Relevance and Tasks of a Responsible Person for Placing Cosmetic Products in the EU Market
Manufacturers must have a Responsible Person to help sell Cosmetic Products in the EU market. QSE Academy has prepared all the crucial information about why your company needs a Responsible Person.
Here you will learn the tasks of a Responsible Person. In this way, you’ll see how this aspect is crucial for your product’s success on the market.
Who is a Responsible Person: Importance of a Responsible Person
A Responsible Person is a natural or legal person, who has to be established within the EU.
Being a Responsible Person is a demanding task, which needs expertise in various areas. Thus, a Professional Cosmetics Responsible Person must be an expert in cosmetics regulation.
Note that each cosmetic product must be connected to a responsible person established within the Community.
In other words, there has to be only one Responsible Person designated per cosmetic product in the whole EU.
Who Can Act as a Responsible Person?
A designated person or company can serve as the Responsible person. However, that person or company must accept the role in writing.
As long as the Responsible Person is based in the EU, you can base the Responsible Person on one of the following:
- Product manufacturer
For products manufactured within the EU, by an EU based manufacturer and not subsequently exported and imported back into the EU, the manufacturer shall be the Responsible Person.
However, the manufacturer can designate a person established in the EU as a Responsible Person.
For products manufactured within the EU by a non-EU based manufacturer, and not subsequently exported and imported back into the EU, the manufacturer shall designate a person established in the EU as a Responsible Person.
- Product importer
For products manufactured outside the EU and imported into the EU, the importer shall be the Responsible Person. However, the importer can designate a person established in the EU as a responsible person.
The distributor becomes the Responsible Person if:
- A distributor placed a cosmetic product on the market under his name or trademark.
- A distributor modified a product already placed on the market in a way that impacts compliance with the applicable requirements.
Note that the translation of the information relating to the product shall not be considered as such a modification.
Responsibilities of the Responsible Person
According to Regulation 1223/ 2009 Article 4.2, “For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation”.
Therefore, the Responsible Person must guarantee compliance with:
|8||Good Manufacturing Practice|
|11||Product Information File|
|12||Sampling and Analysis|
|14||Retraction for Substances Listed in the Annexes|
|15||Substances classified as CMR Substances|
|17||Traces of Prohibited Substances|
|19 (1), (2), and (5)||Labeling|
|21||Access to Information for the Public|
|23||Communication of Serious Undesirable Effects|
|24||Information on Substances|
Important Functions of the Responsible Person
- Ensure that the product is safe and compliant with the regulation. Includes assuring the:
- Execution of the safety assessment
- Labeling compliance
- Substantiated product claims
- Inform the competent authorities if a cosmetic product poses a risk to human health.
- If necessary, take appropriate measures or actions to bring the product into conformity. This may include product recall or withdrawal from the market.
- Cooperate with the EU competent authorities at their request.
- In the event of serious undesirable effects, inform the competent authority of the Member State where the serious undesirable effect happened.
- Keep the Product Information File (PIF) for products placed in the EU market.
- Make the PIF accessible to the competent authority of the Member State in which the file is kept at his address indicated on the label.
- Update the PIF at all times.
- Conduct the notification to the Cosmetic Product Notification Portal (CPNP) before placing the cosmetic product in the EU market.
- Notify the cosmetic products containing nanomaterials to the Commission six months before placement in the EU market.
Why Hire a Professional Responsible Person?
A Professional Responsible Person is an expert in cosmetics regulation, as well in other relevant legislation.
In effect, the RP can monitor the EU legislation to ensure clients are aware of the updates.
Therefore, clients can keep their products compliant with EU legislation. Consequently, manufacturers or importers can dedicate their time or competencies to selling their products.
Since the RP is familiar with the notification process, compiling the PIF becomes accurate and fast. As a result, it becomes easier to put your cosmetic products in the EU market.
In addition, a Responsible Person serves as a neutral party. Hence, there’s no need to worry about conflict of interest with your commercial interests.
Aside from keeping product secrets within the PIF confidential, the RP preserves the PIF for a decade after the last batch of the product has been placed in the EU market.
More than that, the RP can guarantee that cosmetic products are compliant with the regulation. By doing so, clients won’t get into trouble or do product recalls.
Furthermore, the Responsible Person can serve as the single contact point for any regulatory issue in the EU.
Likewise, the RP can represent clients or companies in front of the EU competent authorities. The RP can also handle any questions from them or any crisis.
In the case of changing importers, the Responsible Person remains the same. This removes the need to reprint product labels and re-notifying products.
Are You Ready to Delegate a Responsible Person?
In a nutshell, you must get a Responsible Person that can guarantee compliance with the cosmetic products with the EU Cosmetics Regulation 1223/2009.
Once you are able to delegate a Responsible Person, you’ll be able to place your cosmetic products in the EU market.