Montenegro and Serbia on EU list: what changes for companies operating with the Balkans

Key data

Spanish companies with commercial or contractual relationships in Montenegro and Serbia have relevant news since June 2026: both countries have been included in the list of third countries recognized in accordance with Article 17.1.b) of Delegated Regulation (EU) 2026/131. Implementing Regulation (EU) 2026/1228, published on 12 June 2026, amends Annex II of Implementing Regulation (EU) 2026/636 to incorporate this recognition.

In practical terms, this recognition implies that both countries meet requirements equivalent to those required in the European Union in the field regulated by the regulation. The direct result is the possibility of simplifying procedures and mutually recognizing certain certifications or authorizations between operators in these countries and their European counterparts.

What does this regulation establish?

Implementing Regulation 2026/1228 makes a specific and limited modification: it adds Montenegro and Serbia to Annex II of Implementing Regulation (EU) 2026/636. This annex contains the list of third countries or territories referred to in Article 17, paragraph 1, letter b), of Delegated Regulation (EU) 2026/131.

Inclusion in this list represents formal recognition that the regulatory frameworks of Montenegro and Serbia are equivalent to that of the EU in the field covered by Delegated Regulation 2026/131. This enables operators from these countries to access the European market on more favorable terms and allows mutual recognition of certain certifications or authorizations, without the need to duplicate verification procedures.

The political-regulatory context is relevant: both countries are official candidates for accession to the European Union and are part of the Western Balkans integration process. This measure is a direct consequence of the progressive regulatory convergence that accompanies that process.

Economic and operational impact

The main impact is a reduction in administrative burdens for companies that already operate or wish to operate with counterparts in Montenegro and Serbia. With regulatory equivalence recognized, certain verification, certification or authorization procedures that previously required specific processes for third countries can be simplified or eliminated.

From an operational perspective, the most relevant effects are:

• Simplification of procedures: Spanish operators working with Montenegrin or Serbian companies in the regulated field can benefit from more agile administrative procedures.
• Mutual recognition of certifications or authorizations: Certain accreditations issued in Montenegro or Serbia can be recognized in the EU without the need for complete revalidation.
• Reduction of entry barriers: Operators from both countries gain access to the European market on more favorable terms, which can increase competition in the affected sector.
• Review of existing contracts and agreements: Commercial or contractual relationships already in place with entities in these countries may benefit from the new status, which should be reviewed to take advantage of the benefits.

Who does it affect?

• Spanish and European companies that import products or services from Montenegro or Serbia in the field regulated by Delegated Regulation 2026/131.
• Operators that maintain contractual relationships with Montenegrin or Serbian entities and must manage cross-border certifications or authorizations.
• Companies that are considering initiating commercial operations with counterparts in the Western Balkans.
• Legal advisors and compliance officers who manage regulatory compliance in international operations with these countries.
• Montenegrin and Serbian operators who want to access the European market, as their new recognized status facilitates that access.

Practical example

A Spanish company in the regulated sector that previously imported products or services from Serbia had to subject its Serbian counterparts to specific verification processes for unrecognized third countries, possibly including the submission of additional documentation or obtaining specific authorizations for the European market.

Following the entry into force of Implementing Regulation (EU) 2026/1228, Serbia is recognized as a country with requirements equivalent to those of the EU. This means that Spanish company can review its internal due diligence and compliance procedures for this commercial relationship: certifications or authorizations issued by Serbian authorities in the field of Delegated Regulation 2026/131 can be recognized directly, without the need to duplicate the verification process. The result is a saving of time and administrative costs in each operation.

The same reasoning applies to operations with counterparts in Montenegro.

What should companies do now?

1. Identify if you have commercial or contractual relationships with entities in Montenegro or Serbia in the field covered by Delegated Regulation (EU) 2026/131. If so, this regulation directly affects you.
2. Review the verification and certification procedures that you currently apply to your Montenegrin and Serbian counterparts. Determine which ones can be simplified thanks to the recognition of equivalence.
3. Consult with your legal advisor or compliance officer if existing contracts or agreements with entities from these countries include clauses that should be updated to reflect the new regulatory status.
4. Evaluate new business opportunities with operators from Montenegro and Serbia, given that administrative barriers to entry to the European market are reduced for them, which can generate new suppliers or potential partners.
5. Monitor the entry into force date of Regulation 2026/1228, which has not been specified in the published text, to activate operational changes at the appropriate time.

Official source

Consult full regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601228