THE INSTRUCTIONS ON BIOCIDAL PRODUCT ANALYSIS AND AUTHORISED LABORATORIES HAS BEEN UPDATED!

Content addition date : 04-02-2021

Instructions on Biocidal Product Analysis and Authorised Laboratories which published on 28.01.2019 has been repealed; It has been published on 29.01.2021 to be replaced according to current scientific data and developments.

The analyzes initiated before the publication of this current instruction must be carried out in accordance with the "Instruction on Biocidal Product Analysis and Authorized Laboratories" dated 28.01.2019, and the new analyzes to be made after 29.01.2021 must be made according to this current instruction.

According to the updated instructions, some changes and regulations can be summarized as follows:

1.    The work and operations related to PT 1 and 19 products which are in direct contact with the human body were excluded from the scope of this instruction, and the mandatory organism table previously determined for PT 1 was removed from this instruction. The criteria for these product groups are expected to be determined by TITCK (Drugs and Medical Devices Institution Of Turkey - Management Of Cosmetic Products unit of the Ministry of Health), which evaluates the process.

2.    The list of standard methods for efficacy testing of preservative group products (PT 6-7-8-9-10-11-12-13) and the relevant link has been added as a reference in the scope of ECHA “Guidance on the BPR: Volume II Efficacy, Assessment + Evaluation (Part B+C)” document. It is stated that the relevant analyzes should be worked with the methods specified in the most up-to-date version of the reference publication and/or the provided by the manufacturer to be submitted to the Ministry and the methods in the efficiency and provisional application file.

3.    Test organisms and test methods for anti-fouling products (PT 21) are detailed. It is stated that the relevant products should be effective against one or more of the organisms included in Annex-19 of the instruction.

4.    The requirement for treated article analysis is included in the instruction. Accordingly, it was stated that the articles should be tested according to national/internationally accepted standards and labeled with an efficiency declaration according to the effectiveness value.

5.    It has been stated that accelerated stability and long-term stability will not be performed in systems that are in-situ generated and used directly without packaging, but physical, chemical and efficiency tests will be carried out.

6.    In cases where free radicals and/or ozone are declared as active substances, the criteria for efficiency analysis are detailed.

7.    The definition of biocidal products that do not contain active substances has been added to the instructions, and the criteria for their analysis are detailed.

8.    For product types 2-3-4-5, the SARS COV 2 organism is included in the instructions, optionally to be tested in all areas of use where claimed.

Link for announcement.

Link for Instructions on Biocidal Product Analysis and Authorised Laboratories.

Link for Official letter for Instructions on Biocidal Product Analysis and Authorised Laboratories.

Link for Authorised Laboritories.