Acessibilidade

In Portugal, cosmetic products are governed by the following legislation:

• Regulation (EC) No. 1223/2009, of 30 November, on cosmetic products;
• Decree-Law No. 23/2025, of 19 March, which establishes the national rules for the implementation of the European Regulation;
• Commission Regulation (EU) No. 655/2013, of 10 July, establishing common criteria for the justification of claims related to cosmetic products.

To make a cosmetic product available on the Portuguese market, the following conditions must be met:

1. Responsible Person (Pessoa Responsável): A natural or legal person established within the European Union must be designated to act as the "Responsible Person" (RP) to ensure compliance with all legal safety and regulatory obligations. The name and address of the RP must appear on the product labeling.
2. Notification (CPNP): Before placing a cosmetic product on the market, the Responsible Person (and in some cases, the distributor) must submit a notification through the Cosmetic Products Notification Portal (CPNP). Only one notification is required for the entire EU market.
3. Labeling in Portuguese (Rotulagem em Português): According to Article 19 of Regulation (EC) No. 1223/2009 and Article 10 of Decree-Law No. 23/2025, certain information on the label must be written in Portuguese:
   1. o Nominal content;
   2. o Date of minimum durability or period-after-opening (PAO);
   3. o Particular precautions to be observed in use;
   4. o The function of the cosmetic product (unless clear from its presentation).
4. Product Information File - PIF (Ficheiro de Informações sobre o Produto - FIP): The RP must maintain a PIF for each product, which must be easily accessible to the competent authority at the address indicated on the label. If the RP is established in Portugal, the PIF must be written in Portuguese, although technical-scientific parts may be in English.
5. Good Manufacturing Practices - GMP (Boas Práticas de Fabrico): Cosmetic products must be manufactured in accordance with Good Manufacturing Practices. Compliance is presumed if the manufacturing process follows the ISO 22716 standard

A Compliance Declaration (“Declaração de Conformidade”) issued by INFARMED, I.P. is required in the following cases:

• First-time placement on the market: When an importer based in Portugal introduces a product to the EU market for the first time.
• Significant modifications: When a product previously placed on the market has undergone a change in formulation or any other modification that affects its legal conformity.

Note: This requirement does not apply to non-commercial imports, such as those for personal use, laboratory samples, or catalog purposes.

Application Process:

• Channel: Requests must be submitted via e-mail to pchc@infarmed.pt.
• Cost: There are no costs associated with the request for a Declaration of Conformity.
• Submission Format: The application form (Model M-C-056) must be sent in Word format. If the documentation exceeds 20 MB, Infarmed’s secure file-sharing tool (share.infarmed.pt) can be used upon request.

Evaluation Deadlines:

• The evaluation of requests can take up to 20 working days.
• Processes are analyzed in chronological order of entry.
• Incomplete applications will result in additional requests for information, causing delays. Importers are advised to submit applications well in advance to avoid products being held at Customs.
   

Required Documentation:

For the first import, the file must include:

1. Application Form: Duly completed in Word.
2. Written Mandate: If the importer is not the original Responsible Person.
3. Official Recognition of the Laboratory: Issued by the competent authority of the country of origin.
4. GMP Declaration: Copy of the declaration of compliance with ISO 22716 (Good Manufacturing Practices).
5. Qualitative and Quantitative Formula: Detailed concentration of ingredients (INCI/CAS).
6. Safety Assessor CV: Signed and dated.
7. Quality Control Certificate: For the specific manufacturing batch to be imported, including physical-chemical and microbiological analysis results.

For products previously placed on the market (without formula changes), a copy of the previously issued Declaration of Conformity must be presented to Customs.
 

In accordance with the provisions of the Decree-Law No. 312/2002, of December 20, as last amended, the company responsible for placing cosmetic products on the Portuguese market must pay to INFARMED, I.P. a marketing fee, which is calculated over the amount of cosmetic products sold per month.

Click to see all the necessary information concerning the payment of this fee ("taxa de comercialização de produtos cosméticos e de higiene corporal"), including the legislation.

Click to see a brief note about the procedure. 

Click to see the form.
These documents are only available in Portuguese.

For any question related to the fees, you should contact the Human Resources and Financial Management Directorate (Direcção de Recursos Humanos, Financeira e Patrimonial) of INFARMED, I.P.

The requirements for manufacturing are established in the Article 20, No. 1 of the Decree-Law No. 189/2008, of September 24, as last amended: the installation, adjustment and functioning of industrial units intended for manufacturing and packaging of cosmetic products, are regulated by the Decree-Law no. 169/2012, de 1 de agosto (Sistema de Indústria Responsável).
According to the No. 2 of the same Article, the cosmetic products cannot be manufactured and packaged outside units established in conformity with the provisions of the above mentioned legislation.
The installation, adjustment and functioning of an industrial unit intended for manufacturing and packaging of cosmetic products, depends on the granting of a Manufacturing Licence.

For matters concerned with the Manufacturing Licence, please visit the website Regime de Exercício da Atividade Industrial, da Agência para a Modernização Administrativa.

In terms of Good Manufacturing Practice and Analysis Methods, your company as to comply with

• ISO 22716 (Good Manufacturing Practices- Guidelines on Good Manufacturing Practices);
• Implementing Order No. 503/94, of July 6, altered by Implementing Order No. 1192/97, of November 22 and Implementing Order No. 467/98, of July 30 (Analysis Methods);
• Decree-Law No. 95/2000, of May 23 and Decree-Law No. 99/2000, of May 30 (Good Laboratory Practices).

In the absence of legislation, the criteria and analysis methods established are those of the Portuguese Norms (NP), European Norms (EN) and International Standard Organization Norms (ISO).

In conclusion, your activity as Portuguese cosmetics manufacturer is dependent on the granting of a Manufacturing Authorization and its presentation to INFARMED, I.P., and your cosmetic products have to be notified before being placed on the market.