Cosmetiscope November 2023 by NYSCC Webmaster

November 2023 • Vol. 29 • Issue 9

Cosmetic Colorants …Yun Shao

oloring agents are essential components of certain cosmetic products, especially color cosmetic formulations. Most cosmetic colorants are synthetic and are regulated globally. In the United States, they are regulated by the FDA with monographs for each and all located in Title 21 of the Code of Federal regulations, Parts 73 and 74. In the European Union (EU), allowed cosmetic colorants are listed in Annex IV, Regulation 1223/2009/EC on Cosmetic Products, as corrected by Corrigendum to Commission Regulation (EU) 2021/850, 17 June 2021. Many colorants on that list are also used in food and have corresponding E (Europe) numbers such as E-171 for TiO2 and E-172 for iron oxides. In such cases, the specifications for food colorants are used for cosmetic application. Therefore, it is common to see a note in technical datasheet for a cosmetic colorant stating it complies with the 21CFR and E number (like E-172 for iron oxides) specifications. Although many of us formulate with colorants frequently, we seem to need help on gaining complete clarity on certain aspects of them. In this article, we will go over some fundamentals and a few common confusions about certain pigments. Let’s first start with some terms that we often hear. Dye: It is a material that imparts a color and is soluble in the vehicle or substrate in which it is dispersed. Pigment: It is a material that is insoluble in the vehicle or substrate in which it is dispersed. True pigments are colorants, which are completely insoluble based on their chemical structure and constituent groups. They typically do not contain the normal substitution groups that promote water solubility, such as sulfonate (–SO3), carboxylic acid (–COOH), or hydroxyl (–OH) groups. Hence, there is no bleeding in hydrous systems. There are only two examples of true pigments used in cosmetics: D&C Red No. 30 and D&C Red No. 36. For leave-on cosmetic applications, pigments instead of dyes are often used because dyes are difficult to remove after use, thus, staining the skin. Dyes are more commonly used in rinse-off products such as shampoo and mouth rinse. Now, let’s go a little further. Toner: It is a pigment that is produced by precipitating a water-soluble dye as a metal salt. Typical metals used for this precipitation are sodium, calcium, barium, and strontium (e.g., D&C Red 7 Ca Salt). Be aware that it is not a lake. Lake: It is a pigment produced by absorbing a water-soluble dye or a primary toner onto an insoluble substrate. All the lakes are pigments. F, D, and C codes in the names of a colorant stands for its approved use in Food, Drug, and Cosmetics. A colorant must meet its purities requirements to ensure its safety. The FDA separates color additives into two categories.

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S T R AT E G I E S F O R F R A G R A N C E E C O - C O N C E P T I O N • N O V E M B E R 8 ...see page 7 for more information.

2023 NYSCC EXECUTIVE BOARD & COMMITTEE Chair Stacey House chair@nyscc.org Chair-Elect Amber Evans chair-elect@nyscc.org Treasurer Alex Blakeman treasurer@nyscc.org Secretary Luciana Coutinho secretary@nyscc.org Advisor Giorgio Dell’Acqua advisor@nyscc.org Program Cathy Piterski program@nyscc.org At Home Live Series Susanna Fernandes Susanna.Fernandes@tri-k.com By-Laws Amy Marshall amy.marshall@altana.com Communications Maria Sousa socialmedia@nyscc.org House Chair Alexis Piterski house@nyscc.org Special Events Johanna Gigliotti johanna.e.gigliotti@gmail.com Cosmetiscope Editor Roger Mcmullen roger_mcmullen@fdu.edu Cosmetiscope Advertising Bret Clark rbclark@ashland.com Membership John Carola jc@katonachemical.com

