EUDRAC is launching new regulatory activity in the field of Health and Beauty to help manufacturers, distributors and marketers of Cosmetics


Cosmetics can be classified differently depending on various factors, such as intended use, mode of action and – importantly – local regulatory requirements.

To manage the complexities of international classification EUDRAC offers a comprehensive range of services to ensure products comply with the latest safety regulations.

Development and Compliance Strategy

Cosmetics are regulated differently around the globe. While some countries require full dossiers for registration, others only call for a notification or even a simple declaration.

EUDRAC has ample experience in launching cosmetic products. We carry out both the early regulatory work and strategy-development, where we enable product /brand launch globally. We have a proven track-record in managing cosmetics in Europe, the USA, Asia, Middle East and Latin America.

Furthermore, EUDRAC can offer Responsible Person’s full services as per 1223/2009 regulation and amendments, and be partner of choice to commercialise cosmetics within the European Union.

Due to the continuously evolving nature of the regulatory environment, maintenance of state of the art dossiers is becoming more challenging. EUDRAC’s services include periodic or case by case dossier reviews .

Claim Substantiation and Package Labelling Review

Clinical studies are often required to support cosmetic product claims. They are critical when positioning cosmetic products and highly regulated.

By law, key findings from a product’s development programme must be published in the package labelling, to provide enough information for consumers to use the product safely. The requirements for the content of package labelling, the language of the labelling, and other specific requirements vary from region to region.

EUDRAC can drive adherence to regional and local regulatory compliance. By performing thorough product reviews and in depth analysis, products can be confidently and safely used by consumers.

18 March 2020