May 23, 2024. Here is an overview of national requirements for cosmetics for Portugal. Before entering the Portuguese market, you should check that your products meet the national requirements. In addition to this, we suggest you check with your local importers and distributors whether any additional obligations apply to you.
Applicable laws and competent authorities
In Portugal, Decree-Law n.189/2008 of 24 September and Regulation (EC) no 1223/2009 regulate cosmetic products.
The competent authority in charge of cosmetic products is Infarmed, a governmental agency under the Ministry of Health. On top of cosmetics, Infarmed is responsible for medical devices and human medicines.
Responsible Person and qualified technician
As for the EU Cosmetics Regulation, only products for which a Responsible Person (RP) in the EU has been designated can be placed on the market. EU manufacturers are their own RP; for companies based outside the EU, the RP is the importer. In both cases, another entity can be appointed as Responsible Person by written mandate.
Moreover, Article 24 of Decree-Law n.189/2008 establishes that a qualified technician (técnico responsável) must assist the person responsible for placing a cosmetic on the Portuguese market (whether it is the manufacturer, the importer, or another entity designated as RP). The qualified technician is responsible, together with the RP, for the compliance of cosmetic products.
The qualified technician must have one of the following educational qualifications:
- A diploma in Pharmaceutical Sciences, Chemistry, Biology, Medicine or Chemical Engineering obtain from an EU university;
- A degree in Cosmetic Chemistry or Cosmetology from a foreign university;
- A degree in a course recognized as equivalent to those listed above by the Ministro da Educação.
Importing cosmetic products into Portugal
To import a cosmetic product into Portugal for the first time, Infarmed must issue a declaration of conformity (Documento de Conformidade). The declaration confirms the product complies with the EU Cosmetics Regulation and has been notified to the CPNP. It is necessary for customs clearance. To obtain a declaration of conformity, the importer must submit to Infarmed a request using a specific form available on their website which includes the following:
- Name and contact details of the importer and of the técnico responsável;
- Name, batch number, country of origin, and CPNP number of the cosmetic products.
Further to the form, the importer must provide to Infarmed the following documents:
- RP Mandate, if the importer is not the Responsible Person;
- A declaration signed by the importer and the técnico responsável by which the importer declares that he is assisted by a qualified technician, who, in turn, declares that, regardless of the link to the importer, he assumes joint and several responsibilities for compliance with the regulatory requirements;
- CV of the técnico responsável and the safety assessor;
- Official recognition of the manufacturing laboratory;
- GMP certificate by a third party;
- Qualitative and quantitative composition of the cosmetic product, including INCI name, CAS number and function for each ingredient;
- Certificate of analysis of the finished cosmetic product dated, signed, and approved.
For the subsequent import of the same cosmetic, the importer shall submit only the form and a declaration confirming that the product has not been modified and the importer have all the information mentioned above.
The company responsible for placing cosmetic products on the Portuguese market must pay to Infarmed a marketing fee, calculated on the amount of cosmetics sold.
Labelling requirements
Labels of cosmetic products for Portugal must meet the requirements of Article 19 of the EU Cosmetics Regulation. In addition to this, certain elements must be in Portuguese – they are the nominal content, precautions for use, function, and date of minimum durability (unless a symbol is used).
Subscribe for free to COSlaw and follow us on LinkedIn to remain updated on the latest news.
References
- Infarmed. Cosmetics. Retrieved on 15/05/2024
Leave a Reply