Unofficial Translation
Application instruction for issuance of Compliance Document of cosmetic products
Necessary requirements:
1. Version of the application form for compliance document in force, duly filled in, in Word format:
▪ Identification (name, address, telephone number and e-mail) of the importer;
▪ Identification (name) and direct contacts (telephone and e-mail) of the qualified technician who is responsible for the importation, according to the Articles 24th and 25th of Decree-Law n.º 189/2008, dated September 24th, as amended;
▪ Identification (CPNP reference - Cosmetic Products Notification Portal, full name and production batch) of the cosmetic products to be imported.
2. In the event that the importer is not the person responsible for the cosmetic products to be imported, the written mandate referred to in the nº 5 of article 4 of the Regulation (EC) Nº 1223/2009 should be submitted. This mandate shall clearly and unequivocally identify the importer, the person in charge and the cosmetic products to be imported and must be be duly dated and signed by both.
3. Statement, duly dated and signed by the importer and by the qualified technician who is responsible for the importation, according to the Articles 24th and 25th of Decree-Law n.º 189/2008, dated September 24th, as amended, by which the importer states that he is assisted by the qualified technician, who, in turn, states that, regardless of the link to the importer, he jointly assumes responsibility for compliance with the provisions of Decree-Law No.
189/2008, dated September 24th, in its current wording, and in the regulations applicable to cosmetic products.
4. Curriculum vitae of the qualified technician who is responsible for the importation, according to the Articles 24th and 25th of Decree-Law n.º 189/2008, dated September 24th, as amended, duly dated and signed, including: personal information (name, address, telephone number and e-mail), academic qualifications, professional experience and, in attachment, the certificate which confers the qualifications referred to in Article 25 of Decree-Law No.
189/2008, dated September 24th , in its current wording.
5. Document proving the official acknowledgment of the manufacture laboratory, according to the nº2 of article 22 of Decree-Law No. 189/2008, dated September 24th, in its current wording. This document should be issued by the competent authority of the country of manufacture, in charge of cosmetic products, no certificates or statements issued by companies or other external entities are accepted. If the document has an expiration date, it must be renewed before it expires. If it’s a first application, an authenticated document must be submitted. If the document is written in a foreign language, which is not understandable to the Portuguese competent authority, it should be accompanied by the respective official translation.
Unofficial Translation
6. Qualitative and quantitative formula of the cosmetic product, corresponding to the production batch to be imported, duly dated, containing unequivocal information of the cosmetic product (CPNP reference and full name), chemical identity (INCI nomenclature, CAS number), expected function and exact concentration (with mention of the weight in percentage in the finished product) for each ingredient (including information on regulated substances that are part of the perfume and/or aromatic composition, if present).
7. Curriculum Vitae of the Safety Evaluator, according to no. 2 of article 10 of Regulation (EC) No. 1223/2009, duly dated and signed, including: personal information (name, address, telephone number and e-mail), academic qualifications, professional experience, showing that he has the knowledge and proficiency required to make a precise safety assessment and, in attachment, the certificate which confers the qualifications referred to in the nº2 of article 10 of Regulation (EC) No. 1223/2009.
8. Quality control certificate of the finished cosmetic product, corresponding to the production batch to be imported, ensuring that:
(a) the certificate is approved, dated and signed by the person in charge at the laboratory where the analyses were carried out, stating their name and position;
(b) the certificate has at least, and whenever applicable to the cosmetic product in question, the following information:
▪ identification of the entity that carried out the analyses;
▪ clear identification (full name) of the cosmetic product;
▪ number of the production batch analysed and respective date of manufacture;
▪ Physical-chemical characteristics (such as organoleptic characters, pH, viscosity, density, alcohol content, etc.) of the finished cosmetic product;
▪ Microbiological quality tests of the finished cosmetic product, including the count of the total number of bacteria and fungi per gram or millilitre of product and the tests for Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Candida albicans, when applicable;
▪ Determination of the concentration, in the finished product, of each of the substances subject to restriction;
(c) The analysis certificates should contain information on the tests, specifications, units, results obtained and methods used for the determination of each of the physical-chemical and microbiological parameters that serve as reference to conclude whether the finished product can be considered acceptable from a quality point of view, taking into account EU standards.
Notes:
1) The application for the issuance of a Compliance Document should be done via e-mail to the address [email protected], attaching all necessary documentation; the form should be submitted in Word format. If you find that the documentation exceeds 20 MB, you can use, on request, the tool for secure sharing of documents made available by Infarmed (share.infarmed.pt).
2) INFARMED, I.P. may request additional documentation for the evaluation of the process, whenever necessary.
3) When issued, the Compliance Document is sent by post. If requested, the original document can be scanned and also sent by e-mail.
