{"id":5784,"date":"2026-10-02T15:45:41","date_gmt":"2026-10-02T13:45:41","guid":{"rendered":"https:\/\/cosmetics.trusticert.com\/?p=5784"},"modified":"2026-10-02T15:46:06","modified_gmt":"2026-10-02T13:46:06","slug":"who-does-what-in-the-cosmetics-supply-chain-roles-and-responsibilities-of-economic-operators","status":"publish","type":"post","link":"https:\/\/cosmetics.trusticert.com\/en\/who-does-what-in-the-cosmetics-supply-chain-roles-and-responsibilities-of-economic-operators\/","title":{"rendered":"Who Does What in the Cosmetics Supply Chain? Roles and Responsibilities of Economic Operators"},"content":{"rendered":"
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Several different parties may be involved in the cosmetics supply chain: those who develop the product, those who physically manufacture it, those who market it under their own name or trademark, those who import it, and those who distribute it. Their functions may overlap, but each role is associated with specific obligations<\/strong>.<\/p>\n

The main legal reference is Regulation (EC) No 1223\/2009<\/strong>, which governs cosmetic products in the European Union. Understanding the differences between the various operators is essential in order to correctly identify responsibilities, particularly where production is outsourced or involves suppliers established outside the EU.<\/p>\n

The Responsible Person: the Key Reference for Cosmetic Product Compliance<\/h2>\n

Every cosmetic product placed on the European Union market must have a Responsible Person established in the EU<\/strong>, who is responsible for ensuring compliance with the relevant obligations laid down in the Regulation.<\/p>\n

The term \u201cperson\u201d includes both natural and legal persons, such as companies. It does not therefore necessarily refer to an individual professional or an employee of the company.<\/p>\n

Among other things, the Responsible Person must ensure:<\/p>\n

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  • product safety;<\/li>\n
  • compliance of the formulation;<\/li>\n
  • compliance with good manufacturing practice;<\/li>\n
  • the availability and updating of the Product Information File (PIF)<\/strong>;<\/li>\n
  • notification through the CPNP portal<\/strong>;<\/li>\n
  • the compliance of labelling and advertising claims.<\/li>\n<\/ul>\n

    These obligations also continue after the product has been placed on the market, including the management of non-compliance and cosmetovigilance matters.<\/p>\n

    The Manufacturer: Not Necessarily the Party That Physically Manufactures the Product<\/h2>\n

    The role of the manufacturer is governed by Article 2(1)(d)<\/strong> of the Regulation and is defined as the natural or legal person who manufactures a cosmetic product, or has such a product designed or manufactured, and markets it under their own name or trademark.<\/p>\n

    In everyday language, the manufacturer is generally understood to be the party that physically produces the cosmetic product. Under the Cosmetics Regulation, however, the term also includes a company that has the product manufactured by an external laboratory and markets it under its own name or trademark.<\/p>\n

    For example:<\/strong> an Italian company commissions an Italian laboratory to manufacture a product that will be sold under the company\u2019s own brand on an EU market. In this case, the brand owner is the manufacturer within the meaning of the Regulation and also assumes the role of Responsible Person, unless it designates another person established in the EU by means of a written mandate accepted in writing.<\/p>\n

    The laboratory physically manufactures the product, but this alone does not make it the Responsible Person<\/strong>. It may assume that role only if it is designated in accordance with the procedure laid down in the Regulation.<\/p>\n

    Outsourcing production to a laboratory therefore does not automatically mean outsourcing the role of Responsible Person as well. The manufacturing agreement and the possible designation of the Responsible Person are two separate matters, both of which should be clearly defined before the product is placed on the market.<\/p>\n

    What If the Manufacturer Is Established Outside the European Union?<\/h2>\n

    A manufacturer established outside the EU cannot directly act as the Responsible Person<\/strong>, because the Responsible Person must be established within the Union. In order to determine who assumes this role, two different situations must be distinguished.<\/p>\n

    Products Manufactured in the EU<\/h3>\n

    If the product is manufactured in the EU and is not subsequently exported and re-imported, the non-EU manufacturer must designate a Responsible Person established in the Union by means of a written mandate accepted in writing.<\/p>\n

    For example, a US company commissions an Italian laboratory to manufacture a product marketed under the US company\u2019s own brand and intended for the European market. The US company is the manufacturer within the meaning of the Regulation, but it must designate a Responsible Person in the EU. The Italian laboratory may assume this role if it is formally designated and accepts the appointment.<\/p>\n

    Imported Cosmetic Products<\/h3>\n

    For imported cosmetic products, the rule is different: each importer assumes the role of Responsible Person<\/strong> for the product it places on the market. However, the importer may designate another person established in the EU, again by means of a written mandate accepted in writing.<\/p>\n

    For example, an Italian company imports and places on the European market a product manufactured in the United States and marketed under the US manufacturer\u2019s brand. The Italian company, as importer, is the Responsible Person unless it validly designates another person established in the EU.<\/p>\n

