Expression of abbreviation KKDIK Regulation is “Registration, Evaluation, Permission and Restriction of Chemicals”. The KKDIK Regulation is harmonized for the Turkish Industry as part of EU harmonization laws in Turkey to EU REACH Regulation.
"Communiqué on Biocidal Products without Active Substances" dated 2 August 2013 and numbered 28726 entered into force. "Biocidal Products without Active Substances" should be notified to the Ministry of Health via Biocidal Product Following up System.
As of December 31, 2023, only individuals with a Chemical Evaluation Specialist certificate are authorized to prepare safety data sheets.
Safety Data Sheets prepared for chemical products and substances to be sold in Turkey must be prepared in accordance with Annex 2 of the KKDİK Regulation.
In addition to its legal requirements, it is prepared to give information about the risks of the chemical product or the substance and to take measures against these risks.
The Product Following up System used by the Ministry of Health for the applications of Biocidal Products on the internet. Biocidal Product applications are made primarily via internet using Biocidal Product Following up System. The Turkish abbrevation of Biocidal Product Following up System is used as BUTs.
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.
Essential analyzes required by the Ministry for the Biocidal Product to be approved and passed to the analysis process; physical testing, chemical analysis, short-term stability study, long-term stability study, opened package stability study and efficacy tests against microorganisms declared for the product.
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.
These kind of Biocidal Products don't contain "active substance" in themselves. However, when such product(s) are mixed with another product(s), the Biocidal Product Active Substance is obtained. Such products are called "Precursors" and their intended use is to obtain Biocidal Products. For this reason, it is necessary to evaluate the precursors within the scope of Biocidal Product and make necessary applications to the Ministry of Health in Turkey.
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.
The Biocidal Products should be licensed or notified Ministry of Health in Turkey. The application process depends on the Biocidal Product’s product type. Some product types can only be licensed to be on the market, while some product types can be marketed within the borders of Turkey after the approval of the inventory notification.
Biocidal Product analysis should be carried out in laboratories authorized by the Ministry of Health.
Notifications or licensing applications for Biocidal Products should be submitted to T.C. Ministry of Health Turkey Public Health Institution.
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.
Biocidal Product Application shall be made to the Ministry by natural persons or legal entities which themselves, headquarters, branch or representatives established physically in Turkey. Companies based outside Turkey may appoint a Turkey-based "Only Representative" to take over the tasks and responsibilities of Biocidal Product Applications complying with regarding Regulation for Biocidal Product.
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".
KKDIK was published by the Ministry of Environment and Urbanisation on 23.06.2017. However, it entered into force on 23.12.2017 except for the dates of some exceptional provisions.
The KKDIK Regulation covers the use, manufacture and market supply of the substances in their own form or in a mixture or in articles.
Yes, "Regulation of Chemicals Inventory and Control (KEK)", No:27092 dated on 26.12.2008, has been repealed since the publication of the KKDIK Regulation.
With the draft KKDIK published in 2023, it was announced that there would be a change in the deadline for pre-registration. These dates will be determined within the framework of the Procedures and Principles to be published later.
For substances evaluated within the scope of KKDIK, the Pre-MBDF notification process would be carried out until 31.12.2020, and the registration procedures would be carried out between 31.12.2020 and 31.12.2023. It was announced that the registration dates would be extended with the KKDİK draft prepared in 2023.
"Detergent" is a general definition given to products used for industrial purposes such as liquids, solids, powders, molds and similar forms used in cleaning and washing, as well as for domestic use in the context of "Communiqué on Detergents and Surfactants Used in Detergents".
Detergent products are evaluated within the scope of "Communique on Detergents and Surfactants Used in Detergents’’ was Published by Customs and Trade Ministry with the number 28807 on 31 October 2013.
Products covered by "Detergents" or "Surfactants used in Detergents" should be notified to the Ministry of Customs and Commerce and approved by the Ministry. After approval of notification, "Detergents" or "Surfactants used in Detergents" can be on Turkish market.
"Surface Active Substances" or known as "Surfactants", are chemicals that, through chemical processes, remove pollutants or water-insoluble substances from the surface and prevent them from falling on the same surface again.
If a preservative is used in detergents according to the relevant Communiqué, this protective substance must be indicated on the product label with a special situation.
