The Responsible Person: regulating cosmetics

In order to regulate cosmetics, it is necessary to follow all points required by the European regulation, including the appointment of a responsible person.  Producers are free to choose who should carry out the role of Responsible Person of their products. They can appoint  anybody, as long as this person:

  • is registered and resident in the European Union;
  • received an appropriate mandate;
  • is in a position which allow the competent authorities to have access to the Product Information File informational document (PIF) at the address indicated on cosmetics by the Responsible Person.
  • The Responsible Person may be the manufacturer itself or one of its subsidiaries.

If a cosmetic company located outside the European Union is willing to market one or more products in Italy or in Europe, can rely on PIF ITALIA. Our company can take on the role of Responsible Person, regularise the cosmetics and allow import and distribution in accordance with Regulation (EC) No 1223/2009.

For the products imported in the European Union, the importer can assume this role if no other individual has been mandated to do so. The supplier is considered a Responsible Person when:

  • “places a cosmetic product on the Community market under his own name or trademark”;
  • he or she “modifies a product already placed on the market in such a way that its conformity with the applicable requirements may be affected”, although heor she is not the person responsible for placing the product on the Community market.

For every cosmetic product placed on the market, the Repsonsible Person ensures  its compliance with the relevant obligations set out in this Regulation. (Article 4 of Regulation (EC) No 1223/2009). At any moment, the Responsible Person must be able to demonstrate that the product which he or she placed on the market complies with these requests.  In order for the Responsible Person to fulfil this role, it is necessary for him/her to keep the specific information about the product (“P.I.F.”).


Suppliers shall “in the context of their activities, when making a cosmetic product available on the market, […] act with due care in relation to the applicable requirements” (Article 6.1 of Regulation (EC) No 1223/2009).

The Regulation indicates in a specific way the supplier’s responsibility to check:

  • Some labeling elements of the products (Art. 6.2) in such a way as to ensure suitable transport and storage conditions for the products (Article 6.4);
  • To collaborate with the Responsible Person and the competent authoritieswhen necessary in order to ensure the compliance with the Regulation (Articles 6.3, 23 and 26).


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