TREACH (KKDIK) BY-LAW (Part 6, Section 1)
BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS
SIXTH PART
Evaluation
FIRST SECTION
Dossier Evaluation
Examination of testing proposals
ARTICLE 36 – (1) The Ministry shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes 9 and 10 for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex 1 of Bylaw on Classification, Labelling and Packaging of Substances and Mixtures.
- Hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
- Hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
- Hazard class 4.1;
- Hazard class 5.1.
Information relating to testing proposals involving tests on vertebrate animals shall be published on the Ministry website. The Ministry shall publish on its website the name of the substance, the hazard end-point for which vertebrate testing is proposed, and the date by which any third party information is required. It shall invite third parties to submit, using the format provided by the Ministry, scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received shall be taken into account by the Ministry in preparing its decision in accordance with paragraph 3.
On the basis of the examination under paragraph 1, the Ministry shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 43:
- A decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex 1;
- A decision in accordance with subparagraph (a), but modifying the conditions under which the test is to be carried out;
- A decision in accordance with subparagraphs (a), (b) or (ç) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes 9, 10 and 11;
- A decision rejecting the testing proposal;
A decision in accordance with subparagraphs (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Ministry accordingly within 90 days. If the Ministry is not informed of such agreement within 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them.
The registrant or downstream user shall submit the information required to the Ministry by the deadline set.
Compliance check of registrations
ARTICLE 37 – (1) The Ministry may examine any registration in order to verify any of the following:
- That the information in the technical dossier(s) submitted pursuant to Article 11 complies with the requirements of Articles 11, 13 and 14 and with Annex 3, Annex 6, Annex 7, Annex 8, Annex 9 and Annex 10;
- That the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes 7 to 10 and with the general rules set out in Annex 11;
- That any required chemical safety assessment and chemical safety report comply with the requirements of Annex 1 and that the proposed risk management measures are adequate;
- That any explanation(s) submitted in accordance with Article 12(3) or Article 19(2) has an objective basis.
On the basis of an examination made pursuant to paragraph 1, the Ministry may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and specifying adequate time limits for the submission of further information. Such a decision shall be taken in accordance with the procedure laid down in Article 43.
The registrant shall submit the information required to the Ministry by the deadline set.
To ensure that registration dossiers comply with this Bylaw, the Ministry shall select a percentage of those dossiers, no lower than 5 % of the total received by the Ministry for each tonnage band, for compliance checking. The Ministry shall give priority, but not exclusively, to dossiers meeting at least one of the following criteria:
- The dossier contains information in Article 11(1)(a), (4), (6) and/or (7) submitted separately as per Article 12(3); or
- The dossier is for a substance manufactured or imported in quantities of one tonne or more per year and does not meet the requirements of Annex 7 applying under either Article 13(1)(a) or (b), as the case may be.
Check of information submitted and follow-up to dossier evaluation
ARTICLE 38 – (1) The Ministry shall examine any information submitted in consequence of a decision taken under Articles 36 or 37, and draft any appropriate decisions in accordance with these Articles, if necessary.
The Ministry shall use the information obtained from this evaluation for the purposes of Article 40.
Procedure and time periods for examination of testing proposals
ARTICLE 39 –(1) The Ministry shall prepare the draft decisions in accordance with the Article 36 (3) in order to fulfil the information requirements in Annexes 9 and 10 by 31/12/2025 for the proposals received by 31/12/2023 including the testing proposals.
TURKREACH (KKDIK) BY-LAW
- FIRST PART - General Issues
- SECOND PART - Registration of Substances
- FIRST SECTION - Information Requirements and General Obligation to Register
- SECOND SECTION - Substances Regarded as Being Registered Substances
- THIRD SECTION - Obligation to Register and Information Requirements for Certain Types of Isolated Intermediates
- FOURTH SECTION - Common Provisions for All Registrations
- THIRD PART - Data Sharing and Avoidance of Unnecessary Testing
- SIXTH PART - Evaluation
- SEVENTH PART - Authorization
- EIGHTH PART - Restrictions on the Manufacturing, Placing on the Market and Use Of Certain Dangerous Substances, Mixtures and Articles