"International Nomenclature of Cosmetic Ingredients". The INCI name of the chemicals used is also used when preparing the Detergent Product Content Data Sheet.
It is a mandotory to prepare the "Technical Dossier of the Detergent Product" which has been notified to the Customs And Trade Ministry and approved by the Ministry. The "Technical Dossier of the Detergent Product" is not submitted to the Customs and Trade Ministry during the notification submission or then. This dossier should be present in the company durşng any audit performed by the Ministry.
Chemicals used in products such as detergents and which give cleaning properties to these detergent products, are called "Surface Active Substances".
Soap is not detergent in chemical and technical sense. However, within the context of "Communiqué on Detergents and Surfactants Used in Detergents’’ No.28807, "Detergent" means any liquid, powder, paste, bar, mold, molded product containing soaps and/or other surface active substances intended for use in washing and cleaning processes, any substance or mixture which may be present in any physical form, such as articles, parts, etc., and which can be supplied to the market for use at home, for institutional or industrial purposes".
Document that gives information about the contents of "Detergent" or "Surface Active Substances Used in Detergents".
Cleaning products or Auxiliary Wash Mix, Laundry Softener, Cleaning Mixture, Other Cleaning and Washing Mixtures are evaluated within the scope of Detergent category.
"Ingredient Data Sheet" is prepared for the notified detergent product. The company, which is the notification owner, is obliged to provide access for "Ingredient Data Sheet" via the internet. This document doesn't contain the amount of the ingredients in the product's formulation.
"Registration Certificate" is given for the first application made for the detergent products on behalf of the Applicant Company by the Ministry. The number given to this document by the Ministry is called "Notification Registration Number".
"Cleaning Product Containing Strong Acid/ Base" has at a certain amount strong acid or strong base in its formulation or/and with pH amount is less than 2 or more than 11.
"Detergent" and "Cleaning Products Containing Strong Acid/Base" are both used for washing and cleaning purposes. However, the presence and amount of the Strong Acid or Strong Base and/or product's pH range determines the product's category.
"Cleaning Products Containing Strong Acid/Base" should be notified to the Ministry of Customs and Trade. After approval of the notification by the Ministry, these products can be on the market in Turkey.
It is a mandotory to prepare the Technical Dossier of Cleaning Product Containing Strong Acid/ Base which has been notified to the Customs And Trade Ministry and approved by the Ministry. The Technical Dossier of the product is not submitted to the Customs and Trade Ministry during the notification submission or then.
"Technical Dossier of Cleaning Product Containing Strong Acid/ Base" is prepared after approval of the notification by the Ministry for the regarding product.
Technical Dossier of "Cleaning Product Containing Strong Acid/Base" should be prepared by “Notification Owner” and should be available in the company. Technical Dossier is not submitted to the Ministry.
This product group is evaluated under the scope of "Detergent" in EU.
Any updated information such as label of product, change of classification, company address, change of title, etc., should be notified to the Ministry of Customs and Trade.
"Cleaning Products Containing Strong Acid/Base" must be notified to MoCT and approved by the Ministry before they are put up for sale on Turkish market.
To regulate the administrative and technical procedures and principles related to the registration, evaluation, permission and restriction of chemicals in order to ensure high level of protection of human health and environment, to encourage alternative methods of assessing the harms of the substances, to increase competition and innovation.
The products used for the purpose of protecting the living assets, living areas of the living beings or the products which are in contact with them against various organisms, are called "Biocidal Products".
A Safety Data Sheet (SDS/MSDS) is a document that provides health and safety information about products, substances or chemicals that are classified as hazardous substances or dangerous goods.
