The Cosmetic Summit - Intermountain West Society of Cosmetic

Fourth Quarter 2013
The Cosmetic Summit
Intermountain West Society of Cosmetic Chemists
IMWSCC Board
Chair
Ryan Roberts
[email protected]
Over the year we have enjoyed excerpts from Krissie Bak’s paper on formaldehyde: “Standardization of
Analytical Techniques Used to Quantify Free Formaldehyde Concentration in Cosmetics Containing
Formaldehyde Releasers.” This final portion will complete that preservation saga.
[email protected]
Part IV
Chair Elect
Eric Scarborough
[email protected]
Secretary
Thao Le
[email protected]
Treasurer
Carlos Olmos
[email protected]
Newsletter Editor
Rachel Sabin
[email protected]
Assistant Editor
Aaron Peterson
[email protected]
Newsletter Publisher
Brianna Purinton
[email protected]
Fourth Quarter Sponsors:
Glenn
Corporation
Active
Organics
C NMR: A New Hope
By: Krissie Bak
In many countries the derivatizing techniques
continue to be the standard for calculating
formaldehyde concentration in cosmetic
products. The shift has slowly favored
using the acetylacetone method over other
reagents such as chromotropic acid, hydrogen
peroxide, and DHN because they are more
destructive to cosmetic samples.
The
acetylacetone method has many disadvantages
but is still the standard for Europe and Japan.
The data for FFA concentration exaggerate
the true concentrations which limits the
amount of formaldehyde releaser used in
a product for preservation. This forces
manufacturers to choose other preservatives
in cosmetic products to limit ACD instead
of using formaldehyde releasers. As shown
in Table 1, other preservatives are less
effective in preventing fungal and bacterial
contamination. As formulas increase in
complexity by increasing the number of
ingredients, the need for higher preservative
concentrations increases. However, some
countries put legal limits on the FFA
concentration allowed in the products;
therefore, limiting the complexity of some
cosmetic products, demanding the use of other
preservatives, or underpreserving cosmetics
by decreasing the amount of formaldehyde
releaser allowed in the products.
Several analytical techniques have been
developed to accurately quantify the
formaldehyde concentration. These methods
include HPLC, liquid chromatography with
refractomeric detection method, and combined
headspace-solid-phase microextraction-gas
chromatography. However, Emeis et al3 and
Tallon et al.1 indicate using 2C NMR that
these techniques do not accurately calculate
the FFA concentration. 2C NMR is the
most accurate analytical technique currently
for determining FFA concentration but may
not be used as often because of the cost.
The machinery needed for measurement
is expensive and may not be reasonable for
small companies. However, to meet the legal
standards set by countries, formaldehyde
must accurately be calculated. 2C NMR
seems to be the only method that accurately
calculates the FFA concentration from the
other oligomers and can be done at user
appropriate value of pH, concentration, and
temperature. Therefore, 2C NMR should
become the new worldwide standard for
determining free formaldehyde concentration
in cosmetic and personal care products.
Table of Contents
Free Formaldehyde p.1, 3
Geek is Chic p.5-6
Chemists Corner p.8
Patent Law 112 p.10-11
Grand Seminar Meeting Agenda p.12-13
IMWSCC Spotlight p.14
Third Quarter Meeting Synopsis p.16
The Regulatory Department p.19
Read to Win!
Somewhere in the newsletter we’ve hidden the
IMWSCC favicon symbol it looks like this - . Spot
it and email Ryan ([email protected]) the page
number and place where it is and you’ll be entered in
a drawing for a chance to win a $25 gift card at the
next meeting.
2 IMWSCC
4th Quarter 2013
Annual Scientific Meeting
& Technology Showcase
Dec 12-13th
NYC, NY
Snow ‘n
Learn
February 27th
Park City, UT
Free Formaldehyde Continued:
Table 1. Effectiveness of common preservatives against bacteria and fungi. Data from Roden, Ref. 4
3.