Letter from the Chair

…Stacey House

ow that the leaves have begun to change colors, and there are only two months left in my tenure as Chair, I am grateful to everyone who so far has helped make 2023 a stellar year for the NYSCC! Case in point was our sold-out INDIE 360° symposium that was held in the beginning of October and chaired by Susanna Fernandes. This event featured captivating keynotes, insightful panels, and terrific networking opportunities. Keeping up the momentum, we have some excellent programs and events to round out the year. On November 2nd we hosted the webinar “Top Trending Ingredients and Formulas: Hear from the CEW Supplier’s Award Judges on 2023’s Finalists,” that was moderated by Andrea Nagel with CEW and featured Toussaint Jordan (Edgewell), Eileen Kim (Chanel), Mike Wong (Orveon), and Tao Zheng (Estée Lauder). This presentation, which is available on demand, had a 20% increase in participation over last year. The “Strategies for Fragrance Eco-Conception” dinner program will take place on November 8th at the Pleasantdale Château in West Orange, New Jersey. On December 11th, we will host the “U.S.-China Symposium on Beauty Market Trends” at Convene in New York City before the start of the SCC 77th Annual Scientific Meeting and Showcase. The NYSCC will be a sponsor of this event and will have a presence in the showcase. Also, on December 12th the “NYSCC Supports Education Awards Night” will take place at the Edison Ballroom. This final event of the year for the chapter will be a festive night recognizing numerous scholarship and grant recipients. In addition, the 2024 NYSCC Executive Board will be inducted. For tickets go to https://nyscc.org/blog/events/nyscc-supports-education-night-2023/. Sponsorships are available for both brands and suppliers. Contact suppliersday@nyscc.org to learn how to become a part of this event that supports one of our core missions. This month I am also excited to find out who will be announced as the winner of the Supplier’s Award: Ingredients and Formulation in the prestigious CEW Beauty Awards program. The winners of all the beauty categories will be revealed on November 7th at this luncheon, which is billed as the ultimate beauty insider’s event! In this time of gratitude, I am thankful for all our members, partners, and sponsors who have supported us throughout the year. This incredible industry commitment allows us to create unique programs; provide numerous scholarships and grants benefiting students, young professionals, and our members; and establishes our flagship event, Suppliers’ Day, as the leading North American trade show for ingredients and formulation innovations. I wish you all the best for Thanksgiving and the start of the Holiday Season.

Call for Papers

he Cosmetiscope editorial committee invites all interested parties to submit feature technical articles for publication in the NYSCC monthly newsletter. Authors of feature articles are eligible to win the prestigous NYSCC Literature Award ($1,000) for the best front-page article published during the calendar year. Authors also receive $200 reimbursement to attend a theatrical performance of their choice. Writing an article for your peers is a very rewarding experience, both personally and professionally, and will ensure your place in NYSCC history. You may choose whatever topic you feel would be interesting to fellow colleagues in our industry. We also welcome any other types of commentaries or articles that may be published in the Career Corner, Technical Tidbit section, or as a Letter to the Editor. Please send correspondence to: roger_mcmullen@fdu.edu. 2

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Cosmetic Colorants (continued from Page 1)

Colorant Subject to Certification: They are derived primarily from petroleum and are known as coal-tar. Most synthetic, organic colorants fall into this category. They must be batch certified by the FDA. They are further divided into two categories. 1) Certifiable Primary Colors: They are pure color which contain no extenders or diluents. They have color names and numbers assigned such as FD&C Yellow 5, D&C Red 6, and Ext. D&C Violet 2. 2) Certifiable Color Lakes: Lakes follow the same restrictions as the primary colors with the additional rule that they must have the name of the precipitating metal and the word “lake”. An example would be FD&C Yellow 5 Al Lake. Colorant Exempt from Certification: These are natural organic colorants and synthetic inorganics obtained largely from mineral, plant, or animal sources. Although batch certification is not required, purity must be tested by the manufacturer to meet FDA specifications. Examples are TiO2 and iron oxides.

