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Alternative Preservatives

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Title: Alternative Preservatives


1
Alternative Preservatives
  • SCC Ontario Education Day

R. Nunez/ Lonza Inc./ Sept. 2006
2
Outline
  • Why Preservatives?
  • Conventional
  • Alternatives
  • Preservatives Today Where are we?
  • Preservative Trends
  • Global Regulatory Overview
  • Conventional Preservatives Profiles
  • Alternative Preservative Approaches
  • Ingredients with Antimicrobial Activity
  • Other Preservative Alternative Approaches
  • Conclusions

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

4
Without Preservatives
  • Risky Business
  • Product Spoilage, Recalls
  • Health, Infection Issues
  • Formulating Without a Safety Net

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

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

7
What Preservatives Do We Use Today?
  • 2003 2001
  • Methylparaben 7161 6893
  • Propylparaben 5809 5621
  • Butylparaben 2326 2174
  • Imadazolidinyl Urea 2038 2025
  • Ethylparaben 1725 1451
  • Phenoxyethanol 1670 1480
  • DMDM Hydantoin 993 943
  • Diazolidinyl Urea 725 701
  • MCI/ MI 699 595
  • Quaternium-15 516 505
  • Triclosan 451 462

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

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

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

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

12
Preservatives Today Where Are We?
13
What Drives Preservative Choice?
  • Formulation Type
  • Effectiveness in the Formulation
  • Use Cost in the Formulation
  • Preservative Safety / Perception / Acceptance
  • Compatibility / Stability with Other Ingredients
  • Global Regulatory Approvals

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

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

16
Global Regulatory Overview (2)
  • Other Countries
  • Brazil, Australia, Korea, China
  • Many Driven by US or Europe
  • Gets ComplicatedSeek Regulatory Assistance

17
Conventional Preservatives Profiles
18
Parabens Profile
  • Target Organisms Fungi
  • Mode of Action Nutrient Transport
  • Applications Rinse-offs, Leave-ons
  • Wide Global Acceptance, Long Use History
  • Typically Blended (methyl, propyl, butyl, ethyl)
    / Combined with Bactericides
  • Recent Controversy Study Results, Perception
    Issues
  • Formulating Tips
  • Low Water Solubility
  • Polysorbates/ PE
  • pH range 3.5 6.5
  • 0.1 0.8 as Active

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

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

21
Isothiazolinone Profile
  • Target Organisms Bacteria and Fungi
  • Mode of Action Disulfide Linkage With Cell Wall
    Proteins
  • Applications Rinse-offs, Some Leave-ons
  • Wide Global Acceptance (BIT has Limited
    Approvals)
  • Chloromethlyisothiazolinone, methylisothiazolinone
    , benzisothiazolinone CMI/ MI Most Common Blend
  • Formulating Tips
  • Sensitizations Issues
  • Add at lt50C
  • Primary Amines, Sulfites
  • pH range 2 - 8
  • Up to 15 ppm Active R/O

22
Acids Profile
  • Target Organisms Fungi
  • Mode of Action Denatures Proteins
  • Applications Rinse-offs, Leave-ons
  • Wide Global Acceptance
  • Sorbic, Benzoic, Salicylic, Dehydroacetic, Boric,
    Citric (and salts)
  • Typically used in combination with a bactericide
  • Formulating Tips
  • Low Water Solubility (acid forms)
  • Add at lt50C
  • Primary Amines, Sulfites
  • pH range lt6
  • Up to 0.5 as Free Acid

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

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

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

26
Examples of Blended Preservative Systems
  • Pert Shampoo (PG)
  • CMI MI
  • Herbal Essences Shampoo (Clairol / PG)
  • DMDMH IPBC
  • Nivea Visage Cream (Beiersdorf)
  • Phenoxyethanol Diazolidinyl Urea
  • Plenitude Facial Lotion (LOreal)
  • Imidazolidinyl Urea Parabens
  • Head-to-Toe Baby Cleansing Cloths (JJ)
  • Phenoxyethanol Parabens Citric Acid

27
Alternative Preservative Approaches
28
Alternative Approaches
  • Alternative Ingredients
  • Naturals Glycols
  • Glycerins Antioxidants
  • Surfactants Potentiators
  • Alternative Non-Ingredient Approaches
  • Water Activity pH Adjustment
  • Raw Material Specifications Plant GMP
  • Package Design
  • A cosmetic Ingredient is NOT a Preservative if
  • Its NOT on Europes Positive List
  • Its NOT on Japans Positive List
  • It has an INCI Name Claiming Another Function
  • It Helps Create a More Hostile Formulation
    Environment

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

30
Alternative Ingredients with Antimicrobial
Activity
31
Natural Ingredients
  • Many on the market
  • Used in Combinations or with Traditional
    Preservatives
  • Addresses Growing Natural Trend, but Difficult to
    Execute
  • Typically Have Multi-Functionality and INCI
    Listed
  • Often have Odor, Color and Allergen Issues
  • Tend to be Organism-Specific, not Broad Spectrum

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

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

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

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

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

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

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

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

40
Other Preservative Alternative Approaches
41
Water Activity
  • Definition A measure of waters energy status
    in a system, aw. Bound water is not available
    for microorganism growth.
  • Microorganisms need free water within a product
    to survive and proliferate
  • Water activity and not water content is a better
    measure of the free water
  • Pure water has aw of 1.0, typical shampoo 0.96
  • Goal lower water activity less preservative!

42
Water Activity Requirements
  • 0.95 - 1.0 Gram Negatives
  • 0.90 - 0.95 Staphylococci
  • 0.87 - 0.90 Common Yeast
  • 0.80 - 0.87 Common Mold
  • 0.65 - 0.75 Xerophilic Mold
  • 0.60 - 0.65 Osmophilic Yeast
  • Thereforelower aw, create a more hostile microbe
    environment

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

44
Water Phase pH Impact on Preservatives
  • Methyl Paraben
  • Optimum pH 3.5 - 6.5
  • Generally poor activity gt7.0
  • Organic Acids
  • Optimum pH lt6.0
  • Generally poor activity gt7.0
  • Phenoxyethanol, Formaldehyde Releasers
  • Not affected by pH

45
Raw Material Specifications
  • Ensure that incoming raw materials are as clean
    as possible to minimize bioburden
  • Recommended lt100 cfu per gram
  • Ensure that the water system is checked
    frequently and is free of bacteria
  • Consider it a critical raw material with
    specifications
  • Beware of biofilm buildup in your holding tank,
    pipes and valves
  • Use hot water when possible

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

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

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

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