Doruk Sistem - TURK / REACH
KKDIK(TURK REACH) FAQ
Frequently Asked Questions about KKDIK VII
12.1 Are there any substances currently subject to authorization?
Yes, it does. KKDIK Regulation Annex 14 List of Authorized Substances includes several substances.
Substances are regularly included in Annex 14 by the Ministry. The current Annex 14 link is available on the Ministry’s website.
Detailed information on the procedure for inclusion of substances in Annex 14 of the KKDIK Regulation is available on the Ministry’s website in FAQ 12.4.
12.2 Where can I find the Candidate List of Substances of High Importance for Authorization?
The candidate list of substances of high concern for authorization is available on the Ministry’s website.
Additional substances are regularly included in the Candidate List when they are identified as ‘Substances of High Concern’.
12.3 How are substances included in the Candidate List of Substances of High Concern for Authorization?
When the Ministry is of the opinion that a substance can meet the criteria for a substance of high concern set out in Article 47 of the KKDIK Regulation, it prepares an Annex 15 file. With this Annex 15 file, the Ministry proposes that the substance in question be included in the Candidate List of Substances of High Concern for Authorization by outlining the scientific evidence for the identification of the substance as a substance of high concern.
Before making a decision, the Ministry publishes it on its website, clearly indicating the date of publication, so that all interested parties can comment within three months from the date of publication, in particular on the uses that should be exempted from authorization. The Ministry takes into account the comments received and makes its decision.
A ‘candidate list of substances subject to authorization’ is also available on the Ministry’s website to make it easier for interested parties to familiarize themselves with the substances that are being considered for Annex 15 dossier submission and to prepare in time to comment at later stages of the process.
When Annex 15 high-significance substances dossier is prepared, it is necessary to obtain opinions from the Relevant Organizations as specified in Article 49 of the KKDİK Regulation. Details on this consultation process are available on the Ministry’s website.
12.4 How is a substance moved from the candidate list of authorized substances to the Annex 14 list of authorized substances?
Substances in the candidate list of substances subject to authorization are prioritized and included in the list of substances subject to authorization in Annex 14 of the KKDIK Regulation. Substances included in the Permit List can only be used and / or placed on the market with a specific permit after a certain date.
Interested parties are invited to submit their views throughout the process. The Ministry then decides which of the proposed substances will be included in Annex 14, specifies transitional arrangements, exemptions where relevant, and review periods. Details on the procedure for inclusion of substances in Annex 14 of the KKDIK Regulation are available on the Ministry’s website.
12.5 How are authorizations granted for substances on the list of substances subject to authorization?
If the applicant wishes to use the substance without interruption after the restriction date, applications for authorization must be made by the deadline corresponding to the substance specified in this list.
Permit applications must be submitted to the Ministry. Third parties may provide information on alternative substances and technologies during consultation on the uses for which authorization is sought. These are available on the Ministry’s website. The Ministry conducts a Risk Assessment and Socio-economic Analysis and gives its opinion. The Ministry may commission the Risk Assessment and Socio-economic Analysis mentioned herein to third parties or committees of experts on the subject. The Risk Assessment and Socio-economic Analysis Committees shall submit their draft opinions on the applications. Applicants have the right to comment on these draft decisions. The Risk Assessment and Socio-economic Analysis Committees formulate their final opinions and submit them to the Ministry.
The Ministry takes a decision on granting or denying the permit and publishes the decision on the Ministry’s website.
Additional details on the implementation of the authorization procedure are available on the Ministry’s website.
12.6 In which language should permit applications be submitted to the Ministry?
Permit applications are made in Turkish.
12.7 Does the use of a substance listed in Annex 14 in a mixture below the concentrations specified in Article 46(6)(a) and (b) of the KKDIK Regulation require authorization?
Authorization is required for the use of a substance included in Annex 14, either alone or in a mixture. If the substance is used as is, this is a stand-alone use of the substance and Article 46(6) and (b) of the KKDIK Regulation does not apply. If the substance is used in a mixture, this exemption is applied according to the provisions of the KKDIK Regulation.
13.1 Can sub-users continue to use the unregistered substance?
Sub-users may use substances regardless of whether they are registered or not. In this context, use means any processing, formulation, consumption, storage, preservation, filling into containers, transferring from one container to another, mixing, production of articles or other activities. Placing on the market is not considered as use.
Note that certain requirements related to restriction, authorization and risk management may apply to the use of the substance (registered or unregistered). Guidance on how to comply with these requirements is provided in the Technical Guidance for Downstream Users.
