Frequently Asked Questions About KKDIK III

5.1 Will there be pre-registration?

There is no pre-registration similar to EU-REACH. In order to complete the pre-registration in KKDIK, the Classification and Labeling (S&E) notification of the substance must first be made and then the pre-MBDF registration must be completed. Pre-MBDF registration number can be defined as pre-registration number.

6.1 Who is required to register a substance?

Only natural or legal persons resident in Turkey can be ‘registrants’. Registration must be made by the person in question if the following criteria are met:

It is the companies importing from abroad that must fulfill the KKDIK Regulation obligation. However, the non-resident substance manufacturer or article manufacturer may decide to appoint a ‘Sole Representative’ to alleviate the obligations of importers. (See FAQ Title 2).

6.1.1 Who should register substances for contract manufacturing?

A contract manufacturer is a company that, at the request of a third party, produces a substance or a mixture of substances with its own technical means for an economic price. These substances are usually placed on the market by the third party. This structure is used, for example, as an intermediate step in the manufacturing process (distillation, centrifugation, etc.) that requires complex equipment.

According to the KKDIK Regulation, manufacturers manufacturing more than one ton per year are obliged to register. Therefore, the issue that brings to mind whether a natural or legal person should be registered is whether it manufactures a substance according to the definition in Article 4(p). In this context, an organization that manufactures a substance on behalf of a third party is deemed to be a manufacturer according to the KKDIK Regulation and is required to register accordingly. If the organization carrying out the manufacturing process is different from the organization that owns the production facility, one of these two organizations must register. Detailed information about the actors in the supply chain who are obliged to register and their responsibilities are given under the heading Registration Guide 1.5-Who should register?

6.2 Who is the registrant in multinational companies?

Where a group of companies consists of many natural or legal persons, each of them must determine whether they are defined as ‘registrant’ according to Article 4(ü) of the KKDIK Regulation. Sometimes international companies may have a sister company within the country. If the parent company’s subsidiaries are a separate legal entity from the parent company, then they may be ‘registrants’ under KKDIK. See FAQ Section 2 on who needs to register substances.

6.3 Which substances should be registered?

Registration is required for all substances, regardless of whether they are classified as hazardous or not, which meet the following conditions

If you want to know whether to register an item, you should first refer to the Registration Guide 1.6-‘What to Register’.

In this guide you will find definitions and explanations as well as information on substances exempt from registration.

6.3.1 Should I register alloys?

The KKDIK Regulation defines alloys as ‘mixtures’. Alloys should therefore be treated similarly to other mixtures under the Regulation, which means that the alloy is not subject to registration, but the elements (e.g. metals) that make up the alloy are subject to registration, regardless of the alloy’s manufacturing process. However, components that are not important for the properties of the alloy (i.e. that are part of a substance in the mixture) are treated as impurities and therefore do not need to be registered separately.

It should be noted that intermetallic compounds are mistakenly and commonly treated as alloys even though they have a well-defined mass equivalence. Such substances (e.g. ‘aluminum compounded with iron (1:1)’, ‘iron compounded with titanium (2:1)’, etc.) are listed in EINECS and cannot be considered mixtures. Intermetallic compounds must therefore be registered on their own. This means that separate registrations for Al and Fe do not cover substances such as ‘aluminum iron compound (1:1)’ or ‘aluminum iron compound (1:3)’. Separate registration is required for each intermetallic compound with a different metal ratio.

6.3.2 Should I register intermediates?

Whether registration is required depends on which definition of intermediate the substance meets in Article 4(c) of the KKDIK:

Non-isolated intermediates: The use of a substance as an unisolated intermediate is not liable under the Regulation.
Isolated-in-place intermediates: Manufacturers of in situ isolated intermediates in quantities of 1 tonne or more per year are required to register their substances (see FAQ 6.3 if their substances are not exempt from registration). However, if the manufacturer of in situ isolated intermediates confirms that the substance is manufactured and used under strict conditions in accordance with Article 17(3), it may provide less information than under Article 17(2).
Transported isolated intermediates: Manufacturers of isolated intermediates transported in quantities of 1 ton per year or more must register their substances, unless their substances are exempt from registration (see FAQ 6.3).

However, if the registrant confirms that it manufactures and/or uses the substance under strictly controlled conditions and declares that it has received confirmation from the user of the substance that the substance is used under strictly controlled conditions as defined in Article 18(4), it may submit reduced registration information according to 18(2) and 18(3). In this case, both the registrant and the user are responsible for their own declaration of the strict control conditions.

The Guidance for Intermediates explains how and when the registration provisions for intermediates under the KKDIK Regulation can be used.

6.3.3 If I use a process to extract substances found in nature, do I have to register the substance?

If substances found in nature are not classified as harmful according to the SEA Regulation or do not fall into the substance class of high concern such as PBT or vPvB substances, and have not undergone chemical change, they are exempt from registration according to Article 2 of the KKDIK Regulation and paragraph 8 of Annex 5. If it can be verified that the process applied to obtain the substance in question is one of the processes listed in Article 4(h), the substance is considered to be naturally occurring and registration is not required.

