Preparing a Safety Data Sheet (SDS) is a process that requires not only knowledge of legal regulations but also a deep understanding of chemistry, hazards, and occupational safety principles.

In practice, this task is often outsourced to external companies. However, it is essential to ask one key question: Who is truly qualified to prepare an SDS in compliance with current regulations?Can an occupational health and safety (OHS) officer do it? Can it be the head of a laboratory?It all depends on their knowledge and experience!

Safety Data Sheet – The Foundation for the Safe Use of Chemicals

An SDS (Safety Data Sheet) is a fundamental document transmitted along the supply chain of chemical substances and mixtures. Its purpose is to provide information on:

• hazards associated with the product,

• precautions for safe use,

• emergency procedures,

• transportation, storage, and disposal guidelines.

The rules for preparing SDSs are laid down in Regulation (EC) No 1907/2006 (REACH), specifically Annex II, which sets the format and content of the SDS.The classification and labelling of substances are governed by Regulation (EC) No 1272/2008 (CLP).

Who Can Prepare an SDS – Formal Requirements

Article 31(1) of the REACH Regulation states:"The supplier of a substance or mixture shall provide the recipient of the substance or mixture with a safety data sheet compiled in accordance with Annex II (...)."

Furthermore, Annex II of REACH, in section 0 (point 0.2.3), specifies that:

"The safety data sheet shall be prepared by a competent person who shall take into account the specific needs and knowledge of the users as far as they are known. Suppliers of substances and mixtures shall ensure that such competent persons have received appropriate training, including refresher training."

The official Guidance on the Compilation of Safety Data Sheets also explains:

"No specific definition of the “competent person” is given in the Regulation. However the term may usefully be defined in this context as meaning a person (or combination of persons) – or a coordinator of a group of people - who has or have, as a result of their training, experience and continued education, sufficient knowledge for the compilation of the respective sections of the SDS or of the entire SDS.
The supplier of the SDS can delegate this function to his own staff or to third parties. It is not necessary that the expert knowledge be provided in full by one single competent person.
It is understood that a single person very rarely has extensive knowledge in all the fields covered by an SDS. It is thus necessary that the competent person rely upon additional competences, either internal or external. The competent person should ensure the consistency of the SDS, especially if he acts as the coordinator of a group of people."

The guidance also outlines the required knowledge areas for SDS authors:

1. Chemical nomenclature
2. European Regulations and Directives relevant to chemicals and their implementations into MS national legislation, applicable national legislation (in their valid current versions), to the extent that these are relevant in the compilation of SDSs, for instance (non-exhaustive list, shortened titles):
3. Relevant national or international guidelines of the respective sector association
4. First aid measures
5. Accident prevention
6. Measures for safe handling and storage
7. Physical and chemical properties:toxicology and ecotoxicology (especially Section 11 and Section 12 of Annex II);
8. Toxicology/eco-toxicology
9. Transport provisions
10. National provisions

What Does This Mean in Practice?

🔹 Interdisciplinary knowledge is essential, covering:

• REACH and CLP regulations,

• toxicology and ecotoxicology,

• physical and chemical properties of substances,

• hazard classification rules,

• labelling and transport of dangerous goods (ADR, IATA, IMDG),

• practical occupational safety and environmental protection.

🔹 Experience in interpreting data from:

• manufacturers' safety data sheets,

• raw material SDSs,

• ECHA databases,

• OECD-compliant testing results, is also crucial.

Why Is Safety Data Sheet Authoring Experience as Important as Knowledge?

While the regulations define the framework, many aspects are left to the judgment of the SDS author, such as:

• How to classify a mixture based on partial data?

• How to interpret NOAEL, LD50, or log Kow values in the context of classification and Section 11?

• How to prioritize substance data when multiple sources exist?

• How to assess interactions within a mixture (e.g., acid-base reactions, neutralization of corrosive effects through complexation)?

• How to apply specific exemptions correctly?

👉 No template can answer these questions – only practical experience and a deep regulatory understanding can.

In Practice, This Means:

🔸 SDSs prepared by unqualified individuals may result in:

• incorrect hazard classification,

• improper labelling,

• failure to register substances or notify ECHA,

• non-compliance with ADR transport requirements.

🔸 Consequences may include:

• inspections by environmental, labour, consumer protection, or fire safety authorities,

• product recalls,

• administrative penalties and financial fines.

Who Should You Entrust with SDS Preparation?

Ideally, you should choose experts who:

• have experience preparing SDSs for various types of products (industrial, consumer, biocides, fertilizers),

• stay updated with EU regulations and ECHA interpretations,

• use professional databases (ECHA, IUCLID, PubChem, ESIS),

• offer audits and updates when substance classifications or regulations change,

• work across different industries, ensuring comprehensive regulatory knowledge.

SDS Creation with SDS Create

At SDS Create:

✅ We prepare SDSs in full compliance with REACH and CLP regulations,

✅ We apply ECHA guidelines and national supervisory authority recommendations,

✅ We base our documents on raw material data, scientific literature, and professional databases,

✅ Our documents are prepared by experienced specialists with chemistry backgrounds and deep regulatory expertise,

✅ Over the years, we have supported companies from various sectors in SDS preparation, problem-solving, and inspections, gaining invaluable experience to provide top-quality services.

📌 Remember: As the supplier, you are legally responsible for the contents of the SDS – regardless of who prepared it.

👉 Contact us if you need assistance with:

• preparing SDSs from scratch,

• auditing your documentation,

• updating SDSs in line with the new CLP Regulation.

info@sds-create.com

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