Background

The history of cosmetic regulation in the Europe Union started from July 1976, due to a series of cosmetics serious undesired effects events happened in the EU, the cosmetic directive (76/768/EEC) was issued to regulate the safety of cosmetics. During the 30 years after, from 1976 to 2009, the EU commission published 7 main amendments and over 60 adaptions to technical progress (ATPs) based on the Directive. Meanwhile, the 27 member states also localized the Directive and issued even more regulatory documents. To end this complexity, the EU commission recast the Directive to Regulation (1223/2009/EC), came into force on 11th Jan., 2010, fully implemented since 11th Jul., 2013.

Applicable Countries

European economic area (EEA), including 27 member states of the EU and Norway, Liechtenstein and Iceland.

Definition of Cosmetic Product

Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours*.

*The borderline products need to be analyzed case by case, e.g. washable, temporary tattoos, clothes releasing cosmetic substances, wipes, etc.

Responsible Person (RP)

The legal or natural person designated within the EU:

• Manufacturer

• Importer

• Distributor

• Third Party

Responsibility:

• Product Safety and compliance

• CPNP notification before place on the market

• The name & address of RP should be highlighted on the label

• Prepare PIF and cooperate with the inspection of competent authority

• Archive CPSR at least 10 years after the last batch of products placed on the market

• Update CPNP and PIF (including CPSR)

• Report post-marketing SUEs

Our Services

•  EU RP service as a third party (located in Dublin)

• Cosmetic Products Notification Portal (CPNP) Notification

• Cosmetic Product Safety Report (CPSR)

• Product Information File (PIF)

• Consulting Service

• Customized Training