The Cosmetics Regulation (EC) No. 1223/2009, applies to the European Economic Area (EEA) – the 28 EU Member States, plus Iceland, Liechtenstein and Norway. This regulation imposes significant obligations on companies wanting to place cosmetic products on the EEA market.
Cos Com International provide cosmetics manufacturing companies and cosmetic brands with complete scientific and regulatory support to ensure compliance with current legislation. As your partner of choice we make it simple and easy for you and your organisation to understand and comply with the legal requirements.
THE DUTIES OF THE RESPONSIBLE PERSON
- Notifying products in the CPNP (Cosmetic Product Notification Portal)
- Ensuring compliance with Cosmetic Regulations
- 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 of product claims
WHY YOU MUST HAVE A RESPONSIBLE PERSON
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!