Class
Active
Efficacy
Bacteria
Fungi
Gram-positive
Gram-negative
+
-
+
Phenocyethanol
+/-
+
+/-
Benzyl alcohol
+
-
-
Formaldehyde
Formaldehyde
+
+
+/-
Formaldehyde
Imidazolidinyl urea
+
+
-
releasers
Diazolidinyl urea
+
+
+/-
Soldium hydroxymethylglycinate
+
+
+/-
DMDM hydantoin
+
+
+/-
Halogenated
Methylchloroisothiazolinone
+
+
+
compounds
2-bromo-2-nitropropane-1,3-diol
+
+
+
Chlorphenesin
-
-
+
Iodopropynyl butylcarbamate
-
-
+
Methylisothiazolinone
+
+
-
Benzisothiazolinone
+
+/-
+/-
Phenols
Nonhalogenated
isothiazolinones
Parabens
References
1. Tallon, M.; Merianos, J.; Subramanian, S. Non-Destructive Method
for Determining the Actual Concentration of Free Formaldehyde
in Personal Care Formulations Containing Formaldehyde Donors. J.
Cosmet. Sci. 2009, 135, 22–32.
2. Rivero, R. T.; Topiwala, V. Quantitative determination of
formaldehyde in cosmetics using combined headspace-solid-phasemicroextraction-gas chromatography. J. Cosmet. Sci. 2004, 55,
343–350.
3. Emeis, D.; Anker, W.; Wittern, K. Quantitative 13C NMR
Spectroscopic Studies on the Equilibrium of Formaldehyde with Its
Releasing Cosmetic Preservatives. Anal. Chem. 2007, 79, 2096–2100.
4. Roden, Kevin. Preservatives in Personal Care Products. Microbiology
Austrailia. 2010 195–197.
4th Quarter 2013
IMWSCC 3
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4 IMWSCC
4th Quarter 2013
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Rachel Sabin: [email protected]
Geek Is Chic: A Tale of Two Cons
By: Rachel Sabin
My husband and I have attended San Diego
Comic-Con for a few consecutive years
now. As the elves migrated
west to the Undying Lands,
we too have gladly traveled
westward to be part of
the eternal...the eternally
nerdy that is. So, of course,
when we heard that Salt
Lake City would
be hosting a
Comic
Con
event and the gift of geekery
would be left like a chest full
of Star Coins on our doorstep, we
registered quicker than Sonic runs a
Shuttle Loop.
For those of you that missed my riveting
article a couple of years ago, San Diego’s
Comic-Con is the largest convention
of its kind in the world. This year its
registration was capped at 140,000
attendees yet sold-out in minutes.
Never underestimate the power of
the dark side.
While attending San Diego’s
Comic-Con in July, we heard
from Harrison Ford and Asa
Butterfield in the Ender’s Game
panel. We met most of the cast
of Divergent. Joss Whedon
singlehandedly blew us away with his insight and wit in what
turned out to be our favorite panel of the year. We heard from
talented directors such as Edgar Wright, Alfonso Cuaron and
Marc Webb. Karl Urban good-naturedly humored us, and
thousands of other eager geeks, with his McCoy maxims.
We listened to the perspectives and scores of some of TV’s
favorite actors and cinema’s best superhero composers.
can’t make any guarantees.
As Salt Lake Comic Con approached, the numbers registered
for this convention skyrocketed. They passed 20,000, 30,000
and then, during its last day, they exceeded 70,000, a record
for an inaugural regional Comic Con. That final afternoon
the crowds got so massive that the fire marshal closed the
doors to the convention center and wouldn’t let anyone else
enter until some legions of clone troopers left.
