Cosmetics

What are cosmetics?

Cosmetics are any substance or mixture intended to be placed in contact with the superficial parts of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and oral mucous membranes, with the exclusive or main purpose of cleaning, perfuming, modifying their appearance, protecting, maintaining them in good condition or correcting body odours. Among the most prominent are skin care creams, hair care products and hygiene products. Products or preparations intended for the prevention, diagnosis and treatment of diseases are not considered cosmetics. Nor are they intended to be ingested, inhaled, injected or implanted.
Translated with DeepL.com (free version)

What obligations do companies have before putting a product on the market?

• If the company carries out the activity of manufacturing or importing, they must first make a responsible declaration for the import/manufacture of cosmetics. In the case of manufacturers, it is also compulsory to make a descriptive report.
• Cosmetic labelling must comply with Regulation 1223/2009. LegaleGo can help you to check the composition and labelling of your products to ensure that they comply with the regulation and that there are no incidents when notifying the product.
• Be registered in the CPNP portal as a company.
• Notification of cosmetic products on the portal

Each of these obligations is discussed below.

Responsible declaration

The first step for the manufacture or import of cosmetics is the submission of a responsible declaration to the Spanish Agency for Medicines and Health Products (AEMPS). The Responsible Declaration of cosmetic product manufacturing and importing activities is a declaration of activities in which the owner declares the activities for which he is responsible, whether they are carried out in his own plant or in the plants of subcontracted companies, and takes responsibility for them. For this declaration, the seller must provide the following documentation:

• Company VAT number
• Address of the company
• Details of the company director
• Description of the activity you perform
• Information on subcontracted activities

Once the declaration has been submitted and the receipt has been obtained, the company’s activities can commence.

Labelling of cosmetics

An accurate and compliant label is essential for the successful marketing of cosmetic products as it must be correctly made on the basis of Regulation No. 1223/2009 and Royal Decree 85/2018. It is also necessary to check that the cosmetic ingredients do not exceed the permitted limits according to the applicable regulations. This ensures that the product is not only safe for consumers, but also complies with the applicable laws, thus avoiding possible sanctions.

Discharge from the CPNP

The Cosmetic Products Notification Portal (CPNP) is an online platform established by the European Commission for the notification of cosmetic products placed on the market within the European Economic Area (EEA). This portal is a crucial component of Regulation (EC) No 1223/2009 on cosmetic products, which entered into force in July 2013. The Cosmetic Product Notification Portal (CPNP) is a mandatory requirement for the marketing of cosmetics in the European Economic Area, which must be done before the cosmetic product is placed on the market. This notification is done electronically on the CPNP portal. Currently, it must be done for all cosmetic products placed on the EU market (Article 13, EC Regulation 1223/2009). The following steps are necessary to register in the CPNP:

• EU LOGIN registration: Before accessing the CPNP, companies must register with the EU LOGIN authentication system, which provides secure access to European Commission services.
• Access Request: Subsequently, companies must request access to the SAAS (Service Authorisation and Authentication System) to obtain permission to use the portal.
• Registration and Validation: Once access has been granted, companies can create and validate their CPN account.

The use of CPNP offers multiple benefits:

• • Rapid Access to Information: Authorities and poison centres have immediate access to crucial information, improving emergency response.
  • Trade Facilitation: Simplifies notification procedures, allowing companies to trade their products in a more streamlined and legally compliant manner.
  • Increased Transparency: Enables more effective tracking of products on the market, ensuring regulatory compliance and protecting consumer health.

Notification of cosmetic products in the CPNP

Once you are registered in the CPNP, you proceed to the notification of the products, this step is crucial, because only after the notification, the seller can legally market their cosmetics. It is necessary to notify each and every one of the products to be marketed, the following information must be provided:

• Full trade name of the cosmetic product and its category.
• Name and address of the responsible person. It is at this address that the product information file (PID) remains at the disposal of the competent authorities.
• Country of origin if the product is imported.
• Member State in which the product is placed on the market.
• The coordinates of a natural person who can be contacted if necessary.
• If applicable, identification of exposure conditions for nanomaterials present and CMR category A or 1B substances.
• The formulation.
• Original labelling (photocopy of packaging if legible).

Provision of documentation

Finally, it is necessary to check that all the documentation is correct according to the regulations:

• Descriptive Memories
• Activity reports
• Flowcharts

With the LegaleGo guarantee

Are you planning to start marketing, manufacturing or importing cosmetics? Don’t hesitate. Count on LegaleGo to advise you on all the steps to follow in this process. You will have the full support of our great team of professionals specialised in various legislative and technical matters so that you only have to worry about the most important thing: selling. You will also have all the support we can offer in other areas of your business, such as sanitary registration, labelling review or the preparation of HACCP.