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LAKE EFFECTS

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Cindy Sullivan

California’s Proposition 65 chemical list, safe harbor numbers and influences on formulating personal care products

Tuesday, March 18, 2014

Reception starts at 5:00 pmDinner begins at 5:30 pm

Cafe Bricco (The Chestnut Room)3150 W Market St(Doubletree Hotel across from Summit Mall)Fairlawn, OH 44333

Cost for members is $40 and non-members $50, pay by cash or check at the event.

Please RSVP to Diane Hillman at HillmanD@gojo.com by Friday, March 14, 2014

Please note that if you RSVP, you will be charged for the meeting.

1. Fettuccine with sautéed shrimp, roasted tomatoes, caramelized onions and asiago cream sauce

2. Pan-seared chicken breast glazed in cajun honey over creamy parmesan risotto topped with sautéed peppers and onions

3. Pan-fried eggplant parmesan topped with sliced tomato and mozzarella cheese over fettuccine marinara

Salad, Entree of choice and a Dessert Platter

Abstract: California’s (1986) Proposition 65 entitles California consumers to special warnings for products that contain chemicals known to the state of California to cause cancer and birth defects or other reproductive harm if those products expose consumers to such chemicals above certain threshold levels.

Businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a listed chemical. This warning can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper. Once a chemical is listed, businesses have 12 months to comply with warning requirements.

Current law states that “no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the State to cause cancer or reproductive toxicity without first giving a clear and reasonable warning”. If, you do business or put products in the stream of commerce in California, you should review the Proposition 65 list to determine if your products or activities are likely to expose individuals to any of those chemicals. If you anticipate causing such an exposure, you must provide a warning.

Businesses do not have to provide a warning if the exposures they cause are so low as to create no significant risk of cancer or birth defects or other

Next Meeting

The newsletter of the Lake Erie Chapterof the Society of Cosmetic Chemists

March 2014

COMING SOON...PAYPAL!

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reproductive harm. It is the responsibility of the business causing the exposure to determine whether the exposure poses no significant risk.

For a chemical that causes cancer, the No Significant Risk Level (NSRL) is defined as the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime. In other words, a person exposed to the chemical at the NSRL for 70 years would not have more than a one in 100,000 chance of developing cancer as a result of that exposure.

To assist businesses, the Office of Environmental Health Hazard Assessment (OEHHA) develops numerical guidance levels, known as “Safe Harbor numbers.” A business does not need to provide a warning for exposures below the “Safe Harbor” level and the discharge prohibition also does not apply if discharges are below the Safe Harbor level. OEHHA has established Safe Harbor numbers for over 300 of the 800 chemicals currently on the list and continues to develop Safe Harbor numbers for other listed chemicals.

Understanding PROP 65 list and its safe harbor numbers known as NSRL (No Significant Risk Levels) for carcino-gens and the MADL (Maximum Allowable Dose Levels) for reproductive toxins is crucial for personal care for-mulators and manufacturers, especially considering the

most recent personal care chemicals which were added to the PROP 65 list now including; coconut oil diethanol-amine condensate (cocamide dietha-nolamine), dietha-nolamine, titanium dioxide (airborne, unbound particles of respirable size), and benzophenone.

Bio: Cindy Graduated from Syracuse Uni-versity with a B.S. in Biology, B.S. in Secondary Science Education and a minor in Chemistry. She began her career with Miller Brewing Company as a Quality Control Analyst, followed by quality positions at GOJO Industries, Inc. Akron, Ohio before moving into Regulatory Affairs at GOJO Industries in 1997. Since 2002 she has been at The Lubrizol Corporation (Cleveland, Ohio) and currently holds the position of Global Product Stewardship Manager for Personalcare and Homecare and also has Product Stew-ardship oversight responsibilities for the rest of The Lubr-izol Corporation for the Americas.

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Not just re-organizing (see below), FDA is also looking to revamp its OTC regulatory systems. FDA acknowledges that the existing system, put in place in 1972, is extremely cumbersome, particularly in its inability to quickly add warning labels about emergency safety risks. Many common pain relievers, cough remedies and sunscreens are still technically under review since 1972.

