1. Measuring the Quality of Cosmetics in Relation to their Safety

2. Cosmetic Legislation Cosmetics Directive 76/768/EEC
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

3. Chemical Quality Guarantee of raw materials
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

4. 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):
Lead
Mercury
Arsenic
Cadmium
Antimony
for eyes products
Nill
Nill* 2
Oral hygiene products 1
0.2
0.5
0.1
other cosmetic products 10 3 5
TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

5. Microbiological Quality
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

6. Preservation Sensitization Over-preserve Under-preserve Fail challenge
November 6, 2008
Preservation
Sensitization
Over-preserve
Under-preserve
Fail challenge
TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

7. The Safety Circle Sensitization Re-formulate Re-formulate Preservation
November 6, 2008
The Safety Circle
Sensitization
Re-formulate
Re-formulate
Preservation
TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

8. Low Risk Lipstick November 6, 2008
TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

9. High Risk Flow Through Pens November 6, 2008
TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

10. Low Risk Powder products November 6, 2008
TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

11. High Risk Wet / Dry Application November 6, 2008
TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

12. - MICROBIAL LIMITS IN COSMETIC PRODUCTS
November 6, 2008
- MICROBIAL LIMITS IN COSMETIC PRODUCTS
TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

13. 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

14. 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

15. Factors affecting preservation
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

16. Ideal characteristics of preservative
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

17. Factors affecting action of preservative
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

18. Classes of antimicrobials
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

19. 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