The European Union way to cosmetic regulation: A new burden or a new opportunity for the cosmetic industry?

3^rd International Conference on Pharmaceutical Regulatory Affairs

October 21-23, 2013 DoubleTree by Hilton Hotel San Francisco Airport, CA, USA

Giulio Pirotta

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

In Europe, a new cosmetic regulation entered into force July 11th amending and innovating the old system based on national laws. It is a fact that the EU regulation strongly influences some other geographic areas such as ASEAN countries, New Zealand and is a reference or close to (as Canada) for others. The key points to examine in the new regulation are: ? A new notification system based on the cosmetic products notification portal has been developed by the EU Commission in order to register all products before marketing ? An improved product information file that companies must have available for competent authorities ? A more detailed pre-market safety assessment for each product ? A new cosmeto-vigilance system that will make cosmetics more close to a pharma system ? A total ban on animal testing ? The new system of GMP based on a specific ISO defined for the cosmetic industry This presentation provides an overview of the European regulatory requirements for cosmetics products covered by the new regulation. It explains how products are defined and classified and provides an insight to some specific points such as the role and identification of the responsible person, the manufacturer and the importer. Some tricks will be described in order to allow a useful at a glance description of the specific European system giving some detail on Internet resources helpful to comply with the new rules.

Biography :

Giulio Pirotta holds a Ph.D. Chemistry and Technology of Pharmacy and is a pharmacy and cosmetic science specialist. Presently, is a professional consultant, technical manager and regulatory expert of cosmetic companies. He has cooperated with world cosmetic companies and Universities gaining experience in regulatory, safety assessment and controlled release systems. He launched a company for the production of cosmetic patches controlled release delivery systems and a new technology delivery from fabrics. He published duplicate lecture notes, articles in specialized and scientific journals, some specialized chapters in books and congress presentations. He is a board member and regulatory officer of the Italian Society of Cosmetics Chemists. He is the chairman of international conference of IFSCC2005.