If you're involved in the production or marketing of biocides and are interested in the Montenegrin market, the latest updates might be of interest to you.
A new bylaw has been adopted that enables the beginning of the second phase of biocide registration – full authorization.
But let’s start from the beginning – let’s take a look at how the area of biocides is regulated in Montenegro.
The placing of biocides on the Montenegrin market is governed by the Law on Biocidal Products. The law is largely harmonized with Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products, although some differences do exist.
These mainly relate to the national registration procedure, i.e., the temporary registration of biocides. The lists of active substances are based on those established at the EU level, but they are adopted into national legislation with a certain delay compared to the EU.
Other conditions for placing biocides on the market (e.g., conditions for marketing, classification and labeling) are aligned with EU requirements.
Registration of biocidal products under the Law on Biocidal Products takes place in two phases:
- Entry into the Temporary List based on basic data (temporary registration), and
- Issuance of a permit based on a dossier (authorization).
The registration procedure is carried out by the Environmental Protection Agency of Montenegro, which also maintains the Register of Biocidal Products.
So far, the procedure has been based solely on the first phase – temporary registration. With the adoption of the Regulation on the amount of fees for the procedure of issuing permits for placing biocidal products on the market and for use, the set of bylaws has been completed, allowing for the implementation of authorization – the second phase of registration.
Let’s first look at the procedure for the first phase – entry into the Temporary List, which is based on the Rulebook on the contents of the technical dossier and basic data on the biocide.
This procedure is conducted for biocides already on the market or for products containing an active substance listed in the Review Program or on the list of permitted active substances.
The application for entry into the Temporary List is submitted by a manufacturer or importer of biocides based in Montenegro. The application must include basic data on the biocide, including the Safety Data Sheet for the product and active substances, label, and an efficacy test.
The fee for entry into the Temporary List is €100.00.
The second phase of registration is also carried out by the manufacturer or importer based in Montenegro. In this phase, a technical dossier for the biocide is submitted and evaluated by the Agency or a designated expert commission. The contents of the dossier are prescribed by the Rulebook on the contents of the technical dossier and basic data on the biocide. The authorization fee is €15,000.00 and is doubled for a group of biocidal products.
If the biocide is already registered in one of the EU countries, a procedure for recognition of a foreign permit is possible. In this procedure, instead of the dossier, a Product Assessment Report (PAR) and Summary of Product Characteristics (SPC) are submitted. The fee for recognition of an EU-issued permit is €2,300.00 and is doubled for a group of biocidal products.
It is important to note that a manufacturer or importer of biocides in Montenegro must have a permit for conducting the activity of manufacturing or marketing biocides, issued by the Environmental Protection Agency of Montenegro.
This procedure is based on the Rulebook on requirements regarding personnel, premises, and equipment for legal entities that professionally use biocidal products.
The manufacturer or importer must employ at least one person with appropriate higher education, under whose direct supervision the biocide-related activity is performed.
Also keep this in mind: Montenegro’s chemical legislation has also been harmonized with relevant EU chemical regulations (primarily REACH and CLP.
The Law on Chemicals defines provisions on the content of the Safety Data Sheet and classification and labeling of chemicals, which also apply to biocidal products.
If you need support in preparing for placing biocides on the Montenegrin market, feel free to contact me at nina.pajovic@bens-consulting.eu. Chemius enables the creation of Safety Data Sheets that meet the requirements of Montenegrin legislation.
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