This document provides guidance for interpreting and implementing the Council Directive 2011/84/EU of
20 September 2011 amending Directive 76/768/EEC, concerning cosmetic products, for the purpose of
adapting Annex III thereto to technical progress (hereinafter “the Directive”). It intends to support CED
Members and CED Observers when they contact the Ministries responsible for transposing the Directive
into national legislation and to advise individual dental practitioners. It is important to ensure that CED
Members and CED Observers are heard by the relevant competent authorities in the beginning of the
This document can also serve to support CED Members and CED Observers in providing complete
information about the regulation of tooth whitening and bleaching products to the dentists and the
general public in their countries.
The Directive has entered into force on 18 November 2011. Member States will have to apply the
Directive provisions from 31 October 2012.
Mandatory Language Requirements for Medical Devices
National Registry for EU-Guideline WEEE
Registration of Electrical & Electronic Equipment Waste
Registry Agencies in individual EU Member States