Now that we have gone over the general terms and regulatory aspects of colorants, let’s look at common ambiguities about a few specific pigments.

n Rutile and Anatase

First, they both are TiO2, but refer to two crystalline structures. It is like using Coke or Pepsi to represent carbonated soft drinks. Anatase is slightly softer and less abrasive than rutile. This makes little difference to the skin feel but can make a big difference in the TiO2 production process. Rutile is so abrasive that it can wear out the equipment that processes hundred to thousands of tons per campaign. Consequently, rutile is often surface treated with alumina to extend the useful life of the equipment in addition to providing other benefits. Rutile has a slightly higher refractive index than anatase, and thus, it can scatter light more effectively. So, does it mean that rutile is more opaque? Not quite. Opacity is the result of scattering which depends as much on the size and size distribution of the pigment particles as on its refractive index. In reality, it is rare to find a rutile and an anatase that have the same particle size, let alone size distribution. Therefore, being rutile or anatase does not necessarily indicate a higher or lower opacity. Commercial anatase is usually manufactured to have a small primary particle size, in the range of about 140 – 170 nm. That of rutile is often larger, roughly 170 – 250 nm. Due to its smaller size, anatase scatters blue light slightly more, and thus, imparts a blueish undertone. This is the reason that anatase is often said to be bluer than rutile. Lastly, the production processes (chloride and sulphate) are often brought into discussions about TiO2. In the chloride process, TiCl4 is vaporized and burnt into rutile. In the sulphate process, Ti(SO4)2 is neutralized with base to generate anatase. If aluminum salt is used as the inducer, rutile TiO2 can also be made via the sulphate process.TiO2 made from a chloride process often has a lower level of contaminants, which translates into high purity and clean color. Indeed, this has been the case in the past, but not so much anymore since the sulphate process technology has been greatly improved over the years.

n Carbon Black

Carbon black can be made via several processes. In the U.S., carbon black as a cosmetic color additive is called D&C Black No. 2, a high-purity carbon black prepared by the oil furnace process.1 It is manufactured by the combustion of aromatic petroleum oil feedstock and consists essentially of pure carbon, formed as aggregated fine particles, with a surface area range of 200 – 260 m2/g. The JSCI monograph requires carbon black to be obtained by incomplete combustion of natural gas or liquid hydrocarbon. Such carbon black is often called channel black and is not approved by the FDA. This, unfortunately, adds unnecessary complexity to formulating for the global market. 4

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n Chromium Oxide and Chromium Hydroxide Green

Hexavalent chromium (Cr6+) is known to be carcinogenic, thus, it should not be present or at a very low levels in cosmetics products. However, its presence is unavoidable due to the chemistry and manufacturing process. For both pigments, the FDA set a limit of 2% NaOH extract, not more than 0.1% as Cr2O3 (based on sample weight).2 This limit is equivalent to 684 or 513 ppm maximum hexavalent chromium, respectively. The actual level of Cr6+ in a commercial grade product needs to be tested for calculating the final level in a finished formulation.

n Mica and Pearlescent Pigments

A common restriction people often talk about is the size limit of 150 mm. Mica is an approved colorant for drug use, and the FDA has imposed a size limit on it. Mica can also be used as a colorant for cosmetic applications in which case the FDA does not list any size limit in the monograph. Moreover, mica can be used in cosmetics as filler, a category that the FDA does not regulate with specific requirements. Efforts have been made to list mica-based pearlescent pigments as approved colorants for cosmetic purposes, but this has not happened yet. As of now, such pigments have been approved as colorants only for drug use, and the corresponding specifications require that the mica meets the colorant specifications for drug use. This is likely the reason that we often hear about the 150 mm size limit in our industry. As mentioned above, mica-based pigments are not approved colorants for cosmetic use. Consequently, the composition must be expressed as a mixture of individual components such as, for instance, mica and TiO2. Each of these ingredients needs to meet the corresponding FDA specification if applicable. The size limit on mica for drug use may not be observed.

