Since July 11th 2013, Regulation (EC) 1223/2009 on cosmetic products has been the main regulatory framework governing finished cosmetic products on the EU market. The Regulation replaced Directive 76/768/EC, which was adopted in 1976.
In this article we explain 5 steps how to bring your cosmetic products into compliance with EU laws and regulations and complete the Cosmetic Products Notification Portal notification process – the final line for cosmetics’ entry in the EU market.
1. Designation of an EU Responsible Person (EU RP):
“Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market”
Article 4.1 – Responsible Person
In daily practice, the EU Responsible Person is engaged in:
- Ensuring compliance with the requirements of the Cosmetics Regulation such as: safety (art.3), GMP (art.8), PIF (art.11), notification (art.13), composition (art.14, 15, 16, 17 &18), labelling (art.19), claims (art.20), and communication of serious undesirable effects…).
- Immediate corrective measures, withdrawal/recall if appropriate in case of non-conformities
- Immediate notification to the Competent Authorities (CA) and other economic operators in case of risk to protection of human health.
- Providing information and documentation to demonstrate conformity as per requests by the competent, authorities.
- Keeping the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.
Article 5 – Obligations of responsible Person.
NOTIFICATION PROCESS:
2. Formulation review
Review of the ingredients listed in the composition of the product, namely :
- banned and restricted substances listed in the Annexes of the Regulation,
- substances classified as CMR substances,
- with traces of prohibited substances;
in order to define/establish the compliant INCI list of ingredients.
3. Compilation of Product Information File (PIF)
- Part A – Safety information: compilation of all documentation related to safety, GMP, composition, labeling and packaging, claims, tests, notification, etc.
- Part B – Safety Assessment: “[…]the responsible person shall, prior to placing product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.”
Article 10 – Safety Assessment
4. Label review
Review of the cosmetics’ labeling and packaging in accordance with Article 19 of the Regulation 1223/2009, as well as respect of language requirements and verification of claims in accordance with Commission Regulation 655/2013.
Further details on claims and language requirements are available in the following articles:
5. Notification on the Cosmetic Products Notification Portal (CPNP)
Prior to placing the cosmetic product on the EU market, the European Responsible Person shall notify by electronic means to the Cosmetic Products Notification Portal the cosmetic product that will circulate within the Community.
COSMETIC PRODUCT CAN NOW ENTER THE EU MARKET!
DUTY OF EU RP AFTER COMPLETION OF NOTIFICATION:
Post-market surveillance (Cosmetovigilance)
The last but continuous duty of the EU Responsible Person, once the product is notified to the CPNP, is to report without delay to the Competent Authorities
of any serious undesirable effects that occurred to the end-users.
Please see the links to the video clips which briefly present the compliance process & necessary requirements to place a cosmetic product in the EU market:
- About Obelis Group
- Defining an EU Responsible Person
- Product Information File
- Safety Assessment
- EU Labelling Rules
- Notification process
Laura Mayombo
Expert Consultant, Sales Department
September 30, 2019
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