All cosmetic products on sale in the EU must have a safety assessment or certificate provided by a qualified safety assessor. The rules governing the safety of cosmetics in the EU are currently the EU Cosmetics Directive 76/768/EEC.

The regulations define a so-called "responsible person", who must have an address in the EU and is responsible for holding all the documentation on the product, including the safety assessment in a PIF (Product Information File). They are either the company that manufactures the cosmetic, has it manufactured, or they are the local office or agent for a manufacturer based outside the EU. If there is no local agent for a non-EU manufacturer, then the first company importing the product into the EU is the "responsible person".
Responsible person

a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, 
or a course recognised as equivalent by a Member State.

from July 2013 there will be significant changes when the new EC Regulation 1223/2009 comes into force.

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