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The cosmetic regulation, established by the Cosmetic Regulation n°1223/2009 requires the designation of a Responsible Person for each new product placed on the European cosmetic market.
The Responsible Person, as its name indicates, has a role of guarantor and ensures the cosmetic compliance of the product. This key role is essential for the safety and health of consumers.
Reguloo explains the role of the Responsible Person.
What is a Responsible Person?
The Responsible Person has several key responsibilities regarding the market entry of a new product.
In addition to monitoring to ensure product compliance, it will be the responsibility of the Responsible Person to maintain the cosmetic Product Information File after the product is placed on the market.
The role for the brand
According to the European Regulation (EC) n°1223/2009, "only cosmetic products for which a natural or legal person is designated in the Community as a "responsible person" are placed on the market".
The designation of a Responsible Person is one of the obligations a company must fulfill to position itself in the cosmetic market.
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fabricantThe role of the Responsible Person can be performed by an internal or external person of the company launching the product.
A specific diploma is not necessary for the responsible person. However, his or her level of competence must enable him or her to assess the risks and safety of the product placed on the market.
The Responsible Person can be :
The fabricant
The manufacturer is any natural or legal person who manufactures or has manufactured a cosmetic product and markets it under his name or trademark.
Generally, the manufacturer established in the European Community is the Person Responsible for his products provided that they are not exported outside the EU and then re-imported into the EU.
If the manufacturer does not wish to become the Responsible Person for his cosmetic product, he may designate in writing another person registered in the European Community.
The importer
If a cosmetic product is imported into the EU, the importer becomes its Responsible Person.
Like the manufacturer, the importer may designate another Responsible Person in writing.
The distributor
If the cosmetic product is marketed under his name or brand, the distributor is Person Responsible for the product placed on the market. Likewise, if the distributor modifies the product, which may cause non-compliance with Regulation 1223/2009.
In the case of the use of a third party natural or legal person, the regulation n°1223/2009 imposes the formality of a written agreement. The manufacturer or the importer (who can designate a third party RP) must mandate the new RP in writing and the latter must accept the role in writing. This mandated person accepts to take over all responsibilities of a PR. |
2. The missions of the Responsible Person
The Cosmetic Lead Person is responsible for the following:
Product safety
Guarantees the conformity of the product and ensures that they are safe for human health.
The Product Information File (PIF)
A PIF must be made for each cosmetic product.
Learn how to make a complete PID
The PID must be kept permanently available to the competent authorities by the responsible person, electronically or not. It must be kept for 10 years after the product is placed on the market.
Compliance with manufacturing processes
The Cosmetic Regulation mentions Good Manufacturing Practices (GMP).
Included in the ISO 22716 standard, these GMP are obligations concerning the production, control, storage, and shipment of cosmetic products.
Compliance with the cosmetic formula
As guarantor of the cosmetic product, the responsible person ensures that the cosmetic formula does not contain any ingredient prohibited or restricted by the Regulation (EC° 1223/2009).
The composition of the product must comply with the cosmetic regulations in force.
The ban on animal testing
Ensures that no animal testing has been carried out
The European cosmetic regulation prohibits testing on animals at all stages of product development.
The responsible person must guarantee the respect of this ban.
Compliance with the packaging and labeling
Cosmetic packaging and labeling are mandatory and controlled elements.
The label must contain a certain number of compulsory mentions to be in conformity with the cosmetic regulation:
Name and address of the Responsible Person
Country of origin (if the product has been imported)
Date of durability
Precaution of use
List of ingredients
The function of the product
Lot number
Notification to the CPNP
The marketing of a cosmetic product implies a notification to the CPNP. The role of the responsible person is to transmit to the European Commission the product information useful for marketing.
The European Commission can thus evaluate the product and judge its conformity before its entry into the market.
Communication to the competent authorities
Inform the competent authorities if the product presents a risk to human health.
In addition to keeping the DIP at the disposal of the Member States, the Responsible Person has an obligation to notify these competent authorities immediately after the observation of serious side effects and to communicate the measures taken.
Your Responsible Person: Reguloo
A Responsible Person can be a natural or legal person. Counting as a legal entity, a cosmetic expert can be legally designated as a third-party RP by the manufacturer or importer.
As a specialist in cosmetic regulation, Reguloo has already taken on the role of Responsible Person for brands and accompanied the product to the market.
By providing specific expertise, Reguloo ensures the safe entry of your cosmetic product on the market and the maintenance of the obligations of Regulation (EC) No 1223/2009.
As an expert, Reguloo can :
Evaluate the composition of your product and assess the risks
Produce and provide to the competent authorities any mandatory document for the declaration of your product
Monitor your product after its entry into the market for an efficient cosmetovigilance.