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Alternative Preservatives SCC Ontario Education Day R. Nunez/ Lonza Inc./ Sept. 2006.

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Presentation on theme: "Alternative Preservatives SCC Ontario Education Day R. Nunez/ Lonza Inc./ Sept. 2006."— Presentation transcript:

1 Alternative Preservatives SCC Ontario Education Day R. Nunez/ Lonza Inc./ Sept. 2006

2 slide 2 Outline n Why Preservatives? n Conventional n Alternatives n Preservatives Today: Where are we? n Preservative Trends n Global Regulatory Overview n Conventional Preservatives Profiles n Alternative Preservative Approaches n Ingredients with Antimicrobial Activity n Other Preservative Alternative Approaches n Conclusions

3 slide 3 Why Preservatives n By Definition, Used to Prevent Growth of Microorganisms in a Cosmetic product… n A substance intentionally added to a cosmetic product for the primary purpose of inhibiting the development of microorganisms. n Help Prevent Microorganism Growth During Manufacturing…But Not a Substitute for GMP n Primarily Designed to Prevent Microorganism Growth After Product Sale to Consumers n Therefore… Preservatives Must be Toxic to Microorganisms but Be Safe for Humans

4 slide 4 Without Preservatives n Risky Business n Product Spoilage, Recalls n Health, Infection Issues n Formulating Without a “Safety Net”

5 slide 5 With Preservatives n Preserved Formulations n Low Cost “Insurance” n Tradeoff between Preservation and Formulating Issues n Need Preservative Potency, Compatibility and Stability

6 slide 6 Cosmetic Preservatives History n Pre-1900:Sodium Benzoate, Phenol, Cresol n 1920’s:Parabens, Formaldehyde n 1940’s:Alcohols, Phenoxyethanol n 1960’s:Staph Outbreak from Hospital Hand Lotions - Changed Attitude towards Preservatives n 1960’s:Formaldehyde Studies, Concerns n 1970’s:Imidazolidinyl Urea, DMDMH, Bronopol n 1970’s:FDA Surveyed Cosmetics, Found 24% Contaminated n 1980’s:Diazolidinyl Urea, Isothiazolinones n 1990’s:Blends Introduced, e.g. DMDMH/ IPBC n 2000’s:Blends, Naturally-Derived n Today: Acute Perception Issues, Fragmented Market

7 slide 7 What Preservatives Do We Use Today? 20032001 Methylparaben71616893 Propylparaben58095621 Butylparaben23262174 Imadazolidinyl Urea20382025 Ethylparaben17251451 Phenoxyethanol16701480 DMDM Hydantoin993943 Diazolidinyl Urea725701 MCI/ MI699595 Quaternium-15516505 Triclosan451462

8 slide 8 “Conventional” Preservative Takeaways n All These Commonly Used Preservatives have Limitations n All are Classified as “Conventional” Preservatives and Are Approved by Regulatory Bodies Globally n All Have Been Used for Many Years…..Long Histories and Experiences n All Have Been Found to be Safe and Effective for Use as Directed n And Many are Under Some Sort of Pressure

9 slide 9 Why “Alternative” Approaches? n Attempt to Meet Varied Real and Perceived Needs n Address an Increasingly Fragmented and Confusing Cosmetics Preservatives Market n Address Customer and Retailer Perception Issues n Simplify Formulating – Less Raw Materials/ Testing Required n Allow Global Use of Simplified Systems n However…..

10 slide 10 Is the Perfect “Alternative” Preservative Possible? n Water Soluble n Colorless and Odorless n Cost-Effective n Widely Compatible n Globally Approved n Available for Use Today…..

11 slide 11 Why Is It So Difficult? n Regulatory Barriers n Few Ingredients Acceptable in All Regions n Formulation Barriers n No Single Technology Works in All Types of Products n New Preservative Molecules Unlikely n Due to Cost, Time and Data Requirements vs. Market Size n INCI-Listed, Multi-functional Approaches are Best Bets n “Alternatives” Effectiveness… n Are They Potent Enough? n Can They Replace “Conventional” Approaches?

