ITEN

Responsible Person

The Responsible Person is a central figure established by Regulation (EC) No 1223/2009 on cosmetic products.

In order to be placed on the European Union market, every cosmetic product must be linked to a Responsible Person established within the EU. The Responsible Person ensures that the cosmetic product complies with the obligations laid down by European cosmetic legislation and acts as the main reference point for competent authorities in case of inspections, documentation requests, non-compliance or product safety issues.

Who Can Be the Responsible Person?

The Responsible Person is not always the manufacturer of the cosmetic product.

Depending on the case, the Responsible Person may be:

  • the manufacturer established within the European Union;
  • a natural or legal person established within the European Union, designated by the manufacturer by written mandate;
  • the importer, in the case of cosmetic products coming from non-EU countries;
  • the distributor, if the product is placed on the market under the distributor’s name or trademark;
  • the distributor, if they modify a product already placed on the market in a way that may affect its compliance.

For cosmetic products imported from non-EU countries, the importer is generally the Responsible Person for the cosmetic product placed on the market, unless another designation is made in accordance with the Regulation.

What Does the Responsible Person Do?

The Responsible Person must ensure that the cosmetic product complies with Regulation (EC) No 1223/2009.

In particular, the Responsible Person must ensure compliance with obligations relating to:

The Responsible Person therefore has a key role in coordinating and controlling the overall compliance of the cosmetic product.

Obligations in Case of Non-Compliance

If the Responsible Person considers, or has reason to believe, that a cosmetic product placed on the market is not compliant with the Regulation, they must immediately take the necessary corrective measures.

Depending on the situation, it may be necessary to:

  • bring the product into compliance;
  • suspend commercialisation;
  • withdraw the product from the market;
  • recall the product already distributed;
  • inform the competent authorities, where the product presents a risk to human health.

Where the cosmetic product presents a risk to human health, the Responsible Person must inform the competent national authorities of the Member States concerned, providing details of the non-compliance and the corrective measures taken.

Responsible Person and PIF

One of the main obligations of the Responsible Person is to ensure the availability of the PIF – Product Information File.

The PIF must be prepared before the product is placed on the market and must be kept available to the competent authorities at the address indicated on the product label.

The file must be consistent with:

  • product formula;
  • safety assessment;
  • Cosmetic Product Safety Report;
  • manufacturing method;
  • GMP documentation;
  • label;
  • claims;
  • available tests;
  • CPNP notification.

Incomplete, outdated or inconsistent documentation may represent a significant issue for the Responsible Person.

Responsible Person and CPNP Notification

Before placing the product on the market, the Responsible Person must ensure that the cosmetic product is notified through the CPNP – Cosmetic Products Notification Portal.

The CPNP notification must be consistent with the product actually marketed, the formula, the label, the cosmetic category, the Responsible Person and the information included in the PIF.

Relevant changes to the product may require the notification to be updated.

Responsibility Throughout the Product Life Cycle

The role of the Responsible Person does not end when the product is placed on the market.

Product compliance must be maintained over time, taking into account possible formulation changes, regulatory updates, label changes, new claims, supplier changes, new toxicological information or reports of undesirable effects.

For this reason, the Responsible Person must ensure continuous regulatory management of the cosmetic product.

Support for the Responsible Person

Regulatory support for the Responsible Person may include:

  • review of formula compliance;
  • verification of prohibited or restricted ingredients;
  • preparation and update of the PIF;
  • preparation or review of the CPSR;
  • CPNP notification;
  • labelling review;
  • claims assessment;
  • review of raw material documentation;
  • verification of GMP documentation;
  • support in case of regulatory updates;
  • assistance in managing non-compliance or documentation requests.

Regulatory Management of the Responsible Person

Taking on the role of Responsible Person means ensuring that the cosmetic product is properly assessed, documented, notified and kept compliant throughout its entire presence on the market.

For this reason, regulatory management should not be limited to the initial phase of market placement. It requires continuous control of documentation, formulation, labelling, claims and any regulatory updates.

Appropriate technical support enables the Responsible Person to operate with greater awareness, reducing the risk of non-compliance and ensuring stronger regulatory management of the cosmetic product over time.

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