CosmeticsEnglish

How can I put a cosmetic product on the market in the EU?

First, you must identify your role, and whether or not you are the ‘Responsible Person’ for the cosmetic product.

 

Your role

Identify whether you are:

  • Manufacturer: a natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark; or
  • Importer: any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market; or
  • Distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market.

If you mix your own products, you are a manufacturer. If you purchase products from a non-EU supplier to re-sell them in your web store, you are an importer. If you purchase the products from within the EU, you are distributor.

 

Your responsibilities

You are the Responsible Person for the product you want to make available on the market, if:

  • You are the manufacturer; or
  • You are the importer; or
  • You are the distributor and you place the cosmetic product on the market under your own name or trademark or you modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected. The latter may be the case is you repackage the cosmetic product.

As the Responsible Person of your cosmetic product, you must ensure its compliance with the Cosmetics Regulation (EC/1223/2009). Prior to placing a cosmetic product on the market, you must:

  • Ensure that the cosmetic product has undergone a Product Safety Assessment (PSA). This PSA must be carried out by an expert in pharmacy, toxicology, medicine or a similar discipline. The PSA must be recorded in a cosmetic Product Safety Report (PSR), which must be set up in accordance with the Cosmetics Regulation;
  • Compile a Product Information File (PIF), which you must keep up-to-date, and archive for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
  • Label your product in accordance to the Cosmetics Regulation; and
  • Notify your product electronically to the European Commission via the Cosmetic Products Notification Portal (CPNP).

As a distributor you do not have these obligations, but you do have to verify that the product labelling and language requirements of the Cosmetics Regulation are met and the specified date of minimum durability has not passed. Additionally, you must ensure that storage or transport conditions do not jeopardise the product’s compliance. Lastly, if at any time (you suspect that) anything is not in order, you must make sure that the corrective measures are taken to bring that product into conformity, and/or withdraw it or recall it.