Preparing a Safety Data Sheet (SDS) is a requirement under the REACH Regulation (specifically Annex II, as amended by Regulation (EU) 2020/878). This document is a key source of information about hazards arising from the use of chemical substances and mixtures, safety measures, and rules for using chemical products. But who can be entrusted with the preparation of an SDS, given that the EU market lacks a formal certification system or an "official" body responsible for creating SDSs?
This is a common misconception. No government authority prepares SDSs on behalf of companies. Supervisory bodies (such as the Environmental Inspectorate or Labour Inspectorate) may inspect the correctness of SDSs, but they do not participate in their development.
Responsibility for preparing an SDS always lies with the supplier – the manufacturer, importer, distributor, or downstream user placing a substance or mixture on the market.
Theoretically – yes. Practically – not necessarily. The regulations do not require any certification or license to prepare an SDS. However, according to Annex II of the REACH Regulation, a Safety Data Sheet must be prepared by a competent person.
🔍 A competent person is someone who has appropriate knowledge and experience in chemical regulations, substance classification, and hazard assessment (more on this in our article here: LINK).
In practice, to prepare a reliable SDS, one must:
be familiar with REACH, CLP, and related regulations (e.g. transport, waste),
be able to classify substances and mixtures in accordance with CLP criteria,
know the SDS document structure and the content requirements of its 16 sections,
ideally have knowledge of chemistry and physico-chemical properties.
Of course, not every SDS requires the full range of these skills, and some documents are simpler than others. However, working with experienced professionals helps meet the demands of the most complex cases. It can also save time and money. An experienced SDS author is able to identify opportunities for reducing the amount of documentation or grouping products.
There are various tools available on the market that support SDS preparation. Many different programs claim to enable SDS generation in just a few simple steps. In reality, the situation is not that straightforward.
Firstly, every software tool, regardless of its level of advancement, requires input data – and at this stage, users must already be able to determine which data should be entered and which are unnecessary.
Secondly, programs often use databases and import data from them. This can be a helpful and powerful function – even for advanced SDS authors – but it also carries some risks. Programs typically do not verify the data they retrieve to build the SDS. It is the responsibility of the author to evaluate the relevance and correctness of this information. Without thorough analysis, the data in your SDS may be:
incorrect,
outdated,
inconsistent with the classification,
leading to overclassification of your product.
Thirdly, correctly preparing an SDS requires accurate classification of the substance or mixture. Without expertise, users may fail to identify inconsistencies in the classification proposed by the software. This is particularly risky for more complex mixtures.
Fourthly, users are usually responsible for assigning the transport classification (Section 14 of the SDS). Preparing this section again requires knowledge of additional areas such as transport regulations (e.g., the ADR agreement).
There are even more limitations, but the points listed above clearly show that software alone will not solve all SDS-related issues. Of course, SDS software can be a great tool, but it requires adequate knowledge and training from the user. It’s best to think of it like accounting software – definitely useful, but some matters are best left to a professional accountant. In both cases, improperly prepared documentation may result in financial consequences.
✅ An SDS can formally be prepared by anyone – but only if they possess actual competence.
❌ Lack of knowledge or mistakes in the SDS can result in problems during inspections, administrative penalties, or even liability for damages.
✅ Software can and should be used as support in SDS preparation.
❌ SDS software is not a magic tool that will automatically produce a compliant SDS without an experienced user behind it.
In most cases, companies outsource the preparation of SDSs to specialized service providers. Consulting firms (such as SDS Create) operate on the market and offer:
experienced chemical regulatory specialists,
up-to-date access to substance databases,
knowledge of the EU market and legislation.
By outsourcing your SDS to an external provider, you gain:
✅ compliance with current legal requirements,
✅ correct classification,
✅ time savings, safety, and support in case of inspections.
🔹 Does the company have experience in preparing documentation?
🔹 Do they follow changes in REACH and CLP regulations?
🔹 Do they offer advisory support and help understand applicable regulations?
🔹 Do they provide post-preparation support (e.g., updates, regulatory interpretations, inspection support)?
At SDS Create, we’ve been preparing and updating Safety Data Sheets from the ground up for many years – in line with the latest EU requirements and other GHS implementations. Our approach combines deep knowledge of chemical law with hands-on experience in industry.
Don’t take chances – trust the experts.
Contact us to safely and quickly prepare Safety Data Sheets for your products.