Bosnia and Herzegovina: What to Do If You Need to Update Information for a Biocide Already on the Market?

If you're dealing with the distribution of biocides in Bosnia and Herzegovina, you're aware that there are specific obligations for this product category. Those in the Republic of Srpska, which pertain to the registration of biocides before they hit the market, are particularly important.

Once you've completed the so-called temporary registration currently conducted in the Republic of Srpska, you can freely distribute the biocide. It is assumed that you have prepared a safety data sheet and label, provided the user with adequate instructions for use, and other necessary information.

However, in practice, changes related to the product on the market often occur. These can be cosmetic (such as a label redesign) or substantial (such as a change in product formulation). Sometimes, the product name is changed for marketing or other reasons.

When such changes occur, the question arises of what needs to be done to ensure the product's continued distribution without obstacles.

The obligations of the biocide manufacturer or importer depend on the type of changes that have occurred. The most common changes are as follows:

• change in information about the manufacturer or importer,
• change in the biocide's name,
• change or addition to the composition,
• change in the status of the active substance,
• change or addition to the type of biocide (purpose),
• change or addition to the packaging method or size,
• change in the type of end-user,
• change in classification and hazard labeling,
• change regarding the product's efficiency.

These are changes you must notify the competent authority where the temporary registration was completed – the Ministry of Health and Social Welfare of the Republic of Srpska.

For administrative changes (e.g., information about the manufacturer or importer), you need to submit a smaller volume of documentation along with the notification of the change. Also, for such changes, it is usually sufficient to pay an administrative fee without a special charge for procedural costs.

For substantial changes such as a change in composition, you need to update the entire registration file. Based on the new data, the Ministry assesses whether the product still meets the criteria for efficiency and safety. A new efficiency test may be required for the new formulation. For changes of this type, in addition to the fee, a special charge for procedural costs must be paid.

Some changes, such as regular updates to the safety data sheet that do not affect the registration decision or the label, can be reported without paying a fee or charge, and sometimes even electronically.

Keep in mind that all changes must be reported before you place the product with altered characteristics on the market. The competent authority may require additional data alignment, such as the label, so you can only place the product on the market once all data is aligned.

Another very important thing: monitoring the validity periods of the registration decision. A biocide for which the registration decision has expired cannot be placed on the market. Therefore, regularly check the validity periods of the decisions.

If you are distributing biocides in the European Union, you might be interested in an article written by my colleague Tim Bencik about what to do when there is a change in the composition of a biocide.

If you need help or advice in preparing documentation for a biocide, write to me at nina.pajovic@bens-consulting.eu.