Frequently Asked Questions About KKDIK IV

6.8 How much is the registration fee?

The registration fee for an article varies depending on the registration tonnage, company size and type of presentation. There are lower fees and charges for joint registrations compared to separate registrations. Separate fees have been determined for each category of SMEs. However, an additional fee is charged for applications made for confidentiality requests in accordance with the provisions of the KKDIK Regulation.

Article 59 of the KKDİK Regulation contains basic provisions for fees. For the registration process, the fee specified in the unit price list to be applied in the revolving capital enterprise, published annually on the website of the Ministry, is paid.

6.9 Can a substance producer located outside Turkey register with KKDIK?

The obligation to register a substance applies only to actors resident in Turkey. Therefore, the registration of substances on their own, in mixtures or, in some cases, in goods to be imported into Turkey must be carried out by importers based in Turkey. This requires each importer to register the substance. However, according to Article 9(1) of the KKDIK Regulation, a substance manufacturer, a mixture formulator or an article manufacturer located outside Turkey may appoint a single representative to fulfill its obligations under the registration. This relieves Turkish importers from the obligation to register these substances in the supply chain involving manufacturers outside Turkey. They will be considered as downstream users of this single agent.

You can find further information on the duties of the Only Representative in Section 4 of this FAQ and under section 1.5.3.4 – ‘Only representative of the manufacturer established outside Turkey’ in the Registration Guide.

6.10 What are the options available to an importer of a mixture if it is unable to obtain information about the components of the mixture from its supplier?

The importer of the mixture must have information on the composition of the imported mixture in order to fulfill his registration obligation. Within the scope of the KKDIK Regulation, the importer must know at least the definition and percentage of all substances in the imported mixture that may exceed 1 ton/year.

If the supplier located outside Turkey is unwilling or unable to provide the required information, the importer has the following options:

6.11 Can a third party representative register?

No. According to Article 5 of the KKDIK Regulation, a manufacturer, importer or sub-user may appoint a third party for all transactions under Article 12, Article 19, Part 3 (Sharing Data and Avoiding Unnecessary Tests) and Article 44, including discussions with other manufacturers, importers and, where relevant, sub-users about compliance with the requirements under the Regulation. These operations do not include registration. Unlike the sole representative, the third party representative is only involved in negotiations between (potential) registrants, whereas the obligations of the appointing company under the KKDIK Regulation remain.

6.12 What are the duties of registrants in case they stop manufacturing and importing?

If a registration has been made for a substance, there is an obligation to update the registration (Article 22) and to keep the information (Article 32). This means that registrants terminating the manufacture or import of a substance must inform the Ministry about the new total tonnage (in this case 0 tons/year) manufactured or imported. In addition, the registrant must keep all available information that it needs to fulfill its duties under the KKDIK Regulation for a period of at least 10 years after the latest date on which the substance was manufactured, imported, supplied or used (alone or in a mixture). In this context, the ‘at least 10 years’ period is not started if the registrant has ceased manufacturing and importing but is still supplying and using the substance.

6.13 Does the registration of isolated intermediate in accordance with Article 17(2) or Article 18(2) have to be updated when the tonnage band changes?

A manufacturer or importer who has registered an isolated intermediate according to Article 17(2) or Article 18(2) is not generally required to update this registration if the tonnage band changes. Such a registration file should be updated if the tonnage band changes on two occasions.

Case 1: If the registration is for isolated intermediate transported and the threshold of 1000 tons/year has been reached, the registrant should update the registration by submitting the information specified in Annex 7 of the KKDIK Regulation, if it is not already included in the registration file.

Situation 2: The registrant should fulfill the responsibilities defined in FAQ 6.12, including updating the registration in the event that the registrant stops manufacturing and importing isolated intermediates.

6.14 How can the registration file be corrected if an error was made during the preparation of the file?

After submitting your registration dossier, you may realize that your registration dossier needs to be corrected or updated, except for reasons that require updating the registration according to Article 22 of the KKDIK Regulation. An example would be if you accidentally come across incorrect information in your dossier (such as incorrect information in one of the study summaries that does not affect the assessment for the substance) and realize this after submitting your dossier to the Ministry. In this case, you should update your dossier by indicating your natural reason(s) for the update in the dossier title, as well as the previous valid registration dossier submission references (e.g. ‘last submission number’). There will be no charge for such updates.

