News Releases

No. 81/07
July 5, 2007

EU STRENGTHENS COOPERATION WITH US ON COSMETICS AND MEDICAL DEVICES

The European Commission and the US Food and Drug Administration agreed this week on confidentiality arrangements at a bilateral meeting in Brussels, enabling better health protection and easier trade between the European Union and the United States. The EC and the US Government will from now on be able to exchange confidential information about the safety of cosmetics and medical devices.

“At this year's EU-US Summit we agreed to put in place a new framework for transatlantic economic integration," said EC Vice President Günter Verheugen, European Chairman of the Transatlantic Economic Council and Commissioner for Enterprise and Industry policy. "I'm pleased to see that our ongoing cooperation with US regulators is delivering tangible results for our citizens and businesses. The EU and US will be able to exchange early information to protect public health, whilst taking away stumbling blocks for trade. In the field of cosmetics, today's agreement represents an important step towards our goal of accepting each other’s alternative methods to animal testing.”

Closer economic cooperation is the main aim of the new Transatlantic Economic Council (TEC), launched last week in Berlin. The TEC's work program covers cooperation initiatives to harmonize standards and improve trade in the areas of Regulatory Cooperation, Intellectual Property Rights, Secure Trade, Financial Markets, Innovation and Technology and Investment.

The new confidentiality arrangements will allow exchange of information between the parties as part of their regulatory mandates in the field of cosmetics and medical devices. The types of information covered include:

• Advance drafts of legislation and/or regulatory guidance documents.

• Post-marketing data and information that could have an impact on the public health, such as vigilance data or information about impending regulatory actions.

• Information on ongoing and emerging regulatory issues of health and safety in the US or the EU.

Background

The trade relationship between the US and the EU in the field of cosmetics and medical devices is strong: Around 7 percent of all cosmetic products in the US are imported from the EU, which amounts to a trade volume of almost 3 billion euros per year. US-exports of cosmetics to the EU amount to approx 1.5 billion euros. The bilateral trade volume in medical devices is balanced, with each trading partner exporting about 6.5 billion euros to the other on an annual basis.

For more information on regulatory cooperation with third countries in the field of cosmetics and medical devices, please visit: http://ec.europa.eu/enterprise/cosmetics/index_en.htm (for cosmetics) & http://ec.europa.eu/enterprise/medical_devices/index_en.htm (for medical devices).

Also, please see European Commission Vice President Verheugen's speech "A New Era for Transatlantic Economic Integration."

Further Contact Information
Press and Public Diplomacy
Delegation of the European Commission
2300 M Street, NW
Washington, DC 20037
http://www.eurunion.org/PressRoom
Tel: 202-862-9552
Fax: 202-429-1766