The chemical industry bears a critical responsibility for managing the potential impacts of its products on human health and the environment throughout their life cycle. Within this scope, the safe use of chemicals and effective risk management are not only legal obligations but also essential ethical responsibilities. Safety Data Sheets (SDS), constitute one of the key instruments in this process. However, in specific cases, the requirement for an Extended Safety Data Sheet (e-SDS) may arise. This article explores what an e-SDS entails, the circumstances under which it becomes mandatory, the structure and content of Exposure Scenarios, the implementation of these requirements under Türkiye’s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK) [1], as well as practical examples from the chemical industry and common mistakes encountered during the preparation process.
e-SDS under REACH and KKDIK
The REACH Regulation (EC) is a comprehensive legislative framework governing the registration, evaluation, authorisation, and restriction of chemicals within the European Union [2]. REACH defines the format and content requirements for Safety Data Sheets (SDSs) in Annex II, and mandates their role as communication tools for ensuring the flow of information on hazardous chemicals throughout the supply chain. The concept of an “extended” SDS (e-SDS) under REACH arises from the obligation to include exposure scenarios that define the conditions for safe use of a substance under specific circumstances. REACH Annex I outlines the conditions under which a Chemical Safety Assessment (CSA) is required for a substance. In summary, manufacturers or importers must prepare a Chemical Safety Report (CSR) for substances produced or imported at quantities of 10 tonnes or more per year. The exposure scenarios developed (for certain hazard classifications) as part of the CSR describe the operational conditions and risk management measures necessary for the safe use of the substance in identified applications, and these are annexed to the SDS. According to REACH, any supplier required to prepare a CSR must also provide the relevant exposure scenarios as an annex to the SDS. This obligation applies when the substance is classified as hazardous to human health or the environment and is manufactured or imported above the relevant tonnage threshold. In fact, under EU legislation, the provision of an SDS—and, where applicable, the inclusion of exposure scenarios—is mandatory in cases where the substance is classified as hazardous, is identified as persistent, bioaccumulative and toxic (PBT), or is listed as a Substance of Very High Concern (SVHC).
An Extended Safety Data Sheet (e-SDS) goes beyond the scope of a standard Safety Data Sheet by incorporating additional information designed to ensure the safe use of a substance. Fundamentally, an e-SDS includes Exposure Scenarios (ES) that cover all identified uses of the substance and detail the operational conditions and risk management measures (RMMs) necessary to control the risks associated with those uses [3, 4].
The requirement for an e-SDS arises under the KKDIK Regulation—and by extension, under the REACH Regulation—in the following cases:
· Substances Classified as Hazardous: For substances classified as hazardous according to the criteria set out in Annex I of the regulation.
· Substances Manufactured or Imported at ≥10 Tonnes/Year: If a substance is manufactured or imported at a volume of 10 tonnes or more per year a Chemical Safety Assessment (CSA) must be carried out, and a Chemical Safety Report (CSR) must be prepared. If the substance is classified as hazardous, exposure scenarios are developed as part of the CSR and submitted as an e-SDS.
· PBT and vPvB Substances: If the substance is classified as persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB), the requirement for an e-SDS may apply regardless of the tonnage band.
· Substances of Very High Concern (SVHC): For substances listed on the Candidate List and potentially subject to future authorisation, the provision of an e-SDS is generally required.
What Is an Exposure Scenario (ES) and What Does It Include?
An Exposure Scenario (ES) is a set of information that describes the potential human and environmental exposures associated with a specific use of a substance, along with the conditions and measures required to reduce those exposures to acceptable levels. In essence, it serves as a “prescription” for the safe use of a substance. Each ES may cover one or more identified uses of the substance throughout its life cycle—such as manufacturing, formulation, industrial use, professional use, or consumer use.
A typical Exposure Scenario includes the following key elements:
1. Use Description: A general description of the specific purpose and sector in which the substance is used. Example: “Used as an additive in the production of industrial lubricants.”
2. Operational Conditions (OCs): The physical and chemical conditions under which the substance is used. This includes factors such as temperature, pressure, whether the process is open or closed, and the presence of ventilation systems. Example: “Reaction carried out in a closed system at ambient temperature.”
3. Risk Management Measures (RMMs): Measures required to minimise exposure. These may include:
o Engineering Controls: Ventilation systems, local exhaust ventilation (LEV), closed systems, automation.
o Organisational Measures: Work procedures, training, shift planning, limiting the duration of exposure.
o Personal Protective Equipment (PPE): Gloves, goggles, respiratory protection, protective clothing. The choice of PPE should be based on the level of exposure and the hazardous properties of the substance. Example: “Use of nitrile gloves resistant to nitrous compounds.”
4. Exposure Estimates: Quantitative estimates of expected exposure levels via different exposure routes (e.g. inhalation, dermal). These estimates are typically generated using modelling tools such as EUSES or ECETOC TRA.
