Description
In the Regulation CE 1223/2009 cosmetic products may only be placed on the EU market when the legal designated person as the Responsible Person is located in the European Community.
Therefore is mandatory to appoint a Responsible Person in the EU in order to be able to trade in the European market.
What are the responsibilities of the Responsible Person for a cosmetic product?
The Responsible person for the cosmetic product to be marketed in the EU, must ensure compliance with the la UE CE 1223/2009 regulation , before and after placing the cosmetics on the EU market.
The Responsible Person is not simply a legal address within the European Union. They have specific obligations before, during and after the cosmetic product is placed on the market.
- An EU registered address in the EU at which the Product Information File (PIF) .
- The product claims justification , but also cosmetic product sampling & analysis.
- Correct labelling of cosmetics.
- Be sure that PIF complies with all the requirements set out in the Regulation, that it has been produced according to Good Manufacturing Practice (GMP) standards, etc..
- The CPNP notification
- The reporting of undesirable and serious effects to the competent authorities.
- Reporting of classified susbtances as CMR substances.
Who can be a Responsable Person?
When the manufacturer is established outside the European Union, a Responsible Person established in the EU must be designated to assume the corresponding obligations for products placed on the European market. Alpiguisa Innovación can act as the Responsible Person for international manufacturers and brands wishing to introduce their cosmetic products into the European Union.
Who needs a Responsible Person in the EU?
Manufacturers outside the EU
They must designate a Responsible Person established in the EU when their products are placed on the European market under the conditions provided for by the Regulation.
Importers
The Regulation establishes that, for imported cosmetic products, the importer is the Responsible Person for the specific product they place on the market, although they may designate, by written mandate, a person established in the EU.
Manufacturers established in the EU
The manufacturer established in the EU may act as the Responsible Person itself, although it may designate, by written mandate, another person established in the EU.
Do you manufacture cosmetics outside the European Union?
If you manufacture cosmetics outside the European Union and wish to market them in Spain or any other Member State, you must comply with the requirements established by Regulation (EC) No 1223/2009 and, where applicable, have a Responsible Person established in the EU.
At Alpiguisa Innovación, we act as the Responsible Person for international manufacturers, laboratories and brands, helping them comply with their regulatory obligations and prepare their products for marketing on the European market.
Our company, in addition to being your Responsible Person and carrying out the functions described above, can also take care of the follow-up production of your cosmetics with your formula.
Alpiguisa Innovacion is also a cosmetics production centre, located in Spain.
Which cosmetic products need a Responsible Person?
Every cosmetic product placed on the market in the European Union must have a Responsible Person established in the EU, in accordance with Regulation (EC) No 1223/2009. The Responsible Person assumes the obligations established by European legislation to ensure that the product complies with the applicable requirements before and during its marketing.
The need to appoint an external Responsible Person will depend on who manufactures, imports or markets the product and where the company is established.
Manufacturers established outside the European Union
If the manufacturer of a cosmetic product is established outside the European Union and wishes to market its products on the European market, it must designate a Responsible Person established in the EU by means of a written mandate.
This is a common scenario for manufacturers, laboratories and brands from countries such as Colombia, Mexico, the United States, Chile, Peru, Argentina or any other country outside the European Union wishing to introduce their cosmetics to the European market.
Manufacturers established in the European Union
When the manufacturer is established within the European Union, it may act as the Responsible Person for its own products. It may also designate, by written mandate, another natural or legal person established in the EU to assume this role.
Imported cosmetic products
When a cosmetic product is imported from a country outside the European Union, the importer is, in principle, the Responsible Person for the product they place on the European market. The importer may also designate, by written mandate, another Responsible Person established in the European Union.
Brands and companies marketing cosmetics
Brands that market products manufactured by third parties must ensure that a Responsible Person has been designated for each cosmetic product and that the obligations established by Regulation (EC) No 1223/2009 are fulfilled.
The Responsible Person must be properly identified, and their details must appear on the product labelling where applicable.
What types of cosmetics need a Responsible Person?
The obligation does not depend on the type of cosmetic product, but on whether the product is considered a cosmetic product under Regulation (EC) No 1223/2009 and is to be placed on the European Union market.
Therefore, products such as the following may be included:
- Face and body creams and skincare products.
- Shampoos and hair care products.
- Soaps and personal hygiene products.
- Perfumes and eau de cologne.
- Makeup and make-up products.
- Sunscreens
- Nail care products.
- Cosmetic products intended for babies.
- Natural and organic cosmetics.
If your company manufactures or markets cosmetics outside the European Union and wishes to sell them on the European market, at Alpiguisa Innovación we can act as your Responsible Person and help you comply with the regulatory obligations required for their marketing.
For more information, contact us