12 Preservatives Today: Where Are We?

13 slide 13 What Drives Preservative Choice? n Formulation Type n Effectiveness in the Formulation n Use Cost in the Formulation n Preservative Safety / Perception / Acceptance n Compatibility / Stability with Other Ingredients n Global Regulatory Approvals

14 slide 14 Today’s Preservative Trends n Regulatory Changes Driving Preservative Choices n Many Traditional Materials Being Challenged n Increase in Restrictions, Perception Issues n Increase Preservative System “Safety” But… n Maintain Efficacy n Ensure Formulation Compatibility n More Preservative Studies, Publications, “Pressures” n Naturally-Derived and Blended Preservatives, Use of Potentiators n Confusing Array of “Alternative” Preservative Approaches

15 slide 15 Global Regulatory Overview (1) n NAFTA n Widest Range of Approved Preservatives n Parabens, Formaldehyde Donors, Isothiazolinones, Acids, Alcohols, etc. n Europe n Positive List, Difficult Approval Process,… Plus Green Groups n Close to NAFTA in General, But More Constraints n Most Preservative “Controversies” Start in Europe n Japan n Positive List, Longest and Most Difficult Approval Process n No Formaldehyde Donors, Other Constraints

16 slide 16 Global Regulatory Overview (2) n Other Countries n Brazil, Australia, Korea, China n Many Driven by US or Europe n Gets Complicated……Seek Regulatory Assistance

17 Conventional Preservatives Profiles

18 slide 18 Parabens Profile n Target Organisms: Fungi n Mode of Action: Nutrient Transport n Applications: Rinse-offs, Leave-ons n Wide Global Acceptance, Long Use History n Typically Blended (methyl, propyl, butyl, ethyl) / Combined with Bactericides n Recent Controversy – Study Results, Perception Issues n Formulating Tips n Low Water Solubility n Polysorbates/ PE n pH range: 3.5 – 6.5 n 0.1 – 0.8% as Active

19 slide 19 Formaldehyde Releasers Profile n Target Organisms: Bacteria n Mode of Action: Denatures Proteins n Applications: Rinse-offs, Most Leave-ons n Limited Approval in Japan n Imidazolidinyl Urea, Diazolidinyl Urea, DMDM Hydantoin, Quaternium-15 n Recent Controversy: Gas vs. Liquid Formaldehyde measurement n Formulating Tips n Highly Water Soluble n High Temperatures, Reducing Agents n pH range: 3 - 10 n 0.1 – 0.5% as Product

20 slide 20 Alcohols Profile n Target Organisms: Bacteria n Mode of Action: Denatures Proteins n Applications: Rinse-offs, Leave-ons n Wide Global Acceptance n Phenoxyethanol, Benzyl Alcohol, Ethyl Alcohol, Usually Combined with Fungicides n Formulating Tips n Highly Water Soluble n May Impact Viscosity n May Add Odor n pH range: 3 - 10 n 0.5 - 1% as Active

21 slide 21 Isothiazolinone Profile n Target Organisms: Bacteria and Fungi n Mode of Action: Disulfide Linkage With Cell Wall Proteins n Applications: Rinse-offs, Some Leave-ons n Wide Global Acceptance (BIT has Limited Approvals) n Chloromethlyisothiazolinone, methylisothiazolinone, benzisothiazolinone – CMI/ MI Most Common Blend n Formulating Tips n Sensitizations Issues n Add at <50°C n Primary Amines, Sulfites n pH range: 2 - 8 n Up to 15 ppm Active R/O

22 slide 22 Acids Profile n Target Organisms: Fungi n Mode of Action: Denatures Proteins n Applications: Rinse-offs, Leave-ons n Wide Global Acceptance n Sorbic, Benzoic, Salicylic, Dehydroacetic, Boric, Citric (and salts) n Typically used in combination with a bactericide n Formulating Tips n Low Water Solubility (acid forms) n Add at <50°C n Primary Amines, Sulfites n pH range: <6 n Up to 0.5% as Free Acid

23 slide 23 IPBC Profile n Target Organisms: Fungi n Mode of Action: Nucleophilic Reaction with Thiols, Amines in Cell n Applications: Rinse-offs, Leave-ons n Wide Global Acceptance n Available in Surfactant, Water or Solid Carriers – not sold as 100% n Typically used in combination with a bactericide n Recent Controversy: EU Dosage Levels and Applications n Formulating Tips n Low Water Solubility n Reducing Agents n pH range: Up to 9 n 0.05 – 0.1% as Active

