Doruk Sistem - TURK / REACH
KKDIK(TURK REACH) FAQ
Frequently Asked Questions about KKDIK VI
10.1 When should the registrant 'Lead' company create the joint application in the GDS and is there a deadline for other members to confirm their membership in the joint application?
Companies that come together according to the MBDF Inquiry determine their roles as lead and member companies for the joint application. The Ministry has no role in this determination process. The lead company is obliged to enter the joint application record on the CDS and share the ‘registration number’ generated for the relevant record with the other member companies after the record is approved by the Ministry by making the necessary checks.
Member companies are obliged to indicate the registration number obtained from the lead company on the PDS when making joint applications for the same substance.
- The registration number received from the leader to verify membership in the GDS has a validity period;
- the firm must verify its membership of the common register before submitting its member file; and
- The firm must submit its own member dossier after the lead dossier, but before the relevant registration deadline (see FAQ 6.4).
10.2 How can I, as a member registrant, be aware that the co-registration file has been submitted by the registration leader?
The status of the approval of the joint registration file by the Ministry can be learned by the lead company through inquiries made using the ‘Submitted Items’ module on the CDS. Registration file in ‘Awaiting Approval’ status after submission of the registration to the Ministry,
After approval by the Ministry, the registration becomes ‘Approved’. The active status of the substance registration can be inquired by the registrant through the CDS. A member cannot obtain this information through the CDS as a registrant. The Ministry recommends that registrants make an agreement with their registrants specifying the issues they would like to be informed about by their lead registrants (e.g. about the submission of the lead file, etc.) and how this information will be provided (e-mail, mail, etc.).
10.3 Do registrants have to submit all data jointly?
Based on Article 12 of the KKDİK Regulation, which information should be submitted jointly for registration and which can be submitted is given in the Data Sharing Guidance Document Title 8.1-‘Overview of the technical file that can be submitted jointly for registration’.
Some information of the registration must be submitted jointly, while others must be submitted separately. There is also information that registrants can decide whether to submit jointly or separately according to the criteria defined in Article 12(3) of the KKDIK Regulation.
The following information should be submitted jointly:
- Information on labeling and classification of substances
- Comprehensive Study Summaries or Working Papers
- Indication of which of the information provided on classification and labeling, study summary and comprehensive study summaries has been reviewed by the evaluator.
In special cases where disclosure is required in the dossier, this data can be presented separately (see FAQs 10.4 and 10.5).
In addition, each registrant must separately submit the following information: identity of the manufacturer or importer, identity of the substance, information on manufacture and use(s), exposure information for substances in quantities between 1 and 10 tonnes, indication of which of the submitted information on manufacture and use has been reviewed by the assessor.
Registrants may decide whether the following information may be submitted jointly or separately Guidance on the safe use of the substance, the Chemical Safety Report where requested and information on which of the information submitted for the Chemical Safety Report has been reviewed by the assessor.
10.4 Can registrants submit the information in Article 11(a)(4), (6), (7) and (9) separately?
Under certain conditions set out in Article 11(3) of the KKDIK Regulation, registrants are allowed to submit the information in Article 11(a)(4), (6), (7) and (9) separately. Such ‘opt-out’ may include all or part of the information submitted by the registration leader on behalf of all members.
10.5 If I choose to disagree with all the information submitted by the lead registrant on behalf of registrant members, am I still submitting my dossier as part of the joint submission?
The KKDIK Regulation, in particular Article 12, is based on the principle of ‘one record for one substance’. In line with this principle, Article 12(3) of the KKDIK Regulation states that some information, but not the entire dossier, may be submitted separately under certain conditions. Thus, registrants who disagree with the information should submit their dossier as part of the joint submission even if they do not agree with all the information specified in Article 11(a)(4), (6), (7) and (9) (FAQ 10.3).
10.6 Can different classifications for a substance be included in a common registration dossier?
According to Article 25(2) of the KKDIK Regulation, one of the main purposes of the MBDF is to agree on classification and labeling when there is a difference between potential registrants on the classification and labeling of the substance. However, if all registrants agree, the registration leader may include different classifications of the substance in the common part of the registration dossier, e.g. if different impurity profiles lead to different classifications. In this case, registrants should leave the relevant sections of their member file blank to avoid ‘disagreeing’ with the classification and labeling of the substance.
