It is a legal obligation imposed on the manufacturer, distributor, or importer.
- EU Regulation (EC) No. 1223/2009 states that “only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market”.
For a manufacturer, distributor, or importer of cosmetic products this means that without a Responsible Person your products cannot be sold on the European Market.
Ongoing cosmetovigilance
- The Responsible Person is not only responsible for the notification of the product at the CPNP registration stage, but also for all other regulatory issues which may arise after registration and placement in the EU market. Once the registration, compliance, and conformity has been completed, the Responsible Person must act as a point of contact in Europe for any and all compliance issues put to the manufacturer and answer all queries from Competent Authorities.
One of the practical consequence of cosmetics legislation is the requirement for continuous observation of cosmetic products after marketing. This applies particularly to “adverse effects” and “serious adverse effects”.
Safeguarding of the Product Information File (PIF)
- The Product Information File is a mandatory compilation of technical documentation required for each cosmetic product to be placed on the European Market. It contains all relevant information on safety assessments, formulas, animal testing data, labelling, undesirable effects, effects claimed, and much more.
While the PIF is required for the registration process it is also required to be constantly updated and made readily available to relevant Competent Authorities at the address specified on the product. The onus of which is on the Responsible Person.
Providing a registered address in the EU
- Also stated in regulation EC 1223/2009 (article 4.4) is a stipulation that any manufacturers (including native EU companies who export their products and import them back into the Community) operating outside the EU must appoint a Responsible Person with an address inside the European Union. This is an ongoing requirement and must be adhered to at every stage of production, from manufacturing to distribution.
To find out more about the role of the Responsible Person, or to enquire about our Responsible Person services, contact us now!