Safety data sheets (SDSs) are a well-established method for the provision of information to recipients of hazardous substances and mixtures and in the European Union, they have been made an integral part of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006). The original SDS requirements of REACH have been further adapted to take into account the rules for safety data sheets from the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and its implementation into European legislation through the Classification, Labelling and Packaging of substances and mixtures (CLP) Regulation (EC) No 1272/2008) in the form of a revision to Annex II of REACH through the Safety Data Sheet Regulation, otherwise known as (EU) 453/2010.
Understandably these new requirements, in addition to the transitional measures implemented for the reclassification of substances and mixtures by CLP, have led to some confusion over what is required by companies and users, and by when. In addition to this, companies registering hazardous substances at volumes greater than 10 tonnes under REACH with the European Chemicals Agency (ECHA) have obligations to extract Exposure Scenarios (ES) from the Chemical Safety Report (CSR) and communicate this information down the supply chain in an annex to the SDS (extended or eSDS).
Why adopt GHS?
As trade in substances and mixtures becomes increasingly globalised, a standardised classification is not only an issue relating to the European internal market. The United Nations (UN) set out with a view to facilitate worldwide trade while protecting human health and the environment, and therefore proposed harmonised criteria for classification and labelling. The result is called the Globally Harmonised System of Classification and Labelling of Chemicals and was implemented in Europe through the CLP Regulation. In theory at least, a product classified and labelled according to CLP and supplied with an appropriate SDS will be compliant, excepting a few country specific amendments, within all countries that have adopted the GHS system. This greatly reduces the need for duplicate labelling and testing.
CLP timelines
CLP came into force on 20 January 2009 and implements a number of different timelines for the reclassification of substances and mixtures. This has led to some confusion. Since 1 December 2010, all substances must be classified, labelled and packaged in accordance with CLP, however, until 1 June 2015, the classification of the substance according to both CLP and DSD must be provided in the Safety Data Sheet. This is to ensure formulators can continue to classify their mixtures according to DPD until the 2015 deadline.
Perhaps confusingly, until 1 June 2015, mixtures can be classified and labelled to either CLP or the outgoing Dangerous Preparations Directive (1999/45/EC). Where CLP is adopted early for mixtures, the rules are for as with substances, i.e. the classification according to DPD must also be provided in Section 2.1 of the SDS.
SDS and eSDS Requirements
As a result of a substance’s REACH Registration, there may be new information to be communicated down the supply chain including amongst others: the hazards associated with the substance (or mixture), revised first aid measures, personal protective equipment requirements and safe handling and use.
For substances registered at and above ten tonnes per year, which meet the CLP classification criteria, each identified use of a substance should have an exposure scenario (ES) that will document all the relevant routes of exposure and releases associated with that use. An ES details the operational conditions of manufacture and use, and the risk management measures required to ensure the safe use of the substance for each exposed population during all the lifecycle stages of the substance, including the waste stage and the article service life, where applicable.
ECHA is guiding users and compilers of ES towards the newer, short, 4 part ES. Although the use of this format is not obligatory, it aims to facilitate re-use or update of assessments already done at the level of the single registrants or within sectors, support downstream users in the formulating sectors in processing the received information in an efficient way that conforms with the REACH requirements, and facilitates efficient and targeted compliance checks of the registration dossier by authorities. Perhaps just as importantly, this ES format goes some way towards enabling SDS to be written in standard phrases to facilitate cost effective translations for other Member State markets.
Summary
CLP and REACH have introduced additional obligations for manufacturers, importers and downstream users including the revised SDS, new classification system and, where applicable, provision of exposure scenarios. Undoubtedly, this has increased the amount of paperwork and associated costs in the supply chain; however, it should ultimately ensure the safe use of chemicals throughout the lifecycle, together with reducing the burden of compliance with differing international legislation via a single Globally Harmonised System.
