeled from the der-
mis, and its undersurface retained rete ridges.
Electron microscopy showed the basal sur-
face composed of cells with numerous slender
The global topical drug delivery market villi and cytoplasmic projections. Although
is expected to reach US $125.88 billion intercellular spaces of spinous as well as basal
by 2021, growing at a CAGR of 6.4% layers were wide, desmosomes were intact with
between 2016 and 2021. their accompanying tonofilaments.
Einbinder et al.13 compared the digestive
Source: Research and Markets action on skin of six proteolytic enzymes. Opti-
mal enzyme concentration, pH and time varied.
They ascertained that skin must be incubated

Table 2. Enzymatic Separation
Year Author Enzyme Concentration (%) Ideal dilution Duration time
CT1705_Research_Maibach_fcx.indd 36
Depends on skin
1 1941 Medwar7 Trypsin 0.500 Tyrode’s solution
thickness
30 min (back skin),
1962 Klein8 Trypsin 0.500 Tyrode’s
25 min (ear skin)
1966 Einbinder et al.13 Trypsin 0.025 Tris buffer (0.05 M) 90 min~4 hr (37oC)
Isotonic solution
Purified trypsin 0.500
(NaCl 0.042%, KCl 0.42%)
1958 Fan J12 Isotonic solution 45 min (40oC)
Crystal trypsin 0.100 (CaCl2 4.2%, NaHCO3 0.15%,
glucose 0.1%)
CMF-BSS (Ca++ and Mg++-free
1985 Takahashi15 Trypsin 0.250 12~13 hr (4oC)
Hank’s balanced salt solution)
Ringer-sodium bicarbonate
2 1952 Becker11 Pancreatin 0.250~0.500 10~15 min (38oC)
solution
Isotonic solution
12 (NaCl 0.042%, KCl 0.42%,
1958 Fan J Pancreatin 0.500 45 min (40oC)
CaCl2 4.2%, NaHCO3 0.15%,
glucose 0.1%)
1966 Einbinder et al.13 Pancreatic elastase 0.050 Tris buffer (0.05 M) 90 min~ 4 hr (37oC)
20~25 min (back skin),
3 1962 Klein8 Elastase 0.012 Tyrode’s
10~15 min (ear skin)
1966 Einbinder et al.13 Fungal elastase 0.100 Tris buffer (0.05 M) 90 min~4 hr (37oC)
4 1966 .. Keratinase 0.100 Tris buffer (0.05 M) 30 min (37oC)
5 1966 .. Collagenase 0.100 Tris buffer (0.05 M) 30 min (37oC)
6 1966 .. Pronase 0.100 Tris buffer (0.05 M) 30 min (37oC)
7 1989 Walzer et al.16 Thermolysin 250 & 500 ug/mL Mg++-free PBS 1 hr (4oC)
PBS, Eagle MEM or Eagle MEM
8 1983 Kitano et al.14 Dispase 500 & 1,000 U/mL supplemented with 20% fetal 24 hr (4oC)
bovine serum
1985 Takahashi15 Dispase 1,000 U/mL M-199 containing 10% FCS 24 hr (4oC)
Dulbecco’s modified Eagle
1995 Ohata et al.28 Dispase 1,000 U/mL 45 min (37oC)
medium
Vol. 132, No. 5 | May 2017
4/20/17 3:38 PM
in enzyme solutions for consistent separation, 11. SW Becker, TB Fitzpatrick and H Montgomery, Human
melanogenesis: Cytology and histology of pigment cells
since topical application in vivo or in vitro, as (melanodendrocytes), Arch Dermatol and Syphilol 65 511-
well as intracutaneous injection in vivo, did not 523 (1952)
produce consistent results. 12. J Fan, Epidermal separation with purified trypsin, J Invest
Takahashi et al.15 compared trypsin with Dermatol 30 271 (1958)
dispase isolation using rat skin. Quantitative 13. JM Einbinde, RA Walzer and I Mandl, Epidermal-dermal
separation with proteolytic enzymes, J Invest Dermatol 46
estimations were made of the yield, viability 492-504 (1966)
and number of attached epidermal cells. Dis- 14. Y Kitano and N Okada, Separation of the epidermal sheet
pase was superior to trypsin, especially for cell by dispase, Brit J Derm 108 555-560 (1983)
yield, which was four times higher; 1.1 × 107 15. H Takahashi, K Sano, K Yoshizato, N Shioya and K Sasaki,
vs. 0.24 × 107 cells/10 cm2 of skin, respectively. Comparative studies on methods of isolating rat epidermal-
cells, Ann Plas Surg 14 258-266 (1985)
Viability and rate of attachment of recovered
16. C Walzer, M Benathan and E Frenk, Thermolysin treatment:
epidermal cells were also higher with dispase A new method for dermo-epidermal separation, J Invest
than trypsin. Derm 92 78-81 (1989)
Thermolysin: Thermolysin is isolated 17. A Gragnani, CS Sobral and LM Ferreira, Thermolysin in
from filtrates of Bacillus thermoproteolyticus human cultured keratinocyte isolation, Braz J Biol 67
105-109 (2007)
cultures. Walzer et al.16 reported the human
epidermis could easily be separated from
the dermis following incubation at 4ºC for C&T Online
1 hr in a solution containing 250-500 ug/mL
Find related content at
thermolysin. Light and electron microscopy www.CosmeticsandToiletries.com
revealed dermal-epidermal separation occurred
at the basement membrane between sites of
bullous pemphigoid antigen and laminin, and
the hemidesmosomes were selectively dis-
rupted. They concluded thermolysin treatment
appears to be a useful alternative to trypsin for
dermal-epidermal separation.
Gragnani et al. also compared keratinocyte
isolation methods using trypsin and thermoly-
sin.17 In histological evaluations, thermolysin
caused detachment in the basal membrane
zone, while trypsin caused chaotic segmen-
tation and the digestion of keratinocytes.
Contamination was not present with fibroblasts
in the thermolysin group but it was in the tryp-
sin group. The number of keratinocyte colonies
in the thermolysin group was also significantly
greater than with trypsin.
The final column in this series will focus on
heat and mechanical separation methods—and
offer recommendations for choosing the appro-
priate method.
References
7. PB Medawar, Sheets of pure epidermal epithelium from
human skin, Nature 148 783 (1941)
8. M Klein and LR Fitzgerald, Enzymatic separation of intact
epidermal sheets from mouse skin, J Invest Dermatol 39
111-114 (1962)
9. K Ma, Biochemistry and Physiology of the Skin, Oxford
University Press, New York (1983)
10. SC Liu and M Karasek, Isolation and growth of adult human
epidermal keratinocytes in cell-culture, J Invest Dermatol 71
157-162 (1978)

Research | C&T ®
KEY POINTS
• Intermolecular forces such as dispersion
forces and hydrogen bonds are the basis for a
theory explaining the behavior and benefits of
perfluoropolyethers and perfluorocarbons.
• The former, in liquid form, are explored

here for their application in cosmetics and
personal care; the latter are described for
speculation purposes.
THE NAME'S BOND.

H–F BOND.
all or part of this article is strictly prohibited.
Vol. 132, No. 5 | May 2017
CT1705_Research_Pantini_fcx.indd 38 4/20/17 11:21 AM

Cosmetics Can
Leverage Divergent
Fluorine Forces
Giovanni Pantini
Studio 24, Milan
Editor’s note: Today’s consumers are highly focused on chemistry; it then goes on with advanced discov-
improving their general health and wellness. As such, cosmetics eries in medicinal chemistry to define concepts
and personal care products have aligned with this driver and
become more health-orientated. The rise in dermocosmetics for the formulation of cosmetics.
is a perfect example. As a result, cosmetic companies are
focusing innovation efforts in this direction. Here, we continue Look Within:
a longstanding discussion on fluorine chemistry. Borrowed
from the pharma world, it holds interesting basic concepts for
Intramolecular Forces
cosmetics and personal care. Usually, the molecular structure of a sub-
stance offers valuable indications regarding its
T
properties and, roughly, its behavior in formula-
tion and application. However, for the correct
evaluation of chemicals containing fluorine
atoms, some considerations at the molecular
level are necessary.
he pharma industry is a good For example, despite their differences in
.
example of the importance of chemical structure, perfluorotripropylamine
fluorine chemistry (25–30% of and perfluorodecalin can be components of
new drugs contain fluorine) emulsions used as synthetic blood since they
and of the transfer of concepts are similar in chemical thermal and biological
.
from an industry to cosmetics. stability, insolubility, and capability to carry
This article begins with basic theories to illustrate respiratory gases. These unexpected similari-
the mechanisms, unknown to many, of oil/water ties can be explained by two types of attractive
repellency and insolubility behind fluorine forces, intramolecular and intermolecular, which
Vol. 132, No.