If this error causes the dossier to fail the conformity check, the dossier of record must be resubmitted in the same way as the initial dossier submission, instead of updating the submitted dossier.

6.15 What are the consequences if the submission of the registration dossier to the Ministry is rejected for a second time from the completeness check?

If the registrant fails for the second time to complete the file within the specified deadlines, the Ministry will reject the registration application and will not refund the registration fee. According to Article 7 of the KKDIK Regulation, substances cannot be manufactured or placed on the market unless they are registered.

6.16 Is there an obligation to stop the manufacture or import of the substance according to Article 21 of the KKDIK Regulation during the completeness check?

During the completeness check, there is no reason to stop the manufacture or import of the substance. However, if the initial submission for the registration of the substance is incomplete, the Ministry gives the registrant a deadline to complete the dossier. Until this deadline, the registrant is allowed to continue its activities. If the registrant updates the dossier, the manufacture or import of the substance may continue until the decision of the Ministry on the outcome of the completeness check is communicated. The registrant must stop the manufacture or import of the substance in the event of a decision to refuse registration.

6.17 Are the active substances in biocidal products given a registration number? Does the Ministry publish any information about these substances?

KKDIK does not assign registration numbers to active substances in biocidal products. The registration number is only given for substances whose registration files are submitted to the Ministry in full by the registrant according to Article 20 of the KKDIK Regulation.

Part of the European Commission’s information on information on active substances in biocidal products is available at http://ec.europa.eu/environment/biocides

6.18 Will the registrant need to update its registration if it decides to change its third-party agent and is there a fee for this?

In case the registrant changes the third party agent, the new third party agent will need to open an account with the CDS if he/she does not have an account. In case the third party agent changes, the registrant will follow the steps below to update the details of the third party agent:

Open the Chemical Registration System application at http://online.cevre.gov.tr and include the new third party representative in the company information section: Registrant company and add Third Party Representative here. If the registration file has not yet been submitted, a new third party representative is manually selected for each joint registration.

Since the inclusion of the third party representative in the registration file at the time of submission of the registration file is not required by the KKDİK Regulation, it is not legally required to update the third party representative related to the registration. Since updating the third party representative is at the registrant’s own initiative, Article 22 of the KKDIK Regulation does not include such an update.

However, if the registrant wishes to notify the change of third party representative for a specific registration when submitting an updated registration dossier for any of the reasons in Article 22 of the KKDIK Regulation, it may do so.

No fee required for updating the third party representative in the registration file

7.1 Do I have to register polymers?

Polymers do not need to be registered; however, according to Article 7(3), monomers and other chemicals in the polymer that have not been previously registered by an actor in the supply chain must be registered if both conditions given below are met (KKDIK Regulation, Article 7(3)):

The polymer contains 2% or more by weight of monomer substance(s) or other substance(s) in the form of monomer units and chemically bonded (i.e. free or unbound monomers will not be considered when checking whether this condition is fulfilled);
The total amount of monomer(s) or other substance(s) is one ton or more per year (in this context, the total amount is the total amount of monomer or other substance(s) in the final polymer, either unbound or chemically bound to the polymer).

In the KKDIK Regulation, monomer is defined in Article 4(gg) and polymer in Article 4(hh).

The Ministry may issue legal regulations imposing obligations for the registration of polymers when it establishes a practical and cost-effective way forward, based on sound technical and valid scientific grounds. Detailed guidance and practical examples are provided in the Technical Guidance for Monomers and Polymers

7.2 Can I register monomers as intermediates according to Article 17(2) or 18(2) of the KKDIK Regulation?

According to Article 7(2) of the KKDIK Regulation, the reduced registration requirements for on-site isolated intermediates and transported isolated intermediates do not apply to monomers. This means that the full registration dossier must be submitted even if the monomer is used as an intermediate under strict control conditions.