24 slide 24 Other Conventional Preservatives n Bactericides n Benzalkonium Chloride n Benzethonium Chloride n Chlorophenesin n Methyldibromo Glutaronitrile n Sodium Hydroxymethylglycinate n Thimersal n Triclosan n Triclocarbon n Fungicides n Glutaral n Zinc Pyrithione n Zinc Oxide

25 slide 25 Top Global Choices n Goal: Broad Spectrum, Global As Possible Blends n Acids – Benzoic, Citric, Dehydroacetic, Salicylic, Sorbic n Alcohols – Phenoxyethanol, Benzyl, Ethyl n Formaldehyde Donors – Imidazolidinyl Urea, DMDMH, DI n Isothiazolinones – MI, CMI n Parabens – Methyl, Propyl, Butyl, Ethyl n Many Blends are Patented or Proprietary  Phenoxyethanol + IPBC  Formaldehyde Donors + IPBC  Phenoxyethanol + Parabens  Acids + Alcohols + Quats

26 slide 26 Examples of Blended Preservative Systems n Pert Shampoo (P&G) n CMI + MI n Herbal Essences Shampoo (Clairol / P&G) n DMDMH + IPBC n Nivea Visage Cream (Beiersdorf) n Phenoxyethanol + Diazolidinyl Urea n Plenitude Facial Lotion (L’Oreal) n Imidazolidinyl Urea + Parabens n Head-to-Toe Baby Cleansing Cloths (J&J) n Phenoxyethanol + Parabens + Citric Acid

27 Alternative Preservative Approaches

28 slide 28 Alternative Approaches n Alternative Ingredients n NaturalsGlycols n GlycerinsAntioxidants n SurfactantsPotentiators n Alternative Non-Ingredient Approaches n Water ActivitypH Adjustment n Raw Material SpecificationsPlant GMP n Package Design n A cosmetic Ingredient is NOT a Preservative if: n It’s NOT on Europe’s Positive List n It’s NOT on Japan’s Positive List n It has an INCI Name Claiming Another Function n It Helps Create a More Hostile Formulation Environment

29 slide 29 Create a Self-Preserving Environment n Use Ingredients and Essential Oils that have Antimicrobial Properties but are NOT classified as Preservatives n Create an Environment that is Unfavorable to Microbial Growth either through n substituting alternative chemistries n lowering water activity n changing pH n increasing alcohol, surfactant, other ingredient levels n Ensuring that the product is manufactured under GMP conditions n Use a Package that minimizes introduction of microbes into mass n Minimize incoming ingredient bioload

30 Alternative Ingredients with Antimicrobial Activity

31 slide 31 Natural Ingredients n Many on the market n Used in Combinations or with Traditional Preservatives n Addresses Growing Natural Trend, but Difficult to Execute n Typically Have Multi-Functionality and INCI Listed n Often have Odor, Color and Allergen Issues n Tend to be Organism-Specific, not Broad Spectrum

32 slide 32 Natural Ingredients (2) n Grapefruit Seed Extract n Bactericide n Activity may be due to Other Ingredients introduced during processing n Gluconolactone n Bactericide n Moisturizer n Tea Tree Oil n Bactericide n Humectant

33 slide 33 Natural Ingredients (3) n Usnic Acid n Mostly Gram positive Bactericide n May impart blue color to products n Neem Seed Oil n Bactericide n May impart color and odor to products n Other Oils and Extracts n Cinnamon, eucalyptus, lavender, lemon, rosemary, thyme, honeysuckle….. n Challenge Test, Ensure Compatibility

34 slide 34 Glycols n Possess Humectancy and Potentiation n Propylene, Butylene Glycol (6.0%) n Improves solubility and product stability n Reduces oil/water partitioning n Assists in preservation, lowers water activity n Hexylene, Pentylene Glycol (2.0%) n Preservation Efficacy n Caprylyl Glycol (1.0%) n Preservation Efficacy

35 slide 35 Caprylyl Glycol n Some Broad Spectrum Activity n Often used in Combination with Phenoxyethanol, Other Preservatives n Wide Global Approval n Compatible with Most Formulation Types n Some reports of Irritation when used in combination with other glycols

36 slide 36 Ethylhexylglycerin n Similar to Other Glycerins n Activity against most Gram Positive Species n Lowers Water Activity n Often used in Combination with Phenoxyethanol n Wide Global Approvals n Compatible with Most Formulation Types n Some reports of Irritation when used in combination with other ingredients n Good Humectant Properties