Reproduction 5 | May
in English
2017language
or any other of all or part of this article is strictly prohibited. © 2017 Allured Business Media. Cosmetics & Toiletries® | 39
CT1705_Research_Pantini_fcx.indd 39 4/20/17 3:44 PM

The generic assertion that dispersion forces
are weaker than forces related to
permanent dipoles is misleading.
make perfluorotripropylamine and perfluorodeca- Between Us:

lin homologues in formulation and application.
In a molecule, atoms are held together by
Intermolecular Forces
intramolecular forces that determine how it Generalities: Macroscopic observations
can be modified and to achieve better stability. point out the existence and action of attractive
For example, a fluorine atom can substitute and forces between neighboring molecules of a liquid
mimic a covalently bound hydrogen atom with or solid, referred to as intermolecular forces.
little change of the steric bulk of the molecule. Though much weaker than intramolecular forces,
This fluorine-hydrogen shift produces stronger intermolecular forces determine important
fluorine-carbon intramolecular bonds due to physico-chemical properties of polymers and sub-
fluorine, the most electronegative among all the stances. They are the glue that brings and holds
atomic elements. molecules together; when a solid melts or a liquid
Therefore, the substitution of one hydrogen boils, the intermolecular forces are broken while
atom with a fluorine atom or a trifluoromethyl the intramolecular forces remain intact. Without
group is a route to improve the stability of them, molecules of a substance would move apart
drug molecules. Similarly, by substitution of all from each other and the substance would become
hydrogen atoms with fluorine atoms, very stable a gas.
perfluoromaterials are produced, including two Intermolecular forces depend on the global
families of liquid materials, such as perfluoropoly- polarity of a molecule and on the repartition of
ethers (by far the most important for cosmetics) this polarity in the molecular structure. In the
and perfluorocarbons (that have been added in case of non-polar molecules (by definition, those
this article mainly for speculative reasons since without permanent dipoles), there is only one
too volatile for a general use in cosmetics). type of intermolecular force, which is created
However, when perfluoropolyethers (PFPEs) by the attraction of temporarily induced dipoles
and perfluorocarbons (PFCs) contact other produced by the continuous motion of electrons.
molecules, their interesting properties are Such forces are referred to as dispersion or
not explained intramolecularly; other forces London forces.
determine their behavior and are essential in In polar molecules, where permanent dipoles
formulation and application. are present, in addition to dispersion forces, there
are two other main types of intermolecular forces:
between a permanent dipoles and temporary-
induced dipoles, named also Debye forces, and
between permanent dipoles, named Keesom
forces. These specific denominations are not
Inspired by pharma, cosmeceuticals can always respected and all intermolecular force are
resolve imperfections rather than covering also named collectively van der Waals forces.
them. Due to this ability, they are anticipated The generic assertion that dispersion forces are
to reach US $61 billion by 2020. weaker than forces related to permanent dipoles
is misleading. On the contrary, dispersion forces
are more influential in the majority of substances
Source: Research and Markets and polymers. Present in all molecules, polar and
non-polar, these forces vary enormously from

one molecule to another, depending mainly on cancel each other out, with the net sum of zero.
the size (i.e., molecular weight) and shape (i.e., Further, the polarity of single intramolecular
straight or branched structure). bonds does not match the high difference of
PFPE and PFC specifics: PFPEs and PFCs electronegativity between fluorine and carbon.
present a paradox, because their intramolecular This is due to the low polarizability of fluorine
forces are strong while intermolecular forces are atoms (see Table 1).
weak. However, at molecular level, very weak does The low polarizability corresponds with mini-
not mean negligible; quite the contrary. mum levels of intermolecular forces, 100% of the
On the whole, these molecules are non-polar dispersion type, even in the case of high MW. This
since the (Cδ+–Fδ-) dipoles of the carbon-fluorine explains the similarity between perfluorodecalin
bonds, organized by attraction of head to tail, and perfluorotripropylamine, in contrast with cor-
Table 1. Polarizability of fluorine atoms compared with other atoms1, 2
X (atom) H C F Cl Br
Atom polarizability (10-24/cm )
3
0.67 1.76 0.56 2.18 3.05
Electronegativity (Pauling) 2.2 2.55 3.98 3.16 2.96
C-X, dipole moment (µ) 0.4 n/a 1.41 1.46 1.38
C-X, Δ electronegativity 0.3 n/a 1.43 0.94 0.76

responding hydrogenated compounds. In other initial expectations. This theory may lie in a spe-
words, a perfluoroamine is first a perfluorinated cial category of intermolecular bonds—hydrogen
substance and then an amine. bonds, in addition to halogen bonds; the latter are
More generally, this mechanism explains the only described here in brief for simplicity’s sake as
main properties of PFPEs and PFCs, including they are similar to hydrogen bonds.
opposite properties such as hydrophobicity and In contrast with cosmetics, the intermolecular
lipophobicity, or homophobicity (self-repellency forces in medicinal chemistry are experimentally
and insolubility); the molecules of any other and thoroughly investigated, even when they are
type prefer to interact with themselves rather very weak. This is due to their role in the contact
than with molecules of almost negligible of a drug molecule with a biological target. As
intermolecular forces. noted, more attention is currently being dedicated
It is expected that these intermolecular forces to molecules having one or more hydrogen atoms
determine not only some intrinsic properties replaced by a fluorine atom, which in doing so,
of PFPEs and PFCs, but also their behavior in produces permanent polarity and new intermo-
formulation. However, this occurs only partially, lecular attractions. These interactions should be
since there is a certain dependence on the other classified as Keesom forces for the presence of
components of the formulation. This dependence permanent dipoles, but they are named hydro-
increases with their polarity, suggesting the action gen bonds (H-bonds) because hydrogen atoms
of other types of intermolecular forces in addition are involved.
to dispersion forces. The importance of this aspect Because of its importance in numerous natural
and of the disproportion between causes and processes and its prospects in supramolecular
effects is such that a discussion is necessary. chemistry, today, the H-bond is the most ana-
lyzed non-covalent interaction. It is a bridge
Hydrogen Bonds and (–R–H∙∙∙Y–Z) of a polarized hydrogen atom
Fluorine: A Cosmetic Theory shared between an atom, R, to which it is cova-
Cosmetics typically are complex mixtures of lently bound (R–H) that works as a donor, and
substances and polymers having certain purposes another atom, Y, to which it is electrophilically
as far as performance and presentation. Their attracted (H∙∙∙Y), which works as an acceptor.
complexity increases when PFPEs and PFCs are Usually Y is a nitrogen atom or an oxygen atom.
present, which is due to discrepancies in expected After a decades-long controversy, it is also now
and realized results. These discrepancies are not widely accepted that covalently bound fluorine
always evident and easy to explain. Unexpected atoms may work as proton acceptors with oxygen
phenomena, e.g., the stability of formulations, (–O–H∙∙∙F–C), or nitrogen (–N–H∙∙∙F–C) atoms as
aggregation of molecules, and dissolution (of proton donors in the formation of H-bonds (see
chemically modified PFPEs) in aqueous or oily Pioneering the H-Bond, on Page 45).
phases, occur that would suggest interactions
between molecules of fluorinated and non- From Drugs to Cosmetics
fluorinated substances. Covalently bound fluorine atoms of drug
However, in cosmetics, observations and molecules are usually few and not always identi-
investigations of what happens at molecular level cal, with differences due to the three-dimensional
are simply impracticable. Cosmetic formulators conformation of the molecule, the positioning of
typically learn and build their skills by practice fluorine atoms in the molecule, and the molecular
and application, rather than theoretical concepts context. These differences have a great importance
and laws. Many hardly have the time or oppor- in medicinal chemistry, as illustrated by Bissantz:
tunity (or interest) to learn the basics of fluorine “The same interaction may [be worth] a different
chemistry and systematically combine perfluoro- amount of free energy in different contexts, and it
materials with differentiated cosmetic materials to is very hard to find an objective frame of reference
see their behavior in simple model compositions. for an interaction, since any change of a molecular
This divergent type of research offers oppor- structure has multiple effects.”13 For these reasons,
tunity for discovery but theory is needed to the orientation to the target (often a protein) can-
interpret the results and compare them with the not easily be predicted and demonstrated.

