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Guideline on Safety assessment of cosmetic products

Contents

1. Introduction
1.1 Background
1.2 Legislation
1.3 Elaboration and submission of information
     
2. Product information/dossier requirements
2.1 Product composition
2.2 Physico-chemical and microbiological specifications
 2.2.1 In general
2.2.2 Physico-chemical specifications for raw materials
2.2.3 Criteria for physico-chemical purity of raw materials
2.2.4 Physico-chemical specifications for the finished product
2.2.5 Physico-chemical purity of the finished product
2.2.6 Microbiological control of the raw materials and the finished cosmetic product
2.3 Method of manufacture
2.3.1 In general
2.3.2 Sub-contractor manufacture
2.4 Safety assessment of the finished product
2.4.1 In general
2.4.2 The general toxicological profile
2.4.3 The chemical structure of the substance
2.4.4 Safety assessment
2.5 Educational requirements of the safety assessor(s)
2.6 Undesirable effects on human health
2.6.1 In general
2.6.2 Registration
2.7  Proof of claimed effects
2.7.1 In general
2.7.2 Principles of retrieval of data
        
References
Annex 1 Checklist for retrieval of information on cosmetics
Annex 2 Bibliography - Proposal for literature
Annex 3 Synopsis of efficacy testing of cosmetic products

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