Despite those historic numbers, compared to the relentless
crowds at San Diego this baby was as empty as the sandy deserts
of Tatooine. You actually had room to expand your lungs
on the convention floor, AKA breath. I’m not complaining
though, I’m a fan of that whole inhale/exhale thing. Breathing
On the SDCC exhibit floor we ran into many of the
famous and should-be famous. Between David Duchovny,
Gillian Anderson, Sean Astin, Steve Blum, Brent Spiner,
Marina Sirtis, Michael Dorn, Max Brooks and Brandon
Sanderson we definitely encountered enough stars to be
struck.
So how did our own salty city’s con compare to this behemoth
of nerdom? Read on and all will be revealed, probably at least
a few million years faster than Deep Thought’s answer but I
4th Quarter 2013
IMWSCC 5
Geek Is Chic Continued:
Salt Lake’s Comic Con may have been smaller and less showy
than San Diego’s but, as The Blob can attest, being bigger
doesn’t always win you the battle. Salt Lake proved itself the
quiet superhero of cons in one department: costumes. The
get-ups in Salt Lake were more impressive and prevalent than
in San Diego. Is it possible that the people of Salt Lake have
nothing better to do than sew sequins on their Green Lantern
unitards? Perhaps.
Since my husband and I didn’t have to squish our handmade
outfits into a suitcase, we were all for dressing up. Although
we weren’t planning on donning garments de la geek every
space aside, there was plenty to see in the exhibit hall. Not so
much that you felt completely overwhelmed, like at that other
con, but definitely plenty to keep you drooling and ogling for
hours. We bought author-signed books, artist originals, nerdy
t-shirts and prop replicates. All the wishes of my little geeky
heart were granted; take that Zahra!
The panels were, in general, not as good as those in San Diego
but I went to a few that surprised me with their informative
insightfulness, namely those hosted by various sci-fi and
fantasy book authors. The Will Shatner and Stan Lee panels
weren’t half bad either and by “not half bad” I mean that they
were awesome!
Ample stars congregated at Salt Lake Comic Con. Perhaps
some of these enduring personalities would have been outgleamed by new-found
heartthrobs in San Diego
but in the Beehive State
they were bigger than the
latest Mo Tab album: Will
Shatner, William Kircher,
Henry Winkler, Taimak
Guarriello, Ray Park,
John de Lancie, Dwight
Schultz, Lou Ferrigno,
Peter Mayhew, Kevin
Sorbo, Stan Lee and
David Prowse. Most of
these fellows were pleasant
and friendly but William
Kircher, who plays Bifur
in Peter Jackson’s hobbit
movies, was exceptionally
nice and courteous. Henry
Winkler was also very
cheerful and gracious. He
wandered through his line
of fans shaking hands,
giving hugs and doing
magic tricks.
6 IMWSCC
4th Quarter 2013
day of the con, that’s what we ended up doing. It’s hard to
resist transforming into an uber-nerd when you can smell the
stench of nerdery all around you. From Frodo to Katara the
waterbender, I looked the part of the hopeless fan girl.
Salt Lake Comic Con was a nerdy delight. Being its first time,
it had some glitches but to a veteran of San Diego, where
everything is chaotic lines and stacks of stinky humanity,
it seemed comparatively relaxing. I’m sure the enormous
number of attendees this year attracted the attention of many
self-important celebrities and next year’s con will be wilder
and more packed than the Mos Eisley Cantina. And, unlike
Chalmun’s, at Comic Con droids are always welcome.
You can get updates
and articles on
the web!
www.imwscc.org
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Natural Colorants for Cosmetics
By: Perry Romanowski
Did you know that in the United States it is not permitted by
the FDA to just add any old ingredient into your cosmetic for
the purposes of changing color? In fact, of all the ingredients
in cosmetics, colorants are the most highly regulated. This is
most likely because historically colorants have also been the
most dangerous.
