Regulation on Non-Active Substance Biocidal Products and Technical File Requirements
In order to protect public health and prevent potential harm to the environment, the Regulation on Non-Active Substance Biocidal Products was published in the Official Gazette dated 02.08.2013 and numbered 28726 and entered into force. This Regulation covers biocidal products used for public health purposes that fall outside the scope of the Biocidal Products Regulation published in the Official Gazette dated 31.12.2009 and numbered 27449 (4th repetitive issue).
Purpose and Scope of the Regulation
The main objectives of the Regulation are to:
Prevent products used in the field of public health from causing harm to human health and the environment,
Ensure that such products are supplied to the public in a safe and high-quality manner,
Define the procedures and principles for notification to the General Directorate of Public Health prior to placing products on the market.
In addition, the Regulation sets out the information and documents required in the technical file of the products, as well as the principles governing market surveillance and inspection.
Technical File Content and Additional Information Requests
Under Annex-3 – Information Required in the Technical File of Products, Article eleven of the Regulation states that:
“Other information and documents deemed necessary by the Authority may be requested.”
This provision clearly establishes the Authority’s right to request additional information and documentation, emphasizing the need for a comprehensive and well-prepared technical file during the application process.
Biocidal Products Regulation and Guidance Documents
According to the Biocidal Products Regulation, which entered into force following its publication in the Official Gazette dated 31.12.2009 and numbered 27449 (4th repetitive issue), an important principle is set out in Article 6, paragraph 7 under the General Provisions. This provision states that:
In the preparation and evaluation of application dossiers, priority shall be given to the guidance documents published by the European Chemicals Agency (ECHA). Where these are insufficient, guidance documents issued by other international organizations shall be taken into consideration.
This approach ensures that national regulatory practices remain aligned with internationally accepted scientific and technical standards.
National Guidance Documents
In addition, the General Directorate has published several national guidance documents to be considered during the preparation of technical files, including:
Biocidal Product Physical Test Guidelines,
Chemical Test Guidelines,
Stability Test Guidelines,
Biological Efficacy and Toxicological Guidelines.
These documents constitute essential references for ensuring regulatory compliance and scientific adequacy.
Conclusion and Evaluation
When preparing technical files for products covered by the Regulation on Non-Active Substance Biocidal Products, it is of great importance to consider:
Relevant national legislation,
ECHA guidance documents,
International guidance documents, and
Technical guidelines published by the General Directorate
in a holistic and integrated manner. This approach not only facilitates a smooth application process but also contributes to the effective protection of public health and the environment.