The meeting was held to address the structural and ongoing issues experienced with the Ministry of Health in the licensing, renewal and inspection processes for biocidal products in Türkiye. The aim was to develop a solution strategy by evaluating the costs, bureaucracy and inconsistencies in implementation faced by the sector on a common ground.
The main topics discussed at the meeting can be summarised as follows.
Key Issues
- Legislation and Implementation Inconsistencies: Regulations adapted from EU legislation are implemented in different and unpredictable ways; distinctions between regulatory provisions are not observed, and comprehensive data is requested for each application. Frequent staff turnover leads to a loss of institutional memory.
- High Costs and Lengthy Processes: The treatment of licence renewals as ‘new applications’ incurs significant costs. Licence processes take 1.5–2 years instead of 3–6 months, causing companies to lose market share. Requests for tests of questionable scientific necessity further complicate the process.
- Bureaucratic and Communication Issues: The requirement for wet signatures, lack of online systems, irregular notifications, and uncertainty in file tracking slow down processes. The lack of regulatory and technical knowledge among ministry staff can block decision-making processes.
- Inspection and Unfair Competition: Inspections are mostly directed at registered companies, while unregistered products are not sufficiently inspected. There is a lack of information in provincial directorates; expansions without written justification are being made in practice.
- Approach Problem: The Ministry's approach to biocidal products, which is far from an industrial perspective and focused solely on ‘public health risks,’ makes it difficult to establish healthy dialogue with the sector.
Recommended Steps
- Compiling the problems experienced in the sector in writing with reference to the regulation articles and consolidating them under the TKSD umbrella.
- Initiating the organisation of a face-to-face workshop with the Ministry.
- Involving other ministries (Environment, Industry and Trade) in the process if necessary.
- Submitting a joint application signed by multiple industry associations.
- Establishing a common platform for continuous information sharing within the working group.
In the overall assessment, it was emphasised that the current practices create high costs, uncertainty and unfair competition for companies that comply with the legislation, and slow down the development of the sector.