| What do I have to do to place a cosmetic product on the Portuguese market?
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| How do I proceed?
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| What other documentation do I need?
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| What other requirements does the technician need to fulfil?
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| What are the costs of a notification?
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| What are the requirements to manufacture cosmetic products in Portugal?
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What do I have to do to place a cosmetic product on the Portuguese market?
The Portuguese legislation applicable to Cosmetics (Decree-Law No. 189/2008, of September 24th, as last amended, in attachment) establishes in the Article 3rd, No. 2 and 3, and Article 17th, that the cosmetic products to be placed on the Portuguese market should be notified both to the Portuguese Anti-Poison Centre (Centro de Informação Anti-Venenos, CIAV), and to INFARMED, I.P., before being placed on the market. They must be notified by the Company responsible for placing the product on the Portuguese Market.
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How do I proceed?
Firstly, your company should notify CIAV about the cosmetic products to be placed on the market, providing them all the necessary and appropriate information concerning their composition (frame-formulation), which will only be used for purposes of medical treatment.
Please, note that it's not allowed to place on the market cosmetic products whose composition is not registered at CIAV.
On CIAV webpage (www.inem.pt/ciav) you will find information on how to notify (Notificação de Produtos) and documentation needed (Registo).
After concluding the process of registration, CIAV will send to your company an email with the Proof of registry. Whenever requested this proof of registry should be sent to INFARMED, I.P
INFARMED, I.P. developed a web application to allow online registry of cosmetic and body hygiene products. The Company responsible for placing the product on the Portuguese Market needs to enter the application at http://app.infarmed.pt/Cosmeticos/, to proceed the registration of the notifier and to start the notification of cosmetic and body hygiene products. To help you with the application, please read the User’s Manual for registration of Cosmetic and Body Hygiene Products.
When required by INFARMED I.P., your company must present the CIAV Document together with other documentation needed to submit the notification.
A. If your products are manufactured in the EU or in EEA the documents you have in your possession are:
1. Copy of the document issued by the Portuguese Anti-Poison Centre (CIAV) confirming that the formulations of your products are registered on their files;
2. Legible copies of the packaging/labelling of each notified product with the list of the ingredients, in the INCI Nomenclature.
B. In case your products are manufactured in Portugal you should also keep the following data:
1. 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;
2. Address of the place where the information files of the products are located;
3. Copy of the Manufacturing Licence issued by the General Directorate of the Economical Activities, of the Ministry of Economy and Innovation (or by the local authorities);
4. 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, VI and VII of the Decree-Law No. 189/2008, of September 24;
- Identification of the colouring agents allowed for use in cosmetics, by the Annex IV of the same legislation.
C. In what concerns products imported from third countries, 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.
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What other documentation do I need?
The Portuguese legislation demands exactly what is stated on the Cosmetics Directive 76/768/EEC. As an European manufacturer or responsible for placing a cosmetic product on the European market, your company has to compile and made readily accessible to the National Competent Authority if requested, an information file of each cosmetic product being manufactured and/or represented. That information file has to contain all the information listed in the Article 26, No. 1 of the Decree-Law No. 189/2008, of September 24, and in the Article 7a of the Cosmetics Directive 76/768/EEC. It has to be stated that your company becomes responsible for the legal compliance of the cosmetic products being produced, in terms of good manufacturing practices, quality control, composition, packaging/labelling, and most importantly, safety to human health.
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What other requirements does the technician need to fulfil?
Your company should be assisted by a qualified person: it's his responsibility to review all the data concerned with areas above, according to the European Law. That person must hold a degree as defined in Article 1 of Directive 89/48/EEC and in Articles 24 and 25 of the Decree-Law No. 189/2008, of September 24, in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline.
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What are the costs of a notification?
The notification of cosmetic products to Poison Centre and to INFARMED, I.P. is a legal obligation that has no costs.
In accordance with the provisions of the Decree-Law No. 312/2002, of December 20, 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.
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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: the installation, adjustment and functioning of industrial units intended for manufacturing and packaging of cosmetic products, are regulated by the Decree-Law n.º 69/2003, of April 10th, and fall within the competences of the Directorate-General for the Economical Activities (Direcção-Geral das Actividades Económicas, DGAE), of the Ministry for Economy and Innovation (Ministério da Economia e Inovação).
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, issued by the Directorate-General for the Economical Activities.
As stated on the Article 11, No. 3 of the Decree-Law No. 69/2003, of April 10, in the case of small industrial units (considered to be of the type 4, according to a classification based on the risk potential to humans and environment), the licensing can be granted by the local authorities - the Council House of the area where the industrial unit is located.
For matters concerned with the Manufacturing Licence, you should contact with the Directorate-General for the Economical Activities, of the Ministry for Economy and Innovation (http://www.dgae.min-economia.pt).
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.
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