KKDİK-Compliant Safety Data Sheet

Safety Data Sheets (SDS) are documents prepared for chemical substances, mixtures and articles with intentional chemical release, which explain the physicochemical, health and environmental hazards of chemicals, the measures to be taken against these hazards, and the discipline and set of rules established by official regulations. Looking at the history of SDS preparation in Turkey regarding the hazards of chemicals and measures to be taken, the situation is as follows: • The first official regulation was "the Regulation on the Control of Harmful Chemical Substances and Products, dated 11 July 1993, numbered 21634". This regulation has a special significance as it was the first step taken in terms of raising awareness. However, it did not reach the expected level in terms of implementation by industry. • The "Regulation on the Preparation and Distribution of Safety Data Sheets Relating to Dangerous Substances and Preparations, published on 26 December 2008, numbered 27092", by granting SDS preparation authority to persons qualified to receive a certificate from an accredited organization, both raised the quality of SDSs and increased the level of awareness. • On 13 December 2014, with the "Regulation on Safety Data Sheets Relating to Harmful Substances and Mixtures, numbered 29204", the vast majority of the chemical industry became familiar with the requirements for preparing SDSs for the chemicals they put on the market. • "Annex 2 of Regulation 30105 on CARDReg (Registration, Evaluation, Authorization and Restriction of Chemicals), published regarding the preparation of SDSs", became the latest stage in this process. With the publication of CARDReg, SDSs compliant with Regulation 29204 were permitted to be prepared until 31 December 2023.

After this date, it will be mandatory to prepare SDSs compliant with Regulation 30105 (CARDReg). If the necessary conditions specified in CARDReg can be met, SDSs compliant with CARDReg can also be prepared before this date.

At this point, I would like to provide information about CARDReg-compliant SDSs and their requirements, and correct misconceptions. CARDReg Regulation is largely equivalent to REACH Regulation 1907, published in 2006 in the EU region, and is Turkey's own official regulation. It is also defined in the industry as "Turkish REACH". According to the definition in the Regulation, the purpose of this Regulation is to regulate the administrative and technical procedures and principles regarding the registration, evaluation, authorization and restriction of chemicals so as to ensure a high level of protection of human health and the environment, to encourage alternative methods for assessing the hazards of substances, and to increase competition and innovation. CARDReg consists of a total of 18 annexes, and Annex 2 contains provisions on the preparation of SDSs. Before discussing Annex 2, certain important points regarding CARDReg should be noted.

These are;

1. By 31.12.2020, pre-registration will be made to the Ministry of Environment and Urbanization for substances produced in Turkey or imported to Turkey in quantities of 1 ton or more. 2. Between 1.1.2021 and 31.12.2023, there will be a registration process for substances for which pre-registration was made. After 31.12.2023, if a substance is to be produced or imported in quantities exceeding 1 ton, it cannot be placed on the market without being registered. 3. For substances for which pre-registration was made, preparation of a Chemical Safety Report will commence as of 1.1.2021. A Chemical Safety Report (CSR) is also an element that enables the preparation of a CARDReg-compliant SDS. It is technically impossible to prepare a CARDReg-compliant SDS without a CSR. For this reason, Safety Data Sheets will be required to be prepared in accordance with CARDReg Regulation after 31.12.2023. 4. The provisions relating to Annex 17 on restrictions will enter into force 6 months after publication (31/12/2017), 31/12/2018, 31/12/2019, 31/12/2021 respectively, as detailed in the regulation. For an SDS to be CARDReg-compliant, it must meet the following conditions.

1. The SDS Must Be Prepared by a Chemical Evaluation Expert (CEE)

According to the provisions of the Regulation, Chemical Evaluation Experts, who are required to complete a total of 64 hours of training on topics listed in Annex 18, must receive this training from ministry-approved organizations. Subsequently, by passing the examinations of organizations accredited by TURKAK according to (TS EN) ISO/IEC 17024 standard and obtaining 70 or higher points, they will be entitled to receive a Chemical Evaluation Expert Competence Certificate. Only a CEE has the authority to prepare a Chemical Safety Report. At the same time, only a CEE can prepare a CARDReg-compliant SDS.