Yes. In this case, the substance has 2 different supply chains. Each represented foreign company is selected, and two different pre-SIEFs and registrations are submitted.
a) Radioactive substances and mixtures within the scope of Safe Transportation of Radioactive Substances Regulation,
b) Substances, on their own, in a mixture or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re- exportation, or in transit;
c) Non-isolated intermediates;
d) The carriage of hazardous substances and hazardous mixtures by rail, road, inland waterway, sea or air;
e) Wastes within the scope of Waste Management Regulation and Radioactive Waste Management Regulation,
f) Substances and mixtures which are manufactured or imported for the purpose of defence
a) Medicinal products for human or veterinary use within the scope of Bylaw on the Licencing of Medicinal Products for Human Use, Bylaw on the Packaging and Labelling of Medicinal Products for Human Use and Bylaw on Veterinary Medicinal Products,
b) Food within the scope of the Bylaw on Turkish Food Codex,
c) Feeding stuffs within the scope of the Bylaw on Placing on the Market and Use of Feeding Stuffs,
d) Substances included in Annex 4,
e) Substances included in Annex 5,
f) The substance being re-imported is the same as the exported substance,
g) Previously registered recovered substance,
h) Polymers
Substances in cosmetic products have a registration obligation within the scope of KKDIK. However, they have reduced risk assessment requirements under KKDIK.
Active substances in plant protection products and biocidal products are considered registered
Any producer or importer of articles shall submit a registration to the Ministry through Chemicals Registration System on the website of Ministry for any substance contained in those articles, if both the following conditions are met:
- The substance is present in those articles in quantities totalling over one ton per producer or importer per year;
- The substance is intended to be released under normal or foreseeable conditions of use.
If both of the following conditions are met, the manufacturer or importer of the goods shall submit a registration application to the Ministry through the Chemicals Registration System on the Ministry's website for any substance in the goods:
· The quantity of the substance in the goods exceeds one ton per manufacturer or importer per year,
· The substance is intended to be released under normal or foreseeable conditions of use.
a) Technical file
(i) Identity of the manufacturer or importer
(ii) Identity of the substance,
(iii) Information on production and use, and, if applicable, exposure categories
(iv) Classification and labeling,
(v) Information on safe use
(vi) Summaries of studies on the intrinsic properties of the substances
(vii) Comprehensive summaries of studies on the intrinsic properties of the substances if necessary
(viii) Information that the above information has been reviewed by a Chemical Assessment Specialist (CAS)
(ix) Further test recommendations if deemed necessary
(x) Exposure information for substances between 1 and 10 tons
(xi) A request specifying which information should be considered confidential, with justification
(b) Chemical Safety Report (>10 tons)
Non-isolated intermediates; There are no obligations under KKDIK for the use of non-isolated intermediates (Article 2(2)(c)).
On-site and transported isolated intermediates; Manufacturers of on-site isolated intermediates in quantities of 1 ton or more annually must prepare a registration dossier unless exempted from registration conditions. However, those who will register on-site isolated intermediates may provide reduced registration information according to Article 17(2) of KKDIK if they declare under strict conditions that the substance is manufactured and used.
Polymers are exempt from registration and evaluation. However, registration of their monomers or other substances contained within is required under the following circumstances:
a) If the polymer consists of monomer units and contains at least 2% by weight of a chemically bound monomer or other substance,
b) If the total amount of the monomer or other substance is one ton or more annually.
Within 20 working days, the manufacturer or importer notifies the Ministry of the need for information. The Ministry allows system access for updates. By filling in the updated tonnage and the required information according to the updated tonnage, an update is made via the system. The Ministry charges a fee for tonnage updates.
a) IUPAC name,
b) If available, the name of the substance in EINECS,
c) Classification and labeling of the substance,
d) Data on physico-chemical properties and movement and behavior between environmental compartments,
e) Toxicological and ecotoxicological information,
f) DNEL or PNEC,
g) Safe use guide,
h) If requested under Annex 9 or Annex 10, analytical methods for the detection of a harmful substance in environmental compartments and for determining human exposure information.
The following information will not be made accessible when the Ministry provides valid justification that its publication would potentially be harmful to the commercial interests of the registrant or any other relevant party:
a) If mandatory for classification and labeling, the purity degree of the substance and the identity of impurities and/or known harmful additives,
b) The total tonnage range in which the substance is registered (1 to 10 tons, 10 to 100 tons, 100 to 1000 tons, or over 1000 tons),
c) Summaries of studies or comprehensive summaries,
d) Information contained in the safety data sheet other than the information listed in the first paragraph,
e) Commercial name(s) of the substance,
f) The IUPAC name of substances classified as harmful under Article 26 of the Regulation on the Classification, Labeling, and Packaging of Substances and Mixtures, used only as one or more of the following:
1. As an intermediate,
2. In scientific research and development,
3. In research and development focused on products and processes.
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 definition of the risk arising from the presence or use of a chemical or physical agent.
