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EU 화장품법 & 가이드라인 개요

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등록일 2018-12-27

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출처
1. 기관명 : 유럽연합 위원회
2. 사이트 주소 : http://ec.europa.eu/growth
3. 메뉴별 주요 내용 소개
1) 단일시장 : 단일시장전략, 상품, 서비스, 디지털싱글시장,유럽표중, 무역에 장벽 등의 정보제공
2) 산업 : 산업 정책, 경쟁력, 혁신, 지속가능한 경제, 특허, 기업의 사회적 책임, 국제측면의 정보제공
3) 기업과 중소기업 : 비지니스프렌들리 환경, 기업가 정신, 시장접근 개선, 중소기업 지원등의 정보제공
4) 중소기업을 위한 금융: COSME 금융 상품, CIP재정 수단선택, 정책지역 등의 정보제공
5) 주체 : 항공산업, 자동차산업, 생명공학, 화학물질, 건설, 화장품 등의 뉴스 및 관련 자료제공
 
 
 
 
 
EU 화장품법 & 가이드라인 개요
 
 

Main legislation

Regulation (EC) N° 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products when placed on the EU market. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector. The Regulation simplifies procedures to the extent that the internal market of cosmetic products is now a reality.
The Regulation replaces Directive 76/768/EC, which was adopted in 1976 and had been substantially revised on numerous occasions. It provides a robust, internationally recognised regime, which reinforces product safety while taking into consideration the latest technological developments, including the possible use of nanomaterials. The previous rules on the ban of animal testing were not modified.
The most significant changes introduced by the Cosmetics Regulation include:
  • Strengthened safety requirements for cosmetic products 
    Manufacturers need to follow specific requirements in the preparation of a product safety report prior to placing a product on the market.
  • Introduction of the notion of “responsible person” 
    Only cosmetic products for which a legal or natural person is designated within the EU as a “responsible person” can be placed on the market. The new Cosmetics Regulation allows the precise identification of the responsible person is and clearly outlines their obligations.
  • Centralised notification of all cosmetic products placed on the EU market 
    Manufacturers will need to notify their products only once – via the EU Cosmetic Products Notification Portal (CPNP).
  • Introduction of reporting of serious undesirable effects (SUE)
    A responsible person will have an obligation to notify serious undesirable effects to national authorities. The authorities will also collect information coming from users, health professionals, and others. They will be obliged to share the information with other EU countries. More information on reporting of SUE.
  • New rules for the use of nanomaterials in cosmetic products 
    Colorants, preservatives and UV-filters, including those that are nanomaterials, must be explicitly authorised. Products containing other nanomaterials not otherwise restricted by the Cosmetics Regulation will be the object of a full safety assessment at EU level if the Commission has concerns. Nanomaterials must be labelled in the list of ingredients with the word “nano” in brackets following the name of the substance, e.g. “titanium dioxide (nano)”.
 

Guidelines and Claims

 
이전글 (미국) 화장품, 의약품 구분에 관한 개요
다음글 (미국) 화장품 법 & 가이드라인 개요
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