The processes listed in Article 4(h) of the KKDIK Regulation are manual, mechanical or gravity processes, such as dissolution in water, flotation, extraction with water, distillation by evaporation, heating to remove water and extraction from air. Note that extraction with substances other than water, such as hexane or ethanol, is not covered by Article 4(h). Substances extracted with these solvents are not exempt from registration under paragraph 8 of Annex 5 as substances found in nature.

For example, lavender oil is extracted from the flowers of certain species of lavender (in nature) by evaporative distillation. Subsequent natural oil and water separation allows the lavender oil to be easily separated. As this extraction process is mentioned in Article 4(h), lavender oil can be considered as a naturally occurring substance. In contrast, chrysanthemum (chrysanthemum) oil cannot be considered as a naturally occurring substance as it is dissolved in water and ethanol (1:10) from chrysanthemum buds in nature.

In general, it is the responsibility of the manufacturer to assess the process applied according to the definition in Article 4(h)

6.3.4 What falls under the definition of product and process oriented research and development (PPORD)?

According to Article 4(ll) of the KKDIK Regulation, PPORD is responsible for all scientific activities related to production trials or pilot facilities used to develop production processes and/or to test the application areas of the substance during the development of the product or the development of the substance on its own, in a mixture or in an article. defined as ‘development’.

Developing the substance in any scientific sense, such as improving the production process in a pilot plant or producing it on a large scale, or researching new application areas of the substance regardless of tonnage, is within the scope of PPORD.

In order to encourage innovations, Article 10 of the KKDIK Regulation; It clearly states that a substance manufactured, on its own or in a mixture, or contained in goods to be used for the purpose of PPORD, or contained in imported goods, is exempt from registration for 5 years. In order to be exempt from registration, the company must notify the Ministry of ÜSOAG. Upon request, the Ministry may extend this period for up to 5 years or 10 years for the development of medicinal products (for use in humans and animals) and products that have not been placed on the market before. You can find more detailed information in the Scientific Research and Development and Product and Process Oriented Research and Development Guide.

6.3.5 Do substances manufactured domestically but exported abroad need to be registered under the KKDIK Regulation?

Yes, according to Article 7 of the KKDIK Regulation, substances manufactured in quantities of 1 ton or more per year must be registered regardless of whether they will be exported abroad. Therefore, substances that are manufactured domestically in quantities of 1 ton or more per year and do not meet any of the conditions for exemption from registration specified in Article 2 of the Regulation and will be exported abroad later must be registered. The rationale for this obligation is that exposure from manufacturing and other activities before the substance is exported may affect workers and the environment abroad.

6.3.6 Do I need to register chemically surface-treated substances?

Surface treatment of matter is a two-dimensional modification of particles visible to the naked eye. The ‘two-dimensional change’ is a chemical reaction between the functional group of the particles visible to the naked eye and the substance used in the surface treatment. As can be seen from this definition, in this type of modification, a small part (the surface) of the visible particles reacts with the substance used in the surface treatment. In other words, the majority of the visible particles remain unchanged.

For this reason, chemically surface-treated substances cannot be considered as mixtures or defined according to the criteria in the Chemical Substance Nomenclature Guide within the scope of KKDIK, so they are not within the scope of registration.

For the same reason, chemically surface-treated substances are not reportable for EINECS and cannot be notified according to the SAE Regulation. Because the original substance (visible particles) and the chemicals used in the surface treatment have separate EINECS entries, the chemically surface-treated substance is included in the scope. This means that previous decisions will continue under the KKDIK Regulation. Based on the same grounds, chemically surface-treated substances are not registered under the KKDIK Regulation but the following conditions must be fulfilled:

There should be a record of the actual matter (macroscopic particles),
There must be a record of the chemical substance used in the surface treatment,
In the registration files of the substance used in the surface treatment and the actual substance (macroscopic particles), the surface treatment used must be described,
The risks or any particular hazards of the surface-treated substance should be covered in the classification and labeling, chemical safety assessment and resulting exposure scenarios.

6.3.7 Is there a registration obligation for substances used in medicinal products?

According to Article (2)(3)(a) of KKDIK Regulation; medicinal products used for human and animal health within the scope of ‘Regulation on Packaging and Labeling of Medicinal Products for Human Use’ and ‘Regulation on Veterinary Medicinal Products’ are exempted from the obligations under the KKDIK registration heading. More detailed information can be found in ‘Registration Guide’ 1.6.4.2 ‘Medicinal Products’.

Substances that meet the requirements of Article 2(3)(a) of the KKDIK Regulation are also exempted from the obligations under ‘Sub-Users’, ‘Assessment’ and ‘Authorization’ (Sections 5, 6 and 7).