Intermolecular forces only partly determine
PFPE and PFC properties. Other components
in formulas also influence their behavior.
This means, in the context of drugs, fluorine • A high content of hydrogen atoms, includ-
chemistry is usually not given the right conditions ing hydrogen atoms of hydroxyl groups
to make what is referred to as positive cooperativ- with accentuated protonic character, which
ity; meaning that although a single interaction is are more suitable for H-bonds; and
quite weak, several simultaneously acting interac- • Simple identification of the partner atoms
tions increase effects well beyond their sum. (hydrogen atoms), which can even be regu-
The situation is quite different when a PFPE or lated through the formulation or procedure
a PFC is in the context of a cosmetic formulation, (a key difference that never occurs in
for several reasons. These include: biological systems).
• A much higher fluorine content, from 68% Certain visible manifestations can be ascribed
(for PFPEs) to up to 76% (for PFCs); to the positive cooperativity of H-bonds with
• Multiple fluorine atoms attached to a the involvement of fluorine atoms, consisting
skeleton (usually linear), with the same (or in the fact that despite the weakness of a single
similar) positioning as such that all fluorine bond, multiple interactions with hydrogen atoms
atoms can have the same (or similar) type of oils or glycerol (or other polyols) explain the
of contact; unexpected stability of three-phase o+f/w emul-

sions;14, 15 or of glycerol dispersions containing a Chemically Modified PFPEs
PFPE.16, 17 in Solution
The favorable conditions of cosmetics to the Considering the insolubility of alkaline
formation of H-bonds involving fluorine atoms fluorides in water and of small molecules of PFCs
suggested to investigate PFCs added to model in oils, which are independent from the nature
formulations representative of the investigation of fluorine bonds (ionic or covalent), molecular
carried out previously on PFPEs. Despite absolute weight (MW) or dissolving media (polar or
insolubility and high density, very stable composi- non-polar), it would seem impossible to create
tions, on the shelf and at centrifugation, were the aqueous or oily solutions with a fluorine content
result of this investigation.18 of up to 10-15% by dissolving a polymer with a
Table 2 shows a list of fluorinated materials high fluorine content. Unexpectedly, however,
that have a similar stability behavior in cosmetic both solutions can be prepared with high levels
formulations despite their different chemical of a chemically modified α,ω-Z-PFPE. This is
structures. a surprising fact, from speculation, formula-
Sufficient experimental confirmations exist tion and application viewpoints, and requires
to apply the theory to a long list of fluorine- further discussion.
containing materials having widely differentiated Hydrophilic modification: The substitution
chemical structures. This list includes: of a single fluorine atom of a trifluoromethyl
• Linear, branched and cyclic PFPEs within a group with a hydrogen atom (–CF3 → –CHF2) may
wide range of molecular weights; hardly be defined as hydrophilic modification,
• Fluoro-ether-alcohols and fluoro-ether- which appears negligible in reference to high MW.
carboxylic acids, and their derivatives; and However, it has remarkable consequences when it
• PFCs of various structure: cyclic concerns the two ends of a Z-perfluoropolyether
(e.g., perfluorodecalin), condensed chain. There is an evident cause and effect
polycyclic (e.g., perfluoroperhydro- disproportion; the small CH group, inert and only
phenantrene) and pseudo-cyclic (e.g., slightly polar (the Δ electronegativity between
perfluorotrispropylamine). carbon and hydrogen is only 0.35), which is
typically present in hydrocarbons (i.e., non-polar
This list might also include chemically modi- substances), is able to influence the behavior of
fied PFPEs, but much more interesting prospects a much bigger molecule. Thanks to this small
in formulations and applications are offered for polarity, dihydro-Z-PFPEs, with a MW in the
these materials in solution form. 500-800 range, are soluble in ethanol. Replacing
Table 2. Perfluoromaterials Showing Similar Behaviors in Cosmetics
Molecular Fluorine
Perfluoromaterial Density Boiling point (°C)
Weight Content (%)
High molecular weight
6250 68 1.91 *
Y-perfluoropolyether
Low molecular weight
650 69 1.76 140
Y-perfluoropolyether
Perfluorodimethylcyclohexane 400 76 1.82 102
Perfluorodecalin 462 74 1.91 142
Perfluorotripropylamine 521 76 1.82 130
* Viscous liquid

Pioneering the H-Bond
the hydrogen atom with a more polar hydroxy group,
the solubility is extended to a higher MW (up to 1500).
Therefore, the expectation is that a phosphate
group (i.e., groups more polar than a hydroxy group)
should work even better as the dissolving group. And
indeed, not only concentrated solutions of Z- PFPE
diphosphate in ethanol can be prepared, but it is also
possible to dilute these solutions with the gradual
addition of water in large proportion. By careful
neutralization of phosphate groups, it is even possible
to obtain direct dissolution in water.19
The dissolution of Z-PFPE diphosphates in
aqueous systems is due to the cumulative interactions
(H-bonds) between the molecules of the Z-PFPE chain
and the molecules of ethanol/water (or simply water), It was Linus Pauling (1901-1994), the famous
with the additional contribution of attractions due to chemist and peace activist, who pioneered the
the phosphate groups. These interactions outweigh concept of H-bonds in a book published in 1939, The
the separate interactions between the molecules of Nature of Chemical Bonds.3 Since then, this concept
has been widely used in literature by physicists, biolo-
gists and chemists. The strength of a single H-bond is
Substituting a fluorine in the 3-30 kcal/mol range, depending on the acidity
of the donor and the basicity of the acceptor. This
atom with hydrogen interaction explains common phenomena such as the
relatively high boiling point of some substances, e.g.
is hardly a hydrophilic water or alcohol, or the high viscosities, e.g., glycol
and glycerin. However, of current scientific interest are
modification but the the interactions between different molecules.
effects are remarkable. In the last two decades, the H-bond concept
has experienced a revival with the rise in interest for
fluorine in medicinal chemistry. For this reason, IUPAC
recently (2011) felt the need to update the definition.4
the dissolving media, reaching the conditions to Concisely, the new definition asserts that it is pos-
have dissolution. sible to have H-bonds with any atom that has higher
Interestingly, the low dispersion forces between electronegativity than hydrogen (2.20). Therefore, these
the molecules of the perfluorinated chain, described bonds have more relevance with atoms of high electro-
earlier, cause this behavior, which is demonstrated by negativity (oxygen and nitrogen) than with atoms of
two experimental facts: first, the increase in MW of the low electronegativity (carbon and sulfur).
PFPE chain does not produce the expected decrease The possibility of fluorine atoms to be proton
in solubility, as occurs with hydrogenated chains; acceptors remained controversial due to their oppo-
second, comparable structures (e.g., alkyl phosphates) site influence in having the highest electronegativity
are much less soluble, even in the case of significantly (almost 4.0) and lowest polarizability (0.56) among all
lower MWs. How can this occur, considering PFPEs the atomic elements (see Table 1). The discussion
are completely insoluble and that H-bonds involving involved Pauling himself and in the third edition of
fluorine atoms are weaker than common H-bonds? his book (1960), he better illustrated his thought: “In
Recall that intermolecular forces in PFPEs are general, fluorine attached to carbon does not have
100% weak dispersion forces, due to induced dipoles significant power to act as proton acceptor in the
of poorly polarizable fluorine atoms. Therefore, PFPEs formation of H-bonds in the way that would be antici-
are insoluble in all non-fluorinated substances since pated from the large difference in electronegativity of
the interactions between the molecules of PFPEs carbon and fluorine.”
with molecules of other substances are never able to The controversial positions regarding the partici-
outweigh the interactions between these molecules, pation of fluorine atoms to hydrogen bonds can be
Continued on Page 47

irrespectively of their characteristics. But because forces. This reduction has unexpectedly dispro-
the intermolecular forces of PFPEs are weak, the portionate effects on solubility. In the context of
effects of H-bonds and of the chemical modifica- Z-PFPEs, there are decisive contributions from
tion are relatively enforced, both quantitatively their double functionality and the allocation in
and qualitatively. the α-ω positions of the PFPE chain.
Quantitatively, with an overall remarkable Therefore, there is an apparent paradox
increase in intermolecular forces due to the concerning PFPEs since two opposite extreme
addition of stronger intermolecular forces of the behaviors, i.e., insolubility and high solubility,
permanent dipoles. Qualitatively, with the corre- are ultimately caused by the same dynamics.
sponding reduction in contribution of dispersion All unmodified PFPEs are insoluble due to
Figure 1. Divergence in the development of chemically modified α,ω-Z-PFPEs

