Regarding the regulation of tasks and procedures in the licensing processes of Biocidal Products and the use of auxiliary active substances in Biocidal products, an Official Approval has been published.

About the Published Official Approval

Tasks and procedures related to the licensing of Biocidal Products are carried out in accordance with the provisions of the Biocidal Products Regulation, which was published in the Official Gazette dated December 31, 2009, and numbered 27449 (4th repeated issue).

The licensing processes for biocidal products are conducted according to the Official Approval dated 25/05/2021 and numbered E-19020089-105.99-2217, and the processes related to auxiliary substances that are mandatorily used as pH regulators, preservatives, stabilizers, or fillers in some products are carried out according to the Official Approval dated 26/12/2015 and numbered E-19020089-020-9604.

In order to ensure uniformity in the application of tasks and procedures related to licensing, the Official Approval dated 10.03.2022 and numbered E-19020089-819-1014 has been published, with the provisions of the Official Approvals remaining in effect. Accordingly:

1- With the amendment made in the Official Gazette dated 30.12.2021, the preliminary application has been abolished, and the test methods and principles are explained in paragraphs 3, 4, and 5 of Article 6 of the Regulation, which explains the analysis methods. In accordance with these provisions, the company applying for licensing must deliver product samples to the laboratory for analysis and submit the results along with the information and documents required in Article 14 of the Biocidal Products Regulation, the Annex-IIA and Annex-IIB files, and the technical file prepared to the Authority. If these analyses are conducted in foreign laboratories, provided they meet the conditions in the aforementioned article provisions, the license applications will be accepted.

2- The Biocidal Product License extension procedure will be carried out according to the regulations in the Official Approval dated 10.03.2022 and numbered E-19020089-819-1014, and the following Table.

License Issuance Date	License Validity Period	Time for License Renewal
02.01.2015 – 30.12.2016	31.12.2022	03.01.2022 – 30.12.2022
02.01.2017 – 29.12.2017	31.12.2023	02.01.2023 – 29.12.2023
01.01.2018 – 31.12.2018	31.12.2024	02.01.2024 – 31.12.2024
02.01.2019 – 31.12.2019	31.12.2025	02.01.2025 – 31.12.2025
01.01.2020 – 31.12.2020	31.12.2026	02.01.2026 – 31.12.2026
04.01.2021 – 31.05.2021	31.12.2027	04.01.2027 – 31.12.2027
01.06.2021 – 31.12.2021	Determined based on stability tests and the list of active substances.

3- When an active substance is used as an auxiliary substance:

a) If the active substance used as an auxiliary in a biocidal product is defined as an active substance in the relevant product type and/or in a different product type within the same group:

i) Technical explanations that the amount used does not contribute to the efficacy of the product,

ii) Literature information will be required.

Based on the provided information and documents, if it is understood that the auxiliary substance in the product contributes to efficacy, the auxiliary substance will be evaluated as an active substance. If it is understood that the auxiliary substance does not contribute to biocidal efficacy at the relevant concentration, chemical analyses related to the substance will be required.

b) If former active substances, which were included in the annexes of the Biocidal Products Regulation and later removed from the list of active substances, are used as auxiliary substances:

i) Submission of an evaluation report explaining the reasons for removal of the relevant active substance from the ECHA list,

ii) Scientific explanations that the amount used does not contribute to biocidal efficacy,

iii) Literature information will be required.

Based on the provided information and documents, if it is determined that the substance is used only as an auxiliary substance in the product, the licensing process will be carried out based on the active substance in the formulation, and no action will be taken regarding the auxiliary substance.