Journal of the Society of Cosmetic Scientists of Korea (대한화장품학회지)

Society of Cosmetic Scientists of Korea (대한화장품학회)
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Safety evaluation of cosmetics in Europe

  • Rogiers, Vera (Department of Toxicology, Dermato-Cosmetology and Pharmacognosy Vrije University Faculty of Medicine and Pharmacy Brussel, Belgium)
  • Published : 2002.12.01
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Abstract

Council Directive 76/768/EEC forms the basis of the actual legislation of cosmetics in the European Union (EU). After a short introduction on the background and philosophy of this legislation, the key points will be discussed. In particular, attention will be given to the basic principles for safety and in this context the effects of the implementation of the 6th Amendment (Council Directive 93/35/EC) will be analysed. The major points for discussion will be: the safety requirements for cosmetics and the final responsibility for bringing these products on the EU market; the EU concept of safety of the finished product based on the safety of the individual ingredients; the existence of positive and negative lists of ingredients and the requirement for a European dossier for all finished products. Special attention will be given to the use of validated alternative methods and the consequences of the new proposal of a 7th Amendment. Finally, the safety evaluation as it is done by the SCCNFP (Scientific Committee on Cosmetics and Non-Food Products) in the case of an ingredient present on the positive lists and the evaluation done by a safety assessor in the case of a technical information file for a finished product, both will be discussed in detail.

Council Directive 76/768/EEC는 EU에서 화장품에 대한 기본적인 규정에 대한 기초가 된다. 이 규정의 배경과 원리에 대한 간단한 소개 후에 주요안건에 대해 강연할 것이다. 특히, 안전성에 대한 기본적인 원칙에 대해 주로 다루었으며, 6차 개정 이행(Council Directive 93/3S/EC)에 따른 영향에 대하여 분석 하였다. 토론의 주요 주제는 화장품의 안전성에 대한 요건과 EU시장에서 화장품 출시시 최종적인 책임, 개개의 성분의 안전성을 기초로 한 최종제품의 안전성에 대한 EU의 개념, 모든 최종제품에 대한 유럽에서 요구하는 서류와 개개의 성분들의 positive list와 negative list의 존재여부에 대하여 다루어지며 또한 주요관심인 7차 개정에 의해 새롭게 제안된 것과 동물대체시험법의 사용에 대해 강연할 것이다. 마지막으로, positive list에 존재하는 성분의 경우 SCCNFP에 의하여 이루어지는 안전성평가와 최종 제품에 대한 기술적인 측면에서 안전성평가자로서 이루어지는 평가에 대해 상세하게 다루어 질 것이다.

Keywords

References

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