traced to the question whether C–H groups (weak
donors) and F–C groups (very weak receptors)
really represent the majority of fluorine contacts;
the answer depends on the sources consulted for
“very weak dispersion forces,” while chemically
the screening.
modified α,ω-Z-PFPEs are “highly soluble”—or,
more accurately, can be dissolved using special In 1997, a screening of the Cambridge Crystallo-
procedures and with the potential to incorporate graphic Structural Data Base and energy calculations
higher concentrations of solutions than the cor- of Donitz and Taylor for relevant –C–H∙∙∙F–C contacts
responding non-fluorinated substances—since the led to the conclusion that organic fluorine is, at
“very weak dispersion forces” can be outweighed best, a very weak proton acceptor.5 More recently,
by intermolecular forces consisting of H-bonds a screening of the Protein Data Bank and investiga-
with fluorine atoms, combined with the attractions in the area of biologically active substances
tions due to the permanent polarity produced by
chemical modification.
From an energetic view, there are three
different levels: 1) PFPEs as such, with 100%
weak dispersion forces only; 2) PFPEs in aqueous
formulations, with dispersion forces and H-bonds;
and 3) hydrophilically modified α,ω-Z-PFPEs
in aqueous solutions, with dispersion forces,
H-bonds and attraction forces generated by the
chemical functionality.
Lipophilic modification: Similar reasoning
can be adopted to explain the dissolution of
lipophilically modified α,ω-Z-PFPEs in oils. Only
minor adjustments of the theory are necessary
regarding the ratio between perfluorinated and
lipophilic chains and the polarity of the oils.20, 21
The fact that polarity, e.g., esters vs mineral oils,
is decisive for the dissolution of Z-PFPE dial-
kylamides suggests a key role of fluorine bonds
involving oxygen atoms (carbonyl groups) of
esters or similar oils. In the context of this article, reached other conclusions.6-11 A further decisive step
it is enough to mention this type of fluorine bond, was represented by the work of Zhou, published in
which is usually associated with the behavior of 2009,12 who reviewed the progress of investigations
the other halogens; hence the collective name of on protein-ligand interactions with the involvement
halogen bonds.22 of fluorine. In the same year, Bissantz enforced this
stand in a review on medicinal chemistry: “Interac-
Conclusions tions between F–C and a polar hydrogen (HX, where
X = O or N) frequently occur […], even if such inter-
PFPEs were initially proposed as insoluble
actions cannot be classified as strong H-bonds.”13
liquids to produce three-phase emulsions charac-
terized by the coexistence of two discrete internal The interest in fluorine for medicinal chemistry
phases dispersed in one continuous phase.23 Some began well before these last advancements. Initially,
authors further developed the concept of multiple the introduction of fluorine into drug molecules took
internal phases with the combined use of PFPE the form of aryl fluorination or trifluoromethylation
and silicone oils, to create more complex emul- to enhance stability and lipophilicity—and conse-
sions containing up to five phases.24 quently, the activity of a drug. More recently, the
prospects are less related to these aspects and
The use of PFPEs in cosmetics has allowed
more to focused on devising a tool to regulate the
important improvements in emulsions, par-
conformation and stereo-orientation of molecules.
ticularly moisturizing, stability and sensorial
This mechanism may concern fluorine as a proton
properties. Nevertheless, little attention has been
acceptor, with the objective to achieve a three-, ten-
dedicated to a theory explaining the increase
and even twenty-fold increase in drug activity.
in stability due to ingredients that should work
Continued on Page 49

against it, on the basis of Stokes’ law, in consid- water or in oils. This is likely due to constraints in
eration of the high density of PFPEs, around chemical synthesis and poor attention dedicated
1.9 g /mL. to this chemistry. However, it provides a strong
This article gives theoretical support to what opportunity to leverage the potential impact of
is already a reality of industrial importance. fluorine chemistry in cosmetics, simply exploiting
Besides, it intends to introduce a novel area of the typical cosmetic chemistry already applied
development, paradoxically with great potential to fatty and polysiloxane chains, along with
in monophase systems, in addition to various the choice between aqueous and oily phases.
types of emulsions, including multiple emul- Concisely, it is possible to show graphically the
sions, based on new mechanisms. In relation, strong divergence of this area of development (see
it is necessary here to note that this develop- Figure 1).
ment cannot be reduced simply to a concept of
“soluble PFPEs”, apparently destructive of the References
most typical properties of PFPEs, i.e., water/ 1. L Hunter, The C-F bonds as a conformational tool in organic
oil repellency. and biological chemistry, Beilstein J Org Chem 6 38 4-5
(2010)
Within these materials, the shield of fluo-
2. W Johnson, Invitation to Organic Chemistry, Jones &
rine atoms opposes resistance to attack by any Bartlett Learning, Burlington, MA, USA (1998)
dissolving media, and there is strong conflict 3. L Pauling, The Nature of the Chemical Bond, Cornell
between the major part of the molecule that University Press, Ithaca, NY, (1939 and 1960)
repels water and oils, and the minor part that 4. E Arunan et al, Defining hydrogen bond: An account (IUPAC
Technical Report), Pure Appl Chem 83/8 1619-36 (2011)
loves water or oils. This means that the proper-
5. J Dunitz and R Taylor, Organic fluorine hardly ever accepts
ties of oil/water repellency of PFPEs are not hydrogen bonds, Chem Eur J 3(1) 89-98 (1997)
only retained, but their delivery to the finished 6. HJ Böhm et al., Fluorine in medicinal chemistry, ChemBio-
product is unexpectedly much more important, Chem 5 637-643 (2004)
while it is asymmetric depending on the chemi- 7. P Jeschke, The unique role of fluorine in the design of active
ingredients for modern crop protection, Chem Bio Chem 5
cal modification. 570-581 (2004)
At any rate, it is important to make the 8. C Casorati, S Sciabola and G Crucia, Hydrogen bond-
distinction between dissolution (a kinetic ing interactions of covalently bonded fluorine atoms from
process quantified by mol/min), and solubility, crystallographic data to a new angular function in the GRID
force field, J Med Chem 47 5114-25 (2004)
which represents the state at the equilibrium
9. HF Bettinger, How good is fluorine as a hydrogen-bond
(a thermodynamic condition quantified by acceptor in fluorinated single-walled carbon nanotubes,
mol/g). It is critical to take this distinction into Chem Phys Chem 6 1169-1174 (2005)
account either in formulation, with special 10. D O’Hagan, Understanding organo-fluorine chemistry: An
introduction to the C-F bonds, Chem Soc Rev 308-19
attention dedicated to the procedure, and (2008)
application. Therefore, in the case of chemi- 11. Y Luy et al, Ab initio investigation of halogen bonding
cally modified α,ω-Z-PFPEs, it is always more interactions involving fluorine as an electron acceptor, Chem
Phys Lett 449 6-10 (2007)
correct to use the term dissolution, even it is
12. P Zhou, J Zou, F Tian and Z Shang, Fluorine bonding—How
actually possible to prepare perfectly transparent does it work in protein-ligand interactions, J Chem Inf Model
concentrated solutions. 49(10) 2344-2355 (2009)
Describing the procedures for the formula- 13. C Bissatz, B Kuhn and M Stahl, A medicinal chemist’s guide
tion and potential application of chemically to molecular interactions, J Med Chem 53/14 5061-84
(2010)
modified α,ω-Z-PFPEs is well beyond the 14. S Bader et al, Three-phase emulsions: Perfluoropolyether-
objective of this article. However, it is possible to oil-water, Cosm & Toil 101(11) 45-8 (1986)
provide two key references, including: a vision 15. F Brunetta, L Montesi, M Guarneri and G Pantini, Low
for the chemical functionalization of PFPEs,25 molecular weight PFPEs: A new range of perfluorinated oils
for cosmetics, Proceedings of the 18th IFSCC Congress,
and a recent important development for this Venice (1994)
concept in application.26 16. G Pantini, F Brunetta and V Guidolin, Perfluoropolyethers:
Presently, only one specific perfluorinated Status and new developments, Cosm & Toil 106(10) 71-80
(1991)
chain is used as a building block in the design of
17. F Brunetta and G Pantini, Multiple emulsions comprising a
chemically modified PFPEs that are soluble in perfluoropolyether, SÖFW J 11 (1993)

Today, the state of the art on H-bonds involving
fluorine atoms is as follows:
• The interaction between a polar hydrogen

18. Unpublished investigation
19. G Pantini, R Ingoglia and F Brunetta, PFPE phosphate: A
atom and an organic fluorine atom is not
multifunctional material, Cosm & Toil 114(8) 81-92 (2001) strong (the strength is between one-quarter
20. G Pantini, R Ingoglia, F Brunetta, A De Ascentiis and F and a half of normal H-bonds);
Bernardi, Perfluoropolyether amide, Cosmet Technol 4(3) • The strength increases with the polarity of the
27-32 (2001)
R–H groups (e.g., replacing C–H with C–OH);
21. G Pantini and M San Miguel, Perfluoropolyether amide, 15th
IFSCC Congress, Buenos Aires (2001)
• The shorter the distance between the atoms,
22. G Resnati et al, Halogen bonding after 200 years, 1st Inter-
the stronger the bond, and therefore the
national Symposium on Halogen Bonding, Porto Cesareo, importance of flexibility and geometry (with
Italy (June 18-22, 2014) more possibilities for liquids or solids in
23. F Brunetta, S Bader, G Pantini and M Visca, Three-phase solutions);
emulsions: Perfluoropolyether-oil-water, Cosm & Toil 101(11)
45-49 (1986)
• The significance of H-bonds with fluorine
24. A Bevacqua, K Lahanas, I Cohen and G Cioca, Liquid
depends greatly on the structural context;
crystals in multiple emulsions, Cosm & Toil 106 53-6 (May • The typical favorable context should allow
1991) multiple H-bonds with fluorine; and
25. G Pantini and R Ingoglia, Hydrophilically and lipophilically • The energy of multiple H-bonds with fluorine
modified perfluoropolyethers as ingredients of non-conven-
tional cosmetics, Proceedings of the IFSCC Conference,
is greater than the sum of the single bonds.
Seoul (2003)
26. www.cosmeticsandtoiletries.com/formulating/category/
C&T Online
skincare/Problems-with-Skin-Protectants-Part-III-New-
System-Sets-the-Rules-371399401.html (Accessed Apr 1, Find related content at
2017) www.CosmeticsandToiletries.com

Research | C&T ®
KEY POINTS
• K-beauty appears to deliver its full benefits
when embraced in its entirety, which due to
time constrains, rarely happens in the West.
• This article reviews these important

differences, as well as cultural views and
biological implications.
K-beauty:
Adopting a Mindset
Eastern Ritual vs. Western Pace
Katerina Steventon, Ph.D.

