Sell cosmetics in Bulgaria: regulatory guide

• The Ministry of Health (Министерство на здравеопазването) is the competent authority for cosmetics under Regulation (EC) 1223/2009; Regional Health Inspectorates (RHIs) carry out territorial inspections.
• Bulgarian is mandatory for all Article 19(5) elements: nominal content, minimum durability date, warnings, product function, and the ingredient list; INCI names are exempt.
• No pre-market authorisation is required: a CPNP notification is the sole market-entry step, as in the rest of the EU.

1. The EU framework applies — notify once, sell everywhere

Bulgaria applies Regulation (EC) 1223/2009 directly — the harmonised rules that govern cosmetic products across the entire European Union. There is no parallel national regime: the safety, composition, and labelling rules are the same as in the rest of the EU.

In practice, selling in Bulgaria within the EU framework means meeting four common obligations that are not specific to this country:

• A single CPNP notification covers the entire EU market, including Bulgaria.
• A single EU-established Responsible Person is accountable for the product.
• A single product information file (PIF), which includes the cosmetic product safety report (CPSR).

This guide does not repeat that common framework — it focuses on what is specific to Bulgaria. For the cross-cutting concepts, see also what the CosIng database is and how to use it.

2. The national competent authority

The competent authority for cosmetic products in Bulgaria is the Ministry of Health (Министерство на здравеопазването), accessible at mh.government.bg. It applies Regulation 1223/2009 at the national level and serves as the designated contact point to the European Commission for cosmetovigilance and market control matters.

Territorial enforcement is carried out by the Regional Health Inspectorates (RHIs), present across the country. The RHIs are the front-line inspection bodies: they inspect establishments, verify labelling and PIF documentation, and can withdraw non-compliant products from the market.

For companies, this means the practical interlocutor during an inspection will be the RHI of the region where the product is sold or stored, rather than the central Ministry directly.

The Ministry of Health also issues health certificates for cosmetics intended for export — documents that certify EU regulatory compliance and are frequently required by customs authorities of importing countries outside the EU.

It is important to distinguish this structure from the Bulgarian Drug Agency (Изпълнителна агенция по лекарствата / IAL, bda.bg), whose mandate covers medicinal products and medical devices exclusively. The competent authority for cosmetics is the Ministry of Health.

3. Labelling language requirements

Bulgarian is mandatory in Bulgaria for all Article 19(5) elements of Regulation 1223/2009: nominal content, minimum durability date or period-after-opening (PAO), relevant warnings and precautions, product function, and the ingredient list.

In practice, the consumer-facing text on the packaging — usage instructions, safety warnings, and functional description — must be written in Bulgarian. For imported products, it is common for the importer or local distributor to apply an additional label or insert with the mandatory elements in Bulgarian.

INCI ingredient names are exempt from the language requirement: as internationally standardised nomenclature, they may appear in their original form without translation into Bulgarian. To verify ingredient composition and applicable restrictions under the annexes of Regulation 1223/2009, the CosIng database is the reference resource.

4. National particularities

No pre-market authorisation: CPNP is the sole entry step

Bulgaria does not require any additional national authorisation or registration before placing a cosmetic on the market. The CPNP notification is the only market-entry step, the same as in the rest of the EU. There is no parallel Bulgarian product register for cosmetics.

Territorial inspection through the RHIs

The most operationally relevant feature of the Bulgarian system is the organisation of market surveillance through the Regional Health Inspectorates (RHIs). These Ministry of Health bodies act as the first line of control: they inspect premises, review labelling and PIF documentation, and can initiate withdrawal procedures when Regulation 1223/2009 violations are found.

For businesses, this means maintaining a complete and accessible PIF — and ensuring Bulgarian-language labelling is in place before products reach retail — are the two most practical compliance priorities.

Health certificates for export

The Ministry of Health can issue health certificates for cosmetics destined for markets outside the EU. These documents certify that the product complies with current European regulation and are frequently required by customs authorities in importing countries.

Cosmetovigilance

Serious undesirable effect notifications under Article 23 of Regulation 1223/2009 are channelled through the Ministry of Health, which acts as the national contact point in the European cosmetovigilance system. Economic operators are required to notify the Ministry as soon as a serious undesirable effect is brought to their attention, without waiting for a causal link to be established with the product.

Labelling in practice

For imported products entering the Bulgarian market, the accepted approach is to add an additional Bulgarian-language label or insert that covers the mandatory Article 19(5) elements, without modifying the manufacturer's original packaging. The importer or distributor bears responsibility for ensuring this is in place before the product reaches the retail point. The RHI conducting an inspection will verify both the presence of Bulgarian-language mandatory information and the existence of an accessible PIF for the product.

For other markets in the region, see our guides to Czech Republic, Slovakia, Hungary, Romania, Croatia, and Slovenia.

5. Frequently asked questions

Which authority regulates cosmetics in Bulgaria? The Ministry of Health (Министерство на здравеопазването, mh.government.bg) is the competent authority for cosmetic products in Bulgaria. Regional Health Inspectorates (RHIs) carry out market inspections at the territorial level.

What language must cosmetic labels be in for Bulgaria? Bulgarian is mandatory for the Article 19(5) elements of Regulation 1223/2009: nominal content, minimum durability date, warnings, product function, and the ingredient list. INCI ingredient names are exempt as international nomenclature.

Do I need a separate notification for Bulgaria? No. A single CPNP notification covers the entire EU market, including Bulgaria. There is no additional national cosmetic product register.

Are there national particularities beyond Regulation 1223/2009? The Ministry of Health issues health certificates for cosmetics destined for export, and Regional Health Inspectorates conduct local market surveillance. No pre-market authorisation beyond the CPNP is required.