n Zinc Oxide

Zinc oxide (ZnO) is a long approved cosmetic colorant, though its use as an opacificer in cosmetics is limited. The main reason is that its opacity is much lower than TiO2 due to its lower refractive index (2 vs. 2.7). Roughly three times more ZnO is needed to achieve the same degree of opacity of TiO2. Moreover, ZnO is slightly soluble in water, resulting in the pH of formulations containing ZnO to be above 7.5. As of August 7, 2022, the use of TiO2 as a food colorant has been banned in the EU, directly affecting its use in lip and oral products. Respirable TiO2 is considered carcinogenic, according to Proposition 65 of the state of California, affecting the use of TiO2 in some powder and spray formulations. TiO2 is difficult to replace because of its unique performance and inertness. Considering the regulatory restrictions, ZnO with the right size and high opacity has gained attention recently, especially for anhydrous formulations.

n Red 6 Lake and Red 7 Lake in Japan

Most FDA approved colorants can be used in Japan. Red 6 Lake, widely used in lip products, is a notable exception. The reason is that Red 6 Lake is Red 6 barium salt laked on barium sulfate, but Red 6 barium salt is not an approved colorant in Japan. On the other hand, Red 7 Lake is (continued on Page 6)

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CSR program Naturally committed to a sustainable world

Cosmetic Colorants

(continued from Page 5)

Red 6 calcium salt laked on barium sulfate, but Red 6 calcium salt is approved in Japan. In the case that the shade cannot be achieved without Red 6, Red 6 sodium salt can be used. However, it must be noted that Red 6 sodium salt is water soluble, which is opposite to Red 6 Lake.

n Concluding Remarks

Currently, the FDA has approved 64 color additives for cosmetic use, which all have their merits and drawbacks due to their unique chemistry and production process.3 This knowledge is important not only for formulating the right color shade, but also for troubleshooting instability and especially, regulatory compliance. The author hopes that this article will contribute to your learning of cosmetic colorants. ____________________________________________________________________________________

n References

1. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74/subpart-C/ section-74.2052. Accessed on October 31, 2023.

2. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/ section-73.2327. Accessed on October 31, 2023. 3. https://www.fda.gov/industry/color-additive-inventories/summary-color-additives-useunited-states-foods-drugs-cosmetics-and-medical-devices#table3A. Accessed on October 31, 2023. ___________________________________________________________________

About the Author

Dr. Yun Shao has been working on raw material innovation for over 25 years and is currently the Vice-President of R&D at Kobo Products, Inc. He has expertise in micro TiO2 and ZnO innovation and physical sunscreen technology. He is also experienced in pigment surface treatments, pigment grinding, color cosmetics, and global cosmetic ingredient regulations.

NYSCC and CACPA Collaboration December 11, 2023 8:00 a.m. – 1:00 p.m.

CONVENE 75 Rockefeller Plaza, New York, NY

This event will focus on navigating beauty and personal care sourcing and product development in China. This program will kick-off a week-long SCC immersion, so be sure you are registered for the SCC Annual Meeting and Showcase which starts Monday afternoon! To register, visit https://nyscc.org/blog/events/nyscc-cacpa-collaboration.

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Strategies for Fragrance Eco-Conception November 8, 2023

5:00 – 8:00 p.m. Pleasantdale Château 757 Eagle Rock Avenue, West Orange, NJ

hile consumers are increasingly concerned about sustainability and new claims constantly arriving on the market, there is still no formal definition of sustainable fragrance ingredients. In this seminar, we will explore the multiple concepts that can fall under this general term. We will explore the notion of natural and synthetic ingredients, biodegradability, carbon renewability, and regulatory ISO norms, and see holistically how they can contribute to making a fragrance sustainable. To register, visit the Events section of the NYSCC website (www.nyscc.org). ________________________________________________________________

n Mike Davies

Mike Davies has worked in the personal care industry for more than thirty years with experience as a formulator at Chattem (now Chattem/Sanofi) and Amway, and currently with Essential Ingredients as Technical Fellow. ________________________________________________________________

n Victor Manes

Born in the picturesque south of France, the birthplace of modern perfumery, Victor Mane is a fifth generation family member of the eponymous family owned and operated fragrance company: V.MANE FILS. Trained as a chemist, Victor joined the company in 2015. From 2019 to 2022, he steered the Asian Home and Fabric Care Fragrance Division in Shanghai, gaining invaluable experience in the dynamic Asian market. Currently, in the role of Fragrance Ingredient Director, he remains close to his true passion—the world of fragrance raw materials. Alongside his family members, his mission is to perpetuate the company’s perfumery legacy for generations to come.