Independent Skincare Consultancy
East Yorkshire, UK
K -beauty, an umbrella term for South
Korean beauty, emerged as a trend in
2016. It gained popularity, particularly
in the United States, for its focus on
skin luminosity, hydration and reduced
pigmentation. K-beauty regimens involve
a series of steps including cleansing rituals with both oil- and water-
based products, sheet masks, essences, serums, lotions and high
SPF sunscreens.

Vol. 132, No. 5 | May 2017
CT1705_Research_Steventon_fcx.indd 50 4/20/17 11:23 AM

The commitment and dedication of Asian
consumers to daily, complex, multi-step
routines delivers results.
Asian women in eastern cultures are known application of lotions, essences, serums and
for eagerly embracing new skin care products high-SPF sunscreens for the day, and rich “sleep
and diligently performing complex routines. creams” at night. Ingredients focus on cell
However, one may wonder whether K-beauty regeneration, anti-inflammation, and firming
products perform as well for Caucasian skin, and tightening properties via the likes of snail
in western cultures. Considering biology and mucin, bee venom, marine extracts, ferments,
skin care habits, K-beauty appears to deliver hyaluronic acid and collagen.
its full benefits when embraced in its entirety, Most skin types can benefit from a custom-
which, due to time constrains, rarely happens ized routine that addresses hormonal health
in the West. This article reviews these impor- and lifestyle choices. The repetitive cleansing,
tant differences, as well as cultural views and masks and layered moisturizing ingredients in
biological implications. K-beauty prevent and repair internal and exter-
nal damage—from hormonal fluctuations to UV
K-Beauty and the damage and the dehydrating effects of alcohol.
Immaculate Canvas U.S. dermatologists agree there is an advan-
tage to expanding beauty regimens beyond the
K-beauty represents the cutting edge of
basics of cleansing and moisturizing to address
beauty, especially due to its combination of
specific concerns; i.e., fine lines, enlarged pores
layering, customization and gentle nature-
or uneven skin tone. They report a customized
meets-technology ethos, which boosts its
skin care routine “makes sense from a biology
appeal.1 According to Mintel, Korean women
standpoint,” although complex routines are
have focused on skin care rather than makeup
not new. Informed U.S. consumers typically
for years. Their ultimate goal is to achieve a
have four-step routines, including a daily peel
complexion with a dewy, glowing finish without
and serum. To fully incorporate K-beauty into
the need for concealers and foundations having
typical U.S. routines, adding one effective step
high hiding power.
at a time is recommended.
The ultra-elaborate skin care regimens of
Korean women can incorporate more than 10
steps; starting with double cleansing using both
New Product Concepts
oil- and water-based cleansers, followed by the Korean beauty can bring new product
concepts to the West; e.g., toners as "hydra-
tion primers," which further prepare skin to
absorb the active ingredients from subsequent
U.S. K-beauty sales rose 27% between products. Also, "beauty waters" with micellar
2015 and 2016; 80% came from skin care, technology for softening and mild exfoliation,
and 17% from makeup. Through 2021, the and "essences," which act as hybrids between
market is expected to expand another 16%. toners and serums, to repair and plump facial
skin. Sheet masks also offer intensive hydration
for dry skin as an inexpensive, easy add-on in
Source: Global Cosmetic Industry single doses or a pack.
(www.GCImagazine.com) The combination of these technologies can
address different and contrary concerns, which

can manifest at the same time; e.g., the lack In summary, Caucasian and Asian consum-
of tone and unevenness of skin, spots and oily ers face different skin issues. Asian consumers
patches, as well as localized rough texture and focus on hypo- and hyperpigmentation, the
dryness. Further, packaging as well as effer- removal of sebum as well as skin firming. Their
vescent or self-heating masks, representing a commitment and dedication to daily, complex,
“science project,” can add a playful narrative. multi-step routines as well as hands-on atten-
These also invite the user to pay attention to the tion to their skin delivers results. Their skin
intensified sensation, massaging their face and care routine is a ritual.
cooling during rinse-off to leave a satisfying, Caucasian skin, on the other hand, might
refreshed and clean skin feel. require more efficacious ingredients. The
gentle, anti-inflammatory and hydrating focus
Biology Defines Efficacy of Asian routines, unless introduced in their
Topical systems aside, does K-beauty entirety, may not be enough to alleviate the
deliver equal benefits to Caucasian and Asian key concerns of Caucasian skin; namely lines,
skin? Science has identified differences in skin wrinkles and sagging.
structure and function between ethnicities. The
most obvious is color, primarily due to melanin, References
and while higher levels of melanin delivers Accessed on March 31, 2017.
photoprotection, it also makes Asian skin more 1. wsj.com/articles/k-beauty-the-exhausting-skin-care-
vulnerable to hyper- and hypo-pigmentation. regimen-that-may-be-worth-the-effort-1459970031
In contrast, the Caucasian face experiences an 2. researchgate.net/
earlier and more prominent onset of wrinkles publication/5358567_Ethnic_skin_types_Are_there_differ-
ences_in_skin_structure_and_function
and sagging.
Both Asian and Caucasian skin have similar
baseline barrier properties and ceramide levels.
However, upon mechanical challenges such
as exfoliation, Asian skin has weaker barrier
functioning. It may also be more sensitive to C&T Sponsored Webcast Videos
exogenous chemicals due to a thinner stratum Find current and upcoming webcasts at
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South Korean skin, in particular, has been
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Testing | C&T ®
KEY POINTS
• Inspired by nature, biomimetic peptides are
potent allies in skin care.
Zen
• This paper identifies palmitoyl tripeptide-8
as an effective modulator of neurogenic
inflammation and provides clinical evidence
of its protective and soothing activities in
sensitized skin.
Reaching a
-like State in Skin

Reproduction in English or any other language of all or part of this article is strictly ©prohibited. © 2017
2017 Allured Allured
Business Business Media.
Media.
CT1705_Test_Loing_fcx.indd 54 4/20/17 11:37 AM

Biomimetic Peptide to
Balance Sensitivity
Estelle Loing, Ph.D.
IFF/Lucas Meyer Cosmetics, Québec (Québec), Canada
S kin sensitivity is a
common complaint
among consumers.
The prevalence of
this condition in
Europe, Japan and
the United States is approximately 50% in
women and 40% in men.1 Sensitive skin
is prone to itching, stinging, tingling and
burning sensations. These may be triggered
by external factors—e.g., UV radiation, cold,
heat, wind, pollutants, chemicals, cosmetics,
The French expression, “Avoir les nerfs
à fleur de peau,” poetically describes how
nerves may convey emotion to the edge
of skin. Nerve cells do so by releasing
neuromediators such as substance P (SP),
which acts on both the vascular bed to cause
vasodilation and increase permeability,
and on skin cells to promote the release
of pro-inflammatory cytokines including
some interleukins (IL-1 and IL-8) and tumor
necrosis factor-alpha (TNF-a). This leads to
skin edema and redness in a process called
diet, alcohol, et cetera—or internal factors neurogenic inflammation.3 In sensitive skin,
such as stress, emotions and hormones. inflammation tends to sustain itself in a situ-
No clear pathophysiological definition ation that, if not addressed properly, leads
for skin sensitivity has yet been given. The to more severe skin problems and causes
underlying mechanisms do not appear to be premature aging.
primary immunologic or allergic in nature. The skin has its own way to deal with
Altered barrier function is sometimes present neurogenic inflammation. It may fight
in affected subjects but this is not a univer- back by locally producing the neuropeptide
sal finding. On the other hand, commonly a-melanocyte stimulating hormone (a-MSH).
reported abnormal sensations point to the This decapeptide results from the post-
involvement of the neurological system.2 translational processing of the pro-hormone