    If the non-EU supplier states that an EU Responsible Person has already been appointed, the importer should verify that the designation also covers the products it places on the market and that it is consistent with the mechanism laid down in the Regulation. The mere presence of a European name and address on the packaging is not sufficient<\/strong> to clarify these relationships.<\/p>\n

    The Importer: Obligations Also Apply to Finished Products<\/h2>\n

    The importer is the person established in the EU who places on the Union market a cosmetic product originating from a third country.<\/p>\n

    For imported cosmetic products, each importer is the Responsible Person for the product it places on the market, unless it designates another person established in the EU through a written mandate accepted in writing.<\/p>\n

    Purchasing a cosmetic product that is already finished, packaged and ready for sale does not remove these obligations<\/strong>. Before placing the product on the market, the importer must ensure that the applicable European requirements are met. Documentation or compliance requirements applicable in the country of manufacture are not, by themselves, sufficient.<\/p>\n

    The Distributor: A Role with Its Own Obligations<\/h2>\n

    A distributor is an operator in the supply chain, other than the manufacturer or importer, who makes a cosmetic product available on the market.<\/p>\n

    Although the distributor is not normally the Responsible Person, it must act with due care. Before making the product available on the market, the distributor must verify:<\/p>\n

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    • certain labelling elements;<\/li>\n
    • compliance with applicable language requirements;<\/li>\n
    • where relevant, that the date of minimum durability has not passed.<\/li>\n<\/ul>\n

      The distributor must also ensure that storage and transport conditions do not jeopardise the product\u2019s compliance and must take appropriate action in the event of non-compliance or risks.<\/p>\n

      The distributor becomes the Responsible Person when it places a cosmetic product on the market under its own name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.<\/p>\n

      The mere translation of information relating to a product already placed on the market does not constitute such a modification, without prejudice to any specific notification obligations that may apply.<\/p>\n

      The Safety Assessor: A Separate Function<\/h2>\n

      The Responsible Person should not be confused with the safety assessor<\/strong>, namely the professional holding the qualifications required under the Regulation who is responsible for carrying out the cosmetic product safety assessment.<\/p>\n

      The safety assessor examines the relevant information on the product and its ingredients, exposure and conditions of use, and signs the part of the Cosmetic Product Safety Report<\/strong> relating to the safety assessment.<\/p>\n

      The Responsible Person remains responsible for ensuring that the safety assessment has been carried out before the product is placed on the market and that the safety report is kept up to date.<\/p>\n

      Who Must Appear on the Label?<\/h2>\n

      The Regulation requires the name or registered name and address of the Responsible Person<\/strong> to appear on both the container and the packaging. Where several addresses are indicated, the address at which the PIF is readily accessible must be highlighted.<\/p>\n

      The distributor is not required to appear on the label merely by virtue of being a distributor. Its details may be added voluntarily, provided that this does not create ambiguity regarding the identification of the Responsible Person.<\/p>\n

      For cosmetic products imported from countries outside the EU, the country of origin<\/strong> must also be indicated.<\/p>\n

      Penalties and Contracts: Why Clearly Defining Responsibilities Is Essential<\/h2>\n

      In Italy, the applicable penalties are laid down in Legislative Decree No 204 of 4 December 2015<\/strong>. The consequences vary depending on the type of infringement and the operator concerned; it is therefore neither straightforward nor correct to reduce them to a single range of fines applicable indiscriminately to the Responsible Person.<\/p>\n

      The legislation provides for administrative fines and, for certain offences, criminal penalties. For example, Article 3<\/strong> penalises the manufacture, possession for commercial purposes or marketing of cosmetic products that may be harmful to human health under normal or reasonably foreseeable conditions of use and also provides for imprisonment in certain circumstances.<\/p>\n

      To properly manage relationships within the supply chain, contracts and quality agreements should clearly define:<\/p>\n

        \n
      • who provides the documentation;<\/li>\n
      • who performs the relevant checks;<\/li>\n
      • how changes to the formulation and packaging are approved;<\/li>\n
      • how complaints and non-compliance are managed;<\/li>\n
      • how withdrawals and recalls are handled.<\/li>\n<\/ul>\n

        These agreements govern the relationships between the parties but cannot remove the obligations imposed by law on individual operators<\/strong>.<\/p>\n

        Article 1229 of the Italian Civil Code also prohibits the advance exclusion or limitation of liability for wilful misconduct or gross negligence\u2014not, in general terms, for every form of negligent conduct\u2014and imposes further limitations where obligations arising from rules of public policy are breached.<\/p>\n

        Correctly identifying the respective roles from the beginning of a project<\/strong> makes it possible to properly organise documentation, controls and information flows, reducing the risk that activities essential to the safety and compliance of the cosmetic product are left without a clearly identified responsible party.<\/p>\n<\/div>

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