- General remarks
(1) Parts II and III of the KKDIK Regulation contain provisions requiring chemical manufacturers and importers to share data and jointly submit information to the Ministry of Environment, Urbanisation and Climate Change (i.e. the Ministry).
(2) As the deadline for registrations is approaching and according to the experience gained since the beginning of the registrations, information received directly from stakeholders and through various KKDIK evaluation meetings organised or attended by the Ministry, it is experienced that the provisions of the KKDIK Regulation on data sharing and joint submission are not used to their full potential and their implementation falls short of expectations. This situation is particularly disadvantageous for small and medium sized enterprises.
(3) For the effective functioning of data sharing under the KKDIK Regulation, good management practices should be encouraged and the effective functioning of agreements on the sharing of such data should be ensured. Therefore, for the effective implementation of data sharing, the rules set out in this document and the “Data Sharing Guidelines” should be applied.
(4) Pursuant to Articles 12(1), 19(1), 24(4) and 26(1) of the KKDIK Regulation, costs related to sharing and joint submission of information should be determined in a fair, transparent and non-discriminatory manner.
(5) It should be clarified that, in accordance with Articles 24(4) and 26(1) of the KKDIK Regulation, both administrative costs and costs related to information requirements should be shared where they relate to information in the registration dossier that a party is obliged to submit under the KKDIK Regulation. Costs related to information requirements include any costs that are necessary for an existing study or for conducting a new study, whether related to the preparation of the required specifications, contracting with a laboratory or monitoring its performance. These costs also include the costs of fulfilling a KKDIK information requirement that does not include test studies.
(6) To ensure that data are shared in a transparent and effective manner, all agreements for data sharing for the purposes of the KKDIK Regulation should be structured in such a way that all relevant costs are clearly identified and identifiable. However, if all parties to existing data sharing agreements are satisfied with the functioning of such agreements, it is possible to waive the obligation of itemising costs if all parties give their consent.
(7) To ensure that the costs of data sharing are justified and adequately distributed among the parties to a data sharing agreement, annual records should be kept of the costs incurred and compensation received by those parties. Under Articles 24(4) and 26(1) of the KKDIK Regulation, parties to existing data sharing agreements should make every effort to establish evidence of costs already incurred.
(8) To ensure consistency with Article 23(3) of the KKDIK Regulation and to ensure that the cost of any study that may be subject to a data sharing agreement is documented, these annual records should be kept for at least 12 years following the submission of a study under a registration under that Regulation.
(9) A data sharing agreement should include a model for sharing all relevant costs. In each cost-sharing model, other registrants should be added to that agreement at a later stage. A reimbursement mechanism should also be in place to allow for the potential adjustment of the share of costs paid by each registrant when they participate.
(10) In order to ensure that no unnecessary administrative burden is imposed on the parties to data sharing agreements already in existence at the date of publication of this document, all parties are permitted to waive the obligation to include a refund mechanism, if all parties agree to do so. In the case of such agreements, potential registrants wishing to join the existing agreement may request the inclusion of a refund mechanism.
(11) Under Article 43(4) of the KKDIK Regulation, the costs associated with a substance assessment decision may also apply to registrants that have already ceased their activities in accordance with the second or third paragraph of that Article 43.
(12) Where a party does not require testing on vertebrate animals for registration under the KKDIK Regulation, that party is not obliged to share data with other registrants of the same substance and may choose to submit separately the information referred to in Article 11(1)(a) of that Regulation.
(14) To ensure consistency with the ‘1 substance, 1 register principle, the Ministry shall ensure that the separate submission of information referred to in Article 11(1)(a) of the KKDIK Regulation, justified under Article 12(3) or 19(2), continues to be part of the existing registration for the same substance.
(15) In order to encourage the development and use of alternative methods for assessing the hazardousness of substances and to minimize animal testing, sharing of relevant (animal and non-animal) studies conducted on a substance structurally similar to the substance of concern (grouping or cross-reading) is encouraged under the KKDIK Regulation.
The document “Joint submission and sharing of data in accordance with the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK Regulation)” sets out certain duties and obligations for parties to agreements where information sharing and related costs are required under the KKDIK Regulation.
- Where more than one registrant of the same substance or participants in a Substance Information Exchange Forum (SIFF) have to share information within the scope of their duties under the KKDIK Regulation, they shall make every effort to reach an agreement on the sharing of information. This data sharing agreement, which covers only persons or organizations subject to the KKDIK Regulation, will be clear and understandable by all parties and will include the following sections;
a) the cost of each data item, a description of the information requirement in the KKDİK Regulation to which each cost corresponds, and an itemised listing of the data to be shared, including a justification of how the data to be shared meets the information requirement;
(b) an item-by-item listing and justification of all costs required for the establishment and management of a common information provision and data sharing agreement between registrants of the same substance in accordance with the KKDİK Regulation, as applicable for the data sharing agreement in question
(c) a cost sharing model to include a reimbursement mechanism.
- Where a data sharing agreement already exists, the parties to that agreement may, by unanimous agreement, waive their obligation to itemize data as described in subparagraphs (a) and (b) of paragraph 1.