The biomimetic peptide described is derived
from POMC, a natural precursor of various
physiological neuromediators.
molecule proopiomelanocortin (POMC) itself, a In vitro keratinocyte studies: Keratinocytes

precursor of many biologically active peptides. derived from normal human skin (NCTC 2544)
a-MSH was first known for its pigment- were UVB-irradiated (230 mJ/cm2) to induce
inducing action on melanocytes through the an irritation response, then incubated for
binding of melanocortin receptors on these 24 hr in the presence or absence of palmitoyl
cells. Additional studies have revealed a broad tripeptide-8 (10-7 M and 10-9 M) or a-MSH (10-11
anti-inflammatory effect of a-MSH apparently M), as the positive control. The release of IL-8
mediated by a modulation of nuclear factor was quantified in cell culture media using the
k-b activity (NF-kb). More recently, this anti- enzyme-linked immunosorbent assay (ELISA).
inflammatory activity has been pinned down to In vitro fibroblast studies: Non-confluent
specific peptide fragments of a-MSH that do not normal human dermal fibroblasts (NHDF) were
elicit significant melanogenic activity.4 treated for 24 hr with IL-1 (0.1 ng/mL), as an
In relation, the present paper explores the inducer of IL-8 production, in the presence or
anti-inflammatory and anti-irritation activi- absence of palmitoyl tripeptide-8 (10-7 M) or
ties of a biomimetic lipopeptide derived from a-MSH (10-11 M), as the positive control. Again,
POMC: Palmitoyl tripeptide-8a. the release of IL-8 was quantified in cell culture
media using the enzyme-linked immunosorbent
In Vitro Materials and assay (ELISA).
Methods Ex vivo protocol: Four human skin speci-
mens were obtained from patients undergoing
Ingredient: Palmitoyl tripeptide-8 is a three-
plastic surgery (Caucasian women, 35–45 years
amino acid biomimetic lipopeptide derived
old). Explants were maintained in culture for
from POMC. POMC is a natural precursor of
24 hr in the presence of SP (10-5 M), to mimic
various neuromediators with important roles
inflammation, with or without palmitoyl
in skin physiology including anti-inflammatory
tripeptide-8 (10-7 M). Explants were then fixed
activities. Although not illustrated in the present
and embedded in paraffin. Thick sections
paper, palmitoyl tripeptide-8 did not elicit
of 5 µm were stained with hematoxylin and
melanogenic activity at the concentrations used
eosin in preparation for capillary size and
in the anti-inflammatory/anti-irritation studies
edema evaluation.
described here.
Capillary size evaluation: Morphometric
a
Neutrazen (INCI: Palmitoyl Tripeptide-8), IFF/Lucas Meyer analyses of blood vessels were performed on
Cosmetics stained skin sections. Vessels presenting with an
increased lumen were counted and results were
expressed as a percentage of total vessel counts.
The global online beauty and personal care Additionally, the surface (µm²) occupied by the
market will grow at a CAGR of 16.70% lumen of vessels was measured to evaluate the
from 2016-2020. The rise in demand for mean skin surface occupied by capillaries.
dermocosmetic products will be a key trend. Skin edema evaluation: Edema was evalu-
ated histologically on the papillary dermis and
upper part of the reticular dermis in perivas-
Source: BusinessWire
cular localizations. Edema is characterized by
increased spacing between collagen bundles.
Visual scoring was performed by two dermatolo-

gists in a double-blind manner, using a 10 × normal skin participated in a study for skin
Olympus objective. Four slides per skin speci- soothing effects. On Day 0, single patches
men were scored for each treatment. Scores containing 250 μL of an aqueous 0.5% SDS solu-
ranged from 0 (negative) to 4 (maximum), as tion were applied for 24 hr on separate areas of
follows: No edema = 0; slight edema = 1; moder- the volar side of the forearm. On Day 1, patches
ate edema = 2; marked edema = 3; and severe were removed. On Day 2, subjects applied a
edema = 4. placebo or test formula (same Formula 1) con-
taining 4 × 10-6 M palmitoyl tripeptide-8 three
Clinical Study Protocols times daily for two days (Day 2 to Day 4). On
Preventing irritation: Eight volunteers of an Day 4, skin temperatures were measured using
average age of 42.1 years old with normal skin thermovision on all test areas and images were
participated in a skin irritation prevention study. taken using a video microscope.
Subjects applied a placebo or test formula (see
Formula 1) containing palmitoyl tripeptide-8
Results: Keratinocytes and
(4 x 10-6 M) three times daily for eight days on Fibroblasts
separate areas of the volar side of the forearm As the first step in evaluating palmitoyl
(Day -8 to Day 0). tripeptide-8 to modulate inflammation, in vitro
On Day 0, single patches containing 250 µL experiments were conducted with keratinocytes
of an aqueous 0.5% sodium dodecyl sulfate and fibroblasts to assess the effects of the
(SDS) solution were applied for 24 hr. On peptide on the production of pro-inflammatory
Day 1, all patches were removed. On Day 2, skin cytokines by these cells.
temperature was measured using thermovision Keratinocytes: In the skin, keratinocytes
on all test areas and images were taken using a are generally the first cells to be challenged
video microscope. Thermovision measures skin by external stimuli. They respond to external
surface temperature by recording thermal heat aggressions such as UV by producing cytokines
emissions. This provides quantitative informa- including IL-8 that serve as messengers.6
tion on the status of inflammation in the skin.5 Cytokines act through specific receptors found
Used in combination with photodocumentation at the surface of various cell types, including
(video microscope), the two methods give a neat immune cells, making them powerful mediators
estimation of inflammatory skin responses. of inflammation. Cytokine-driven inflammatory
Soothing irritation: A total of 13 volunteers reactions are a major cause of skin erythema
of an average age of 42.1 years old having (redness) and edema (swelling). Alterations
Formula 1. Gel-crème Test Formula
Water (aqua) 58.88% w/w

Acrylates/C10-30 Alkyl Acrylate Crosspolymer 0.60
PEG-8 5.00
Phenoxyethanol (and) Methylparaben (and) Ethylparaben (and)
Butylparaben (and) Propylparaben (and) Isobutylparaben 0.80
Glyceryl Stearate 5.00
Cetyl Alcohol 2.00
Dicaprylyl Carbonate 3.00
Paraffinum Liquidum 4.00
Parfum 0.02
TEA 0.70
Water (aqua) qs
Palmitoyl Tripeptide-8 (Neutrazen, IFF/Lucas Meyer Cosmetics) 0.0005

in cutaneous and systemic immunity also presence of a-MSH, which served as a positive
occur due to UV-induced inflammation and control in this experiment. Such data supports
cytokine production. palmitoyl tripeptide-8 as an efficient inhibitor
Here, in UVB-irradiated keratinocytes, of UVB-induced cytokine-mediated cutaneous
palmitoyl tripeptide-8 dose-dependently inflammation.
inhibited IL-8 production. Inhibition reached Fibroblasts: Although keratinocytes produce
-32% when the peptide was used at a concen- IL-8 when activated by external stimuli, their
tration of 10-7 M (see Figure 1, top). This was production is usually low. By contrast, dermal
comparable to the inhibition observed in the fibroblasts generate 100 to 1,000 times more
IL-8 than keratinocytes
when stimulated by
IL-1.7 IL-1 is released
by activated keratino-
cytes when the skin
is challenged and this
mobilizes fibroblasts
to produce additional
IL-8. IL-1-driven
IL-8 production
therefore represents
a potent pathway for
the amplification of
inflammatory signals.
In IL-1 treated
fibroblasts, palmitoyl
tripeptide-8 inhibited
IL-8 production more
potently than a-MSH,
which served as the
positive control. Inhi-
bition reached -64%
when the peptide was
used at a concentration
of 10-7 M (see Fig-
ure 1, bottom). This
data confirmed that
palmitoyl tripeptide-8
has the potential to act
as a strong modulator
of pro-inflammatory
cytokine production in
skin cells.
Results:
Vasodilation
and Edema
To document the
effects of palmitoyl
tripeptide-8 on neu-
rogenic inflammation
Figure 1. In vitro modulation of pro-inflammatory cytokines in the skin, additional
experiments were

Palmitoyl tripeptide-8 may be useful to
prevent and sooth irritated skin and restore
a normal skin sensitivity threshold.
conducted using skin explants exposed to SP. right). These results demonstrate palmitoyl
The latter is a neuropeptide released by nerves tripeptide-8 can inhibit microvascular vasodila-
and inflammatory cells during inflammation. tion in the skin.
SP, acting through selective receptors, increases Edema: In SP treated skin explants, the
vascular permeability, causing local redness formation of edema appeared as an increase in
(erythema) and swelling (edema). SP also trig- white spaces between bundles of collagen (see
gers the release of pro-inflammatory cytokines Figure 2, lower left). The addition of palmitoyl
including IL-1 and IL-8 by keratinocytes and tripeptide-8 during SP treatment, though,
fibroblasts.8-10 significantly inhibited the phenomena by -60%,
Vasodilation: As shown in Figure 2 (left), which was an improvement even over the
topical application of SP induced vasodilation, control (see Figure 2, lower right). Such results
increasing the number and size of dilated capil- demonstrate palmitoyl tripeptide-8 can reduce
laries in the superficial dermis of skin explants. edema in skin.
However, these effects were significantly
reduced in the presence of palmitoyl tripep- Results: Clinical Studies
tide-8. Inhibition reached -30% for the number The potential of palmitoyl tripeptide-8 to
of dilated capillaries (not shown) and -51% for prevent and stop skin inflammation and irrita-
the size of dilated vessels (see Figure 2, upper tion under real-life conditions was assessed by

