The "Communiqué on Biocidal Products without Active Substances" published in the Official Gazette dated August 2, 2013 and numbered 28726 has entered into force. Manufacturers or importers of "Biocidal Products without Active Substances" must notify the Ministry of Health, General Directorate of Public Health of Türkiye.
Applications for biocidal products that fall within the scope of product type 1 and product type 19 and come into direct contact with the human body are made to the Turkish Medicines and Medical Devices Agency (TİTCK) through the Product Tracking System (ÜTS).
Laboratories authorized to perform Biocidal Product analyzes by the Ministry of Health Turkish Public Health Authority are called "Authorized Laboratories". Biocidal Product analysis can only be performed in these laboratories.
For biocidal products, physical and chemical analysis, short-term stability, long-term stability, opened package stability tests (depending on product type) and efficacy tests must be carried out.
Concentrated products used to obtain Biocidal Product are called "Technical Substance". The Technical Substance itself is not used as a Biocidal Product. However, it is added to the formulation to obtain the Biocidal Product. For this reason, they are not evaluated within the scope of "Biocidal Products Regulation".
"Wet Wipes" are evaluated within the scope of Biocidal Product if they have antibacterial, hygienic or disinfectant properties.
On-site biocidal product is obtained by producing the active substance as a result of the reaction of one or more precursors directly at the place where it will be used. In accordance with the provisions of the Biocidal Products Regulation, a formulation that falls within the definition of a biocidal product and contains a precursor is licensed as a biocidal product. Method types are taken into consideration when licensing these products. There are 4 main method types. For detailed information, you can refer to ON-SITE PRODUCTION SYSTEMS INSTRUCTIONS.
In such cases, the intended use of the products is important. Products should be evaluated according to their intended use and usage category and it should be determined under which regulation the applications will be made.
Biocidal product manufacturers and importers must obtain a biocidal product license in order to place their biocidal products on the market. Applications must be made to the Turkish Medicines and Medical Devices Agency (TİTCK) via ÜTS for Product Type 1 and Product Type 19, and to the General Directorate of Public Health (HSGM) for other product types.
Biocidal Product analysis should be carried out in laboratories authorized by the Ministry of Health.
Notifications or license applications regarding biocidal product applications must be made to the Turkish Medicines and Medical Devices Agency (TİTCK) for Product Type 1 and Product Type 19, and to the Turkish Ministry of Health, General Directorate of Public Health (HSGM) for other product types.
Yes. There are 3 lists as follows named List A, List I and List IB. The active substances present in the Biocidal Products formulations should be in one of these lists. List A is constituted based on the “Under review” substances as to List I is constituted based on “Approved” substances by Commission Delegated Regulation (EU) No 1062/2014.
"Only Representative" has to be real or legal entity located within the borders of Turkey. The Only Representatives are obliged to fulfill the legal requirements for the importers.
According to the Biocidal Products Regulation, license applications can only be made by companies established in Turkey. The manufacturing company itself, its headquarters or branch must be established within the borders of Turkey. Companies that do not meet this condition can appoint an "Only Representative" established in Turkey for Biocidal Product applications. They can make the necessary applications regarding Biocidal Products through this "Only Representative" they have appointed.
Biocidal Products acquire these properties with special chemical substances present in their formulations. Chemical substances present in Biocidal Product's formulation and having activity against microorganisms are called "Active Substances".
Products that contain one or more active ingredients and are used to destroy, remove, render harmless, or prevent the effects of harmful organisms, especially microorganisms, or to create a controlling effect on them are called Biocidal Products.
The General Instruction dated 30.07.2018 and numbered 2018/3 on the Registration of Medical Devices. Cosmetic Products in the Product Tracking System (UTS) have been updated with the Instruction dated 21.10.2021 and 2021/1. Applications for biocidal products that directly contact the human body can also be received through UTS.In this context, UTS Biocidal Module studies for PT1 and PT19 biocidal products have been completed.
Risk assessment is the identification of all kinds of hazards, characteristics and effects that may occur on humans, animals, plants and the environment during the production, storage, packaging, marketing, import and export stages of biocidal products.
A risk assessment report should be prepared by taking into account the information in Annex VI of the Biocidal Products Regulation. The risk assessment report can be prepared by Chemical Assessment Experts.
The Risk Assessment report should consist of the following 4 main headings. Detailed information is provided in Annex VI.
After using the product, how much and how often the product is applied to the skin should be known. This information should be provided by the holder as the amount of product used per cm2 of skin, using a reliable calculation method.
In this context, the frequency of use (max. amount of product that can be used daily) determined due to the risk assessment should be stated on the label under Annex-XII of the Biocidal Products Regulation.
In the Regulation on Opening and Operating Licenses; It is defined as «Non-sanitary enterprises: It refers to establishments that cause or are likely to cause more or less damage to those around them in terms of biological, chemical, physical, spiritual and social aspects, or that may cause pollution of natural resources. »
In the relevant Regulation, while classifying non-sanitary establishments, information is given about the distance of the manufacturing facilities from the residences and other places for human habitation and the operating conditions. Accordingly, at least 2nd class GSM license (business license) should be obtained for disinfectant production.
In this respect, it is considered that sufficient conditions have been fulfilled while obtaining business licenses for biocidal production sites.
Pursuant to Article 27 of the Regulation on the Methods and Principles of Use of Biocidal Products, ‘’Biocidal Responsible Manager Training’’ is organized. Participants are required to have a bachelor’s degree in Medicine, Veterinary Medicine, Pharmacy, Chemistry, Engineering (Chemistry, Agriculture, Environment, Food, Aquaculture, Tobacco Technology), Biology or a master’s or doctorate degree in entomology, toxicology. In addition to the specified professional groups, the Council of State Tenth Chamber’s decision dated 10/2/2021 and numbered E.2019/10215 has deemed it appropriate for Bioengineering department graduates to participate in this training.