13.2 Does the KKDİK Regulation require changes to be made to the Safety Data Sheet (SDS)?
Yes, according to Articles 27 and 28 of the KKDIK Regulation, some changes need to be made to the SDS. However, the duties and responsibilities for the SDS remain largely the same. Guidance for the preparation of Safety Data Sheets is given in Annex 2 of the KKDIK Regulation.
The list below summarizes the main changes:
- Risk management measures for human health and the environment for the identified uses will be summarized in SDS Section 8 (and 7). This includes communication of consumer-related measures to the downstream user producing mixtures or articles intended for the consumer. In addition, the relevant DNEL and Predicted No Effect Observed Concentration (PNEC) should be indicated there.
- The information on physicochemical properties, toxicology and eco-toxicology in the SDS should be updated in line with the information requirements in Annex 6 to Annex 11 of the KKDIK Regulation.
- The results of the PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative) assessment will be given in Section 12 of the SDS.
- The 'information on uses to be avoided' in Section 16 of the SDS should be updated depending on the results of the manufacturer's Chemical Safety Assessment.
- Where exposure scenarios are developed as a result of conducting a chemical safety assessment in accordance with Article 15 of the KKDIK Regulation, the 'exposure scenario' should be attached to the safety data sheet and communicated down the supply chain as appropriate. The information on the use of the substance in SDS heading 1.2 should be consistent with the short titles of the 'exposure scenario' in the annex, indicating which uses are covered by the exposure scenario.
- Since KKDIK requires waste disposal information to be included in the chemical safety assessment prepared by the manufacturers of the substance, Section 13 of the SDS may need to be updated with information on waste management specific to the substance in the exposure scenario. Another important change in the SDS is that for substances assessed as PBT or vPvB, the Safety Data Sheet is additionally required for substances likely to be included in Annex 14 of the KKDIK Regulation and also for mixtures containing these substances. Additional information can be found in the Technical Guidance on the Preparation of Safety Data Sheets on the Ministry's website https://kimyasallar.csb.gov.tr/rehber-dokumanlar/18. For consultation purposes, the Registration Guide is available under 3.1.1.1.-'Providing Safety Data Sheets to Customers'.
13.4 In which language should the Safety Data Sheet be prepared?
The SDS is provided in Turkish according to Article 27(5) of the KKDIK Regulation.
13.5 Employees of transportation companies may be exposed to chemicals (e.g. when loading and unloading chemicals or when installing or opening transfer pipelines). In such cases, should transportation companies be considered as downstream users?
The transportation of hazardous substances and mixtures by train, road, inland waterways, sea or air is outside the scope of the KKDIK Regulation (see Article 2(a)(4)). Transportation activities (including loading and unloading) by freight forwarders do not constitute ‘use’ under KKDIK.
Loading and unloading operations performed by the employees of the transportation company are within the scope of the legislation on the Transportation of Dangerous Goods and therefore outside the scope of the KKDIK Regulation. Activities carried out before loading and after unloading at the facility are mostly ‘uses’ that require exposure scenario and chemical safety assessment within the scope of KKDIK Regulation.
It is important to note that the transportation of substances and mixtures within the industrial facility is within the scope of the KKDIK Regulation, even if it is carried out by another company.
13.6 According to KKDIK Regulation, what information can sub-users convey to their suppliers in order to cooperate within the scope of registration preparation?
Sub-users may notify their suppliers in their supply chain before submitting a manufacturer or importer registration application in order to make their use a ‘designated use’. This is provided in Article 33(2) of the KKDIK Regulation. In order to make a use specified, the downstream user must provide the manufacturer, importer, downstream user or distributor supplying the substance with sufficient information to prepare an exposure scenario for its own use. It can be equivalently identified using the use identification system presented in document R12-‘Identification of uses’ in the Guidance on Information Requirements and Chemical Safety Assessment. This route does not require significant disclosure of technical details of the use.
In some cases, communicating uses up the supply chain can be done as a collective action in sectors coordinated by sector organizations. Where the company is not part of a trade association, or where very specific uses need to be specified, one-to-one communication between the sub-user and its supplier may be necessary.
More detailed information on when a use becomes a ‘designated use’ can be found in Chapter 8 of the Technical Guidance for Sub-Users.
13.7 When should the registration number be communicated to the downstream supply chain?
For a substance or mixture for which a SDS should be prepared according to Article 27 of the KKDİK Regulation, the registration number given according to Annex 2, Article 20 of the KKDİK Regulation must be given in the SDS.