clinical studies. For this purpose, as noted, the challenge was reduced an average of -78% when
skin of human volunteers was challenged with palmitoyl tripeptide-8 was applied afterward to
SDS 0.5%, an ionic surfactant known to be a sooth skin. Placebo results were not significantly
skin irritant. Palmitoyl tripeptide-8 was applied different from the data obtained with SDS (not
to the skin before or after the SDS challenge, shown). Again, photographs documented a
and skin inflammation and irritation were docu- neat reduction of SDS-induced redness when
mented trough thermovision measurements palmitoyl tripeptide-8 was applied to the skin
and imaging. (Figure 4, bottom right) post-challenge. A typi-
Preventive: As shown in Figure 3 (upper cal result is shown here.
right), when palmitoyl tripeptide-8 was applied
to prevent irritation, the increase in skin Conclusions
temperature caused by the SDS challenge Palmitoyl tripeptide-8 is a biomimetic
was reduced an average of -112%, or down to active derived from a neuropeptide with known
baseline level. Placebo results were not signifi- anti-inflammatory activity. It is shown here to
cantly different from the data obtained with modulate the production of pro-inflammatory
SDS (not shown). Photographs also documented cytokines by skin cells, which is key to stopping
a neat prevention of SDS-induced redness when the initiation of inflammatory cascades that con-
palmitoyl tripeptide-8 was applied to the skin tribute to modifications of the microvasculature
(Figure 3, bottom right) before the challenge. A and lead to edema and redness in sensitive skin.
typical result is shown here. Palmitoyl tripeptide-8 also successfully
Soothing: In Figure 4 (upper right), the prevented and alleviated irritation and inflam-
increase in temperature caused by the SDS mation in chemically-challenged but otherwise
Figure 2. Ex vivo inhibition of neurogenic inflammation

Figure 3. In vivo skin irritation study: Preventive action
Figure 4. In vivo skin irritation study: Soothing action

normal skin. It may therefore be useful in both 6. A Grandjean-Laquerriere et al, Contribution of protein kinase
A and protein kinase C pathways in ultraviolet B-induced
preventive and soothing care to help restore and IL-8 expression by human keratinocytes, Cytokine 29(5)
maintain a normal skin sensitivity threshold. 197-207 (2005)
The ingredient is well-indicated for formulations 7. IL Boxman et al, Role of fibroblasts in the regulation of pro-
aimed at reducing skin irritation caused by UV, inflammatory interleukin IL-1, IL-6 and IL-8 levels induced
by keratinocyte-derived IL-1, Arch Dermatol Res 288(7)
immune reactions, internal stress or mechanical 391-398 (1996)
stress, returning sensitive skin to a peaceful, 8. JY Liu et al, Effect of matrine on the expression of sub-
“zen-like” state. stance P receptor and inflammatory cytokines production in
human skin keratinocytes and fibroblasts, Int Immunophar-
macol 7(6) 816-823 (2007)
References 9. MC Branchet-Gumila et al, Neurogenic modifications
1. R Kamide, Sensitive skin evaluation in the Japanese popula- induced by substance P in an organ culture of human skin,
tion, J Dermatol 40(3) 177-181 (2013) Skin Pharmacol Appl Skin Physiol 12(4) 211-220 (1999)
2. L Misery et al, Sensitive skin, J Eur Acad Dermatol Venereol 10. D Roosterman et al, Neuronal control of skin function: The
30 (suppl 1) 2-8 (2016) skin as a neuroimmunoendocrine organ, Physiol Rev 86(4)
3. D Roosterman et al, Neuronal control of skin function: The 1309-1379 (2006)
skin as a neuroimmunoendocrine organ, Physiol Rev 86(4)
1309-1379 (2006)
4. TA Luger and T Brzoska, alpha-MSH related peptides: A
new class of anti-inflammatory and immunomodulating C&T Webcasts
drugs, Ann Rheum Dis 66 (suppl 3) iii 52-55 (2007) Find current and upcoming webcasts at
5. I Całkosi ński et al, The use of infrared thermography as a www.CosmeticsandToiletries.com
rapid, quantitative and noninvasive method for evaluation
of inflammation response in different anatomical regions of
rats, Biomed Res Int I972535 1-9 (2015)

Formulating | C&T ®
KEY POINTS
• Conveying the right color and imagery can
fulfill consumer desires for a given persona.
Making this color connection is up to not only
consumers, but also product developers.
• This article describes tips and tricks to

ensure shade-matching success.
Make
the Color
Connection
Vol. 132, No. 5 | May 2017
CT1705_Form_House_fcx.indd 64 4/20/17 11:57 AM

The Art and Science of
Shade-matching with
Pigments
Stacey House and Edward Bartholomey

Kobo Products, Inc., South Plainfield, NJ USA
binations for consumer appeal. This article
C
describes tips and tricks to ensure successful
shade-matching.
Shade-matching Basics
Regardless of the application category, the
process of shade-matching for color cosmetics
can be simplified if the appropriate resources
olor cosmet- and tools are available and leveraged. Initially,
ics capture it is important to understand the regulatory
consumers’ restrictions of pigments based on the body
purchase site of application and region where they will
intents through be distributed. This will identify the available
need and desire. pigment selection for matching shaded proto-
Color evokes an emotional connection; e.g., a types and ensure the pigments are appropriate
lipstick blended in the perfect combination of for a given formula and processing equipment.
organic reds and red iron oxides can conjure Optimal pigment performance is a critical
a fresh, bright red apple or deep, sleek red aspect of shade-matching, as it enables repro-
vinyl heels. ducibility on the bench and during scale-up.
Conveying the right color and imagery can The art of matching a color cosmetic can
therefore fulfill consumer desires to project a be challenging, especially when no initial
given persona. Making this color connection information is given regarding pigment
is up to not only consumers, but also product combinations or use levels. Therefore, prior
developers to select and design pigment com- to receiving benchmarks, if the base formula
Vol. 132, No.

Reproduction 5 | May
in English or any 2017
other language of all or part of this article is strictly prohibited. © 2017 Allured Business Media. Cosmetics & Toiletries® | 65

Creating a 2 × 2 chart on the forearm to
apply color and compare with a standard
gives perspective of how the shade appears
at different angles.
was not previously shade-matched, it is helpful help maintain a consistent texture and rheology.
to set up a basic shade library to determine Start by adding the highest amount of
color extremes and see how color behaves in pigment that could potentially be used. If only
the formula. 20% color is allotted in a formula, add 20% of
Such a shade library should be developed a single pigment as the monochrome standard,
for each formula base, since color will not then press the sample in the appropriate pan,
translate identically. Color depends on formula conduct a drop test and evaluate the product’s
type, the opacity of the bulk, wetting agents and application to determine if it performs well. If
ingredient ratios in the formula, among other this use level is acceptable, reduce the pig-
factors. Thus, understanding the capacity of the ment to 5% using the filler for balance, then
formula’s limits—i.e., maximum color concen- repeat the evaluation. If this is acceptable, then
tration use levels and chemical interactions, incorporate pigment combinations to observe
will save time and effort. the color developed; for example, a 1:1:1 ratio
of red, yellow, and black iron oxide. Introduc-
Creating a Shade Library ing other colorants at variable levels will
To set up a shade library, document the identify how color interacts with and influences
results achieved with an actual set of color the formula.
samples to reference the color combinations Note that approaches to shade-matching as
as they are created. Begin with iron oxides well as the pigments use can vary with product
and titanium dioxide, then incorporate other categories such as liquid foundations that com-
permitted inorganic and organic colorants that pliment a range of skin tones and undertones;
might be used. Take eye shadow, for example. powder blushes bursting with organic colo-
First determine what percentage of the formula rants; or anhydrous eye shadows incorporating
will be allocated to colorants and fillers. Fillers colorful pigment combinations and layered
play an important placeholder role—often with effects pigments and pearls.
referred to as quantum sufficit or “enough”—to Typical colorants used in color cosmetics
for shades in foundations, concealers, pressed
powders for the face, eye shadows, lipsticks, lip
gloss and eye and lip liners include red, yellow
and black iron oxide, and titanium dioxide.
Organics include FD&C Red 6, 7, 33, 28, 40;
Yellows #5 and #6; and Blue #1. There are also
The color cosmetics market, including
carmine, ferric ammonium ferrocyanide, chro-
products for nails, lips, eyes, face, hair and
mium oxide green, chromium hydroxide green,
other special effects, will reach $77.7 billion
ultramarines and manganese violet. However,
by 2020. not all are permitted across every category or
for use in all regions the product may be sold.
Source: Global Cosmetic Industry
(www.GCImagazine.com) Regulatory Constraints
Regulatory requirements for inorganic
and organic colorants permitted in respective
cosmetic categories are regulated by governing

