Safety Data Sheets (SDS) are essential documents required under the EU’s REACH and CLP regulations for the safe use, classification, and communication of hazards related to chemical substances and mixtures. Regulatory inspections in EU Member States typically focus on the presence, accuracy, format, and currency of SDS documentation. In this article, we explore what inspectors look for, which SDS sections are most critical, and the consequences of non-compliance.
In the European Union, the enforcement of REACH and CLP is the responsibility of national competent authorities. Depending on the country and the scope of activity, inspections can be carried out by:
Health and Safety authorities – verifying that workers have access to SDS and understand the risks (REACH Article 35).
Environmental authorities – checking for environmental hazard classification, spill response, storage, and waste handling measures.
Market surveillance bodies – ensuring that SDS are provided free of charge to recipients in accordance with REACH Article 31, and that product labels match SDS data.
Fire safety and emergency response units – assessing hazard communication for emergency planning and proper labeling of storage facilities.
These authorities evaluate whether SDS are supplied as required, whether they are up-to-date, and if they meet the requirements of Annex II of REACH, which sets out the structure and content of SDS.
Under REACH Article 31, suppliers must provide a safety data sheet:
when a substance or mixture is classified as hazardous,
when a substance is persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB),
or when a substance is included on the Candidate List for Authorisation.
An updated SDS must be provided whenever new information becomes available, or when an authorisation or restriction is granted, modified, or refused.
Failure to comply may result in administrative or criminal penalties, as specified by national legislation. According to REACH Article 126 and CLP Article 47, these penalties must be:
“Effective, proportionate, and dissuasive.”
National authorities may impose fines, suspend product sales, require corrective labeling, or order product recalls.
While all 16 sections of the SDS are subject to legal scrutiny, Sections 2 and 3 are the most critical during inspections:
This section defines how the product is classified and labeled, including hazard statements, precautionary statements, signal words, and pictograms.
Errors in Section 2 can lead to:
non-compliant product labels,
incorrect workplace hazard communication,
problems with transport and storage classification.
Since labeling is directly derived from classification, incorrect information here affects the entire downstream communication chain.
This section identifies the substances responsible for the classification of the mixture and provides concentration ranges.
Mistakes or omissions in Section 3 may impact:
hazard classification (Section 2),
exposure controls (Section 8),
transport classification (Section 14),
emergency response information.
Regulators often cross-check Section 3 against classification claims. A mismatch can invalidate the SDS and result in enforcement action.
The risks of non-compliant SDS go beyond legal consequences:
Incorrect classification may result in improper labeling, triggering costly relabeling, recalls, or withdrawal from the market.
Business partners (e.g., retailers or distributors) may impose contractual penalties for non-compliance.
Authorities can impose fines, corrective measures, or even halt product sales until documentation is corrected.
A professional SDS audit is the best preventive measure to identify inconsistencies or outdated elements before an inspection occurs.
REACH and CLP enforcement differs slightly between countries, but fines can be substantial:
Bulgaria: fines from €5,000 to €50,000 for REACH Article 31 violations
Cyprus: up to €20,000 for failure to supply SDS
Italy: fines from €3,000 to €18,000
Slovakia: fines from €16,000 to nearly €30,000
Such penalties far exceed the cost of proper SDS preparation and regular updates.
Ensuring SDS compliance means more than just avoiding penalties – it protects your business, your customers, and the environment.
At SDS Create, we specialize in:
SDS authoring and multilingual documentation,
REACH Annex II updates and CLP compliance,
SDS audits and gap analysis,
Regulatory support across the EU and beyond.
Let us handle the complexity so you can focus on your core business.