You read it hear first. REGULATORY UPDATE reported last issue that polyethylene beads were becoming an issue for contaminating lakes and streams. Now, New York and Cali-fornia are considering legislation to ban microbeads less than 5 millimeters in size from all cosmetic products. Naturally, several suppliers have promptly begun or revitalized campaigns for suitable substitute ingredients.

FDA has unveiled major organizational changes to allow greater specialization and to deal with increasing complexity. Regulatory and compliance activities will be “be organized around distinct commodity-based and vertically-integrated regulatory programs.” The Office of Regulatory Affairs will now divide based programs and function with commodity specific offices, instead of geographical divisions. Implementation plans for all aspects of the changes are to be completed by Oct 1.FDA has extended its comment period (to April 7th) for its proposed guidance “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND”. This guidance will delineate exactly which products will require an IND. The proposal adds cosmetics for the first time. Any product which claims ‘beautifying’ will require an IND. According to the proposed guidance “a study of the effect of a cosmetic product containing human or animal biological material (such as placenta) on skin repair mechanisms would require an IND, even if the study is intended only to support a claim of younger looking skin”.

The State of Sao Paulo in Brazil has followed the lead of the EU, India and Israel and has banned area companies

Regulatory Update

(about 700) from the sale of cosmetics and cosmetic ingredients that have been tested on animals. The fines for first offenses are quite heavy and double for repeat offenders. Professional personnel involved will also face fines. Australia, South Korea and New Zealand are likely to follow suit. Cruelty Free International is now concentrating its efforts on the US.

The PCPC has responded to the new California database of cosmetic ingredients saying that the listings require more context if they are to be meaningful to the consumer. PCPC points out that the listing does not provide information about usage patterns which sharply diminish exposures or the use concentration at which ingredients have been deemed safe by several authoritative bodies, including such bodies of the State of California.

Those of us who develop makeup would do well to read the article about the color-changing abilities of cuttlefish at https://www.seas.har vard.edu/news/2014/01/chameleon-of-sea-reveals-its-secrets and consider the possibilities. The legalities would, of course, be another entire question.

P&G’s Direct Peptide Reactivity Assay has been approved by the European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) as the first non-animal alternative method for skin allergy testing. P&G says they are continuing to work on the assay in

order to make it more sophisticated

You can see the proposed changes to the Cosmetics Ingredient Hotlist, Health Canada at: http://hc-sc.gc.ca/ cps-spc/legislation/consultation/ 2013/hotlist_cosmetic_liste-critique/ consult-eng.php

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The International Conference on Harmonization (ICH) has announced that its long-awaited Photosafety Evaluation guideline will soon be implemented by global regulators.

ICH’s guidelines are binding on its three main member regulators: The US FDA, the EU’s European Medicines Agency and Japan’s Pharmaceutical and Medical Device Agency.

In mid-January FDA released a draft guidance on how it thinks companies should use and not use social media. FDA specifically referred to all “interactive promotional media,” including blogs, microblogs, social networking sites, online communities and live podcasts. Given the extensiveness of information required by FDA for fair balance, safety, “Black Box” requirements including Warnings, FDA questions whether social media has room or the time. Certainly 140 characters will not suffice. FDA said it “intends to exercise its enforcement discretion under certain circumstances due to the high volume of information that may be posted within short periods of time using interactive promotional media that allow for real-time communications.” Comments on the guidance are due in 90 days.

Aspiring cosmetic chemist Hayley Thomason, together with other researchers at University of Liverpool, has published an article in International Journal of Cosmetic Science: “Developing a quick and inexpensive in vitro (non-animal) bioassay for mascara irritation.” In addition to the new method not using rabbits, it was found to be cheaper and more reliable. The assay uses protozoa.

China FDA has removed the Compulsory Animal Testing for Non-special Use Cosmetics Produced in China after six weeks of public consultations. Cosmetics with skin-whitening and skin

Regulatory Update, cont.