37 slide 37 Antioxidants n BHA, BHT, Propyl Gallate, t-Butyl Hydroquinone, Tocopherol n All Provide Varying Benefits, Mainly as Formulation Stabilizers n Sodium Sulfites n Technically are Preservatives n Strong Reducing Agents n Stabilizer for Other Ingredients n Sodium Erythorbate n Isomer of Vitamin C n Strong Reducing Agent n GRAS, wide use in food industry

38 slide 38 Other Ingredients with Antimicrobial Activity n Lauricidian Surfactant n Effective Against Gram Positive Bacteria n Sometimes combined with Lactic Acid and EDTA n Biosurfactants n Activity against Pseudomonas n Fragrances and Fragrance Mixtures n Enzymes, Phospholipids, Mono-Esters

39 slide 39 Potentiators: Multifunctional EDTA n Chelating Functionality Improves Preservative Performance n Has Activity against Pseudomonas n Helps Prevent Resistance to Antimicrobials n Helps Stabilize Color and Fragrance, Control Fading n Other Chelators/ Potentiators Include: HEDTA, DTPA, Etidronic Acid

40 Other Preservative Alternative Approaches

41 slide 41 Water Activity n Definition: A measure of water’s energy status in a system, a w. “Bound” water is not available for microorganism growth. n Microorganisms need “free” water within a product to survive and proliferate n Water activity and not water content is a better measure of the free water n Pure water has a w of 1.0, typical shampoo 0.96 n Goal: lower water activity = less preservative!

42 slide 42 Water Activity Requirements n 0.95 - 1.0Gram Negatives n 0.90 - 0.95Staphylococci n 0.87 - 0.90Common Yeast n 0.80 - 0.87Common Mold n 0.65 - 0.75Xerophilic Mold n 0.60 - 0.65Osmophilic Yeast n Therefore…lower a w, create a more hostile microbe environment

43 slide 43 Water Phase pH n Knowing the optimum pH for each of your preservatives is important in using preservatives effectively n Extreme pH’s can have an inhibitory affect on bacteria, yeast and mold n By using a combination of pH and Water Activity control, you are creating an environment which is hostile to microbial growth

44 slide 44 Water Phase pH Impact on Preservatives n Methyl Paraben n Optimum pH 3.5 - 6.5 n Generally poor activity >7.0 n Organic Acids n Optimum pH <6.0 n Generally poor activity >7.0 n Phenoxyethanol, Formaldehyde Releasers n Not affected by pH

45 slide 45 Raw Material Specifications n Ensure that incoming raw materials are as clean as possible to minimize bioburden n Recommended <100 cfu per gram n Ensure that the water system is checked frequently and is free of bacteria n Consider it a critical “raw material” with specifications n Beware of biofilm buildup in your holding tank, pipes and valves n Use hot water when possible

46 slide 46 Good Manufacturing Practice (GMP) n Ensure that the manufacturing tanks and filling lines are properly cleaned and sanitized n All transfer lines and storage tanks are properly cleaned and sanitized n That stored product is tested before filling and that partial drums are not returned to the warehouse

47 slide 47 Product Package Design n Package design can play a big role in minimizing contamination once in the hands of the consumer n It can act as a physical barrier to the external environment n Examples include: n One way valves n Pressurized components n Airless tubes, sealed tops n Unit dose packaging

48 slide 48 Conclusions n The Cosmetic Preservative Market Will Continue to Fragment n Regulations and Perception Will Continue to Drive Conventional Preservative Choices, Particularly as More Studies are Published n There is No Conventional or Alternative Preservative “Holy Grail”. The Market Will Mix and Match Preservatives to Meet Product Needs. n “Alternative Approaches” Should Focus on Creating as Hostile and Self-Preserving an Environment as Possible n There are Many Alternative Ingredients Available in the Market, as Reviewed. Most Have Unique, But Limited, Applicability. n There are Many Non-Ingredient Approaches Possible, Such as Water Activity Reduction, Which Can be Used Widely to Improve the Self-Preserving Environment

49 slide 49 Acknowledgements My Thanks to the Following Colleagues and Groups for Their Input and Support in Creating this Presentation n Lonza Teammates: Carl Cappabianca, Crystal Arlea n David Steinberg: Steinberg & Associates n Steve Schnittger: Estee Lauder n SCC Ontario Chapter n The CTFA Microbiology Committee

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