NATURAL PRESERVATIVES:

Myth or Magic?

AdelineTew
Adeline Tew
THORSPECIALTIESSDNBHD,MALAYSIA

THOR worldwide
Australia • Benelux • Brazil • China • France • Germany • Italy • Japan •
Malaysia • Mexico • New Zealand • South Africa • Spain • Sweden • UK • USA
 Preservatives

‰ Chemical compounds added to products to prevent the

growth of microorganisms
‰ Compounds capable of killing microorganisms
‰ Interfere with cell walls, internal structures or processes
to cause cell death
‰ May be toxic to
mammalian cells
‰ Toxicity depends on
• active,
• concentration
concentration,
• point of contact
• duration of contact

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 Natural Preservatives
‰ Preservatives are regarded by some segments of the
public as toxic chemicals put into our food and personal
care products
d t by b uncaring
i manufacturers
f t indifferent
i diff t to
t
the fact that they are causing all types of horrible effects
on unsuspecting
p g consumers.

‰ Many consumers also believe that any “chemical”

included in cosmetics is unsafe. This has created a
market for “natural” ingredients and in particular “natural”
preservative system that can be used in personal care
products.
products

‰ These natural ingredients have the claimed advantage

that they are gentle,
gentle mild and above all,
all much safer than
synthetic ingredients, especially preservatives.
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 Natural Products

‰ Consumers associate
natural with well being,
safety and purity
‰ Are natural products safe?
‰ Are natural products pure?
• Fungi
• Mycotoxins
• Aldulteration
• Contamination
• Substitution
The EU Cosmetic Directive Annex II, List of Substances Which Must Not Form Part of
the Composition of Cosmetic Products, lists 32 botanical species that may not be
included in cosmetics
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 EU Cosmetic Directive - Annex 6

‰ “1. Preservatives are substances which may be added to

cosmetic pproducts for the p
primary
yppurpose
p of inhibiting
g the
development of micro-organisms in such products”

‰ “3
3. Other substances used in the formulation of cosmetic
products may also have anti-microbial properties and thus
help in the preservation of the products ,as, for instance,
many essential oils and some alcohols
alcohols. These substances
are not included in this Annex”

‰ The new EU regulations definition:

• “Preservatives mean substances which are exclusively or
mainly
y intended to inhibit the development
p of micro-
organisms in the cosmetic product”

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 Preservatives

‰ Preservative is defined in the cosmetic directive and regulation

‰ A number of substances used in cosmetics that are not listed
in Annex VI are now claimed to have preservative activity but
claimed to be preservative free
‰ A preservative is a substance added to inhibit the
development of microorganisms
‰ The only way a substance or preparation or botanical extract
added to a cosmetic to stop growth of microorganisms is not a
preservative is if it doesn
doesn’tt work
‰ The claim of preservative free is only correct if you accept that
only products listed as allowed preservatives in Annex VI
should be called preservatives
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 Annex VI - Preservatives

‰ The Scientific Committee on Consumer Safety

(SCCS) sets toxicity data requirements for listed
preservatives:

‰ Non-listed substances require less data

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 The ASEAN Harmonised Cosmetic
Regulatory Scheme

‰ The ASEAN Harmonized Cosmetic Regulatory

g y Scheme
was signed on September 2003.

‰ The ASEAN Cosmetic Directive was required

q to be
implemented by all member countries by January 2008.

‰ It is similar to the EU Cosmetics Directive and consists of

12 Articles.

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EU Cosmetic Directive - Preservatives

9
Preservatives

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 Natural Preservatives
‰ Is a “natural preservative” a preservative?
• If it is advertised as a preservative
• If it is used as a preservative
• If it works as a preservative
• Then it is a preservative
‰ As such it should be declared on packaging and approved
for use
‰ Annex VI is allowed preservatives, anything not listed
must not be used, it can’t be used as a “non preservative”
‰ Consumers deserve to be advised of the content
• Warning: this product contains a natural preservative of
unknown toxicity.
toxicity Use with caution and discontinue use if
any skin reactions occur.
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 Choices of Preservative
‰ Paraben esters - methyl, ethyl, propyl, butyl, isobutyl
‰ Phenoxyethanol
‰ Benzyl alcohol
‰ Isothizolinone types
yp
• Methylchloroisothiazolinone (MCI)/Methylisothiazolinone (MI)
• Methylisothiazolinone (MI)
‰ Polyaminopropyl biguanide
‰ Organic acids
‰ Chlorphenesin
‰ 3-Iodo-2-propynylbutyl carbamate (IPBC)
‰ Emollients - pentylene glycol, caprylyl glycol, decylene glycol
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Isothiazolinone Sensitisation Potential

Active Sensitisation Product Name Concentration In finished

threshold
h h ld (
(ppm)
) product
d
(ppm)(1) (ppm)
MCI 82 Microcare IT 11,000 11

MI 4000 Microcare MTB7 50,000 100

Microcare MTC 9 500

9,500 100

Microcare MTP8 20,000 100

Microcare MTD1 9,500

9 500 100

(1)Local Lymph Node Assay (LLNA) EC3 values – concentration of chemical required to
induce a stimulation index of 3 derived mathematically by linear interpolation

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 Summary of Activity (ppm)

nd: not determined

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 Mirocare® Products
• Microcare® IT – MI/MCI
• Microcare® PM5 – methyl, ethyl, propyl, butyl, isobutyl parabens
iin phenoxyethanol
h th l
• Microcare® DB – benzyl alcohol and dehydroacetic acid
• Emollients:
‰ Microcare® PTG – pentylene glycol
‰ Microcare® PHG – phenoxyethanol + caprylyl glcycol
‰ Microcare® DCG – decylene glycol

Microcare® MT-family
• Microcare® MTB7 – MI + polyaminopropyl
Mi l i l bi
biguanide
id
• Microcare® MTC – MI + chlorphenesin
• Microcare® MTP8 – MI + methyl & propyl parabens
• Microcare® MTD1 – MI + decylene gycol
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 Dosage Recommendations

‰ The above serves as an guide and need to be further confirmed

via Preservative Efficacy Testing
‰ Dosages may vary from one formulation to the other

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 Irritancy Testing by Thor IVT

‰ Water in oil emulsion containing various preservatives

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 Preservative Selection
‰ It is critical that the preservative selected for a product is
matched to the physical and chemical requirements of the
product and will provide protection against the full spectrum of
microorganisms likely to be encountered.
‰ The p preservative must be used correctly y
• Addition point
• Concentration
‰ The toxicity, or the perceived toxicity of the active must also be
compatible with the intended use and market.
‰ Use onlyy approved
pp p
preservatives
‰ Basing the selection of preservative actives on these criteria and
ensuring good manufacturing practices should enable
production of personal care products with no fear of
contamination or adverse effects
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 Microbiology Analytical testing
• Sterility check
• Stability
St bilit check
h k
• TVC
• Ingredient determination
• Challenge Test
• New methods
• MIC
• New Methods

Hygiene Regulatory
Affairs
• Hygiene audits of
Cosmetic production • REACH / BPD
facilities • Ecolabel
• Hygiene training for
Technical Support • Ingredient support
operators

Risk Assessment
Training Formulation • Skin Irritation (Vitroderm)
• Process validation • Cytotoxicity (3T3 NRU)
- In house seminar • Incorporation • Inflammatory markers
- Microbiology
gy • Stability • Phototoxicity
- Formulation • Performance • New ocular / epithelium models
- Regulatory Affairs • Compatibility
- Analytic
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THANK YOU FOR YOUR ATTENTION

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at booth no: E10