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FAQs – Cosmetics

It is the European Regulation of cosmetic products, introducing the Cosmetic Product Safety Assessment, the European Centralised Notification, the Cosmetovigilance, the compliance with the Good Manufacturing Practice and the rules for the use of nanomaterials in cosmetic products.  Moreover, the responsibility for the product is totally attributed to the trademark owner, that takes on the role of Responsible Person.

A substance or mixture to be applied on external surfaces of the human body or on teeth and oral mucosae with the sole or prevailing purpose to clean them, perfume them, change their appearance, protect them, maintain them in a good state or correct body odours.

The Responsible Person is a natural or legal person established in the European Union, responsible for the marketing in the EU of a cosmetic product or appointed as such.  The Responsible Person can be:

  • the manufacturer in the EU;
  • a person appointed by a manufacturer established outside the EU;
  • the distributor, if changing a product already marketed in such a way as to compromise the compliance with the cosmetic Regulation, or if marketing a cosmetic product with its own name or trademark in the EU;
  • the importer(s);
  • a third party with a written mandate by the cosmetic manufacturer or importer.

The importer is a natural or legal person established in the European Union marketing a cosmetic product from a Third Country in the EU market.  For imported cosmetic products, the relevant importer is the Responsible Person.  The importer can appoint by written mandate a person established in the EU as Responsible Person, who shall accept in writing.

It is required that an importer resulting as Responsible Person for the imported product is present in the Union territory. The cosmetic product must meet all safety requirements, including the compliance with the Good Manufacturing Practice (GMP) for the cosmetic sector, the drafting of the Product Information File and the electronic notification into the European portal CPNP

It is the acronym of Product Information File, i.e. the technical dossier of the product including the Cosmetic Product Safety Assessment.

It is the acronym of Cosmetic Products Notification Portal, i.e. the electronic portal for the centralised notification of cosmetic products instituted by the European Commission?

Regulation EC 1223/2009 dictates to the cosmetic product Responsible Person to set up a surveillance system of the product.  This system provides for the reporting of all serious undesirable effects occurred and related to the use of the cosmetic product following its marketing to the competent authorities of the Member States.

Yes. The reference standard for the cosmetic sector is the EN ISO 22716.  There is no obligation for the companies to be certified according to the ISO 22716, however they must comply with this guideline.

No. The Responsible Person, even in the case of a trading company, is responsible of the cosmetic manufacturing, although this is manufactured under contract by a third party.  The Responsible Person is bound to check that the manufacturing company follows the norm ISO 22716 by a specific auditing inspection.  The relevant audit report must be enclosed in the product dossier.

It is any insoluble or bio-persistent material intentionally manufactured, having one or more outer sizes, or an inner structure sized 1 to 100 nm.

Cosmetic products containing nanomaterials are to be notified by the Responsible Person to the Commission in electronic format six months before their marketing.

Yes. The Ministry of Health issues free sale certificates to export cosmetic products to extra-EU countries on request of responsible and/or manufacturing companies established in Italy.