KKDIK Compliant Safety Data Sheets?
The Turkey’s EU REACH based KKDIK Regulation was published on June 23, 2017 and came into force on December 23, 2017. KKDIK Regulation was implemented to control the use of hazardous substances in the Turkish market to protect human health and the environment. KKDIK Safety Data Sheet are intended for hazard communication with the entire supply chain of the physico-chemical data, potential hazards, and procedures for safe use of chemicals.
KKDIK safety data sheet should be prepared by certified Chemicals Assessment Experts. Safety data sheets (SDS) should be provided either before or at the time of first delivery of the substance or mixture. Manufacturers, importers, distributors, and downstream users must make sure their current safety data sheets for substances and mixtures comply with KKDIK Regulation to keep their products on the Turkish market.
Note: Safety data sheets can also be prepared in accordance to the current SDS Regulation in force till December 31, 2023. The current Regulation on Safety Data Sheets for Hazardous Substances and Mixtures (29204 – December 13, 2014) will be repealed as of December 31, 2023.
When does a KKDIK compliant Safety Data Sheet need to be supplied?
A KKDIK Safety data sheet should be provided either before or at the time of first delivery of the substance or mixture if the product is:
- a substance or a mixture that is classified as hazardous, or PBT/vPvB or SVHC
- a mixture that is not classified as hazardous, but contains a substance posing human health or environmental hazards with a concentration of >1% w/w for non-gaseous mixtures or 0.2% v/v for gases
- a mixture that is not classified as hazardous, but contains a substance that is persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB), or substance of very high concern (SVHC) in an individual concentration of ≥ 0.1 % by weight for mixtures that are solid or liquids (non-gaseous mixtures)
What is extended Safety Data Sheets (eSDS) under KKDIK?
A safety data sheet annexed with exposure scenarios (from Chemical Safety Report – one part of registration dossier) is called as extended Safety Data Sheet (eSDS).
An Exposure Scenario is a chemical safety document which has to be prepared for substances that are manufactured or imported in quantities of more than 10 tonnes per year in/to Turkey, and are considered being hazardous or PBT/vPvB substances.
The exposure scenario is a system of conditions that describes that how a chemical substance on its own or in mixtures as well as in articles is manufactured or used during its life cycle, and which control methods are recommended by the manufacturer, importer or downstream user to avoid or reduce the human and environmental exposure.
KKDIK Regulation [O.G. 30105 – 23.06.2017]
Requirements for safety data sheets
Article 27
(1) The supplier of a substance or a mixture shall provide the recipient of the substance or mixture with a safety data sheet compiled in accordance with Annex 2 (Guide to the Compilation of Safety Data Sheets) and prepared by a certified chemicals assessment expert according to Annex 18 (Certification Requirements for Chemical Assessment Experts):
a) Where a substance or a mixture meets the criteria for classification as hazardous in accordance with the Bylaw on Classification, Labelling and Packaging of Substances and Mixtures or
b) Where a substance is persistent, bio accumulative and toxic or very persistent and very bio accumulative in accordance with the criteria set out in Annex 13 (Criteria for the Identification Of PBT Substances, and vPvB Substances); or
c) Where a substance is included in the list established in accordance with Article 49 (Defining the Substances in Candidate List of Substances Subject to Authorisation) for reasons other than those referred to in points (a) and (b).
(2) Any actor in the supply chain who is required, under Articles 15 (Chemical Safety Report and Duty to Apply and Recommend Risk Reduction Measures) or 33 (Downstream User Chemical Safety Assessments and Duty to Identify, Apply and Recommend Risk Reduction Measures) to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a mixture and the actor in the supply chain has prepared a chemical safety assessment for that mixture, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the mixture instead of with the chemical safety report for each substance in the mixture.
(3) The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex 2 (Guide to the Compilation of Safety Data Sheets), where a mixture does not meet the criteria for classification as hazardous in accordance with Bylaw on Classification, Labelling and Packaging of Substances and Mixtures, but contains:
a) In an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or
b) In an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1, respiratory sensitizer category 1 or is persistent, bio accumulative and toxic or very persistent and very bio accumulative in accordance with the criteria set out in Annex 13 (Criteria for the Identification Of PBT Substances, and vPvB Substances) or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 49(1) (Defining the Substances in Candidate List of Substances Subject to Authorisation);
c) A substance for which there is workplace exposure limits.
(4) The safety data sheet need not be supplied where substances that are hazardous offered or sold to the general public, are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor
(5) The safety data sheet shall be supplied in Turkish.