Anyway, the only colorants you are allowed to use in the
United States are laid out by the FDA. If you are a “natural”
formulator there are only a few on the list of approved colorants
that you would be allowed to use. They are as follows:
Annatto
beta-Carotene
Caramel
Carmine
Chlorphyllin Cu complex
Guaiazulene
Henna
Guanine
Annatto
This is a yellow to orange colorant derived from a shrub that
grows in a number of places in the southern hemisphere. It can
be used in the US, EU and China.
beta-Carotene
Another yellow to orange pigment that can be used for
cosmetics around the world. It’s derived from a fungus and
exhibits good stability.
Caramel
A brown colorant that comes from the burning of sugars like
sucrose, dextrose, malt syrup, molasses, etc. It’s highly stable
and can be used for formulating products around the world.
Carmine
This is a bright, red colorant which has
a bluish shade. It is derived from female
cochineal beetles that are collected
primarily in Peru. The color can be
used in cosmetic products around the
world. It was traditionally used to dye
textiles. Carmine is also one of the
brightest of all natural colorants.
Chlorophyll Cu Complex
This is a green colorant obtained
from alfalfa. To get the final product
it is reacted with copper to replace
the naturally occurring magnesium
found in the molecule. It is approved
throughout the world.
8 IMWSCC
4th Quarter 2013
Guaiazulene
This ingredient is a blue colorant that is derived from the
chamomile plant. It is legal in the US but is not allowed in
products in the EU or China.
Henna
This is a brown dye derived from the Henna plant. It primarily
comes from India. This natural colorant is allowed in the
US but not in the EU or China. However, it is specifically
prohibited for use in coloring eyelashes and eyebrows due to its
known ability to cause irritation.
Guanine
This colorant is derived from herring fish scales and has a
purplish color. It is used in all types of cosmetic products. It
is approved for use in the US but not in EU or China. This
is primarily because it hasn’t been economically feasible to go
through the testing to get it approved in these countries.
Outside the US
While the colors listed are the natural colorants allowed in the
US for cosmetics, there are a number of ones approved outside
the US so if you are a natural formulator in these markets you
might be able to use some of the following:
Lycopene – reddish / orange color derived from tomatoes
Vegetable Carbon – Black color derived from burnt vegetable
matter
Curcumin – Yellow color derived from the spice turmeric
Capsanthin/Capsorubin – Orange color derived from sweet red
peppers. Commonly known as paprika
Canthaxanthin – yellow – red color derived from mushrooms
or shrimp.
There you have it. The color choices for a natural formulator
are limited but you do have some choices.
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4th Quarter 2013
IMWSCC 9
[email protected]
Patent Law 113: Fast Tracking Patent Examination
By: Ryan Marshall
Patent examination is often a long process with delays that
leave the applicant uncertain about the patentability of an
invention. Patent applicants are understandably frustrated
with such delays because patent rights cannot be enforced
until a patent is granted. There are, however, techniques to
expedite the examination process.
New patent applications are taken up for examination in
the order of their effective filing dates, and typically do not
receive a first action for almost two years.
A final action allowing or rejecting the
application typically takes almost three
years, and in some technology areas, this
period is often five years. In some cases,
an extended period of examination is
acceptable. Other circumstances may
justify faster examination such as business
advantages from excluding competitors
from the market, the prospect of licensing
and other revenue generating opportunities,
and in quickly changing technology fields.
How then, can an applicant expedite review
of an application?
Patent Prosecution Highway (PPH)
Several patent offices have agreements
enabling an applicant to obtain the same
claims at one patent office following the
allowance of claims in another office. In
such proceedings, the patent applicant
presents the allowed claims from a first
patent office to a second patent office with
a “Patent Prosecution Highway” request. Such
requests significantly shorten the examination period by the
second patent office. The presented claims will be examined
to insure that the claims meet the second patent office’s
formal requirements, but the novelty of the claims will be
given deference based on the first patent office’s finding of
patentability. This procedure works well if you have already
received allowance of your claims in some jurisdiction.
Special Status
Applicants at the U.S. Patent and Trademark Office can
request “special status.” An application can qualify for special
status based on (1) an inventor’s infirm health or being at least
65 years old or for (2) inventions that materially enhance the
environment, conserve energy resources or counter terrorism.
