To paraphrase an adage, a Responsible Person is for life, not just for registration. The role of the Responsible Person has become absolutely crucial to almost every step of the cosmetic product manufacturing-to-distribution process. While it is true that to complete Cosmetic Product Notification Portal (CPNP) registration a Responsible Person (RP) is required, the role of the Responsible Person is far more diverse than that. In this blog, we will take a look at some of the duties the Responsible Person performs after the initial CPNP registration process and how they influence the importance of the role to the manufacturer.
Before outlining the importance of the Responsible Person after the CPNP registration process, perhaps it would first be a good idea to communicate some of the key duties performed by the RP at each stage. The duties of the Responsible Person include, but are not limited to:
- Notifying products in the CPNP (Cosmetic Product Notification Portal)
- Ensuring compliance with Cosmetic Regulation
- Compiling and providing product safety reports
- Ensuring Good Manufacturing Practices
- Preparing and updating the Product Information File
- Storing and readily providing information and documentation to demonstrate conformity as and when requested by Competent Authorities
- Notification of serious undesirable effects
- Handling product claims
With the wide array of duties of the Responsible Person in mind, there are many factors which influence the need for their ongoing presence in the process. Such factors include:
I. It is a legal obligation on the behalf of the manufacturer
It states in EU Regulation (EC) No. 1223/2009 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”. The importance becomes immediately evident here as from a manufacturer’s standpoint, without an RP their products simply cannot be sold on the European Market – with or without CPNP notification.
II. Ongoing cosmeto-vigilance
The RP is responsible for the notification of the product at the CPNP registration stage, but also for all other regulatory issues which may arise after. 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.
III. 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.
IV. Providing 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 regulation 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 today!