Potential registrants of a substance for which a data sharing agreement has been reached by previous registrants requesting the sharing of a study or a series of studies in accordance with Articles 24 and 26 of the KKDIK Regulation shall not be bound by an existing waiver unless they have given their signed consent to the previous registrants and shall be entitled to request itemized listing of costs as described in subparagraphs (a) and (b) of paragraph 1.
Where such a request is made, previous registrants shall
(a) itemize all relevant costs incurred after the date of publication of these procedures, as described in points (a) and (b) of paragraph 1;
(b) provide evidence(s) requested under Article 26(1) of the KKDIK Regulation of the cost of any work completed before the date of publication of these procedures;
(c) make every effort to provide a breakdown of all other relevant costs, including administrative costs incurred before the date of entry into force of the Regulation of these procedures as described in subparagraphs (a) and (b) of paragraph 1 and study costs not covered by subparagraph (b).
The itemised list of costs shall be provided to the potential registrant within 10 working days at the latest.
- Where registrants of the same substance share and jointly submit information under the KKDIK Regulation, they shall annually document any other costs incurred in relation to the operation of data sharing agreements.
The annual documentation shall include the sections referred to in paragraph 1 and shall include a record of each reimbursement received from new registrants for the purposes of the reimbursement mechanism.
In the absence of detailed documentation of costs incurred or compensation received prior to the publication of this document, the parties to an agreement shall make every effort to collect evidence of, or make the best estimate of, such costs and compensation.
Such annual documents shall be kept by the registrants for at least 12 years following the last submission of a study and shall be made available free of charge upon request of any party to the relevant data sharing agreement, at the latest within 10 working days and taking full account of the requirements relating to the last applicable registration date.
One substance, one register
- Without prejudice to Articles 12(3) and 19(2) of the KKDIK Regulation, the Ministry shall ensure that all registrants of the same substance are part of the same register under that regulation.
- Where the Ministry allows a potential registrant of a substance already registered under the KKDIK Regulation to refer to the information requested, the Ministry shall ensure that any subsequent submission of information by that potential registrant is part of the current joint application for that substance.
- Where a potential registrant fulfils its obligations under Articles 24 or 25 of the KKDIK Regulation and determines that it is not required to share tests on vertebrate animals for the purposes of registration, it shall apply Article 12(3) or 19(2) to submit separately all or part of the relevant information in Article 11(a) above.
In such cases, the potential registrant shall inform the previous registrants about the essence of his decision. He is also required to apply to the Ministry with a petition in this case.
Fairness and non-discrimination
- Pursuant to Articles 24(3) and 26(1) of the KKDIK Regulation, the registrant of any substance shall only be required to share the costs of the information that such registrant is obliged to submit to the Ministry in order to fulfil its registration obligation under that regulation. This requirement shall also apply to administrative costs.
- The cost-sharing model referred to in Article 2(1)(c) shall apply to all registrants of that substance, including the possibility for future registrants to join the data sharing agreement at a later stage.
The cost-sharing model shall include provisions for all registrants of a given substance to share any costs arising from a potential substance assessment decision.
When agreeing on a specific cost-sharing model, the following factors shall be taken into account: a) the number of potential registrants estimated to register the substance in question; and b) the likelihood of future additional information requests for the substance in question (other than those arising from a potential substance assessment decision).
Where a cost-sharing model includes the possibility of covering the costs of future additional information requirements for that substance, other than those arising from a potential substance assessment decision, this possibility shall be stated and justified separately from other costs in the data sharing agreement.
The compilation of information to ensure substance uniformity should not be the subject of any cost sharing between previous registrants and potential registrants.
- Under Articles 24 and 30 of the KKDIK Regulation, if the participants in a data sharing agreement cannot agree on such a cost sharing model, each participant shall pay an equal share of the costs of their participation. Reimbursement of part of such costs paid shall nevertheless take place as if a reimbursement mechanism had been agreed, subject to the first paragraph of Article 4, paragraph 4 of this document.
- The reimbursement mechanism referred to in Article 2(1)(c) of this document shall be provided for in each cost-sharing model and shall include a method of proportionate redistribution to each participant of the cost shares paid when a potential registrant joins this agreement.
The reimbursement mechanism will also take into account the following factors: a) the possibility of additional future registration requirements for that substance, other than those arising from a potential substance assessment decision; and b) the economic viability of certain reimbursements where the costs of reimbursement are higher than the amount to be reimbursed.
- Where a data sharing agreement already exists at the time of publication of this document, the parties to that agreement may, by consensus, waive their obligation to include a reimbursement mechanism in their cost-sharing model.
A potential registrant intending to join an existing data sharing agreement will not be bound by an existing waiver unless it has given its signed consent to the previous registrants and will be entitled to obtain the inclusion of a reimbursement mechanism in the cost sharing model.
- Any registrant that ceases its activities in accordance with paragraph 2 or 3 of Article 43 of the KKDIK Regulation may nevertheless have to share the costs resulting from a substance assessment decision in accordance with Article 43(4).
- When resolving a data sharing dispute under Articles 24(6) and 26(3) of the KKDIK Regulation, the Ministry shall take into account whether the parties have acted in accordance with the obligations set out in Articles 2, 3 and 4 of this document.
- The rules in this document shall apply without prejudice to the full and complete application of the competition law legislation in force in Turkey.