Many frustrated applicants, however, have found that special
status has not resulted in quicker examination.
Accelerated Examination
U.S. applicants may also file requests for “Accelerated
Examination.” Such requests must be accompanied with a
10 IMWSCC
4th Quarter 2013
statement that the applicant conducted a pre-examination
search and provide support documents explaining why prior
art identified from the pre-examination search does not defeat
the patentability of the claimed invention. This procedure
is not often used by applicants because of the amount of
pre-filing diligence required, and the risk that someone
could challenge an applicant’s characterization of prior art as
misleading.
Track I Program – Prioritized Examination
Track I requests, also called prioritized
examination, became available for U.S.
applications on September 26, 2011.
The U.S. Patent and Trademark Office’s
objective with track I requests is to reach
a final disposition within twelve months.
The patent office, however, will not offer
a refund if the deadline is missed. Final
disposition occurs when there is a notice
of allowance, a final office action, a request
for continued examination (RCE) or
notice of appeal filed by the applicant, or
abandonment. Also, an application reverts
to regular status at final disposition or if the
applicant files a petition for any extension
of time.
Eligible applications include utility
and plant applications and continuation
and divisional applications. Ineligible
applications include design, reissue
and reexamination applications, and Patent
Cooperation Treaty (PCT) applications.
The USPTO has stringent formal requirements for an
applications qualifying for
prioritized examination.
For
example,
an
application can have
no more than 30 total
claims and 4 independent
claims and no multiple
dependent claims. Normal
examination
requires
payment of a $1,600
filing fee ($800 for small
entities). In addition to the
normal examination fee,
a prioritized examination
fee must be paid which
is $4,000 ($2,000 small
entity) plus $130 petition
and $300 publication fees.
Patent Law 113 Continued:
If a petition for prioritized examination is denied, the
prioritized examination fees will be refunded except for
the petition fee.
Prioritized examination enables a number of new
strategies. For example, prioritized examination enables
an applicant to quickly ascertain the patentability of an
invention. If unpatentable, this early determination may
obviate the need for foreign filings and related fees. If
an invention is not a strong candidate for a patent, an
applicant can request non-publication of the application
and maintain the innovation as a trade secret.
On the other hand, following a successful prioritized
examination, an applicant can pursue Patent Prosecution
Highway (PPH) proceedings in some countries to
rapidly acquire foreign patent rights and avoid some
prosecution expenses.
Patent Prosecution Highway and prioritized examination
procedures, among others, provide applicants procedural
flexibility in expediting patent examination. These
options may also enable applicants to reduce their
overall patent expenses.
This article is intended to provide information of general interest
to the public and is not intended to offer legal advice about specific
situations or problems. Brinks Hofer Gilson & Lione does not intend
to create an attorney-client relationship by offering this information,
and review of the information shall not be deemed to create such a
relationship. You should consult a lawyer if you have a legal matter
requiring attention. For further information, please contact a Brinks
Hofer Gilson & Lione lawyer.
Snow ‘n Learn
February 27, 2014
Hotel Park City
Make your plans to SnL next quarter. We will be having breakfast, meeting, and
lunch from 9am to 1pm, and then it is off to Gorgoza Park for some fun in the
snow. Tubing ends at 4pm. We hope to see you there!
4th Quarter 2013
IMWSCC 11
Grand Seminar
IMWSCC 4th Quarter Meeting
November 14 , 2013
The Grand America Hotel
Salt Lake City, Utah
Schedule
8:30am – Breakfast, registration, check-in, and announcements
9:30am – Jamie Singer, Creating a Sensory Experience
10:15am – Q&A
11:00am – Robert Harper, Testing of Cosmetics for Claim
Substantiation: Past, Present, Future
11:45am – Q&A
12:00pm – Lunch
Thanks for your attendance!
