Registration of food supplement

Everyone who places food supplement on the market is fully responsible both for its food safety and compliance with respective Slovak and EU legislation. This means that food supplement must comply with, besides general requirements of food legislation (Act No. 152/1995 Coll. of Laws on Foodstuffs as amended further, Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, legislation concerning particularly food additives, extraction solvents, flavourings, food enzymes, contaminants in foods, pesticide residues in foods, food contact materials, general labelling and especially labelling of allergens, general hygiene, microbiological criteria on foodstuffs and particular additives to foodstuffs and other legislation in this area) also requirements of Decree of Ministry of Agriculture of the Slovak Republic and Ministry of Health of the Slovak Republic No. 16826/2007- OL, issuing the 7th Chapter of the second part of the Codex Alimentarius of the Slovak Republic on Foodstuffs intended for Particular Nutritional Purposes and Food Supplements as amended further (further only „decree No. 16826/2007–OL“) and Commission Regulation (EC) No. 1170/2009, amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements as amended further. In case of using nutrition and health claims in labelling, promotion and advertising of mentioned food supplement you are obliged to follow requirements of Regulation (EC) No. 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods in valid wording. At the same time we would like to draw your attention to respect § 17 sec. 2 of decree No. 16826/2007–OL which states: „Labelling, presentation and advertisement on food supplements must not declare abilities such as prevention, treatment of human diseases or refer to such abilities.”

From 1 January 2016 according to § 5 sec. 4 letter an) of the Act No. 355/2007 Coll. of Laws on protection, promotion and development of public health and on change and amendment of some acts in wording of later regulations (further only Act No. 355/2007 Coll. of Laws) there is a duty for every operator responsible for placing of food supplement on the market in the Slovak Republic (i.e. manufacturer, importer or distributor) to notify Public Health Authority of the Slovak Republic by delivering Notification on composition and labelling of food supplements or novel foods at the latest on day of its placing on the market in the following ways:
 

Slovensko.sk
 

  1. Electronic submission through Central Government Portal – Slovensko.sk (in the left menu choose „všeobecná agenda“, typ poskytovateľa - „ Úrad verejného zdravotníctva SR“), type accompanying text and insert filled-out electronic form - then sign it through identity card or mandate certificate and send it through Slovensko.sk to the Public Health Authority of the Slovak Republic.
  2. Sending to the email address  oznamenie_vd@uvzsr.sk in the format *. pdf. with electronic authorization (electronic signature) (not in the formats: .XLS, .JPG, .DOC, .XLSX etc.). In subject line of the email state: „exact and complete name of the food supplement _notifier_exact and complete name of the firm including the form (e.g. Inc., Ltd.) which fulfils notification duty towards PHA SR (e.g. Vitamin C 100 mg _Anna Maja_ Citadela, Ltd. Nábrežná 3, Bratislava 50). In this case, PHA SR has an automatic responder  with the signature: "You have fulfiled the notification duty according to § 52 sec. 1 letter q) of the Act No. 355/2007 Coll. of Laws on protection, promotion and development of public health and on change and amendment of some acts. Your notification will be registered by PHA SR in the register of kept notifications on composition and labeling of food supplements. The form needs to be stored at the disk of computer, fill out in the program  Adobe Acrobat Reader and send as an enclosure inserted to the email, NOT in the Adobe Acrobat Reader via the button Send the form.
    Video instructions for signing of the document with electronic signature: directly in the pdf file:
    https://www.sslmentor.sk/napoveda/ako-podpisat-pdf-dokument or online
    https://www.youtube.com/watch?v=Xc3c2J0QQ_Q 
  3. In case of sending of the nonification without electronic authorization on email address   oznamenie_vd@uvzsr.sk (i.e. registration form in the format *. pdf.(not in the formats: .XLS, .JPG, .DOC, .XLSX a pod.). (Form needs to be saved on computer disk, fill out in the program Adobe Acrobat Reader and send as an enclosure inserted into the e-mail, NOT in Adobe Acrobat Reader via the button Send the form), it is needed to send to PHA SR via official mail also Amendment to notification signed by authorized person (sample of notification in writing pdf, 77 kB).

Only one Notification on composition and labelling of food supplement can be sent in one electronic notification. As a subject of the message please state: VD_name of the product. In case of the procedure according to the point 3  -  Amendment to notification signed by authorized person sent via official mail – more names of the notified food supplements can be stated.

After expiration of bank order (PP) it is needed to ask for issuance of the new bank order. As a Subject of the mail state: ž. o nový PP k č. ....../19... VD_name of the product.

Date of the last update: 22.08.2019
You can download Notification on composition and labelling of food supplement here: Registračný formulár  . The form Notification on composition and labelling of food supplement is continuously updated. That is why the latest version always needs to be sent.  

Guidance on filling of Notification on composition and labelling of food supplement

Registration of food supplement in register of food supplements is carried out only after payment of administrative fee according to the item 150 of the Enclosure to the Act No. 145/1995 Coll. of Laws on administrative fees in wording of later regulations and § 6 sec. 2 of the Act No. 145/1995 Coll. of Laws on administrative fees.
 
After processing of sent notification on composition and labelling of food supplement you will receive by email a receipt confirming that Public Health Authority of the Slovak Republic received your notification on composition and labelling of food supplement (§ 5 sec. 4 letter an) of the Act No. 355/2007 Coll. of Laws) and at the same you will be sent bank order with the file number.
 
Payment of bank order can be done in different ways:

  • through KIOSK using QR code stated in left upper corner of bank order (KIOSK for cashless transfer is located also on the ground floor of PHA SR building, opposite to the Registry),
  • transfer on bank account which is stated in bank order including other payment instructions (variable, constant and specific symbol).
    In case of payment from foreign account, E2E reference from bank order needs to be mentioned in „Note“. 
  • payment by postal order which is part of bank order,
  • payment at PHA SR cash desk (cash, cashless).

Proof of payment needs not to be sent to PHA SR, this information will be displayed automatically in central system. 
Observe strictly due date stated in bank order. In case of payment after due date stated in bank order, or when the number of account is incorrect, or variable symbol is incorrect, fee will be returned to you. https://www.posta.sk/sluzby/platobny-system-e-kolok.

Index of registered notifications on compoosition and labelling of food supplements is updated monthly, on the 5th day of the following calendar month. 

Registered notifications on composition and labelling of food supplements - towards 7 April 2021*
*food supplements are registered only after payment of administrative fee

Notifications on composition and labelling of food supplement can only be sent in the format (pdf), filled out in application Adobe Acrobat Reader, which you can download on this web page.

Please send your requests for information regarding food supplements on e-mail: hv@uvzsr.sk.