Food supplements are foodstuffs intended to supplement the normal natural diet. They are concentrated sources of nutrients. They are not medicinal products, they are not intended for treatment of human diseases and that is why in their case it is misleading, deceptive and at the same time forbidden to state any information about prevention, treatment and healing of human diseases. Food supplements must not contain ingredients in quantities which are present in medicinal products, they must not contain narcotic, psychotropic substances and any other components, which are not safe, or in quantities which are not proved as safe. In case they contain “novel food” ingredients, these must comply with the Regulation (EC) No. 258/97.

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 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.“
 

On 1st January 2016 amendment of the Act No. 355/2007 Coll. of Laws on Protection, Promotion and Development of Public Health and on change and amendment to some acts in wording of later regulations (further only “Act 355/2007 Coll. of Laws”) came into effect, according to which current food supplements assessment activity completed by decision of the Public Health Authority of the Slovak Republic (further only PHA SR) according to § 13 of the Act No. 355/2007 Coll. of Laws is being replaced by notification duty of the applicant without issuance of decision of PHA SR. Into the Act 355/2007 Coll. of Laws a new duty for physical person – entrepreneur or legal person (food business operator responsible for placing of food supplement on the market in the Slovak Republic)– to submit to PHA SR notification on composition and labelling of food supplements or novel foods for placing on the market at the latest on day of its placing on the market of the Slovak Republic, as well as subject matter of administrative trespass for disobedience of this duty has been incorporated.

This means that since 1st January 2016, according to § 5 sec. 4 letter an) of the Act 355/2007 Coll. of Laws, each food business operator responsible for placing of food supplement on the market in the Slovak Republic (i.e. manufacturer, importer or distributor) has a notification obligation to the PHA SR through delivery of completed Notification on composition and labelling of food supplement on email address: This e-mail address is being protected from spambots. You need JavaScript enabled to view it Táto adresa je chránená pred robotmi nevyžiadanej pošty. Ak ju chcete vidieť, musíte mať povolený JavaScript. in format *. pdf. (not in formats: .XLS, .JPG, .DOC, .XLSX etc.). A completed Notification form must be saved on computer disk, completed in Adobe Acrobat Reader and send as an attachment of email. It must not be send in Adobe Acrobat Reader through the button Send form.

In one email message send only one completed Notification on composition and labelling of food supplement. As a subject of email message please state: VD_name of the product.

Last updated on: 4 February 2016
 

Notification form on composition and labelling of food supplement can be downloaded here: Registračný formulár . A  Notification form on composition and labelling of food supplement is continuously updated. Therefore it is necessary to send always the most recent version. 

Guidance for completing the Notification Form 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 in the amount of 50,00 €.

The system will generate a receipt attesting that the 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).

PAYMENT OF ADMINISTRATIVE FEE

Demand for payment of administrative fee, which is delivered as feedback information by email, is unique and serves only for coverage of transaction marked on Demand for payment, it is not possible to use payment data for repeated transaction.

Settlement of Demand for payment can be done in different ways:

-     through KIOSK using QR code stated in upper left corner of Demand for payment (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 Demand for payment including other payment instructions (variable, constant and specific symbol).

In case of payment from foreign account, E2E reference from Demand for payment needs to be mentioned in “Note”.

-     payment by postal order which is a part of Demand for payment,

-     payment at PHA SR cash desk (cash, cashless).

Proof of payment needs not to be sent to the PHA SR, this information will be displayed automatically in central system. 

Observe strictly due date stated in Demand for payment. In case of payment after due date stated in Demand for payment, or when the number of account is incorrect, or variable symbol is incorrect, fee will be automatically returned to you. 

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

Registered notifications on composition and labelling of food supplements towards 31.12. 2016*
*Food supplements are registered only after payment of administrative fee

Registered notifications on composition and labelling of food supplements towards 31. 12. 2017*
*Food supplements are registered only after payment of administrative fee

Registered notifications on composition and labelling of food supplements towards 31. 12. 2018*
*Food supplements are registered only after payment of administrative fee

Registered notifications on composition and labelling of food supplements towards  31. 12. 2019*
*Food supplements are registered only after payment of administrative fee

Registered notifications on composition and labelling of food supplements towards  31. 12. 2020*

Notifications on composition and labelling of food supplement can be sent on email address: This e-mail address is being protected from spambots. You need JavaScript enabled to view it only in *.pdf 

format.

In case of information about food supplements, please send questions on email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it Táto adresa je chránená pred robotmi nevyžiadanej pošty. Ak ju chcete vidieť, musíte mať povolený JavaScript. .

All available information is located on web page: www.uvzsr.sk, section Food supplements.