2023 NYSCC Events Calendar

• For updated NYSCC information, visit us on the web at: www.nyscc.org • For National SCC information: www.scconline.org November 8 Strategies for Fragrance Eco-Conception, Pleasantdale Château, West Orange, NJ

December 11 NYSCC and CACPA Collaboration, CONVENE, 75 Rockefeller Plaza, New York, NY December 11-13 SCC Scientific Meeting and Showcase, New York, NY December 12 NYSCC Supports Education: Winter Awards Night, Edison Ballroom, New York, NY

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NYSCC History Project

...Steve Herman

2013 – The NYSCC Enters the Digital Age

he NYSCC was packed with activities in 2013, including the 1st U.S.-China Regulatory Symposium held jointly with the CACPA and a Cosmetic Technology Transfer Conference. The Chapter programs evolved from monthly meetings with one or two speakers to a series of full-day technical seminars, which in 2013 dealt with formulation, regulatory affairs, professional development, and cosmetology. The 5th Annual Culinary event at the Midtown Loft in Manhattan featured roasted lamb kebobs. The 20th Annual Golf Outing was held at Crystal Springs Golf Course in Hamburg, New Jersey. These social events retain their popularity and usually sell out every year.

Financially the NYSCC was in robust health, mostly due to the ever-increasing success of Suppliers’ Day. The March 2013 Cosmetiscope included this paragraph in the message from the Chair: “We are a large, successful, and financially secure chapter. The past year we have instituted formal systems to keep closer financial control of our activities because of the sheer size and complexity of our events. The NYSCC Chapter now employs a professional accountant, financial advisor, and lawyer to provide guidance on key policy and procedural manners. You elect your officers with the understanding that we are the guardians of the Chapter’s reputation and resources, and we have been taking that obligation very seriously. In fact, we have set a standard for fiscal responsibility that has become a model for all the other chapters and the national organization.” These systems are still in place along with the later addition of professional management of Suppliers’ Day, which have made the NYSCC a model of a well-run organization that has sound professional support for the Executive Committee and allows us to function consistently as a global leader in the cosmetic industry. 8

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December 2013 marked the final issue of the print edition of the Cosmetiscope, as it moved to the website in an electronic format. Of course, there was some controversy over this, but it coincided with the worldwide demise of print and the simultaneous rise in social media. In fact, the last print edition of the Cosmetiscope was devoted to introducing our members to the wonders of Facebook, LinkedIn, Twitter, and Instagram. All the photographs for this history column come from an iPhone or the NYSCC Facebook posts, another radical change in how we interact with and record the world. The position of the NYSCC photographer disappeared at this time. Thus, 2013 can be identified as the year when the NYSCC Chapter completed its transition to the Digital Age. The print edition of the Cosmetiscope is missed as are the meetings we routinely once had on the first Wednesday of the month at the Robin Hood Inn in Clifton with the Board sitting at a head table like a wedding. But the changes exemplified by the actions of the 2013 Board keep the Chapter moving forward in ways that continually enhance its value to our members and the industry at large.

n 2013 NYSCC Board

• Chaiman – Steve Herman • Chair-Elect – Steve Neidenberg • Treasurer – Sonia Dawson • Secretary – Kim Burch • Advisor – Brian Hom • Program – Cathy Piterski • Suppliers’ Day – Juliana Rumbaugh and Danielle Kennedy

n 2013 NYSCC Programs

• February 20 – Formulation Seminar • March 14 – Professional Development Symposium • April 10 – Regulatory Seminar • May 14-15 – Supplier’s Day • May 16 – 1st U.S.-China Regulatory Symposium • July 26 – Golf Outing • August 14 – Cosmetology Seminar • September 19 – Culinary Event • October 2 – Safety Assessment and Cosmeticovigilance • November 13 – Cosmetic Technology Transfer Conference

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BEAUTY

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December 12, 2023 7:00 – 11:00 p.m.