CALL FOR PAPERS:Podium Presentations

ANNUAL SCIENTIFIC MEETING & TECHNOLOGY SHOWCASEDECEMBER 11-12, 2014NEW YORK HILTON HOTEL, NEW YORK CITY

Authors are invited to submit titles and abstracts of no more than 150 words for original papers to be presented in podium format. All topics related to cosmetic science will be considered for presentation. Topics of particular interest for submission of abstracts are:

• Color Cosmetics (Formulation and Performance for Skin)

• Fragrances in the Cosmetic Industry (Fine Fragrances, Regulations, Fragrancing Personal Care Products)

• Basics of Cosmetic Formulations (Emulsion & Surfactant Chemistry)

• Topical Delivery Systems (Liposomes, Encapsulations, Micro-emulsions, Devices)

• Current Regulations affecting the Cosmetic Industry (US Regulations, OTC Products, cGMPs)

• Online Formulating and Research Tools for the Cosmetic Chemist (Social Media, Computer Apps, Websites, Databases)

• Emerging Trends and Innovations in the Cosmetic Industry

SUBMISSION DEADLINE: MAY 2, 2014All abstracts must be submitted online at our website www.scconline.org.

After acceptance of abstracts by the Committee, all presenters will be required to submit preprints 12 weeks prior to presentation (minimum of 600 words, maximum of 2 pages, including figures). All presenters will be eligible for the Shaw Mudge Award sponsored by BASF Corporation, which is given for the Best Paper presented at the Society's Annual Meeting. The honorarium for this award is $2,500. Presenters are required to register for the Meeting.

pigmentation reduction claims will be classified as special use cosmetics (anti-freckle category) from 16th Dec 2013. Record-keeping requirements will be reduced while post-market supervision will be strengthened.

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by Kelly DobosA staggering number of microorganisms inhabit the human body, out numbering our cells by 10 to 1. With skin being the largest exposed organ, it is also one of the largest microbial habitats. However, we are just beginning to understand the microorganisms’ complex relationships with each other and our bodies in addition to the cosmetic and drug products we apply to our skin.cosmetic-microbiome

Discovering human microbiotaUntil recently, methods used to identify and study these microbes (our skin microbiota) relied on the ability to culture individual species in the laboratory. Culture methods depend on an understanding of the nutrients and environmental factors that promote the growth of specific microorganisms, but in reality the many different habitats of the skin are too diverse and dynamic to truly replicate in a Petri dish. Now, new sequence-based metagenomic techniques allow for the analysis of entire environmental niches and have demonstrated that previous culture techniques substantially under estimated the skin’s microbial population and diversity.

The Human Microbiome Project (HMP), launched in 2008, has already begun to dramatically change our understanding of the skin’s microbial ecology. The project aims to define the skin microbiome in addition to 4 other human microbiomes. A microbiome is defined as all the microbes and their interactions with each other and their host in a defined habitat. Future goals of the project are to identify the role of our microbiome in disease and in maintenance of our health.

Microbiome ResearchThis metagenomic research has already provided new insights into the skin microbiome in terms of its diversity and composition. Grice et al. sampled the inner elbow of 5 volunteers and found Pseudomonas and Janthinobacterium, two genera both commonly

The Human Skin Microbiome and Cosmetics Part I

found in soil, water and the gut which are not typically considered skin microbes based on culture assays.(1) It is possible that these organisms may have initially been acquired from transient environmental exposure and colonized because they were not eliminated from the habitat by physical or immune defenses.

