The Safety Data Sheet

The Safety Data Sheet is part of the requirements contained in the UN GHS model regulations of the “UN Purple Book“. Section 1.5 describes for which products SDSs need to be created, and how the SDS with its 16 main sections should be structured in principle.

In the European Union the Safety Data Sheet is enshrined in Article 31 of Regulation (EC) No 1907/2006 (REACH) and is defined in detail in Annex II. The Annex II is kept up to date by other EC regulations. Usually the title of the SDS refers to the basic regulation, the REACH Regulation itself.


Annex II was last updated by Regulation (EU) 2015/830 of 28 May 2015 with entry into force 1 June 2015. The previous Regulation (EU) 453/2010 provided, for the transitional period to the mandatory application of classification and labelling according to CLP regulation on mixtures until 01-06-2015, two different versions of Annex II.

Apart from the commitment to the version according to CLP/GHS, the new regulation has introduced some editorial and some substantive changes, e.g. information on the risk of dust explosion (if required) and to the (now mandatory) mentioning of many types of toxicological effects in Section 11.


It should also include an assessment (“Classification criteria are met / not met”) in accordance with Section 2. For this Prosisoft provides a new FCC calculation package, so that these new requirements can be met even in highly automated SDS generation.

There is a paper of CEFIC (the European Chemical Industry Council) on the most important changes of the revised Annex. We will incorporate these changes as soon as possible. ECHA has published a new version of their Guidance on the compilation of Safety Data Sheets in August 2015, taking into account the new regulation.