Croatian food supplements are regulated not only by EU food supplement legislation, but also by specific national rules governing vitamins, minerals, botanicals and other substances that may be added to foods and food supplements.
A key piece of legislation is the Croatian bylaw on substances that may be added to food and used in food production, including substances whose use is prohibited or restricted. The regulation contains:
- Positive lists of permitted substances
- Negative lists of prohibited substances
- Maximum permitted daily intake limits for certain ingredients
- Specific conditions of use
- Mandatory warning statements for particular substances and botanicals
Products that fully comply with these requirements may generally follow the notification procedure with the Croatian Ministry of Health. If products are outside of these requirements, they would require an approval of Ministry before placing in the market.
The SISSI Platform Challenge for Foreign Companies
One of the unique characteristics of the Croatian notification system is the use of the SISSI (Central Information System of Sanitary Inspection) platform.
The Ministry requires notifications and applications to be submitted through the SISSI portal. Access to the system requires authorised responsible persons and Croatian e-Građani credentials.
For international manufacturers, this often becomes a practical obstacle:
- Foreign companies frequently do not have local personnel able to access the platform.
- Regulatory communication is conducted with Croatian authorities.
- Documentation must be prepared in accordance with Croatian requirements.
- Product labels must be assessed against both EU and Croatian-specific provisions.
Without local support, market entry can become unnecessarily complex.
How REGNOVA® Can Help
REGNOVA® provides a complete regulatory support service for food supplements entering the Croatian market, including:
Formula Compliance Assessment
We evaluate formulations against Croatian positive and negative lists, maximum permitted levels and national restrictions before notification.
Labelling Review and Localisation
We verify compliance with EU and Croatian labelling requirements, including mandatory warnings and specific information required for food supplements.
Advertising and Claims Compliance
We assess nutrition and health claims to help ensure marketing materials remain compliant with Croatian and EU legislation.
Product Notification and Ministry Procedures
We manage notifications through the Croatian system and support applications requiring Ministry of Health assessment.
Responsible Person Support
For international businesses, we can act as the local regulatory partner and coordinate the notification process and communication with Croatian authorities.
What Do You Need to Market a Supplement in Croatia?
A key practical requirement is that the product must have a food business operator established in Croatia, typically a local importer or distributor registered with the competent authorities.
Once an appropriate local structure is in place, regulatory compliance and notification can be managed efficiently with the right local expertise.
Planning to Launch a Food Supplement in Croatia?
REGNOVA® supports manufacturers, brand owners and distributors with practical regulatory solutions for the Croatian market, from initial formulation review through notification and post-launch compliance support.
Contact our team at www.regnova.eu to discuss your Croatian food supplement project and determine the most efficient route to market.