ATTENTION – FSC can only be issued for products to be exported by the issuing country, i.e. Portugal.
A Free Sale Certificate (FSC) is a document issued by the DGAV, which guarantees that a food supplement has been produced in an establishment legally authorised for that purpose. The FSC are intended for presentation to the competent authorities of an importing third country and are therefore issued only in the case of export.
This document is necessary when a third country (non-EU), to which a company wishes to export food supplements, so requires. Therefore, when a food business operator intends to export food supplements, it must first find out whether the country to which it is going to export requires this document and, if so, request it in advance.
The Free Sale Certificate is a single document and cannot be replicated. A certificate is issued for each product and one presentation.
FSC issuance is subject to a fee of €25.
1. How to Apply for a Free Sale Certificate
FSC requests are made by e-mail to the following email address email@example.com and shall be accompanied by the following documents:
a)Certificate Model completed in accordance with the requirements of the Competent Authorities of the Third Country.
b) Proof of payment of the relevant fee as referred to in point 2.
c) A copy of an official document showing that the manufacturing establishment is duly authorised for this purpose.
+ When the manufacturer is based in another Member State, the economic operator shall provide an official document issued by the Competent Authority of that MS. No FSC shall be issued for food supplements manufactured outside the EU.
This document may be issued in the following languages - Portuguese, English, French or Spanish. If the MS Authority issues the document in another language, the operator must also provide a translation into Portuguese, duly validated by the respective Consulate.
d) Proof of Notification*
* Note: If the notification was submitted prior to 01 October 2015, the operator shall update the details relating to the product/operator by sending the current notification table duly completed.
This model is intended for the correct indication of invoicing data. There is also a framework for the operator to check whether he has gathered all the necessary documents.
f) If the food supplement is not placed on the national market, the operator must send the Technical File of the product, issued by the manufacturer, dated and signed and duly authenticated. This document may be written in Portuguese, English, French or Spanish. If it is in another language, the DGAV may require a translation certified by the Consulate. Within the scope of an application for a Free Sale Certificate, the applicant assumes full responsibility for any erroneous, inaccurate or falsified information transmitted to the DGAV, including the guarantee that the authorisation for the manufacture of food supplements has not been revoked.
2 - Issuance of the Certificate – Operators registration
In order for the certificate to be issued, the operator must be registered in the SIPACE, a database under the responsibility of the DGAV, which has been drawn up with a view to gathering reliable information on companies in the agri-food sector. The updated information, collected in this way, contributes to a better response to the sector by the Administration, so that all operators are encouraged to register it, with no costs associated with the process. This procedure falls within the framework of official control and is therefore intended only for operators based in national territory. There are no costs associated with this registration.
3. How to proceed to pay for the issue of a Free Sale Certificate (FSC)
The amount is €25.00 per notified product and/or per country of destination, according to the Order No. 5165-A/2017.
Payment must be made by bank transfer according to the following information:
DGAV – DIRECTORATE GENERAL FOR FOOD AND VETERINARY (DIREÇÃO-GERAL DE ALIMENTAÇÃO E VETERINÁRIA)
0781 0112 0000000 778496
PT50 0781 0112 0000000 7784 96
The DGAV will send the receipt relating to the payment of the fee to the applicant's e-mail address.
4. Deadline for Issuance of the FSC
If the requested documents are compliant and there is no question about the product/process, the FSC will be issued within 10 working days. If it is necessary to request clarifications from the operator, the deadline for replying by the DGAV will be interrupted and will resume after the verification and validation of the above documents.
The certificate is validated by digital signature of the responsible person, and the document is sent to the operator by e-mail.
IMPORTANT NOTE: If the certificate cannot be issued for reasons attributable to the applicant, the amount charged shall be at the expense of the proceedings and shall not be refunded.
From 1 September 2018, only corrections to requests for FSC for food supplements will be accepted until the 3rd interaction with the Competent Authority. If the administrative and technical requirements established are not met, i.e. the operator does not collaborate in order to proactively correct the listed non-conformities, namely with regard to notification, the FSC will not be issued and the respective payment will be lost, and the fee will not be refunded.