A lipstick blended in the perfect combination of
organic reds and red iron oxides can conjure a
bright red apple or deep, sleek red vinyl heels.
bodies in the United States, European Union, the top color tone, i.e., looking directly at the
Mercosur, Japan and China for their respec- applied shade, as well as the undertone or sup-
tive markets. For current differences between porting color beneath it—observed by changing
permitted colorants and use levels, it is recom- the viewing angle.
mended to refer to each region’s legislation. As The reproducibility of color is critical.
stated, understanding the regulatory rules for The color developed on the bench must yield
the pigments used from the beginning will save the same in repeat batches and in scale-ups.
time when selecting colorants to match shades. Formula processing is one aspect vital to color
reproducibility; for example, adding more
Shade Benchmarks energy to a batch can develop a color further,
Shade inspirations come from various so processing the same formula with the same
sources, ranging from products on the market, level of pigments may produce a different color
paint chips, Pantone colors, pictures, trends or if the same energy is not employed.
even the sunset. After a color cosmetic shade When selecting colorants to match shades, a
benchmark is selected, it will become easier remedial should be considered in the event that
to estimate pigment starting points once the the color is off during production and manufac-
product is developed and applied. Application turing, or if quality control accepts a lot that is
to the forearm gives a better understanding of within acceptable color tolerances but not an

exact match. Using a remedial with supporting sirable results; for example, incomplete color
pigments will help to adjust the shade to match development, instability, breakage in a pressed
the lab or previous production, and is helpful powder, settling in an emulsion, and poor
even if only used in amounts as low as 0.001%. skin feel and performance. This is due to the
surface of an untreated pigment, which con-
Stability Considerations tains polar hydroxyl groups having adsorbed
In addition to color, the addition of pigments moisture, contributing to the agglomeration
to a formula base will also affect its stability of particles, in turn causing poor skin feel and
and rheology. Therefore, not only is the chal- potential instability.
lenge to develop the desired color and ensure it While wetting agents and emulsifiers can
abides by a regulatory set list, but it also is to help with pigment development, formula
confirm that no adverse effects in the formula limitations may not permit pigments to be
occur by attaining this goal. consistently scaled up. Also, as noted, during
Testing shades and shade extensions is vital shade adjustments, more energy is applied dur-
to ensuring that catalysts like heat, pH and ing formula processing, which causes untreated
light do not change the product. Also consider pigments develop further. Color dispersions or
product placement on the commercial market hydrophobic surface-treated pigments can help
into your stability testing; i.e., if the formula to address many of these problems.
will be sitting on shelf in a drugstore. Testing Surface treatments often are used in the
color stability in a light box to replicate what cosmetics industry to improve adhesion and
may occur will also help to minimize consumer wear, enhance physical and chemical stability,
returns and complaints. Potential weather diminish the dusting of powders and to aid
influences such as high humidity and vari- in pigment dispersion in various media. This
able temperatures should also be considered, helps to better control rheology and create
especially when shipping the finished goods for textures that are more consistent with the shade
distribution to sale sites. range selected.
Color dispersions enable high pigment loads
Evaluating Color otherwise not be possible to be dispersed into
The most reliable tool we have for evaluating formulas with relative ease. Dispersions offer
color is the human eye. While each evaluator benefits of uniform color, consistency and con-
sees color slightly differently, we still are able to venience while helping to provide the desired
compare a sample to a standard for differences. intensity and optimize product payoff. The use
If possible, drawing down the batch against of pigmentary dispersions in shade-matching
the standard with a metal spatula, or using a helps to circumvent time consuming intermedi-
drawdown bar on a black and white Leneta ate steps to attain desired shades.
card can identify differences. These drawdowns
can be measured using a spectrophotomer to Conclusions
give L*a*b* results with the degree of lightness, Color-matching is an art that results in a col-
red/yellow, green/blue, color strength and hue orful masterpiece. Developing a shade library,
delivered in the batch. however, supports the art with the science
In vivo application also can demonstrate behind pigment interactions, to approximate
how the color produced fares with what was what the anticipated shade will be. Ensuring
expected. Creating a 2 × 2 chart on the forearm the selected pigments conform to regulatory
to compare with a standard gives perspective of restrictions and formula stability/rheology
how the shade appears even at different angles. requirements will open the door to a wide range
Also, applying the products to the palm of the of successful and marketable shades.
hand or even the intended application site will
capture how the products look, comparatively. References
1. www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveIn-
Tools to Improve ventories/ucm115641.htm
Performance 2. www.fda.gov/cosmetics/labeling/ingredientnames/
ucm109084.htm
Depending on the system, formulating with 3. https://data.europa.eu/euodp/en/data/dataset/
untreated pigments may, at times, yield unde- cosing-list-of-colorants-allowed-in-cosmetic-products

InfraGuard
Mibelle AG Biochemistry, 5033 Buchs / Switzerland, Phone + 41 62 836 17 31
Powerful protection against

IR-induced photo-aging
Infrared rays (IR) are known to penetrate deeper into the skin than UV-rays.
Due to radical formation, they inhibit mitochondrial energy production, which is
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Clinical tests carried out during the summer holidays proved that IR adversely
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the loss of firmness and density. However, upgrading the SPF30 cream with
InfraGuard significantly improved these skin parameters. Consequently
InfraGuard opens the doors to a new generation of sun care formulation.
www.mibellebiochemistry.com
USA office: Mibelle Biochemistry

White Plains, NY 10604 / USA
Phone +1 844 642 3553

Formulating | C&T ®
Skin Cleansing Formulary

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This gentle and effective cleansing mousse contains a

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Advertiser Index | C&T ®
May 2017 | Volume 132, number 5
ActivON Co. Ltd. Ikeda Corp. Sabinsa Corp.

52 24 33
activon@activon.kr info@ikeda-america.com info@sabinsa.com
www.activon.kr www.ikeda-corp.co.jp www.sabinsacosmetics.com
AMA Laboratories, Inc. Innospec Ltd schülke, Inc.

41 63 C4
www.amalabs.com americas-pc@innospecinc.com info@schuelke.com
www.innospecinc.com www.schuelke.com
AMETEK/Brookfield
37
Engineering Labs, Inc. Lipotec, LLC Silab
27 19
info@brookfieldengineering.com salesoffice@lipotec.com silab@silab.fr
www.brookfieldengineering.com www.lipotec.com www.silab.fr
Clariant International Ltd. Lucas Meyer Cosmetics Siltech

5 7 49
info@clariant.com info@lucasmeyercosmetics.com www.siltechpersonalcare.com
www.personalcare.clariant.com www.lucasmeyercosmetics.com
Sinerga
C2
Excellentia International MacroCare info@sinerga.it
9 53
sales@excellentiaint.com isales@macrocare.net www.sinerga.it
www.excellentiaint.com www.macrocare.net/en
Sytheon Ltd.
C3
Grant Industries Mibelle AG Biochemistry info@sytheonltd.com
1 69
info@grantinc.com info@mibellebiochemistry.com www.sytheonltd.com
www.grantinc.com www.mibellebiochemistry.com
Wacker Chemie AG
3
Ichimaru Pharcos Co. Ltd. MORRE-TEC Industries, Inc. www.wacker.com/personalcare
71 31
gifu@ichimaru.co.jp sales@morretec.com
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CT1705_Advertiser_Index_fcx.indd 72 4/20/17 1:47 PM

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38 The Name’s Bond. H–F Bond.

2 | www.CosmeticsandToiletries.com Vol. 132, No. 5 | May 2017

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NEW! GENTLE CLEANSING,

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Testing Executive Assistant Maria Romero

OTHER ALLURED PRODUCTS

Formulating Face & Body Southeast Spa Conference and Expo

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Little Jars, Big Effects

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STRONG ENOUGH TO RESIST… … BUT SOFT ENOUGH TO SEDUCE

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Don’t Count On Genetics,

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Osborne: In the 10% of women having younger-

looking skin, we examined skin samples for molecular

Russel Walters, Ph.D. Neuser: Hand in hand, we introduced

1. www.cosmeticsandtoiletries.com/research/ Want More?

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• Skin care products in a K-beauty system are

K-beauty From A to Z: An Interview

Rachel L. Grabenhofer What is K-beauty?

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Photo Credit: Botanic Innovations Photo Credit: Lipoid Kosmetik

Skin Barrier Defender Active to Age Well

Photo Credit: Silab

Silab has launched Wellagyl (INCI: Rosa Damascena

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Traffic Across the Globe

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Classification of Sunscreens least number of approved sunscreen actives,

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Sunscreen Active European Union United States Australia Canada

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Test Type # of Subjects Skin Types # of Exposures SPF Determination

ISO 24444:2010 In vivo 10-20 (18-70 yrs) I, II, III ≥5 Calculated

Table 3. Broad Spectrum (UVA/UVB) (290–400 nm) Testing Requirements

Application Requirement for Number of

Table 4. In vivo UVA Testing Requirements

Test Type # of Subjects Skin Types # of Exposures UVA/PF Determination

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