EU Member States
As EU Member States, Croatia and Slovenia follow EU legislation, however, some national particularities remain.
National vertical legislation: Both countries maintain specific regulations setting detailed requirements for individual product categories (vertical legislation). Typically, a mutual recognition clause is included in such regulations, allowing deviation from the set requirements and legal denominations for goods lawfully produced in another EU Member State.
Non-regulated areas: Where EU law does not set requirements, local rules may still apply. One example is national legislation for food supplements, which includes national lists — in Slovenia, there is a list of authorized amino acids, whereas Croatia maintains a comprehensive list of authorized botanicals and other substances, along with corresponding limits and additional warning labelling statements.
For manufacturers, this means that EU compliance is a solid foundation, but verifying country-specific rules is essential before placing products on these markets.
Non-EU Western Balkans: Alignment in Progress
The rest of the Western Balkan region: Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia, and Serbia is at various stages of the EU accession process. These countries have adopted, or are in the process of adopting, food laws closely aligned with EU principles.
Despite this alignment, challenges persist: delayed transposition; EU rules may take years to be adopted nationally and divergent interpretation: local authorities may interpret EU-like provisions differently from their EU counterparts.
For global companies, this means that while legislation appears similar to EU law, local practice and implementation can differ significantly, affecting market access timelines and compliance strategies.
3 Key Regulatory Challenges in the Western Balkans
Food Labelling Requirements
Most Western Balkan countries have national food labelling rules modeled on EU Regulation 1169/2011. However, differences often arise in interpretation and enforcement. A recurring example concerns country of origin labelling. Although, according to national food labelling legislation, this information should be mandatory only in specific cases as defined in EU Regulation 1169/2011, some authorities in the region still request it for all products, invoking consumer protection legislation. As a result, companies may be asked to declare the finished product origin, which consequently requires indicating the primary ingredient origin if it differs from the finished product.
Vertical (Product-Specific) Legislation
Many Western Balkan countries — particularly those with legal frameworks inherited from the former Yugoslavia — maintain vertical legislation defining composition, quality, and legal denominations for numerous product categories. For instance, a product sold under a descriptive name in the EU may be required to use a specific legal denomination locally. Additional information may also be required on the label. Before market entry, companies should always review applicable vertical regulations to ensure compliance.
Health Claims and Novel Foods
While these countries only allow EU-authorized health claims and novel foods, several have introduced national registration procedures. This means that even if a health claim or novel food is used in line with EU legislation, additional local registration steps may be required, extending timelines and increasing costs. Expanding into the Western Balkans requires both EU-level understanding and local regulatory insight.
Need a hand turning complexity into a clean launch plan? REGULATORYA helps international brands navigate the Balkan markets end-to-end: formula and label reviews, multi-country registration strategies, dossier preparation and submission, authority dialogue, import classification, and post-market compliance. If you’re weighing market entry—or untangling an in-progress filing—let’s align your regulatory path with your growth goals.
This guide offers general information, not legal advice. Regulations evolve; for ingredient- and country-specific questions, consult a qualified regulatory expert.