As of 1 January 2026, the process of placing on the market and use of biocidal products in Moldova is to be amended. A Government Decision introduces amendments to Decision No. 344/2020, which approved the Sanitary Regulation on the placing on the market and use of biocidal products. The changes align Moldovan legislation more closely with EU Regulation (EU) No 528/2012 on biocidal products, as last amended by Delegated Regulation (EU) 2024/1398.
This decision modernizes Moldova’s framework for the regulation of biocidal products, ensuring alignment with EU law, greater administrative efficiency through digitalization, and enhanced health and environmental safety controls. It represents another step toward regulatory harmonization in the context of Moldova’s EU integration process.
The Decision also specifies that it will cease to apply upon Moldova’s accession to the European Union.
Key Amendments
1. Harmonization with EU law
- The Regulation now explicitly references Regulation (EU) No 528/2012, incorporating its latest amendments.
- Terminology updated: “in the state language” is replaced with “in Romanian language”.
2. Institutional and procedural updates
- References to the former Minister of Health, Labour and Social Protection are replaced with Minister of Health.
- New definition added for “expert” — a qualified professional authorized to evaluate and report on the safety and quality of biocidal products.
- Online submission introduced for applications via www.servicii.gov.md or the NAOZ one-stop portal.
- NAOZ (National Agency for Public Health) must issue registration certificates within 60 working days after approval.
3. Simplified registration procedure (New Chapter IV¹)
- A new simplified registration procedure for low-risk biocidal products is established.
- Eligibility conditions include:
- Active substances are listed and approved by the Minister of Health.
- Product contains no hazardous substances or nanomaterials.
- Product is effective and safe to handle without protective equipment.
- Applicants submit documentation online; NAOZ issues certificates within 30 working days once documentation is complete.
4. Clarifications on exceptional and emergency registration
- Biocidal products may be temporarily authorized during public health emergencies, even if not all standard criteria are met, provided risk-reduction measures are applied.
5. Technical and safety requirements
- The format of the biocidal product characteristics summary is detailed — including composition, manufacturer information, uses, dosages, hazards, and disposal instructions.
- New rules for efficacy testing (must be conducted in accredited laboratories for disinfectants and related products).
- Ministry of Health will develop technical guidance for implementing these requirements.
- Provisions on maximum residue limits (MRLs) for active substances are updated to align with Moldovan and EU food safety regulations.
6. Safety data and risk management
- Safety Data Sheets must comply with Law No. 277/2018 on chemical substances.
- Serious health risks from biocidal products are to be managed and reported under Law No. 131/2012 (state control) and Law No. 162/2023 (market surveillance).
7. Administrative and linguistic corrections
- Obsolete references and outdated provisions (e.g., to repealed regulations) are removed.
- Several paragraphs and annex points are repealed for consistency with updated legislation.
Entry into Force
The amendments come into effect on January 1, 2026.