Edison Ballroom, New York, NY

Attire: Festive white • Cost: $175 per person

eld in conjunction with the December SCC Annual Scientific Meeting and Showcase, the NYSCC Supports Education Night will be held at one of New York City’s most iconic venues located in Central Times Square. Show your support of NYSCC education scholarships and grants and join us for a night of festivities, networking, and much more! The world of cosmetics is ever changing, especially as more and more consumers focus on their health, wellness, individuality, and purpose. Consumers are more aware of the tremendous impact we have on the environment and are mindful and intentional in their purchasing decisions. The beauty and personal care industry represented by the NYSCC acknowledges this shift and is actively making strides to meet the demand of consumers who are driving the change, which starts with engaging students involved in this evolution! By facilitating and furthering education in the beauty and personal care industry, we will be well-equipped to source and create ingredients that meet consumers’ demands. For event information, please reach out to Giorgino Macalino – Event Lead Organizer for NYSCC Awards Night Events at gmacalino0713@gmail.com. For sponsorship inquiries, please reach out to Jane McDermott (jmcdermott@ecmallp.com). Numerous sponsorship packages and private seating areas are available for your company and guests.

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In Memoriam: Salvatore Barone

June 5, 1953 – October 14, 2023

t is with great sadness we announce that on October 14th Salvatore (“Sal”) Barone left this world. He had extensive formulation experience, working in the personal care industry for over 30 years, resulting in more than 80 patents to his name. He was experienced in all aspects of product formulation for all personal care and color cosmetic product types, and even co-wrote a monograph about lipstick technology for the Society of Cosmetic Chemists. Sal was at Coty for 17 years where he held the position of Director of R&D responsible for the Basic and Applied Research Group. Prior to Coty, Sal spent 13 years at Revlon where he held the position of Manager of the Lipstick Lab. Sal’s wife wrote the following public obituary for him: “This morning God and his angel escorted my husband, my best friend, and my soulmate, Sal Barone, through the final phase of his earthly journey into heaven. Although I do and will continue to miss him terribly, I know he’s in a better place. I also know that heaven just got better! Sal will be greatly missed by so many. He was a great husband to me, kind and generous stepfather to Lauren (Mag) Mallisk, excellent devoted father to two sons, Vincent and Adam, and loving cat dad to Zorro, Sophie, and Char. Sal was a brilliant scientist who contributed greatly to his industry as a generous mentor and teacher and inventor of many patents. He was a great friend to so many. Thank you for the wonderful life that you have given us. Thank you for improving the lives of so many. Your presence made Earth a much better place. Godspeed to you, my love!” Sal will be sorely missed by his family as well as his friends and colleagues in the industry. May he rest in peace.

Exploring Cosmetic Science: Books to Beauty

November 15, 2023 • 1:00 – 9:00 p.m.

Ohio Valley SCC Symposium

Celebrating 50 Years of Cosmetic Science Education at the University of Cincinnati and Looking into the Future of the Industry

he event will kick off with a welcome by Dean Surratt of the Winkle College of Pharmacy and a presentation on the history of the world-renowned cosmetic science program by none other than the esteemed, Dr. R. Randall Wickett. Venue 1 1:00 – 5:00 p.m. Presentations start at 1:30 p.m. in Kowalewski Hall, 3255 Eden Drive, Cincinnati, OH (James L. Winkle College, University of Cincinnati) Venue 2 5:00 – 9:00 p.m. Dinner and more technical presentations at The Graduate Hotel (just steps away from Kowalewski Hall), 151 Goodman Drive, Cincinnati, OH To register, visit the SCC website at: https://www.scconline.org/OVSCC/Events/OVSCC-Meetings-Registration. Students – $25 • Members – $75 • Non-members – $85 12

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