Measuring the Quality of Cosmetics in Relation to their Safety

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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