KKDIK Stands For
KKDIK Regulation stands for 23/06/2017 – 30105 (Bis) “Kimyasalların Kaydı, Değerlendirilmesi, İzni ve Kısıtlanması Hakkında Yönetmelik”
| Turkish | English |
|---|---|
| Kimyasalların | Chemicals |
| Kaydı | Registration |
| Değerlendirmesi | Evaluation |
| İzni | Authorisation |
| Kısıtlanması | Restriction |
Registration: Substance assessment, preparation of a dossier and registration by industry
Evaluation: Evaluation of registration dossiers by the Ministry of Environment and Urbanization (MoEU); checking for quality and completeness
Authorisation: Authorisation of Substances of Very High Concern (SVHC) for certain uses by the MoEU
Restriction: Restriction of the manufacture, use or placing on the market of hazardous substances by the MoEU
Scope & Principle
KKDIK is a Turkish regulation based on EU’s REACH, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the Turkish chemicals industry.
KKDIK Regulation was published on June 23, 2017 and came into force on December 23, 2017.
KKDIK regulation compliance requires companies manufacturing or importing chemical substances on their own or in mixtures as well as in articles in Turkey to register these substances with the Ministry of Environment and Urbanization (MoEU).
Principle; No Data No Market
Chemical substances may only be manufactured, used or placed on the market in Turkey if they are registered under KKDIK.
Key task of manufacturers and importers is to assess substances and register them with the MoEU.
It is the responsibility of industry (manufacturers, importers, users) to demonstrate the safe handling of the substances in all their applications. To this effect, a substance evaluation and assessment is performed on the basis of defined set of criteria. Data requirements for substances are specified dependent on their tonnage band.
Differences with EU REACH
KKDIK regulation is closely harmonized with the EU REACH provisions and requires companies to pre-register and register substances (on their own, in mixtures or in articles) manufactured in Turkey or imported into Turkey with volumes equal to or above 1 tonne per year.
One of the key differences between REACH and KKDIK is that; under KKDIK regulation there are no specific deadlines for tonnage bands above one tonne (1-10, 10-100, 100-1000, 1000+) per year as it’s in EU REACH. Registration period is the same for all substances pre-registered and a 3 years’ time frame is envisaged for the registration period.
KKDIK regulation also requires that only qualified and certified Chemical Assessment Specialist sign off registrations and notifications during registration process. SDSs also have to be prepared in Turkish and signed by certified Turkish specialists.
What Must be Registered?
Companies are affected by KKDIK if they manufacture or import a chemical substance in volumes ≥ 1 tonne per year.
- Substances on their own (single substances and no mixtures)
- Substances as components of mixtures
- Substances in articles (if these are intended to be released under normal or reasonably foreseeable conditions of use (e.g. scented candles, perfumed textiles).
- Substances as a component of articles with properties of very high concern (SVHC) that are named on the Authorisation List (KKDIK Annex XIV) and contained in products at a concentration of ≥ 0.1 %.
Note: Under KKDIK, only chemical substances, NOT products/product names are registered.
Company Obligations under KKDIK
Obligations in the supply chain
| Role | Obligations | Potential obligations |
|---|---|---|
| Manufacturer and importer of substances, mixtures, articles | Pre-registration Registration Sharing information with customers Information archiving | Application for authorisation Compliance with the restrictions Notification of hazardous substances in the classification and labelling inventory Chemical Safety Assessment |
| Importer of articles | – | Notification of the SVHC* Sharing information about SVHC* Compliance with the restrictions Information archiving |
| Downstream users | Check of eSDS Implementing risk management measures Information archiving | Feedback to supplier about the use Preparation of the SDS Sharing information with customers |
| Traders | Information archiving | Sharing information with customers (e.g. SDS) Sharing information with suppliers (e.g. use, substance release) |
Timeline & Transition Periods
Exemptions on KKDIK Regulation
Substances exempted from KKDIK
- Substances contained in waste
- Radioactive substances
- Substances in transit (customs supervision)
- Non-isolated intermediates
Substances exempted from the registration obligation
- Substances manufactured and/or imported in volumes < 1 t/a
- Active substances in plant protection and biocidal products
- Substances regulated more strictly under other regulations, e.g. food additives, pharmaceuticals, cosmetic products
- Polymers (monomers must be registered)
- Substances included in KKDIK Annex 4.
- Substances covered by KKDIK Annex 5.
Authorisation of SVHC
The KKDIK Regulation provides for an authorisation process for Substances of Very High Concern (SVHC).
The objective is:
- to properly control the risks arising from the substance.
- a replacement by suitable alternative substance or technologies while at the same time ensuring the smooth functioning of the EU internal market. Alternatives must be economically and technically viable.
Substances of Very High Concern are
- CMR (carcinogenic, mutagenic or toxic to reproduction) category 1/2 (as per GHS 1A or 1B)
- PBT (persistent, bioaccumulative, toxic) and vPvB (very persistent and very bioaccumulative) according to KKDIK Annex XIII
- Endocrine disruptors (substances that interfere the hormone system)
The SVHC List will be published later on the MoEU’s website
Restrictions & Bans
The manufacture, marketing or use of a substance may be restricted or banned. The process for restrictions was amended and included in the KKDIK Regulation under Annex XVII. The aim is to protect human health and environment from unacceptable risks posed by chemical substances.
- Unlike an authorisation, restrictions do not necessarily refer to a SVHC.
- Restrictions are independent from the manufactured and imported quantity of a substance.
- A restriction may relate to the substance on its own, in a mixture or in an article. It also applies to imported substances, mixtures and articles.
- Depending on the type of restriction, implementation may affect the manufacturers, importers or placers on the market of substances, mixtures and articles, and also the downstream users.
- If the use of a substance has not been assessed as being safe, the restriction process may also lead to a complete ban of its use within Turkey.
- Substance-specific types of manufacture and use that are subject to restrictions are listed in Annex XVII of the KKDIK Regulation.