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Measuring the Quality of Cosmetics in
Relation to their Safety
November 6, 2008
Cosmetic Legislation
Cosmetics Directive 76/768/EEC
Illustrative list by category (Annex I)
Article 2:
A cosmetic product put on the market within the Community must not cause
damage to human health when applied under normal or reasonably
foreseeable conditions of use
Article 3:
Member States shall take all necessary measures to ensure that only cosmetic
products which conform to the provisions of the Directive and its Annexes may
be put on the market
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Chemical Quality
Guarantee of raw materials
Incompetent application (originate unwanted components,
Wrong formulation introducing components not allowed or
components exceeding required measures
Impurities
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Impurities
Many heavy metals are prohibited as ingredients in cosmetic products in Saudi
Arabia. But In case of of its presence as an impurity or contaminant, should not
exceed the following limits (in ppm unit):
for eyes products
Oral hygiene products
other cosmetic products
Lead
Nill
1
10
TAIEX Seminar EU Cosmetics Legislation Zagreb
Mercury
Nill*
0.2
3
Arsenic
Nill
0.5
3
Cadmium
Nill
0.1
3
Author | BSc. Durk J. Schakel
Antimony
2
0.5
5
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November 6, 2008
Microbiological Quality
Safety Potential: A preservative system is not always
responsible for the irritation and sensitization potential of a
product (resistance of m.o.)
Risk Potential: Not all products should be evaluated under the
same criteria or may not require the same level of preservation
Preservative Optimization:
Optimize preservative system
Linkage to product type
Linkage to pass/fail criteria
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Preservation
Sensitization
Over-preserve
Under-preserve
Fail challenge
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
The Safety Circle
Sensitization
Re-formulate
Re-formulate
Preservation
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Low Risk
Lipstick
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
High Risk
Flow Through Pens
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Low Risk
Powder products
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
High Risk
Wet / Dry Application
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
- MICROBIAL LIMITS IN COSMETIC PRODUCTS
Types of microorganisms
Products specifically intended for
under three year old children
and eye area
Other products
Total Aerobic Mesophilic
Microorganisms (Bacteria, yeast and
< 1x102 CFU per g or ml
(1)
< 1x103 CFU per g or ml
mold)
Escherichia coli
Absence in 1 g or 1 ml
Absence in 1 g or 1 ml
Pseudomonas aeruginosa
Absence in 1 g or 1 ml
Absence in 1 g or 1 ml
Staphyloccocus aureus
Absence in 1 g or 1 ml
Absence in 1 g or 1 ml
Candida albicans
Absence in 1 g or 1 ml
Absence in 1 g or 1 ml
(2)
Due to inherent variability of the plate count method (See USP 35-<61> interpretation of the results):
1): result considered out of limit if ≥ 200 CFU/g or ml
2): result considered out of limit if ≥ 2000 CFU/g or ml
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
preservation
Def.: prevention of product spoilage from the time of manufacture
until the end of use.
• Radiation
• Heat
• Chemical and Natural Preservatives
– Water activity reducers
– Antimicrobials
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Preservatives
Ingredients which prevent or retard microbial growth and thus protect
products from spoilage.
Use is required to prevent rancidity, appearance/odor changes to the
product caused by microorganisms
Protects activity/functionality of the product
Protects from inadvertent contamination by consumer during use or
production.
The functionality of many classes is determined by the pH, conditions
of manufacturing and order of addition. To prevent microbial
growth in a product
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Factors affecting preservation
Physical form
Packaging
Consumer
Row materials
Way to use
Storage conditions
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Ideal characteristics of preservative
Effective under condition of use
Combatable
Effective under wide range of pH
Optimum PC
Stable
Non irritant ,non toxic
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Factors affecting action of preservative
Concentration
Solubility relationship (PC)
pH
Surfactants
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Classes of antimicrobials
Organic acids (benzoic ,sorbic)
Alcohols (ethanol, benzyl alcohol)
Benzoic acid esters (parabenz)
Aldehydes (Formaldehyde)
Phenolic compounds (phenol, chlorocresol)
Mercury salts (phenyl mercuric salts)
Q a comp (Bezalconium chloride)
polyalcohols
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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November 6, 2008
Verification
First line control is the use of a standard reference material
Second line control is analysis of a blind sample presented
by the lab manager
Third line control is the participation in proficiency studies
Internal audit
External audit
TAIEX Seminar EU Cosmetics Legislation Zagreb
Author | BSc. Durk J. Schakel
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