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Alternative Preservatives
Conclusions
slide 2
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.
slide 3
Without Preservatives
Risky Business
slide 4
With Preservatives
Preserved Formulations
slide 5
Cosmetic Preservatives History
Pre-1900: Sodium Benzoate, Phenol, Cresol
1920’s: Parabens, Formaldehyde
1940’s: Alcohols, Phenoxyethanol
1960’s: Staph Outbreak from Hospital Hand Lotions -
Changed Attitude towards Preservatives
1960’s: Formaldehyde Studies, Concerns
1970’s: Imidazolidinyl Urea, DMDMH, Bronopol
1970’s: FDA Surveyed Cosmetics, Found 24% Contaminated
1980’s: Diazolidinyl Urea, Isothiazolinones
1990’s: Blends Introduced, e.g. DMDMH/ IPBC
2000’s: Blends, Naturally-Derived
Today: Acute Perception Issues, Fragmented Market
slide 6
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
slide 7
“Conventional” Preservative Takeaways
All These Commonly Used Preservatives have Limitations
All Have Been Found to be Safe and Effective for Use as Directed
slide 8
Why “Alternative” Approaches?
Attempt to Meet Varied Real and Perceived Needs
However…..
slide 9
Is the Perfect “Alternative” Preservative
Possible?
Water Soluble
Cost-Effective
Widely Compatible
Globally Approved
slide 10
Why Is It So Difficult?
Regulatory Barriers
Few Ingredients Acceptable in All Regions
Formulation Barriers
No Single Technology Works in All Types of Products
“Alternatives” Effectiveness…
Are They Potent Enough?
Can They Replace “Conventional” Approaches?
slide 11
Preservatives Today: Where Are We?
What Drives Preservative Choice?
Formulation Type
slide 13
Today’s Preservative Trends
Regulatory Changes Driving Preservative Choices
Many Traditional Materials Being Challenged
Increase in Restrictions, Perception Issues
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
slide 15
Global Regulatory Overview (2)
Other Countries
Brazil, Australia, Korea, China
Many Driven by US or Europe
Gets Complicated……Seek Regulatory Assistance
slide 16
Conventional Preservatives Profiles
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
slide 18
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
slide 19
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
slide 20
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 <50°C
Primary Amines, Sulfites
pH range: 2 - 8
Up to 15 ppm Active R/O
slide 21
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 <50°C
Primary Amines, Sulfites
pH range: <6
Up to 0.5% as Free Acid
slide 22
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
slide 23
Other Conventional Preservatives
Bactericides
Benzalkonium Chloride
Benzethonium Chloride
Chlorophenesin
Methyldibromo Glutaronitrile
Sodium Hydroxymethylglycinate
Thimersal
Triclosan
Triclocarbon
Fungicides
Glutaral
Zinc Pyrithione
Zinc Oxide
slide 24
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
slide 25
Examples of Blended Preservative Systems
Pert Shampoo (P&G)
CMI + MI
Herbal Essences Shampoo (Clairol / P&G)
DMDMH + IPBC
Nivea Visage Cream (Beiersdorf)
Phenoxyethanol + Diazolidinyl Urea
Plenitude Facial Lotion (L’Oreal)
Imidazolidinyl Urea + Parabens
Head-to-Toe Baby Cleansing Cloths (J&J)
Phenoxyethanol + Parabens + Citric Acid
slide 26
Alternative Preservative Approaches
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:
It’s NOT on Europe’s Positive List
It’s NOT on Japan’s Positive List
It has an INCI Name Claiming Another Function
It Helps Create a More Hostile Formulation Environment
slide 28
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
slide 29
Alternative Ingredients with Antimicrobial Activity
Natural Ingredients
Many on the market
Used in Combinations or with Traditional Preservatives
slide 31
Natural Ingredients (2)
Grapefruit Seed Extract
Bactericide
Activity may be due to Other Ingredients introduced during
processing
Gluconolactone
Bactericide
Moisturizer
slide 32
Natural Ingredients (3)
Usnic Acid
Mostly Gram positive Bactericide
May impart blue color to products
slide 35
Ethylhexylglycerin
Similar to Other Glycerins
Activity against most Gram Positive Species
Lowers Water Activity
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
slide 37
Other Ingredients with Antimicrobial Activity
Lauricidian Surfactant
Effective Against Gram Positive Bacteria
Sometimes combined with Lactic Acid and EDTA
Biosurfactants
Activity against Pseudomonas
slide 38
Potentiators: Multifunctional EDTA
Chelating Functionality Improves Preservative Performance
slide 39
Other Preservative Alternative Approaches
Water Activity
Definition: A measure of water’s energy status in a system,
aw. “Bound” water is not available for microorganism growth.
slide 41
Water Activity Requirements
0.95 - 1.0 Gram Negatives
slide 42
Water Phase pH
Knowing the optimum pH for each of your preservatives is
important in using preservatives effectively
slide 43
Water Phase pH Impact on Preservatives
Methyl Paraben
Optimum pH 3.5 - 6.5
Organic Acids
Optimum pH <6.0
slide 44
Raw Material Specifications
Ensure that incoming raw materials are as clean as possible to
minimize bioburden
Recommended <100 cfu per gram
slide 45
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
slide 46
Product Package Design
Package design can play a big role in minimizing contamination
once in the hands of the consumer
Examples include:
One way valves
Pressurized components
slide 47
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
slide 48
Acknowledgements
slide 49