If agreement cannot be reached between the registering members to include all the different classification information of the substance in the common part of the registration dossier, one or more of the registering members may decide to provide separate classification of their substances (by filling in the relevant sections in the member dossier), providing the necessary justification in accordance with Article 12(3). In addition, where the harmonized classification for a substance is in Annex 6 of the SEA Regulation, the harmonized classification and labeling should be used.
10.7 Does the joint registration file need to include all existing studies?
Yes. According to Annex 6 of the KKDIK Regulation, available and relevant physicochemical, toxicological and ecotoxicological information should be provided in the registration dossier. In practice, the registrant should select reliable, relevant and sufficient information after all available information has been collected and evaluated. Reliable study summaries should be provided for key studies; study summaries for supporting studies are sufficient.
Additional guidance on the collection and evaluation of information is provided in sections R.3 and R.4 of the Guidance on Information Requirements and Chemical Safety Assessment.
Further information on the reliability, relevance and adequacy of the information selected is provided in Implementing Guidance -4. Chapter 2.1.1 ‘Obligation to provide all available and relevant information’.
10.8 Can registrants involved in a joint application submit the same generic spectral data or chromatograms?
According to Article 12(1) of the KKDIK Regulation, detailed information on the identification of the substance referred to in Article 11(a)2, including spectral data and chromatograms, etc. should be submitted separately by each registrant of the joint application.
This information is important for the Ministry to check the ‘sameness’ of substances from different registrants. Generic spectral data and chromatograms should therefore not be used. Instead, each registrant involved in the joint application should submit specific spectral data and chromatograms for the substance they intend to register.
10.11 A firm successfully submitted its individual registration dossier and received a registration number without being a member of the common registry. If the company later updates its individual registration to become a member of the common registry, will it receive an invoice for this update?
Registrants of the same article must be part of a common register.
The Ministry will not charge an additional fee to the individual member of the joint submission if the company only wishes to connect to the relevant joint registration and does not update either its tonnage or its request for additional confidentiality subject to a fee.
Due to technical implementations in the CDS, the change from individual to collective registration requires registrants to update. The reason for the update is the change in tonnage.
11.1 According to which test method and standards should new tests be performed?
According to Article 13(3) of the KKDIK Regulation, new tests should be conducted in accordance with the Regulation on Test Methods for Determination of Physico-chemical, Toxicological and Ecotoxicological Properties of Substances and Mixtures. Furthermore, the use of various OECD Test Guidance Documents is required where EU Test Methods are not available for the standard information requirements set out in Annexes 7 to 10 of the KKDIK Regulation.
Article 14(3) of the KKDIK Regulation states that information can also be obtained using other test methods if the conditions listed in Annex 11 are met. These conditions include ensuring that the results are sufficient for the purpose of classification and labeling and/or risk assessment and that adequate and reliable documentation of the method applied is provided (See Annex 11 of the KKDIK Regulation for more information).
Furthermore, Article 14(4) of the KKDIK Regulation introduces specific requirements for ecotoxicological and toxicological tests. Ecotoxicological and toxicological tests should be carried out in accordance with the good laboratory practices stipulated by the Regulation on Principles of Good Laboratory Practices, Harmonization of Testing Units, Supervision of Good Laboratory Practices and Studies. For physico-chemical tests, the tests can also be performed in accordance with good laboratory practice (GLU) but are not mandatory.
The Information Requirements and Chemical Safety Assessment Guidance for PPEIK includes the specific Integrated Testing Strategy for each endpoint (e.g. aquatic, toxicity, mutagenicity) that should be consulted before new testing is carried out.
11.2 Are there other international test methods recognized by the Ministry and referred to in Article 14(3)?
Other international test methods recognized by the Ministry that meet the requirements of Article 14(3) are not currently available.