12 IMWSCC
4th Quarter 2013
Presenters for Grand Seminar
Jamie Singer
CP Kelco
Robert Harper
Consultant, Personal Care Industry
Creating a Sensory Experi- Testing of Cosmetics for Claim Substantiation:
ence
Past, Present and Future
IFood science and cosmetic chemistry share many parallels in the consumer marketplace. Both disciplines
of science are dedicated to provide
consumers with products that evoke
emotions and create a sensory experience. Many times the scientist is so
focused on the product, that the end result of an emotional
consumer experience is forgotten. In culinary innovation,
the sensory experience of the consumer is at the forethought
and the product is built from the end result backwards. Applying this thought process to food science and cosmetic
chemistry allows the scientist to see their product development path from a new perspective, allowing for an expansion of the mental toolbox. Additionally, the scientist can
draw from experiences of both disciplines as we see many of
the same types of products in both the food and cosmetics
marketplace; such as, emulsions, suspensions, and concentrations.
Jaime Singer is an accomplished Food Scientist with more
than 10 years in the industry and over 200 active products
in the Retail and Foodservice markets. Currently in the role
of Technical Service Representative with CP Kelco, Jaime is
contributing to the company’s success with her unique skill set
of Foodservice product development knowledge paired with
her passion for Culinology inspired innovation. Culinology
inspired Jaime to return to school to become a Certified Culinary Scientist, which should be completed by the end of 2013.
She is also an active member in both the Research Chef ’s Association and the Institute of Food Technologists.
When Jaime is not driving innovation with her customers
she enjoys exploring the culinary and mixology trends in her
home town of Chicago, as well as long distance running, and
developing culinary delights in her own kitchen.
Jaime is a member of the Chicago Area Runner’s Association
and acts as a mentor for younger athletes looking to build a
lifelong health and fitness routine.
Claim support for cosmetics goes back to the 1920’s when
statements were made primarily concerning the safety of
products. Later in the 1930’s efficacy claims began to emerge
based primarily on consumer studies. By the 1980’s non-invasive, instrumental methods were introduced to substantiate skin care product claims. Claims such as skin moisturization, skin lightening, skin firmness and elasticity, skin
barrier function, and skin mildness (just to name a few) are
now being routinely substantiated by instrumentation. The
FDA as well as other regulatory bodies provide oversight for
cosmetic product claims. Over the years a number of cosmetic companies have received letters from the FDA stating that the company is making a drug claim rather than a
cosmetic claim. Occasionally regulatory actions end up in
court as was the case with the cosmetic companies using the
term “hypoallergenic” back in the 1970’s. Today testing for
cosmetic claim support involves a combination of clinical
evaluations by physicians, in vitro assays, consumer studies,
clinical studies, and non- invasive instrumentation. With
the use of cosmeceuticals, nutraceuticals, nutri-cosmetics,
nano particles and cosmetic devices, the testing arena will
need to become even more sophisticated that it is today.
Dr. Harper is a personal care and pharmaceutical expert with
more than 30 years experience in clinical and scientific research in the areas of dermatology and topical products. He
obtained a Ph.D. in Biochemistry from N.C. State University
and spent 17 years in academic research in dermatology at the
Skin and Cancer Hospital, Temple University Medical School
, Philadelphia, Pa. and the Connective Tissue Research Institute, University of Pennsylvania.
Dr. Harper’s industry experience includes Manager of Biotechnology at Helene Curtis, Chicago, Ill., Director of Product
Safety Testing at Hill Top Research, Cincinnati, Ohio, Director
of Clinical Research at PRACS Institute, Fargo, ND, and Vice
President of Clinical Research at Derm Tech International
and Cosmederm Inc., San Diego, CA. More recently, he was
President of Hill Top Research, St. Petersburg, FL. Presently,
he works as a consultant to the personal care and pharmaceutical industries.
4th Quarter 2013
IMWSCC 13
Spotlight:
Brian Cook
Where were you born?