Article 27(9) sets out specific situations in which an updated SDS should be provided without delay. The assignment of a registration number is not listed as one of these situations. However, in the case of the assignment of a registration number to a substance, which is one of the situations of most interest to downstream users, it is recommended that the updated SDS be provided to existing customers immediately or at the next delivery of the substance or mixture containing the substance. The SDS should be updated to include the registration number(s) for first-time customers of the substance or mixture. In particular, the last sentence of Article 27(10) stating that ‘each update of the registration shall include the registration number(s)’ should be taken into account. (Please note that Regulation (EU) No 453/2010 amending Annex 2 of the KKDIK Regulation contains many detailed provisions regarding the removal of part of the registration number (the last 4 digits of the original full registration number) corresponding to the individual registrant of a joint submission by the supplier acting as a downstream user or distributor).
Similarly, Article 28(1)(a) specifies when registration numbers should be communicated to customers according to Article 28 (Communication responsibilities for substances and mixtures not requiring SDS). The circumstances in which an update must be made without delay are set out in Article 28(3). Obtaining a registration number is not listed as one of the situations requiring an update of the SDS. For similar reasons, sending updated information can still be considered optional. Again, the last sentence of Article 28(4), ‘any update to the registration shall include the registration number’, should be taken into account.
The provisions of Articles 27 and 28 shall apply irrespective of whether the relevant registration dates have passed or not.
13.8 Does the Turkish supplier of substances and mixtures meeting the criteria of Article 27 of the KKDİK Regulation have a duty to provide a SDS compliant with this regulation to its non-resident customer?
According to the KKDIK Regulation, suppliers of substances and mixtures that meet the Article 27 criteria are not obliged to provide SDSs to their customers who are not resident in Turkey. Article 27(1) refers to ‘recipients of substances or mixtures’. Article 4(dd) of the KKDIK Regulation defines “recipient of a substance or mixture” as the distributor or downstream user to whom the substance or mixture is supplied. Both the downstream user and the distributor are natural or legal persons resident in Turkey in accordance with the definitions in Article 4(b) and Article 4(ğ) respectively. The obligation to provide a SDS under Article 27 of the KKDIK Regulation therefore only applies to purchasers of substances or mixtures resident in Turkey.
However, the obligation to provide a SDS compliant with the KKDIK Regulation to the non-resident customer in Turkey within the scope of exports may arise due to other legislation. For example, Article 16(3) of Regulation (EC) No 689/2008 on the export and import of hazardous chemicals implementing the Rotterdam Convention in the EU requires companies exporting certain hazardous chemicals under this Regulation to provide a SDS compliant with REACH.
13.9. Should the substance names in the SDS be in Turkish?
Yes. According to Article 27(5) of the KKDIK Regulation, SDSs are provided in Turkish. The names of these substances are already listed in Turkish in Annex 6 Part 3 of the SEA Regulation.
13.10. Is it possible to use the code translations in Annex 6 and Annex 7 of the SEA Regulation instead of the full classification in SDS Parts 2 and 3?
No, it is not possible. The full text of the hazard classification according to Section 2 of the SDS is written or hazard class and category codes can be used. If the full text is used, it must be in Turkish. If hazard classes and categories are to be used, it is important to note that the abbreviations for each hazard class should be codes that are not really translatable. The codes should thus remain as in SEA Annex 6 and Annex 7. If other abbreviations and acronyms are used, all wording and explanations should be given in Turkish in Section 16.Translated with DeepL.com (free version)
Codes for mixtures may be used in heading 3.2.3. as given in Annex 6 and Annex 7 of the SEA Regulation. Section 16 should contain the full description.
13.11. Is it necessary to communicate the notification number received when the substance is notified to the Classification and Labeling Inventory throughout the supply chain (SDS, label, etc.)?
No, manufacturers and importers are not obliged to inform downstream users that they have notified the Classification and Labeling inventory. In addition, downstream users are not required to obtain confirmation from suppliers further up the supply chain that substances have been notified to the Classification and Labeling inventory in order to continue using the substances in their products. Similar to the KKDIK registration number, the Classification and Labeling notification number is a document/proof of the importer’s/manufacturer’s notification for internal use. It does not need to be communicated to downstream users/distributors.
The notification number cannot be considered as the identity of the substance according to Article 20 of the SEA Regulation. It is not the inventory reference number published in the Classification and Labeling Inventory.
13.12. Can list numbers given to substances only with CAS Number or without a numerical identification code be used in the SDS?