11.3 Are reference books and databases considered reliable sources of information for substance data?
In general, it is possible to use data from reliable, scientifically accepted literature and databases if the substance to be recorded and the substance defined in the reference are comparable in terms of properties such as homogeneity, impurities, particle size. References to literature or databases usually use secondary databases. When using such data, the original source must be cited and the data checked by an expert.
Some useful reference books and compilations containing expertly reviewed data are listed under each endpoint in the Guidance on Information Requirements and Chemical Safety Assessment, Section R.7a,b,c: Endpoint specific guidance is listed under each endpoint.
11.4 What is the OECD Mutual Acceptance of Data (MAD) system?
The OECD decision on the Mutual Acceptance of Data (MAD) ensures that data generated by testing chemical substances in OECD Member States in accordance with OECD test guidance documents and OECD ILU criteria are accepted in other Member States for the protection of human health and the environment. This system also covers non-OECD countries. Non-OECD countries have been requested to join the OECD ILU and the MAD system. Non-OECD member countries can be divided into two groups: 1. Fully committed countries to the OECD MAD system. 2. Countries provisionally affiliated to the OECD MAD system. Countries fully adhering to the OECD MAD system are required to accept data generated in OECD countries and other adhering countries under MAD conditions. In addition, non-clinical safety data developed in these countries must be accepted by the OECD and affiliated countries. Countries that are provisionally affiliated to the OECD MAD system must accept data generated in OECD member countries and other affiliated countries under MAD conditions. However, during the period of temporary affiliation, ILU monitoring activities carried out by the ILU Monitoring Authority in the country do not have to be accepted by members subject to the OECD MAD Decision.
11.5 Which studies does the Ministry recognize as ILU studies?
In general, the Ministry accepts as ILU data from (i) OECD member countries or full parties to the OECD Mutual Data Acceptance provisions and (ii) countries adhering to the provisions of the OECD MAD system and from laboratories jointly audited by the relevant ILU Monitoring Authority and the OECD ILU Monitoring Authority.
Studies carried out in a laboratory in a country not affiliated to the OECD MAD System may be accepted by the Ministry as compliant with ILU if the following conditions are met
- Laboratory compliance with ILU is checked prior to the performance of the study: other ILU Monitoring Authorities of OECD Member States, or from countries that are fully committed to the OECD Mutual Data Acceptance system on a case-by-case basis; and
- Laboratories that are found to be operated in accordance with ILU Principles.
11.6 Registrants submitting test proposals in accordance with Annexes 9 and 10 of the KKDIK Regulation may opt out of 28-day studies if they fulfill certain conditions. However, it is not possible to derive a Derived No Derived Effect Not Observed Level (DNEL) if there are no results for the 28-day repeated dose toxicity study due to a test offer for the 90-day repeated dose toxicity test. What interim risk management measures can be recommended for this situation?
Interim risk management measures are included in the Chemical Safety Report (Article 27 or 28 of PPEIK, in the form of an exposure scenario, or otherwise) and communicated to users of the substance. Such ‘risk management measures’ should describe how a substance should be handled in the appropriate way in the absence of adequate toxicological data and pending the results of recommended tests for long-term hazards.
Where a Derived No Observed Effect Level (DNEL) is not available, the registrant is expected to make a qualitative risk characterization, referring to the identified uses, expected exposure and demonstrating that the measures are adequate (based on available information) to control the risks. Typical risk management measures applicable to such situations are described in the Guidance on Information Requirements and Chemical Safety Assessment – Part E: Risk Characterization Table E. 3-1.
When hazard information on the substance is unavailable or insufficient, the registrant must demonstrate that the risks are controlled by minimizing the emission of and/or exposure to the substance. In doing so, it may use containment and/or contamination and/or Local Ventilation Exit and/or Personal Protection Equipment as temporary risk management measures to protect workers from exposure. Due to the temporary nature of the measures, Personal Protection Equipment may play a more important role compared to the recommendations in Table E.3.1 of the above guidance. The registrant may need to update the ‘chemical safety report’ and ‘exposure scenario’ when they receive the result of the test proposal and derive a DNEL (or determine that emissions/exposure should be minimized if ‘non-threshold’ effects were identified in the tests). This applies in particular where temporary measures are based on Personal Protection Equipment rather than containment or other engineering measures.
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