Crete, Nebraska
What was your favorite subject in grade school?
Science
As a child, what did you want to be when you
grew up?
Forrest Ranger
Favorite Hobbies?
Road Biking, Mountain Biking, Fly Fishing, Skiing
Favorite TV Show?
I don’t watch much TV but I’ve seen all the Drake
Magazine 5-minute videos.
.
BOTANICAL
EMOLLIENTS
& SPECIALTY
PARTICLES
Favorite Movie?
Get Shorty
On the weekend, you will most likely be found…
on a river or on a mountain.
Any nicknames we should know about?
None, as far as you know.
What is the most adventurous thing you’ve
ever done?
I like to mountain bike and float rivers at night.
A headlamp makes everything feel more
adventurous.
www.floratech.com
24/7 Online Ingredient Information:
The Natural Solution
i
Label
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www.floratech.com/info
Intermountain West Region:
Brian Pickel | 480.545.7000 | [email protected]
CHT.7022-SCC Chemtec Ad 4 x4 r.1_Layout 1 1/21/13 1:39 PM Page 1
What was your last vacation?
A summer trip fishing and biking around
Breckenridge, CO with the family.
If you could have a super-power what would
it be?
I always thought that laser beams coming out of
my eyes would be handy.
What is your favorite quote?
“I have not failed. I’ve just found 10,000 ways
that won’t work.” - Thomas Edison
What are you most proud of?
I have a great wife and two super kids.
14 IMWSCC
4th Quarter 2013
CHEMTEC Chemical Company
is a member of the NACD and
practices product stewardship.
Tel: 818.700.0071 • Fax: 818.700.1301 • www.chemteccc.com
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Silicone solutions for every body
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Represented by:
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International Cosmetic & Food Regulatory Consultants
We’ve got the whole world in our hands……….
well 100 countries at least.
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Ingredient/formula compliance reviews
Claims development/review
In-country regulatory maintenance
Vendor documentation assessments
www.theregulatorydepartment.com
Scott Taylor
(801) 754-4443
[email protected]
4th Quarter 2013
IMWSCC 15
[email protected]
TNT Synopsis
By: Carlos Olmos
The 2013 IMWSCC TNT event was a great success. More than 80 people attended and all had a great time.
This year’s TNT was hosted in Park City, UT and, as usual, was full of beautiful landscapes and scenery.
The event kicked off with presentations by David Fielder from Ceapro Inc. and Jeffrey Easley from Stepan.
David gave an overview of oat-based ingredients and how formulators can use them, while Jeffrey explained
Hair Shampoo vs. Laundry Detergent.
The golf portion of the event was played at the Park City Golf Course. After playing a challenging 18 holes,
and losing many golf balls, there was a luncheon with awards for those who swung great and scored high,
really high. It was a fun affair filled with education and good golf.
16 IMWSCC
4th Quarter 2013
PersonalCare
Lonza Personal Care
Recapturing beauty
through technology
For product information, please
visit www.lonza.com or email us at
[email protected].
70 Tyler Place,
South Plainfield, NJ 07080
+1-908-561-5200
4th Quarter 2013
IMWSCC 17
Sponsor the IMWSCC in 2014
Because of our sponsors, our chapter goes to only the finest venues. We are also able to provide delicious snacks
and beverages at our meetings, and offer fun activities for our attendees.
There are two different ways to sponsor the IMWSCC:
Newsletter
2013 sponsor have their company ad in each of our four newsletters. This year we are offering a standard “buy
now” range of sizes via the IMWSCC website. You can pick one of the preselected sizes and purchase with a credit
card. Then all you need to do is send the high resolution graphic to [email protected] and you are all set for
the year! If you want to do a different size ad, just email [email protected] with the ad size. The cost is $60 per/
sq inch, and you may now pay online by Paypal or credit card.
