What Changes Have Been Introduced with the Authority Approval on the Safe Use of Biocidal Products?

According to the announcement published on the website of the General Directorate of Public Health of the Ministry of Health of the Republic of Türkiye, the authority approval dated 6 January 2018 and numbered 19020089-111.99-E.118 has been repealed.

In line with scientific data, a new authority approval has been published stipulating that the evaluations of all biocidal products, including rodenticides used for mouse and rat control, shall be carried out by licence evaluation groups, and that separate label approvals shall be issued for multiple user groups.

The decisions adopted under the said Authority Approval are as follows:

Classification and Labelling of Rodenticides: It has become mandatory to classify mixtures containing the rodenticide active substance brodifacoum at concentrations of 0.003% or higher as Reproductive Toxicity Category 1A, and mixtures containing chlorophacinone, coumatetralyl, warfarin, bromadiolone, difenacoum, difetialone, and flocoumafen at concentrations of 0.003% or higher as Reproductive Toxicity Category 1B.
H360D Hazard Statement: It has become mandatory for mixtures containing these substances at or above the specified concentrations to include the hazard statement “May damage the unborn child” (H360D) on their labels.
Use of Secure Bait Stations: Rodenticides used for mouse and rat control must be designed so that they cannot be opened when supplied to the general public and must be placed within secure bait stations.
Establishment of Evaluation Groups: The following groups have been established for the assessment of biocidal products: “Chemical Assessment, Efficacy Assessment, Toxicology/Ecotoxicology Assessment, Administrative, Registration and Coordination.”
Publication of Guidelines and Instructions: The following documents have been published: “Biological Efficacy Laboratory Authorisation Instruction for Product Types 14-18-19,” “Guideline for the Assessment of Microbiological/Biological Analyses,” “Biocidal Product Physical, Chemical and Stability Test Analysis Guideline,” and “Biocidal Product Risk Assessment Guideline.”
Licence Evaluation Processes: It has been decided that the assessments of all biocidal products and active substances, including rodenticides, shall be carried out by the established licence assessment groups.
User Group–Specific Labelling: Separate label approvals have been mandated for different user groups such as the general public, professional users, and trained professional users.

You may click here to access the published “Authority Approval on the Safe Use of Biocidal Products.”

For further information and support regarding your biocidal products, you may contact us.