In Article 14 of the Biocidal Products Regulation;
It is stated that the notarized copy of the workplace and working license of the production site, the diploma of the manager to produce the production site, and the original or approved copies of the employment contract to be made with the manufacturer should be sent to the Ministry. If the companies that have contract manufacturing do not produce within their own structure, it is sufficient to have the GSM license (business license) and the documents of the production manager, which meet the conditions of the contract manufacturing site.
Types of licenses according to active substance types are specified in Article 8 of Biocidal Products Regulation:
a) Biocidal products containing a new active substance and evaluated active substances included in List-I or List-IA in terms of product types subject to the application are granted a license according to Article 12.
b) For a low-risk Biocidal product containing a new active substance and evaluated active substances in List-IA in terms of product types subject to application, registration is made under Article 13.
c) Biocidal products included in List-A but not included in List-I or List-IA lists, since there is no evaluation decision yet, containing an existing active substance, are registered according to Article 14.
ç) Biocidal products that need to be used for intervention in exceptional and emergencies are licensed and registered under Article 15.
d) For the frame formulation of Biocidal products, the main formulation has been licensed or registered before, licensing and registration are made according to Article 16.
TheBiocidal Products Regulation Article 22:
The obligation of the registration or registration holder to provide information
• Even if it is not requested, the license holder must submit to the Ministry, within thirty working days, new information about the Biocidal product and the changes in the following subjects, which may affect the continuity of the license or registration.
• New information on the effects of the active substance and biocidal product on humans, animals, and the environment,
• Any changes to the manufacturer of the active substance,
• Any changes in the composition of each active substance,
• Any changes in the composition of the biocidal product,
• The resistance development,
• Significant changes to the company, such as name, title, change of production manager,
• Information on other matters, such as the nature of the packaging.
Notifications of changes that do not cause a change in the licensed document/label:
Change of manufacturer of active substance/addition of manufacturer of the active substance
Whether a chemical in the active ingredient lists can be used as an auxiliary in the formulation of a biocidal product depends on the evaluation to be made. Information on the function used in the product and whether it contributes to its effectiveness should be submitted to the authority
Biocidal Products Regulation Article 20- «(2) The Ministry may request additional information and documents from the applicant if it deems necessary for the files. It gives the applicant a reasonable period depending on the nature of the requested information or document.»
In this context, the Ministry has the right to request all kinds of information depending on the nature of the application. If a component in the product composition is classified as “protective” or a different function but included in the active ingredient lists used in PT1 and PT19, evidence is requested that the said substances do not show biocidal activity.
The CAS and EC numbers of biocidal active substances should be included in the ECHA active substance lists. It will be sufficient for the manufacturer to cite alternative CAS and EC numbers for ingredients.
The Ministry does not require the production manager to sign the raw material’s SDS and packaging TDS.
Documents requested to be sent signed by the production manager:
• Production flow chart for manufactured products
• Product specification document
• 100% formulation of the product
• Product label samples
More than one production site can be declared for the biocidal product.
Under the Instruction on PT1 and PT19 Biocidal Product analysis, physical and chemical analyses and short-term stability tests should be made with the samples taken from each manufacturing site.
Address changes can be made for biocidal products whose licensing process is still ongoing, and the following documents must be attached to the application when applying for deficiency:
• Trade registry gazette showing the change of address
• The original or notarized copy of the changed workplace opening and operating license
• Application documents with updated address information (Annex-IIB, SDS, label samples)
For companies whose licensing process continues;
The following documents must be attached to the application:
For companies that are not in the licensing process;
Required information regarding the compatibility of the packaging material with the product::
• Types of packaging material,
• Technical data forms of the packaging material and analysis reports, if any,
• Study reports, if any, on whether the components used in the product interact with the packaging material,
• Physical observations on packaging material and product compatibility stability analyses,
• Manufacturer’s declaration of compatibility of the product with the packaging material.
The cosmetic products regulation is as follows; «In case the concentration of allergens exceeds 0.001% in unrinsed products and 0.01% in rinsed products, the presence of this substance must be specified in the “PRODUCT COMPONENTS” list mentioned in Article 10 (2)(f) of the Cosmetics Regulation.»
Since PT1 and TP19 biocidal products that come into direct contact with human skin are in a similar category with cosmetic products in terms of their target group and application area, if the allergens originating from perfume in the formulation are above the specified limits, they should be stated on the label.
It is listed as in the Turkey Biocidal Products Regulation Article 36 – «(3) will cause deception of the consumer regarding the purpose and qualities of the biocidal product and thus create an exaggerated impression of the product; It is forbidden to give false, misleading or incomplete information and to hide the true qualities of the product. In addition, expressions such as ‘low-risk biocidal product,’ ‘non-toxic,’ ‘unhazardous’ are prohibited on the label of the biocidal product.»
The statements that should be included in the label have been determined in Annex-XII of the Biocidal Products Regulation. The claims regarding the efficacy must be compatible with the biological/microbiological efficacy test results.
Biocidal products applied directly to the human body should not cause skin irritation, and irritation tests should already prove that the products don’t cause skin irritation.
Dermatological tests other than the irritation test are not included in the legislation. Different claims shouldn’t be specified on the label, except for the statements specified in the Biocidal Products Regulation Annex-XII.
For adding a nominal amount to the label;
Documentation Renewal Application is required, and the documents are:
• Registration certificate and originally approved label,
• Three current label samples with wet signature, approved by the production manager,
• Related documents with nominal amount updated (Annex-IIB etc.)