Most importantly, these substances are exempted from these sections only when used in medicinal products in accordance with the ‘Regulation on Packaging and Labeling of Medicinal Products for Human Use’ and the ‘Regulation on Veterinary Medicinal Products’. There is no exemption for the use of these substances for other purposes.

This exemption covers products to be manufactured and exported domestically and the manufacture of active substances within the scope of the legislation on medicinal products to be exported. Intermediate products not included in medicinal products ‘Human

They are not exempt from registration as defined in the ‘Regulation on Packaging and Labeling of Medicinal Products’ and the ‘Regulation on Veterinary Medicinal Products’.

6.3.8 Can substances manufactured or imported before the relevant deadline for registration be placed on the market without registration after that date?

The answer to this question depends on the role of the legal entity to which the registration obligation applies.

Article 6 of the KKDİK Regulation states that ‘…substances shall not be manufactured or placed on the market unless they are registered in accordance with the relevant provisions under this Part’.

Articles 7, 8, 17 and 18 set out the obligation to register and specify to whom it applies. The Articles impose the obligation to register on manufacturers or importers (and in special cases on manufacturers or importers of articles), but not on downstream users, distributors or suppliers of substances. In principle, the manufacturer/importer can also be defined as a ‘substance supplier’ if it places the substance on the market.

6.3.9 Is a metal hydroxide synthesized from metal oxide covered by the registration exemption in paragraph 6 of Annex 5 of the KKDIK Regulation?

According to paragraph 6 of Annex 5 of the KKDIK Regulation, hydrates or hydrated ions of a substance (anhydrous form, etc.) that is registered by the manufacturer or importer of the substance are exempt from registration.

Hydrates of a substance are characterized by water molecules – in particular hydrogen bonds – linked by intermolecular movements to other molecules or ions of the substance. For the purpose of Annex 5, hydrates and anhydrous forms of compounds are considered to be the same substance (CuSO4.5H20 and CuSO4).

In contrast, metal hydroxide (e.g. Ca(OH)2) and metal oxide (e.g. CaO) should not be considered as the same substance if both substances have different structures, regardless of the manufacturing process. The formation of hydroxide – unlike the formation of a hydrate, which contains only weak molecular bonds – creates new covalent bonds. Therefore, metal hydroxide produced from metal oxide does not fall within the scope of the registration exemption in Annex 5 paragraph 6.

6.3.10 Are substances banned under ozone depleting substances subject to registration?

Yes. Ozone depleting substances covered by the Regulation on the Reduction of Substances that Deplete the Ozone Layer are not exempt from registration. FAQ 6.3 explains which substances need to be registered.

6.3.11 Does the registrant need to update the registration file each time a substance is imported from a manufacturer located outside Turkey?

There is no explicit legal obligation for the registrant to update the registration dossier each time it imports from a new source located outside Turkey. However, according to Article 22(1)(b) of the KKDIK Regulation, it is mandatory to update the composition of the substance as given in Annex 6 Part 2. The registrant has to verify the sameness of the substance each time it imports from a new source according to the ‘Guidance on Identification and Nomenclature of Substances’.

There are two possible outcomes of this assessment:

If the registrant demonstrates that the previously imported substance and the substance they are registering have the same impurity profile, they do not need to update the registration file for the substance.
If the registrant demonstrates that the previously imported substance and the substance registered by the registrant do not have the same impurity profile, the registrant shall update the relevant sections of the registration dossier for the substance (e.g. concentration range or change in classification and labeling sections) with the new composition of the substance.

6.3.12 A metal may form in a solution of a complex agent and a metal salt. This complex remains in aqueous solution and can never be separated. Should this complex be recorded?

According to Annex 5 Guidance document Annex 1: Ionic mixtures, ionic substances in solution are exempt from registration under the following conditions

Therefore, this exemption does not apply and the complex is subject to registration.

Registration is made according to the provisions of the Second Part of the KKDİK Regulation.

6.5 How to calculate tonnage?

Each registrant must calculate the annual tonnage for the registration file. Annual tonnage is calculated as the annual quantity per manufacturer/importer in Turkey unless otherwise stated. The quantity of substances manufactured/imported in Turkey for the last three years is the calculated annual average quantity of substances manufactured/imported over a period of the last 3 years (KKDIK Regulation, Article 4 (oö)). Detailed guidance and practical examples are given in the Registration Guide 1.6.2-‘Calculation of quantities to be registered’.

6.6 Can I register for a higher tonnage band than the actual tonnage of the item?

Yes, it is possible. Companies are free to register a substance for a tonnage range higher than its actual tonnage. This is stated in the Registration Guide 1.6.2.2.2-‘Calculation of total quantity’.

This section clarifies that companies are free to register for any tonnage range they wish. Registration for a higher tonnage range will require a higher registration fee. In addition, the technical file must contain all the information required for the tonnage range for which the substance is to be registered.

6.7 How do I register my articles and do I need any computer program?

All records must be made to the Ministry. The CDS provides an online service for data submission. For more information, please visit the Chemical Registration System page at http://online.cevre.gov.tr/ .

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