5. Risk Characterisation: A comparison of the estimated exposure levels with relevant reference values (e.g. DNELs or PNECs) to assess whether the risk is acceptable. If the risk is not acceptable, the OCs and RMMs must be revised and the assessment repeated.
6. Guidance for Downstream Users: Guidance for downstream users on how to apply the information in the e-SDS to their specific use conditions. This section is particularly important for supporting downstream users in conducting their own risk assessments.
Each exposure scenario may form part of a series of scenarios that together cover the entire life cycle of the substance. These scenarios should provide detailed information on every stage—from manufacturing to final use.
Implementation of e-SDS under KKDIK in Türkiye
With the enforcement of the KKDIK Regulation in Türkiye, the implementation of e-SDS has become mandatory. Manufacturers and importers of chemical substances (registrants) who place hazardous substances on the market at quantities of 10 tonnes or more per year are required, in accordance with Annex-1 of KKDIK, to carry out a Chemical Safety Assessment (CSA) and prepare a Chemical Safety Report (CSR) for these substances. As an output of the CSR, Exposure Scenarios are developed that describe the identified uses of the substance and the corresponding risk management measures. These Exposure Scenarios are then appended to the Safety Data Sheet to form the e-SDS.
The role of the e-SDS is also critical for downstream users (DUs). A DU must carefully review the e-SDS received through the supply chain and assess whether their own use conditions align with the exposure scenarios defined in the e-SDS [5]. If their specific use conditions are not covered in the e-SDS, or if the defined risk management measures are insufficient for their operations, the DU is required to take the following steps:
1. Notify the Supplier of Their Use: The DU may inform their supplier of their specific use and request an update of the e-SDS.
2. Conduct Their Own Chemical Safety Assessment (CSA): The DU can perform a CSA tailored to their own use conditions and prepare their own Chemical Safety Report (CSR). This is particularly applicable if the supplier is unwilling to update the e-SDS or if the DU’s conditions are more specific.
3. Source from an Alternative Supplier: If the above options are not feasible or technically possible, the DU may consider sourcing the substance from a different supplier.
Within the scope of KKDIK, the Ministry of Environment, Urbanization, and Climate Change conducts inspections to ensure the accurate and complete preparation and implementation of e-SDS. In cases of non-compliance, administrative fines may be imposed.
Practical Example from the Chemical Industry: Industrial Cleaning Products
Let us consider a chemical company that produces a solvent-based cleaner used in industrial facilities. The main component of this cleaner, a solvent, is manufactured in quantities exceeding 100 tonnes per year and is classified as “flammable” and “irritant to the respiratory system.”
In this case, the manufacturer is required to conduct a Chemical Safety Assessment (CSA) and prepare a Chemical Safety Report (CSR) for this solvent. The CSR will include Exposure Scenarios (ES) covering all identified uses of the solvent.
Example Exposure Scenario (ES) Content:
· Use Description: "Use in industrial metal surface cleaning by spray application."
· Operational Conditions (OCs):
o Temperature: Ambient temperature (20–25°C).
o Process: Spray application in an open system.
o Ventilation: In addition to general room ventilation, the use of a local exhaust system (LES) is required. The LES must provide a minimum airflow velocity of 0.5 m/s.
· Risk Management Measures (RMMs):
o Engineering Controls: Work within a spray booth or a well-ventilated area. Regular maintenance and efficiency checks of the LES are mandatory.
o Organizational Measures: Minimum personnel presence during cleaning operations. Work area must be restricted and warning signs posted. Personnel should receive annual training on the proper use of the solvent and associated risks.
o Personal Protective Equipment (PPE):
§ Respiratory Protection: Use of NIOSH N95 or equivalent particulate/vapor mask (P3 filter). The need for a self-contained breathing apparatus (SCBA) should be assessed, especially during intensive spray applications.
§ Hand Protection: Use nitrile or butyl rubber gloves (penetration time > 8 hours, thickness > 0.4 mm).
§ Eye Protection: Protective goggles or face shield against chemical splashes.
§ Skin Protection: Chemical splash-resistant protective suit.
· Exposure Estimates: Respiratory and dermal exposure levels are calculated using modeling software (e.g., TRA). Calculated values must be below the substance’s Derived No-Effect Level (DNEL).
· Risk Characterization: It is concluded that the exposure levels are below the established DNELs, thus the risk is acceptable.
· Guidance for Downstream Users: Clear instructions on how users should adapt this e-SDS to their specific work environments and processes. For example, "If the spray application is not performed in a closed system, ensure that the ventilation and PPE measures described above are fully implemented."
This e-SDS will help industrial facilities using the cleaner understand how to safely handle the solvent and develop their own risk management plans.
