SDS Software: Drafting and Distribution of Safety Data Sheets

What Are SDSs and Why Are They Mandatory?

SDS (Safety Data Sheets), historically also known as MSDS (Material Safety Data Sheets) or Safety Data Sheets, are mandatory regulatory documents for all hazardous substances and mixtures, as well as for PBT/vPvB substances and those included in the SVHC Candidate List, placed on the European market. The format and content of SDSs are defined in Annex II of the REACH Regulation (EC) 1907/2006, as amended by Regulation (EU) 2020/878.

Each SDS must contain 16 standardized sections covering: identification of the substance/mixture, hazards, composition, first aid measures, firefighting measures, accidental release, handling and storage, exposure controls, physical and chemical properties, stability and reactivity, toxicological information, ecological information, disposal, transport, regulatory information, and other information.

The European Chemicals Agency (ECHA) publishes Guidance on the compilation of SDSs, which provides detailed instructions on how to correctly draft each section. Non-compliance with SDSs can lead to penalties, marketing bans, and legal liability.

SDS Authoring with kemXpro: Complete Functionality

Drafting in accordance with Regulation 2020/878

The kemXpro SDS module guides the user through the compilation of all 16 sections of the Safety Data Sheet in accordance with the format prescribed by Regulation (EU) 2020/878. The system includes pre-filled templates, automatic validation of mandatory fields, and consistency checks between sections (e.g., consistency between classification in Section 2 and composition in Section 3).

Standardized and Multilingual H and P Statements

kemXpro manages the entire database of H hazard statements and P precautionary statements in accordance with the CLP Regulation, updated to the latest revisions of the ATP (Adaptations to Technical Progress). The statements are automatically inserted in the target language of the SDS, with support for combined statements and EUH supplemental statements.

Composition and Annex II REACH

Section 3 of the SDS (Composition/information on ingredients) is automatically generated from the product formulation registered in kemXpro. The system applies the rules of Annex II REACH to determine which components must be declared, with the correct concentration ranges, CAS numbers, EC numbers, and harmonized classifications from Table 3 of Annex VI CLP.

SDS Generation in 40+ Languages

kemXpro automatically generates SDSs in over 40 languages, covering all European and international markets. Translation is not a simple language change of H/P phrases, but includes complete localization of: section headings, standard phrases, local regulatory requirements, national emergency numbers, and country-specific legislative references.

Digital Distribution of SDS

kemXpro integrates a dedicated portal for the digital distribution of Safety Data Sheets to customers. Each recipient receives access to the updated SDSs for the products they have purchased, with automatic notification when an SDS is revised. The system tracks accesses and acknowledgments of receipt for REACH Article 31 compliance.

Exposure Scenarios and Extended SDS (eSDS)

For REACH-registered substances in quantities of 10 tons/year or more, kemXpro supports the generation of extended SDSs (eSDSs) with attachments containing Exposure Scenarios. The system manages operating conditions (OC), risk management measures (RMM), and DNEL/PNEC parameters in accordance with ECHA guidelines.