Ads run 4 times each year in the IMWSCC newsletter and are distributed at each of the quarterly meetings:
February, May, August, and November. Additionally, the newsletter is available for download on the IMWSCC
website. Sponsors have the option of changing their advertisements each newsletter. If you choose to publish a
larger ad we pro-rate it based on the previous size. If you choose to publish additional ads you can also do this and
that price is also pro-rated based on how many editions the ad will be published in our newsletter(s).
Quarterly Sponsorship
You can sign up now to be a quarterly meeting sponsor of the IMWSCC. The cost is $350 and there is a limit of
3 sponsors per quarter.
Our quarterly sponsors have approximately 2-3 minutes
to introduce their company, employees, products,
capabilities and services during our meeting. They have
the exclusive right to distribute literature and samples
at the meeting. We also provide a table adjacent to the
registration table to distribute literature and samples by
one or two company employees.
Your company name will appear for three months
on the IMWSCC website main page as a
Quarterly Sponsor (sorry we cannot do logos).
Your company name will also appear on
the front and back cover of the quarterly
newsletter as well as on a poster at the
quarterly meeting.
Visit our imwscc.org now to
become a sponsor!
18 IMWSCC
4th Quarter 2013
[email protected]
BIG
Small Changes Have
Regulatory Consequences
By: Scott Taylor
The formula is finally done, right? It’s sent off to
regulatory for review and they come back and say
that everything is approved. Product is notified, labels
created, customers begin purchasing and the world keeps
turning. Marketing comes by a couple months later and
says, “You know that formula you just made? Well, our
Asian market would like it to be a bit more viscous and
less vanillaeee.” Then a couple quick adjustments are
made, no ingredient changes
just levels, and product is sent
back to Asia. No need to notify
everyone since no ingredients
have changed, everything
should be fine. In regulatory
we call that “cracking the
whip”, not like cracking the
whip over a mule’s ear to get
it moving, but more like the
game you used to play in your
neighborhood. (Or, for city
slickers, the game you’ve seen
in movies.) There’s a long line of kids and they run
around the yard with their arms or hands interlocked.
Marketing and R&D are in the front of the line where
not much happens. They just keep running since they
are in the lead but regulatory is the 6-year-old neighbor
kid who gets thrown 20 yards when the leader starts in
a slightly different direction.
From a regulatory standpoint, this is now what has
happened with that small adjustment. If the product has
been notified with the current formula, notifications may
need to be redone and levels of ingredients will have to
be checked again to make sure that they are still within
the range allowed by each country. If you have compiled
a product information file (PIF) for Europe or Asia, that
also has to be redone. In some cases, all of the product
testing will need to be redone: PET, RIPT, efficacy,
substantiation, etc. The label order of ingredients may
have changed and the documentation, specs, CofAs,
MOMs, SOPs, and multiple other acronyms will need
to be updated and changed.
I was working at an unnamed company when I received
some final formulas. I created the labels, notified the
products, etc. A couple of months later I received an
email with the formulas attached. I noticed they had some
adjustments and, much to
my surprise, the preservatives
had gone up because of
shelf-life issues. I checked
the levels and, sure enough,
the preservatives were over
the allowable amount in
multiple products. Launch
was already planned, labels
printed, etc. I sent the news
over to R&D, who hadn’t
bothered to tell me that the
formulas had changed, and
then that can of worms wasn’t opened, it exploded.
Needless to say, those adjustments caused some very
exciting (sarcasm intended) setbacks.
Make sure to involve regulatory in any changes you are
making to a formula that has already been checked.
What you make and what is notified, labeled, etc. needs
to match. A phone call or an email is much better than
endless meetings with a cranky
regulatory nerd.
Freiheit und Gesundheit,
D. Scott Taylor
The Regulatory Department
4th Quarter 2013
IMWSCC 19
IMWSCC would like to thank
our Fourth Quarter
Meeting Sponsors:
Active
Organics
Glenn
Corporation
20 IMWSCC
4th Quarter 2013