Measuring the Quality of Cosmetics in Relation to their Safety

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 2

Cosmetic Legislation

Cosmetics Directive 76/768/EECIllustrative 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

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 3

Chemical Quality

Guarantee of raw materials Incompetent application (originate unwanted components, Wrong formulation introducing components not allowed or components exceeding required measures Impurities

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 Antimonyfor eyes products Nill Nill* Nill Nill 2

Oral hygiene products 1 0.2 0.5 0.1 0.5other cosmetic products 10 3 3 3 5

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 4

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 5

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 preservationPreservative Optimization:

Optimize preservative system

Linkage to product type

Linkage to pass/fail criteria

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 6

Preservation

Under-preserve

Over-preserve

Sensitization

Fail challenge

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 7

The Safety Circle

Preservation

Sensitization

Re-formulateRe-formulate

November 6, 2008

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

- MICROBIAL LIMITS IN COSMETIC PRODUCTS

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 12

Types of microorganismsProducts specifically intended for

under three year old childrenand eye area

Other products

Total Aerobic Mesophilic

Microorganisms (Bacteria, yeast and

mold)

< 1x102 CFU per g or ml (1) < 1x103 CFU per g or ml (2)

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

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 ml2): result considered out of limit if ≥ 2000 CFU/g or ml

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 13

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

PreservativesIngredients 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 microorganismsProtects activity/functionality of the productProtects 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

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 14

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 15

Factors affecting preservation

Physical formPackagingConsumerRow materialsWay to use Storage conditions

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 16

Ideal characteristics of preservative

Effective under condition of useCombatableEffective under wide range of pHOptimum PCStableNon irritant ,non toxic

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 17

Factors affecting action of preservative

ConcentrationSolubility relationship (PC)pHSurfactants

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 18

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

November 6, 2008

TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel 19

Verification

Second line control is analysis of a blind sample presented by the lab managerThird line control is the participation in proficiency studiesInternal auditExternal audit

First line control is the use of a standard reference material