It is required to designate an EU Responsible Person (RP) for each cosmetic product placed on the EU market. The RP is responsible to ensure that all the obligations related to product conformity have been carried out.
Regulation 1223/2009 came into force in July 2013 and establishes rules to be complied with by any cosmetic product made available on the EU market, in order to ensure the functioning of the European internal market and a high level of protection of human health.
Kinesis Medical can act as your RP to ensure a smooth EU market entry.
When do you need an EU Responsible Person?
The Regulation stipulates that only cosmetics with a designated RP may be placed on the EU market. That means that a Responsible Person is always necessary to market your cosmetics.
The general rule is that the manufacturer established in the EU is the RP for the cosmetic products it manufactures. The manufacturer may designate, by written mandate, a person established within the EU as the RP. When the manufacturer is established outside the EU, the manufacturer must designate a person established within the EU as the RP.
Who is the Responsible Person?
The Responsible Person may be a manufacturer, importer, distributor, or a third party. The situation determines who the RP is. The RP is:
- The manufacturer established in the EU;
- Each importer if the cosmetic product is manufactured outside the EU;
- Each importer if the cosmetic product is manufactured within the EU, and subsequently exported and imported back into the EU;
- The distributor if the cosmetic product is placed on the EU under his own name or trademark or modifies a product already on the market in such a way that is may affect the compliance with the Regulation;
- Any person established in the EU, by written mandate designated by the manufacturer or importer as RP who accepts this role in writing.
The designated RP can be any legal or natural person established in the EU who is able to comply with the regulatory requirements. So you can designate Kinesis Medical as your Responsible Person.
The obligations of the Responsible Person
The Responsible Person is in charge of ensuring compliance of the cosmetic product with Regulation 1223/2009. The Regulation stipulates that the RP:
- Guarantees the safety of the product;
- Guarantees that every cosmetic product placed on the EU market is linked to a Product Information File (PIF) and keeps a copy at its office;
- Verifies the compliance of the formula with the Regulation;
- Checks the compliance with the prohibition of animal testing;
- Ensures that the product is manufactured according GMP guidelines;
- Verifies that packaging and labels meet the requirements;
- Notifies each product at the Cosmetic Products Notification Portal;
- Monitors the safety of the product after placing it on the market: post-market surveillance or cosmetovigliance;
- Maintains contact and notifies any undesirable and serious health effects to the competent authorities in the EU.
The Notification Process
The Regulation stipulates that only cosmetics with a designated RP may be placed on the EU market. That means that an RP is always necessary to market your cosmetics. You can designate Kinesis Medical, by written mandate, as your RP. Subsequently, we will accept this mandate which engages us with the obligations mentioned above.
First we review the formulation. We check the ingredients (INCI) and concentrations. Some ingredients are prohibited to use in cosmetics, other ingredients may be restricted, such as a limitation on its concentration. If everything is alright, we prepare a Preliminary Report and then we can move on to the next step. If there are certain restricted or banned ingredients in the formulation, we make a suggestion to reformulate in order to determine a compliant ingredient list.
Maybe you already have a Product Information File (PIF). If not, we can assist you with compiling a PIF. The PIF is a key-element that is necessary to place your cosmetic product on the EU market. This file contains all information about the product, from manufacturing to labeling. Our team knows exactly how to compile a PIF. Our PIFs are therefore guaranteed to:
- meet all the requirements of the Regulation
- have been compiled by a professional team
- contain a scientifically based Safety Assessment
Certain elements should appear on a cosmetic product label and packaging. We review if all necessary information and symbols appear and verify possible claims in accordance with Regulation.
After compiling the PIF and when the label and packaging comply, we notify the product at the European Cosmetic Products Notification Portal (CPNP).
We submit certain information about the product in this online portal. The CPNP is not open to the public. Its access is restricted to the Competent Authorities (for the purposes of market surveillance, market analysis, evaluation and consumer information) and to the Poison Centres or similar bodies established by Member States (for the purposes of medical treatment) and is not available for consultation by the public.
After notification the cosmetic product can enter the EU market.