Preparing Safety Data Sheets (SDS) – Part 2
Responsibilities and the SDS Compilation Process
MSDS-Europe – Safety data sheet knowledge base – Preparing Safety Data Sheets (SDS) – Part 2: Responsibilities and the SDS Compilation Process
In the previous installment (Preparing SDS – Part 1), we reviewed what a safety data sheet (SDS) is and its legal foundations (REACH and CLP).
Now we will discuss who should prepare the safety data sheet and how it should be done, what responsibilities are involved, and what to pay attention to during the process. We will also cover when an SDS is required for a product, how SDS compilation proceeds step by step, and what to know about updating, language requirements, and distribution.
(Detailed guidance on this topic is provided in the official ECHA document titled “Guidance on the compilation of safety data sheets” (2021), available on the ECHA website.)
Who is responsible for preparing the SDS?
Laws clearly define that the company that places the product on the market is ultimately responsible for the content of the SDS – this is typically the manufacturer or importer. They are obliged to ensure that the SDS for the product complies with REACH requirements and that it is delivered to downstream users.
Every manufacturer or importer who places a hazardous substance or mixture on the EU market must provide an SDS in the appropriate language to their customers.
Distributors (resellers) are also responsible for ensuring that the product’s SDS is passed along to professional users.
For example, a paint distributor must make sure that the product’s SDS in Hungarian is made available to the purchaser.
When is a safety data sheet mandatory?
In general, a safety data sheet is required for any hazardous substance or mixture. This means that if a product falls into any hazard class under the CLP regulation (e.g. flammable, corrosive, toxic, irritant, etc.), the distributor must provide the SDS to the user without prior request.
Additionally, there are cases where a mixture is not classified as hazardous, but due to certain components an SDS is still required (at least upon request).
Some examples of such cases include:
- Non-hazardous mixture containing a hazardous ingredient above a specified concentration: in such cases, a professional user may request a safety data sheet, and it must be provided. For example, if a mixture contains a health-hazardous substance in a significant amount, then under REACH Article 31(3) the user can request the SDS and it must be made available.
- Mixture containing a component with an occupational exposure limit: if the mixture has a component that has a mandated workplace air concentration limit, then an SDS must be provided on request, even if the mixture itself is not classified as hazardous.
- Mixture not intended for consumer use but which requires certain labelling elements: such products must also have an SDS prepared, and it should be made available to professional users upon request.
Important: Not every product requires an SDS.
If a mixture contains no hazardous ingredients and is intended for consumer (household) use, generally a safety data sheet does not need to be provided.
However, some industrial customers may still request a data sheet for the product. As a good practice, the manufacturer might still prepare an information sheet or a voluntary SDS for the product, as this helps customers in using the product safely.
Language requirements
An SDS must always be provided in the official language of the country where the product is marketed. In Hungary, for example, a Hungarian-language safety data sheet is required. If a company supplies a product to multiple EU countries, the SDS must be prepared or translated in each target country’s official language.
How to compile a Safety Data Sheet
Competent person and expertise
According to the rules, a safety data sheet must be prepared by a “competent person.” This refers to a professional with appropriate qualifications and chemical safety knowledge. The official guidance also emphasizes that competent persons should receive continuous training, since regulations related to hazardous materials are frequently updated.
If such expertise is not available in-house, it is advisable to turn to an external consultant. Numerous companies specialize in SDS compilation and review, acting as chemical safety experts to help prepare data sheets that comply with legislation.
Steps to prepare an SDS
The preparation of an SDS is a multi-step process that involves gathering and organizing many types of information. Below is a general outline of the process, which in practice helps ensure that each part of the SDS is consistent and complete:
1. Information gathering:
Collect all relevant data for the substance or mixture in question. This includes the exact identification of the product (name and any identification numbers such as CAS number, EC number, and for mixtures the unique formula identifier – UFI code), the list of components and their concentrations, physical and chemical properties (e.g. boiling point, density, pH, flash point), as well as toxicological and ecotoxicological data. Sources can include existing SDSs of the components, ECHA databases, literature data, and in-house experimental results. Gathering this information forms the foundation of the SDS.
2. Determine hazard classification:
Based on the collected data, determine the product’s hazard classification according to the CLP regulation. This involves deciding which hazard categories the substance/mixture falls under (e.g. Flammable Liquid Category 2, Skin Corrosion Category 1A, Acute Toxicity Category 3, etc.), and identifying the appropriate H statements (hazard statements) and P statements (precautionary statements). Classification is derived from the hazards and concentrations of the components.
Ensure that any specific concentration limits and M-factors are taken into account, and that all relevant hazards of the mixture have been assessed.
3. Fill in the SDS sections:
Once classification is complete, the 16 sections of the safety data sheet can be filled out with the appropriate information. It is important to adhere to the correct sequence and numbering of sections in the SDS. Each section has certain required content elements – for example, Section 1 requires product identifiers and supplier details, Section 2 contains the hazard identification details, Section 3 lists the ingredients, etc.
Consistency is crucial: the information provided in different parts of the SDS must not contradict each other. For example, if Section 2 labels a mixture as flammable, then the flash point data in Section 9 should support that classification.
4. Review and approval:
After completing the SDS, it should be reviewed thoroughly. As part of a quality check, verify that all necessary information is included and that there are no missing sections or mistakes (e.g. typos, incorrect units). It can be helpful to get an internal expert to review the SDS or to compare it with data sheets of similar products. Make sure that the latest regulatory references are cited (e.g. the relevant EU regulations and their amendments).
5. Distribution to users:
The finished safety data sheet must be delivered to the product’s users. This can be done electronically (for example, via email as a PDF) or in paper form, but in all cases it must be made available free of charge (REACH stipulates that the SDS must be provided to the customer at no cost).
In practice, many companies send the SDS to the buyer with the first order or shipment, or make it available for download on their website.
It is also important that the SDS be kept up-to-date: if new information or risks emerge regarding the product, or its classification changes (for example, if component concentrations change or new toxicological data become available), the data sheet must be updated without delay.
6. Ongoing updates and version control:
If new information or hazards come to light about the product, or if its classification changes, the SDS must be revised promptly.
The updated version should be sent to all users who received the previous version in the past year (typically within the last 12 months).
Additionally, previous versions of the SDS and related data should be archived for at least 10 years, so that they are available in case of regulatory inspection or for future reference. It is advisable to assign a version number and date to each SDS, so it’s clear which one is the most recent valid version. For example: Version 1 – 2021.06.01; Version 2 – 2023.03.15 (revised in accordance with Regulation (EU) 2020/878).
When a change occurs (new information, regulatory change, product composition modification, etc.), issue a new version and note in Section 16 what has changed. This way, users can see that an update has occurred and can more easily stay current.
In summary,
preparing an SDS is a complex task that requires expertise and attention. Throughout the process, one must keep in mind that the goal is to inform and protect users and to ensure regulatory compliance. It is not just “paperwork,” but an important tool for occupational safety and environmental protection.
In the following sections, we will turn to the specific content elements of a safety data sheet: we will review in detail what information needs to be provided in each section of the SDS.
Further parts:
- Part 1: Introduction and Regulatory Background
- Part 3: The first 8 sections of the SDS in detail
- Part 4 The remaining SDS sections (9–16)
- Part 5: Special cases and best practices
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