Safety Data Sheet Compliant with KKDIK

Safety Data Sheet (SDS) is written for chemical substances, mixtures and designed for articles with chemical release. Physicochemical, health and environmental hazards of chemicals, the measures to be taken against these damages, official regulations and framework defined in a certain set of discipline and documents are defined.

In Turkey, when we look at the history of the preparation of SDS on the hazardous of chemicals and the precautions to be taken, the situation is as follows:

• The first regulation was "Regulation on Control of Harmful Chemical Substances and Products", No. 21634 dated 11 July 1993. This regulation was important because it was the first step for awareness raising. However, this legislation did not achieve the expected limits for industry application. • "Implementing Regulation on the Preparation and Distribution of Safety Data Sheets No 27092 on Dangerous Substances and Preparations" was published on 26 December 2008. Authorization to prepare SDS was given to accredited institutions. Therefore, quality and awareness were increased. • The Regulation of Hazardous Substances and Mixtures, No. 29204, was published on 13 December 2014. The majority of the chemicals industry fulfilled the SDS requirements for their chemicals to place on the market. • This was the final step in the process for writing SDSs, published as Annex II of KKDIK (Registration, Evaluation, Authorization and Restriction of Chemicals) No. (TC) 30105. The SDS written in accordance with Regulation No. 29204 will be valid until 31 December 2023. After this date, it will be obligatory to write SDSs in compliance with Regulation (TC) No 30105. If necessary, KKDIK-compliant SDSs can be prepared before this date.

At this point, I would like to inform about SDSs compatible with KKDIK and its requirements and to correct misconceptions.

KKDIK regulation is substantially equivalent to REACH Regulation No. 1907, published in 2006 in the EU region. It is also defined as "Turkish REACH" in the chemical industry. The purpose of this Bylaw is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances while enhancing competitiveness and innovation. The KKDIK Regulation consists of 18 annexes in total and Annex-2 includes the provisions on the preparation of SDSs. Before mentioning Annex-2, some important points about KKDIK should be noted.

These are:

1. Pre-registration for substances manufactured in Turkey or imported into Turkey in quantities of 1 tonne or over must be done by 31 December 2020. 2. Registration will be done between 1 January 2021 and 31 December 2023 for pre-registered substances. Substances over 1 tonne cannot be placed on the market without registration after 31 December 2023. 3. For substances that have been pre-registered, preparation of a Chemical Safety Report will begin as of 1 January 2021. The Chemical Safety Report (CSR) is also a factor that enables the preparation of a KKDIK-compliant SDS. It is not technically possible to prepare a KKDIK-compliant SDS without a CSR. For this reason, it will be obligatory to prepare Safety Data Sheets in accordance with the KKDIK Regulation as of 31 December 2023. 4. The provisions of Annex 17 will come into force 6 months after its publication (31 December 2017) and subsequently on 31 December 2018, 31 December 2019, 31 December 2021, 31 December 2022 as detailed in the regulation. SDS should meet the following conditions to be compliant with KKDIK (Turkish REACH) regulation.

1. SDS Should be Prepared by a Chemical Assessment Specialist

Chemical Assessment Specialists who complete a total of 64 hours of training in accordance with the provisions of the KKDIK Regulation and the headlines specified in Annex 18 must take this training from ministerially approved institutions. After taking examinations at institutions accredited by TÜRKAK in accordance with (TS EN) ISO/IEC 17024 standard, they will be eligible to receive a Certificate of Proficiency by passing the exam with a grade of 70 or higher. Only a Chemical Assessment Specialist is authorized to prepare a Chemical Safety Assessment. Also, only a Chemical Assessment Specialist can write an SDS that is compliant with KKDIK (Turkish REACH).