7.3 What is an impurity in a polymer?

An impurity in a polymer is defined as ‘an undesirable component present in the polymer produced’. The impurity may arise from starting materials, such as monomers or other reactants, or from incomplete or secondary reactions during the production process. The impurity is present in the final product but is not intentionally added. Examples of impurities in the polymer are unreacted monomers or other substances, residual polymerization catalyst, or impurities from the production process. Detailed information and definitions on how to handle impurities can be found in the Chemical Substance Nomenclature Guide, Chapter 4.2 – ‘Substances of well-defined composition’, Chapter 4.3 – ‘Substances of unknown or variable nature or complex reaction products or substances of biological materials’ and Chapter 5 – ‘Criteria for checking the identity of substances’.

7.4 What is an additive in a polymer?

Some substances are often added to polymers to improve or adjust the appearance and/or physico-chemical properties of polymeric materials.

According to the definition of substance in Article 4(çç) of the KKDİK Regulation, additives added to maintain the stability of the polymer are considered as a component of the polymer. Apart from this, other additives that do not bind to the polymer are not considered as an additive, but as a component of the mixture.

The importer of a polymer containing additives is not required to register the added additives, provided that they are intended to ensure the stability of the polymer. The substances contributing to the composition of the substance should therefore be fully identified. It should also be noted that there is a general obligation to register substances imported in a polymer blend of at least 1 ton per year. Detailed and practical examples are given in the Technical Guidance for Monomers and Polymers.

7.5 Apart from registration obligations, do I have any other obligations for polymers under the KKDIK Regulation?

Transmission of information along the supply chain (Chapter Four), authorization (Chapter Seven), restrictions (Chapter Eight) under the KKDIK Regulation are also applicable for polymers. More information on this subject is given under the headings 3.2.2-‘Application for authorization’, 3.2.3-3.2.3-‘Compliance with restrictions’, 3.2.4-‘Classification and labeling’ and 3.2.5-‘Transmission of information along the supply chain’ in the Technical Guidance for Monomers and Polymers.

7.6 Is there a registration obligation for manufacturers and importers of non-chemically modified natural polymers?

Natural polymers should be understood as polymers that are the result of a polymerization reaction occurring in nature, independent of extraction processes (i.e. they may or may not meet the criteria in the KKDIK Regulation). Following Article 2(7)(a) of the KKDIK Regulation

Any polymer that meets the criteria in Article 4(hh) of the KKDIK Regulation does not need to be registered.

According to Article 7(3) of the KKDIK Regulation, any polymer manufacturer or importer shall register monomer substances or other substance(s) that meet the criteria in the relevant article of the Regulation.

However, monomer substance(s) or other substances in the form of monomer units and chemically bound substances contained in natural polymers may, for practical reasons, be treated as ‘non-isolated intermediates’ and do not need to be registered.

7.7 Is there a registration obligation for manufacturers and importers of chemically modified natural polymers?

Following Article 2(7)(a) of the KKDIK Regulation, any polymer that meets the criteria in Article 4(hh) of the KKDIK Regulation does not need to be registered. This includes chemically modified natural polymers (e.g. post-treated natural polymers).

Monomer substance(s) or other substances in the form of monomer units and chemically bound substances contained in natural polymers can, for practical reasons, be treated as ‘non-isolated intermediates’ and do not need to be registered.

Substances used to chemically modify the natural polymer and chemically bound in the final polymer must be registered according to the KKDIK Regulation obligations.

7.8 The importer of polymers has an obligation to register a monomer or other substance chemically bonded to the polymer. Does the importer have to submit spectral data and chromatograms of the original substance used in the manufacture of the polymer?

Description. The record of the monomer or substance chemically bound to the polymer includes spectral data and chromatograms of the original monomer or other substance used in the manufacture of the polymer.

If this is not technically feasible or if it is not scientifically necessary to include this information, the reasons for this should be clearly stated. Generic spectral data or a generic chromatogram are not acceptable as they do not reflect the actual composition of the monomer or other substances used in the manufacture of the polymer. A company may import one type of polymer from different sources and therefore the monomer or other substances used in this polymer are likely to come from different sources. Even if the company imports the polymer from a single source, the monomer or other substances used in the production of the polymer may come from different sources. In such cases, the polymer importer is responsible for assessing whether the monomers or other substances from different sources are the same. If the importer considers that substances from different sources are the same, it must submit a single registration file containing a set of spectral data and a sample chromatogram of that substance. In this process, the company may find that the same substance from different sources contains different impurities. The company should therefore refer to these different components of the substance in the registration dossier.

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