On October 19, 2023, with the participation of sector representatives, under the chairmanship of Mr. Recep AKDENİZ, General Manager of the General Directorate of Environmental Management, at the Ministry of Environment, Urbanization and Climate Change, "KKDIK Evaluation. Meeting" was held.
What was discussed at the meeting is as follows.
A draft is planned as attached regarding the extension of time regarding the KKDIK preliminary MBDF notifications and registration dossier processes.
Based on the draft.
DRAFT REGULATION ARTICLE-1: The Ministry will publish the Procedural Principles to be carried out by the relevant sector councils within TOBB within 1 year regarding the joint registration process, which includes leader selection and data and cost sharing.
DRAFT REGULATION ARTICLE-2: Amendment articles related to preliminary MBDF dates.
ARTICLE 24 – (1) Potential registrants send the following information to the Ministry through the Chemical Registration System on the Ministry's website to inquire about the registration status of the same substance as of 31/12/2027:
ARTICLE 25 – (1) All potential registrants, downstream users and third parties who have sent a pre-Substance Information Exchange Forum (pre-MBDF) to the Ministry regarding the substance, or registrants who have applied for a registration before the specified date of 31/12/2027 regarding the substance, become participants of the Article Information Exchange Forum (MBDF).
(3) MBDF participants shall provide existing studies to other registrants, respond to other registrants' requests for information, jointly define the needs for future studies, and arrange for the conduct of such studies to be carried out for the purposes specified in subparagraph (a) of the second paragraph. Each MBDF continues to operate until 31/12/2029.
(KKDIK) PROVISIONAL ARTICLE 1 – (1) All registrants submit the pre-SIEF containing the following information to the Ministry through the Chemical Registration System on the Ministry's website until 31/12/2027.
DRAFT REGULATION ARTICLE-3:
The list of substances nominated for authorization will be published from the end of 2023. The candidate list will be submitted for industry comment before publication. As of 2025, the industrialist will not be able to place the substances that are candidates for permission on the market without permission.
Placing substances on the market
ARTICLE 6 – (1) Substances subject to Articles 7, 8 and 21 may not be manufactured or placed on the market unless they are registered in accordance with the relevant provisions of this Part.
PROVISIONAL ARTICLE 2 – (1) If the annual quantity is one ton or more for substances manufactured or imported on their own or in a mixture before 31/12/2023, the provisions of Articles 7 and/or 8 or 17 or 18 shall apply between 31/12/2020 and 31/12/2023.
DRAFT REGULATION ARTICLE-4:
Procedure and deadlines for reviewing test proposals
(KKDIK)- ARTICLE 39 – (1) The Ministry prepares the draft decision 2 years after the expiry of the periods specified in the same paragraph for all proposals that include test offers and have been received until the deadlines determined depending on the amount of tonnage within the scope of the first paragraph of the provisional second article of the regulation, in order to fulfill the information requirements set out in Annex-9 and Annex-10 in accordance with the third paragraph of Article 36.
DRAFT REGULATION ARTICLE-5:
PROVISIONAL ARTICLE 2 – Provisions of Articles 7 and/or 8 or 17 or 18 of the Regulation
a) Until 31/12/2025 for substances that meet the following conditions
1) Substances manufactured or imported in an annual quantity of 1000 tons or more in their own form or in a mixture
2) Substances manufactured or imported in an annual quantity of 100 tons or more in their own form or in a mixture and classified as Aquatic Acute 1 and Aquatic Chronic 1
3) Substances classified as carcinogenic, mutagenic and toxic to the reproductive system Category 1A and 1B, which are manufactured or imported in their own form or in mixtures in an annual quantity of 1 ton or more
b) Until 31/12/2026 for substances manufactured or imported in an annual amount of 100 tons or more, either in their own form or in a mixture or in goods,
c)It is applied until 31/12/2027 for substances manufactured or imported in an annual amount of 1 ton or more in their own form or in a mixture or in goods.