2. It Must Have a Chemical Safety Report

Annex 2 to CARDReg Regulation 30105, regarding SDSs, Article 0.1.2, explains as follows: The information provided in the Safety Data Sheet is consistent with the information provided in the Chemical Safety Report. Where the Chemical Safety Report has been completed, the relevant exposure scenario is attached to the SDS. For substance SDSs to be CARDReg-compliant, they must have a CSR, whereas for mixture SDSs, it is expected that substances affecting the hazardous classification of the mixture have a CSR. This is stated in the SDS section titled "15.2 Chemical Safety Assessment". Given that CSRs will be created as of 1.1.2021, the preparation of CARDReg-compliant SDSs from 2022 onwards may be calendrically possible.

3. The Substance Must Have a CARDReg Registration Number

The registration number must be specified in the substance SDS under heading 1.1, and in the mixture SDS, the registration numbers of components meeting the CARDReg registration condition must be specified under SDS heading 3.2.

Chemical Safety Report

A Chemical Safety Report is a document created as a result of the CARDReg registration process and is the primary source of information provided by the registrant to all users of chemicals through exposure scenarios. It also forms a basis for other CARDReg processes including substance evaluation, authorization and restriction. Chemical Safety Assessment demonstrates that when certain operational conditions and risk management measures are applied, risks arising from exposure to a substance are controlled during manufacture and use. These use conditions of a substance form the exposure scenario, which is an important component of the Chemical Safety Report. A Chemical Safety Report must be easily understandable as a standalone document in all its sections and must contain all information related to chemical safety assessment. The principles applied in hazard and exposure assessments, the assumptions made and the conclusions reached must be transparent, reliable and properly documented. The Chemical Safety Report to be submitted in the registration file must be in the format specified in Annex 1. A chemical safety assessment is conducted and a Chemical Safety Report is prepared for all substances subject to registration in accordance with CARDReg Regulation in annual quantities of 10 tons and above per registrant. The Chemical Safety Report contains, in its own right, in a mixture or in an article, the chemical safety assessment prepared for each substance or group of substances as specified in the relevant articles of the regulation and in Annex 1. Any actor required to conduct a Chemical Safety Assessment ensures that the information in the Safety Data Sheet is consistent with the information in this assessment. Where a Safety Data Sheet has been prepared for a mixture and an actor in the supply chain has conducted a Chemical Safety Assessment for the mixture in question; the mixture, it is sufficient for the Safety Data Sheet to be consistent only with the Chemical Safety Report of the mixture itself, rather than with the Chemical Safety Report of each individual chemical substance in the mixture.

Exposure Scenario

According to the definition specified in the Regulation: "A set of conditions, including operational conditions and risk management measures, which the manufacturer or importer describes the manufacture or lifecycle use of the substance, encompassing one or more specific processes or uses of the substance to control the exposure of humans and the environment to the substance, and explaining the exposure controls or advice on exposure controls to downstream users, in order to bring human and environmental exposure to the substance under control." A Chemical Safety Report prepared for substances in annual quantities of 10 tons and above per registrant, which have a hazardous classification and are subject to registration in accordance with CARDReg Regulation, must also include an exposure scenario.

e-SDS (Extended Safety Data Sheet)

SDSs containing exposure scenarios are referred to as e-SDSs. They are created by being added to the main body of the Safety Data Sheet. The format of the exposure scenario is not defined in CARDReg. While this means that suppliers can present information in different ways, ECHA (European Chemicals Agency) and stakeholders have worked to align the arrangement and expressions used and have proposed a format for exposure scenarios containing the following four sections: • Title section, • Use conditions affecting exposure, • Exposure estimate, • Guidance for downstream users to assess whether their uses are within the boundaries of the exposure scenario. An exposure scenario must be present not only in substance SDSs but also in mixture SDSs. Some sector organizations, using an accepted format called SUMI (Safe Use of Mixtures Information), may develop safe use information for common product types. Formulators can select appropriate SUMIs for their products and uses and provide them as an attachment to the Safety Data Sheet. CRAD was the first training organization authorized by the Ministry to provide CEE training. It provides CEE training with expert trainers in its field. At the same time, with its team holding CEE certification, it can provide the chemical industry with all necessary services for CARDReg compliance. Bülent Özdemir Chemical Legislation Expert Manager CRAD Chemical Legislation Consulting Services    

Sources 1- Regulation 30105 on Registration, Evaluation, Authorization and Restriction of Chemicals and its annexes. 2- ECHA website, current publications.