Substances, i.e. substances that have been registered, queried or notified to the Classification and Labeling Inventory, are automatically assigned a list number with only the CAS number or without any numerical identification code. Unlike EINECS, ELINCS and NLP entries, list numbers and list inventories do not form the basis for legal acts or obligations and are not published in the Official Journal. Therefore, list numbers do not have the same significance as EC numbers and only share a common numerical format. Most importantly, the majority of list numbers and the substance description to which they relate are not checked for accuracy, approval or compliance with the Guidance on the Identification and Nomenclature of Substances under the KKDIK Regulation.
Industry is therefore advised not to use list numbers in their own documentation.
However, if the supplier wishes to include a list number in the document, e.g. in the safety data sheet, it must make it clear that this number is not an EC number and has no legal significance.
13.13 Do distributors/formulators of chemicals with multiple suppliers have to indicate all registration numbers in the SDS?
Distributors/formulators may not give the last 4 digits of the registration numbers of their suppliers in the SDS according to paragraphs 1.1 and 3.2.4 of Annex 2 of the KKDİK Regulation.
In case of joint registration, the first part of the item’s registration number is the same. Therefore, only one registration number needs to be included. However, if the registrant has not registered under the joint registration, the registration number will be different. Therefore, all relevant registration numbers must be indicated in the SDS.
13.14 Should the substance supplier, which is both the manufacturer and distributor of the same substance, provide the full registration number or the last four digits (missing registration number) in the SDS?
In this case, manufacturers are not allowed to omit the registration number, so they must indicate the full registration number (including the last four digits) in the SDS. However, if they are also distributors of the same substance manufactured by others and their own registration number is different from the first part of the registration number, e.g. if they or their suppliers are not registered under the joint registration, their suppliers must also indicate the missing registration number.
13.15 Article 27(9) of the KKDIK Regulation requires suppliers to update their SDSs without delay and provide them to the recipients of the substance or mixture they supply within 12 months. Does this obligation also apply to the substance or mixture in question that is not supplied?
Yes. The end of the supply of a substance or mixture does not exempt the supplier from compliance with the KKDIK Regulation or from communicating updated information in the supply chain. Therefore, the SDS with updated new information should be communicated by the supplier to all recipients of the substance or mixture within the following 12 months, as it may affect risk management measures or new information on hazards, authorization outcome or restriction process. The updated SDS should be provided by the supplier without delay. This task should be understood as the distribution of the SDS in written or electronic form.
13.16 Is it mandatory to ensure that registration numbers for recovered substances and substances included in Annex 4 and Annex 5 of the KKDIK Regulation are transmitted in the supply chain?
Substances included in Annex 4 and covered by Annex 5 are exempt from registration (Article 2(5) of the KKDIK Regulation). Annex 4 lists substances for which there is sufficient information that they are considered to be substances that may cause minimal risk to human health and the environment. Annex 5 includes 13 categories of substances for which registration is considered inappropriate or unnecessary if the specified conditions are met. Recovered substances that fulfill the conditions in Article 2(5) of KKDIK are also exempted from registration. The recovery operator who proves the sameness of the previously registered substance and is ‘knowledgeable’ according to Articles 27 and 28 of the KKDIK Regulation is exempt from the registration of the substance in question.
Manufacturers or importers under any of these exemptions are not required to submit a registration dossier. In such case, the manufacturer or importer will not be able to obtain a registration number and consequently will not be able to report a registration number in the supply chain. To avoid confusion, an explanation of why a registration number is not available may be provided in the safety data sheet as described in Title 4.1 of the Technical Guidance on the Preparation of Safety Data Sheets.
Companies wishing to benefit from such an exemption should assess the exemption criteria of their substances. They should also provide the appropriate information to the authorities upon request to demonstrate that their substances meet the exemption criteria.
More detailed information, including the information expected from suppliers, is available from key information sources that provide important information for buyers of substances under Article 2(5) of the KKDIK Regulation.
13.17 Where the Ministry authorizes the use of alternative names for registered substances in mixtures/mixtures, is there an obligation to report the registration number of this substance in the SDS?
No, there is no obligation to report the registration number for this substance in the SDS for mixtures/mixtures when an alternative name is authorized by the Ministry. Firstly, it should be noted that SDS heading 1.1, according to the Technical Guidance on the Preparation of Safety Data Sheets, only applies to substances and not to mixtures in the sense of publishing a registration number for product identification. Secondly, for registered substances contained in mixtures, it is a general requirement to give the registration number, EC number and other unambiguous chemical identifiers in SDS heading 3.2.4. However, if an alternative name has been given for the substance in the mixture according to Article 26 of SEA, only the alternative name should be given for the registered substance together with its classification.
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