2. Chemical Safety Assessment Must be Available

Annex-2 of the KKDIK Regulation No. 30105 regarding GBFs, Article 0.1.2, explains as follows: The information given in the Safety Data Sheet is consistent with the information provided in the Chemical Safety Report. When the Chemical Safety Report has been completed, the relevant exposure scenario will be attached to the Safety Data Sheet. A Chemical Safety Assessment of the substance must be available for compliance with KKDIK. Also, a Chemical Safety Assessment of the substance that affects the classification of the mixture is expected to be available in the mixture SDS. This situation is specified under the heading "15.2. Chemical Safety Assessment". It is possible to prepare an SDS that is compliant with KKDIK after 2022, when it is taken into consideration that Chemical Safety Assessments will be prepared as of 1 January 2021.

3. Substance Must Have Registration Number

The registration number should be specified under section 1.1 for a KKDIK-compliant SDS for a substance and should be specified under section 3.2 for substances that fulfill the requirements of KKDIK registration conditions in the mixture.

Chemical Safety Report

The Chemical Safety Report is a document created as a result of the KKDIK registration process and the primary source for the registrant to provide information to all users of chemicals through Exposure Scenarios. It also provides a basis for other KKDIK processes including substance assessment, authorization and restriction. The Chemical Safety Assessment demonstrates that when specific operational conditions and risk management measures are implemented, risks arising from exposure to a substance are controlled during manufacture and use. These terms of use of a substance constitute the exposure scenario, which is an important component of the Chemical Safety Report. The Chemical Safety Report should be easily understood as a standalone document in all its parts and should contain all relevant information on the chemical safety assessment. Principles applied in the assessment of hazard and exposure, assumptions, and extracted results should be transparent, reliable and documented correctly.

The Chemical Safety Report to be submitted in the registration dossier must be in the format specified in Annex-1.

A Chemical Safety Assessment shall be carried out for all substances subject to registration in accordance with the KKDIK regulation in quantities of 10 tonnes or more per registrant per year and a Chemical Safety Report is prepared. The Chemical Safety Report shall contain a Chemical Safety Assessment in its own form, in the mixture or in articles for each substance or group of substances that should be prepared in the relevant articles of the regulation and as specified in Annex-1. Any actor who should make a Chemical Safety Assessment ensures that the information in the Safety Data Sheet is consistent with the information contained in this assessment. If the Safety Data Sheet was prepared for a mixture and the actor in the supply chain made a Chemical Safety Assessment for the mixture, it is sufficient that the Safety Data Sheet is consistent with the Chemical Safety Report of the mixture rather than the Chemical Safety Report of each chemical substance in the mixture.

Exposure Scenario

Definition in the regulation is: "The set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate." The Chemical Safety Report must also include an exposure scenario for all substances of 10 tonnes or more per year per registrant, with a hazard classification and which must be registered in accordance with the KKDIK Regulation.

SDS (Extended Safety Data Sheet)

The SDS containing the Exposure Scenario is named e-SDS. It is created by adding it to the main body of the Safety Data Sheet. The format of the exposure scenario is not defined in the KKDIK Regulation. Even though this means that the supplier can present information in different ways, the ECHA (European Chemicals Agency) and its stakeholders have worked to harmonize the layout and the expressions used, and have proposed a format for the exposure scenario, which includes the following four chapters: • Title, • Term of use affecting exposure, • Exposure estimation, • Guide to assess whether their use is within the limits of the exposure scenario for downstream users. Exposure Scenarios will be present in the SDS of mixtures, not only in SDSs of substances. Some sector organizations can improve the safe use of information for common product types, using an accepted format called SUMI (Safe Use of Mixtures Information). Formulators can select the appropriate SUMIs for their products and their uses and provide them in addition to the Safety Data Sheet. CRAD is the first training institution authorized by the ministry to provide trainings for CSA (Chemical Safety Advisor). CRAD provides CSA training with its expert trainers. At the same time, with its CSA certified team, it is able to offer all necessary services to the chemical industry for adaptation with KKDIK. Bülent Özdemir Chemical Regulatory Specialist Director CRAD Chemical Legislation Consultancy Services References 1- No. 30105 Bylaw on Registration, Evaluation, Authorization and Restriction of Chemicals and their annexes. 2- ECHA web page, current publications.