Common Mistakes and Key Points to Consider:
Some common mistakes made during the preparation and implementation of e-SDS can lead to serious non-compliance and risks:
· Incomplete or Incorrect Definition of Identified Uses: Failure to accurately determine all actual uses of the substance may lead to some exposures being overlooked. In particular, neglecting feedback from downstream users is a significant shortcoming.
· Unrealistic Exposure Scenarios: When the defined operational conditions and risk management measures do not reflect real-life practices, the e-SDS fails its purpose. For example, specifying a high-efficiency ventilation system on paper that does not exist in the field.
· Insufficient Risk Management Measures (RMMs): The RMMs identified may be inadequate to reduce risks to acceptable levels. This is particularly critical in personal protective equipment (PPE) selection, where standards may be ignored or information may be incomplete.
· Ignoring Downstream Users’ Responsibilities: Merely publishing the e-SDS is not enough. Downstream users must adapt this information to their own operations and conduct their own assessments when necessary. As a supplier, supporting downstream users in understanding and applying the e-SDS is crucial.
· Data Quality Issues: Input data used for exposure estimates (physical-chemical properties, operational data) being incorrect or incomplete leads to inaccurate risk assessments.
· Outdated Information: Failure to update the e-SDS in light of new information about the substance (new hazards, new uses, etc.) or changes in regulations. KKDIK requires safety data sheets and thus e-SDS to be kept current.
· Lack of Communication: Ineffective sharing of information and feedback related to the e-SDS throughout the supply chain, from manufacturer to downstream user.
Critical Notes for the Industry / Compliance Risks
Compliance with e-SDS is not only a legal obligation for the chemical sector but also a strategic issue that carries significant operational and reputational risks.
· Legal Risks: Non-compliance with the KKDIK Regulation can lead to substantial administrative fines, suspension of activities, and even legal proceedings. Particularly in cases of occupational accidents or environmental damage, incomplete or incorrect e-SDS increases legal liability.
· Operational Risks: Incorrect or incomplete e-SDS information can cause unsafe working conditions, occupational diseases, and environmental pollution. These issues may result in production interruptions, employee health problems, and increased remediation costs.
· Supply Chain Risks: Failure to provide suitable and clear e-SDS to downstream users can lead customers to reject the product or switch to other suppliers, causing market loss and erosion of competitive advantage.
· Reputational Risks: Negative incidents related to chemical safety can damage the company’s reputation among the public and stakeholders, reducing brand value.
To minimize these risks, companies in the chemical sector should pay particular attention to the following points:
· Proactive Approach: Closely monitor legal changes and industry guidelines, managing compliance processes proactively.
· Expertise and Capacity Building: Obtain support from competent internal or external experts for preparing and evaluating e-SDS. Ensure regular training and keep staff knowledge up to date.
· Data Management: Establish a robust data management system to ensure hazard, exposure, and usage data are accurate, complete, and current.
· Supply Chain Communication: Create transparent and effective communication channels throughout the supply chain to correctly understand incoming e-SDS information and provide clear, understandable information to downstream users. Improve the e-SDS by considering feedback from downstream users.
· Verification and Auditing: Regularly verify prepared e-SDS through independent experts or internal audits and check their consistency with field applications.
Conclusion and Recommendations
Extended Safety Data Sheets (e-SDS) are an indispensable part of modern chemical legislation aimed at ensuring the safe use of chemical substances and managing associated risks. With the implementation of the KKDIK Regulation in Türkiye, this requirement imposes significant responsibilities on manufacturers, importers, and downstream users alike.
The purpose of the e-SDS is not merely to fulfill a legal obligation but also to enhance the effectiveness of risk management throughout the supply chain and to ensure a safer working environment for all stakeholders. Therefore, it is critically important for companies in the chemical sector to take the preparation and implementation of e-SDS seriously, to develop the necessary technical capacity, and to establish a strong communication network across the entire supply chain.
Properly prepared and effectively utilized e-SDS documents will not only contribute to environmental sustainability but also play a vital role in protecting human health. In the future, with the opportunities presented by an increasingly digital world, e-SDS information is expected to become more interactive and accessible. These developments will further strengthen risk communication and open new horizons in the safe management of chemicals.
References
1) Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDİK), Official Gazette Date: 23.06.2017, Number: 30105. (Ministry of Environment, Urbanization and Climate Change)
2) Regulation (EC) No 1907/2006 (REACH) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals
3) ECHA (European Chemicals Agency) Guidance on the compilation of safety data sheets (Version 4.0, December 2020)
4) Republic of Türkiye Ministry of Environment, Urbanization and Climate Change – KKDİK Guidance Documents – Guidance on the Preparation of Safety Data Sheets
5) Turkchem Issue: 101, Erkin Kocaman, Doruksistem A.Ş. - Review of Downstream Users and Downstream User Obligations under KKDİK
