Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDİK)

The Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDİK), published in the repeated issue of Official Gazette No. 30105 of 23 June 2017, sets the administrative and technical rules on the registration, evaluation, authorisation and restriction of chemicals in order to ensure a high level of protection of human health and the environment and to enhance competition and innovation (Article 1). It was prepared taking into account the EU REACH Regulation No. 1907/2006 (Article 65), is administered by the Ministry of Environment, Urbanisation and Climate Change, and was amended in the Official Gazettes of 29 November 2019 (No. 30963) and 23 December 2023 (No. 32408).

Who and which substances does KKDİK cover?

The Regulation covers the manufacture and placing on the market of substances, their use on their own, in mixtures or in articles, and the placing on the market of mixtures (Article 2(1)). Radioactive substances, certain substances in temporary storage and transit, non-isolated intermediates, the transport of chemicals, and wastes covered by the Waste Management Regulation and the Radioactive Waste Management Regulation are excluded (Article 2(2)). The obligated parties are manufacturers, importers and downstream users, all of whom must ensure that substances are manufactured, placed on the market and used without adversely affecting human health or the environment (Article 5).

How do registration, safety data sheets, authorisation and restriction work?

A substance that has to be registered may not be manufactured or placed on the market unless it is registered (Article 6). A manufacturer or importer of a substance in quantities of one tonne or more per year applies for registration through the Ministry’s Chemical Registration System (Article 7). Producers and importers of articles register the substance in articles if its release is intended in normal use and the quantity exceeds one tonne per year, and notify if a substance identified as a substance of high concern is present in an article above 0.1 percent by weight (Article 8).

A supplier of substances and mixtures classified as hazardous provides the recipient with a safety data sheet (Article 27). A substance listed in Annex 14 may be placed on the market or used only with an authorisation (Article 46), and a substance restricted in Annex 17 may not be manufactured, placed on the market or used in breach of the restriction conditions (Article 57). The 23 December 2023 amendment phased the registration timetable: depending on tonnage and hazard class, the obligation applies by 31 December 2026, 31 December 2028 and 31 December 2030 (Transitional Article 2). The articles on prioritisation and evaluation (Articles 40-44) and on identifying substances of high concern (Articles 47-49) are set to enter into force on 31 December 2026, and the authorisation articles (Articles 45-46 and 50-56) on 31 December 2028 (Article 66).

How does KKDİK relate to recall and destruction?

KKDİK does not create a general recall or destruction procedure like product safety legislation does. Its only direct provision in this area concerns the product and process oriented research and development exemption: the Ministry ensures that the substance is used only by employees of listed customers and may recall the remaining quantities for disposal after the exemption period (Article 10(4)). The exemption lasts five years and, on request, may be extended by up to five years, or ten years for certain uses (Article 10(1) and 10(6)).

For substances in articles, the producer or importer is not subject to the notification obligation if it can prevent exposure of humans or the environment under normal and foreseeable conditions of use, including disposal, and in that case provides the recipient with the necessary instructions (Article 8(3)).

Is waste management covered by KKDİK?

No. The management of chemical waste is a matter for the Waste Management Regulation and other waste legislation; KKDİK excludes wastes from its scope (Article 2(2)(d)). A restriction or authorisation requirement on a chemical therefore does not by itself regulate how existing stocks are to be disposed of. The fate of such stocks is assessed under waste legislation, depending on whether the material counts as waste.

What are the inspections and sanctions?

Inspections concerning the authorisation and restriction provisions are carried out by the relevant institutions under Laws No. 4703, 6331, 5442 and 5996; inspections of the other provisions are carried out by the Ministry under the Environmental Law No. 2872 and Law No. 4703 (Article 62). In case of breach, administrative and criminal sanctions apply under Articles 12, 13 and 20 of Law No. 2872, Articles 11 and 12 of Law No. 4703, Articles 36 to 42 of Law No. 5996 and Article 66 of Law No. 5442 (Article 63). Under Article 25 of Law No. 7223, references to Law No. 4703 are deemed to refer to Law No. 7223.