Additionally the data indicated that Staphylococcus epidermidis and Propionibacterium acnes in total accounted for less than 5% of the microbiota recovered which is in contrast to the commonly held belief that S. epidermidis is a dominant member of the epidermal habitat from culture-based studies. But, it is important to keep in mind that this study was limited by small sample size and selection of only one microbial habitat. In a second study, published in May of 2009, Grice et al. probed 20 sites on ten healthy individuals to develop a larger body map of the skin microbiome. This study showed that Corynebacteria (62%) were, by far, the most frequently detected followed by Propionibacteria (23%) and Staphylococci (16.8%). (2)

Diversity in the MicrobiomeA 2009 publication by Costello, et al., found that body sites across individuals (n= 7 to 9) such as the palm and forearm exhibit high levels of microbial diversity by phylotype (a measure of evolutionary similarity) while other sights like the forehead showed lower levels of diversity.(3) The high level of diversity on the hands is

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not a surprise considering the frequency with which our hands touch various surfaces and the ability of various microorganisms to persist on inanimate surfaces for days or months.(4) The lipid rich environment of the forehead may favor adhesion of organisms like P. acnes, which hydrolyze triglycerides to free fatty acids that can inhibit other microorganisms.(5,6)

These studies suggest the diversity of the entire skin microbiome is more complex than previously expected. In fact, high diversity sites harbored as many or more phylotypes than the gut or oral cavity.(3) A high degree of inter-individual differences also exist in the composition of skin microbiota and these differences in microbial populations were shown to be distinct enough to distinguish individuals in forensic identification.(7)

More research aheadIt is clear that the skin microbiome is quite complex and there still is much to learn. These studies and further advances in metagenomic research will allow us to better understand the role of microbes in skin disease and

The Human Skin Microbiome and Cosmetics Part I, cont.

health, which could provide more holistic approaches to the development of topical products that consider the integral contributions of skin microbiome.

References1. Grice EA, Kong HH, Renaud G, et al. A diversity

profile of the human skin microbiota. Genome Res. Jul 2008;18(7):1043-1050.

2. Grice EA, Kong HH, Conlan S, et al. Topographical and temporal diversity of the human skin microbiome. Science. May 29 2009;324(5931):1190-1192.

3. Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. Dec 18 2009;326(5960):1694-1697.

4. Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infect Dis. 2006;6:130.

5. Gribbon EM, Cunliffe WJ, Holland KT. Interaction of Propionibacterium acnes with skin lipids in vitro. J Gen Microbiol. Aug 1993;139(8):1745-1751.

6. Thormar H, Hilmarsson H. The role of microbicidal lipids in host defense against pathogens and their potential as therapeutic agents. Chem Phys Lipids. Nov 2007;150(1):1-11.

7. Fierer N, Lauber C, Zhou N, McDonald D, Costello E, Knight R. Forensic identification using skin bacterial communities. Proceedings of the National Academy of Sciences. 2010;107(14):6477.

8. Holland KT, Bojar RA. Cosmetics: what is their influence on the skin microflora? Am J Clin Dermatol. 2002;3(7):445-449.

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Happy New Year everyone! I hope you all had a wonderful holiday season. At this point I’m sure we are all getting tired of the snow! Your board members have already been busy this year preparing for upcoming meetings, setting up the website, looking for ways to entice you to come to our 4 meetings of the year, and investigating our chapter holding a social event this year.

Check out our new site when you get a chance: www.lescc.com. It is still in development so not each page is complete yet. We hope to include all meeting information on this site, as well as contact info, local job opportunities, and upcoming SCC events.

The Lake Erie Chapter has also been fortunate enough to get a free course this year. We will be receiving information soon for which course and when it will be held. As we finalize the plans we will share with you so you can plan to be there.

I hope you all have a fantastic 2014 and we hope to see you at our meetings and events this year!

Diane Hillman

A Message From Your New Chair

LeadershipTeam:

TO ADVERTISE IN THIS PUBLICATION, CALL SCOTT MARKOV AT 216.225.6036

Chair: Diane HillmanGOJO IndustriesOne GOJO PlazaSuite 500Akron, OH 44311

Chair-Elect: Franklin WarrenGOJO IndustriesOne GOJO PlazaSuite 500Akron, OH 44311

Secretary: Steve SmithLubrizol9911 Brecksville RoadBrecksville, OH 44141

Treasurer: Amanda CopelandGOJO IndustriesOne GOJO PlazaSuite 500Akron, OH 44311

Newsletter: Scott MarkovLubrizol9911 Brecksville RoadBrecksville, OH 44141