What is the regulatory framework for cosmetic products in Portugal?
What do I have to do to place a cosmetic product on the Portuguese market?
Some elements of the cosmetic¿s labelling should be written in Portuguese, namely the nominal content, date of minimum durability, particular precautions to be observed in use and the function of the cosmetic product.
- In case your products are manufactured in Portugal you should also keep the following data:
- Name, qualifications, address and contacts of the qualified technician, established in the European Union, who is responsible for the products in terms of manufacturing, quality control, composition and packaging/labelling, according to the Articles 24 and 25 of the Decree-Law No. 189/2008, of September 24;
- Copy of the Manufacturing Authorization. The Manufacturing Authorization is regulated by Decree Law n.º 169/2012, of August 1st (Sistema de Indústria Responsável), to learn more about this subject please visit the website Regime de Exercício da Atividade Industrial, da Agência para a Modernização Administrativa.
- Quality Control Certificates of the finished product, one for each manufactured batch. Only the original Certificates will be accepted and they should be dated, signed and approved by the qualified technicians, indicating their name and position. The Certificates must have the identification of the entity that has done the analysis, the batch analysed, the identification and brand of the product and, at least, the following analytical determinations, as well as their specifications, that the finished product must comply:
- General features of the product (colour, odour, aspect, pH, viscosity, density, alcohol content if applicable, etc.);
- Microbiological control (total bacterial amount per gr or mL of product, and if above 100, the identification of the contaminating microorganism);
- Amount of the substances with a maximum authorized concentration, by the Annexes III, V and VI of the Regulation (CE) Nº. 1223/2009;
- Identification of the colouring agents allowed for use in cosmetics, by the Annex IV of the same legislation.
B. In what concerns products imported from third countries:
In conformity of articles 22 and 23 of Decree Law 189/2008, of September 24th, as last amended, you should present a Quality Control Certificate and the Official Recognition of the Manufacturing Laboratory, besides the documents required for the countries of the EU. The requested data for Portuguese manufacturers is compulsory in this case as well. The imported products must have the ingredients written in INCI nomenclature and the indication of it¿s origin on the labelling.
You should also request a Compliance Document to present to the Portuguese Customs, for clearance of the goods.
What do I need to do to import cosmetic products from third countries to Portugal?
This document is required for purposes of importation and clearing from customs, of products imported to Portugal from third countries, and intended to be placed on the Portuguese market.
In order to submit the request, the importer must send the following information (document sent):
- Fulfilment of specific form, which should have the following information:
- Name and address of the economic operator reponsible for the importation and placing of the products on the Portuguese market;
- Identification of the qualified technician who is responsible for the importation, according to the Articles 24th and 25th of the Decree-Law n.º 189/2008, of September 24th, as amended;
- List of the cosmetic products to be imported. For each product should be indicated the name, brand, batch number, CPNP Reference of notification.
- Name, professional address, phone number and Curriculum Vitae of the qualified technician who is responsible for the compliance with the law in force (articles 24 and 25th of the Decree-Law n.º 189/2008, of September 24th, as last amended, http://www.infarmed.pt);
- Document issued by the Competent Authority of the country of manufacture, recognizing the manufacturer of the products as being licensed and authorized to produce cosmetics.
- Quality Control Certificates of the products (Certificates of Analysis). There must be sent one Quality Control Certificate for each product and for each batch to be imported. The certificates should mention the name, brand, batch number and date of manufacture of the product being analysed, together with the specifications and the analytical determinations of chemical and microbiological parameters.
- Curriculum Vitae of the Security Assessor according to no. 2 of article 10 of Regulation (EC) No. 1223/2009.
What requirements does the technician need to fulfil? Do I need to be assisted by a technician?
Are there any costs for marketing cosmetic products in Portugal?
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.
All the necessary information concerning the payment of this fee ("taxa de comercialização de produtos cosméticos e de higiene corporal"), including the legislation, is available at the following address:
http://www.infarmed.pt/portal/page/portal/INFARMED/TAXAS/COSMETICOS. A brief note about the procedure to take can also be found at http://www.infarmed.pt/portal/page/portal/INFARMED/COSMETICOS/FORMULARIOS. 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.
What are the requirements to manufacture cosmetic products in Portugal?
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.