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INTERNATIONAL CONFERENCE ON Harmonization OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Harmonized TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIA

It has been made publicly available at the Commission's ICH Website (). The Commission will monitor the implementation of the Guideline and take any necessary measures, if necessary and justified in the particular circumstances, following the publication of the next revision of the Directive or Directive 2002/57/EC as appropriate. The ICH Working Group established for this Directive has the responsibility for this Directive's conformity assessment. The Working Group has established a list of the substances and mixtures and their toxicological properties included in this Directive. The Working Group maintains ongoing contact with regulatory authorities and other interested parties. When new information becomes available, the Working Group updates and makes Public versions of the list, as it becomes available. INTRODUCTION This Guideline sets out the procedure for the assessment and safety evaluation of substances which are intended for human consumption and can be classified, represented or identified in their products (in particular cosmetics/cosmetics products). It also sets out the general provisions for hazard identification by means of hazard symbols. For products which are intended for the use of animals, the Commission has issued a separate Directive on “Hazard identification”, harmonizing the procedures for hazard identification in this product category, for both cosmetic and non-cosmetic products containing substances that are designated as animal by the Commission. DEFINITIONS Hazard symbols for substances which can be classified, represented or identified in their products are provided in Annexes I and II. These are intended to be understood in the same way as those used for safety indications used for substances that have been classified, represented or identified in the product. Hazard symbols are defined in Annex I. Hazard symbols refer to indications which refer to hazards as well as other issues about safety and quality of products as well as public health. In addition, the products to which the Hazard symbols apply are: cosmetics, cosmetics products or cosmetics substitutes or ingredients of other products; products intended for use by children under three years of age at the same time as the product containing the hazard symbol; products intended for use by infants at the time of birth, or intended for use by pregnant women. REFERENCES A.I.H. (2010). Guideline on hazard symbols.

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