Risk Assessment consists of 4 main sections;
1. Hazard assessment
2. Dose-response assessment
3. Exposure assessment
4. Risk characterization
A risk assessment report should be prepared, considering the information in Annex-VI of the Biocidal Products Regulation.
• MoS calculations are made for cosmetics and pharmaceuticals, and MoE calculations are made for non-pharmaceutical products.
• The NOAEL values for the routes of exposure resulting from the use of the product should be taken into account.
For example, if it is a product with dermal use, using the NOAEL value for dermal exposure,
• If NOAEL value is available, subchronic and chronic NOAEL values can be used, but if they are not available, reproductive toxicity and developmental toxicity values, which have already been done in a long time, can also be used,
• If dermal absorption in humans is not known, 50% can be taken as in cosmetic products,
• Considering the properties of its active substances, oral exposure from hand to mouth can be neglected due to the volatility of ethanol.
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.
In the Biocidal Products Regulation; It refers to the chemical engineer, environmental engineer, chemist, biologist, veterinarian, and pharmacist responsible, together with the employer, for producing biocidal products or active substances under this Regulation.
In addition, there is not any requirement to have any 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.
Since active substance evaluation has not yet been carried out in our country, only active substances registered in ECHA lists (List-I and List IA and List A) can be used in biocidal products, and active substance manufacturers are not required to be an ECHA-approved producers.
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.)
SEA (CLP) Regulation is a regulation that regards the classification, labelling, and packaging of substances and mixtures. It is the adaptation of the European Union CLP Regulation to Turkish legislation.
The SEA (CLP) Regulation is aimed at ensuring the free circulation of substances, mixtures, and certain goods through proper classification, labelling, and packaging and to protect the environment and human health from the effects of these chemicals.
It covers issues such as the classification of substances and mixtures, labelling and packaging of harmful substances and mixtures, as well as the obligations arising accordingly for importers, exporters, downstream users, goods manufacturers and all relevant parties.
According to Articles 40 and 41 of the Regulation, substances subject to registration according to KKDİK (Turkey REACH) Regulation, substances classified as hazardous and mixtures containing these substances must be notified when placed on the market.
Packaging must be produced from durable materials to prevent the leakage of the substance or mixture inside, and the use of packaging designs that might mislead consumers should be avoided. SEA (CLP) Annex 2 should be reviewed for details on the preparation of packages.
According to SEA (CLP) Regulation Article 33, the label must be affixed horizontally to the face of the package and must be readable. The color of the label should be adjusted in a manner that does not affect the readability of the information on the label and this information should be written in a way that prevents it from being erased. For details regarding the preparation of chemical labels, SEA (CLP) Annex 1 should be reviewed.
According to SEA (CLP) Regulation, Article 19, chemical labels must contain the contact information of the supplier, the nominal amount of the substance and mixture in the packaging offered to the public (if not stated elsewhere), the identity of the substance and mixture, hazard pictograms, signal words, hazard statements, precautionary statements, and additional information section.
Labels of substances and mixtures that will be released to the market in Turkey must be prepared in Turkish. Besides Turkish, the same information can be given in additional different languages as well.
If the substance in question meets the criteria given in the first annex of the Regulation and the inclusion of the substance identity on the label or in the safety data sheets would be harmful in terms of the intellectual property rights of the relevant party, a request can be made through the Chemical Registration System (KKS) to use the functional chemical group name or an alternative name. The request is finalized six weeks after it is evaluated.
According to SEA (CLP) Regulation, Article 40, notifications must be made through Chemical Registration System (KKS). If substances are to be imported on their own or in mixtures, the importer may take the responsibility himself and do so through the Turkey representatives of natural persons or legal entities abroad resident.
In this case, there is no need to perform a notification again.
According to Article 41 of the SEA (CLP) Regulation, notifications must be made within one month after substances and mixtures are placed on the market.
Information used by the supplier for classification and labeling purposes must be collected and kept available for at least 10 years from the last date of supply. If the supplier ceases its activities, this liability belongs to the party to whom the supplier transfers its responsibilities.
No. The substance or mixture cannot be placed on the market without being classified, packaged, and labelled in accordance with the relevant provisions.
