How REACH amends safety data sheets
Safety Data Sheets (SDS) are a key resource for employers carrying out risk assessment on hazardous substances or mixtures handled and stored in the workplace. The current SDS requirements in REACH are being amended to take into account the implementation of the Globally Harmonised System of Classification and Labelling (GHS), so Mark Blainey provides an overview of the changes.
Chemicals are widely used in the occupational setting but the reality is we still know very little about them. The majority of substances on the market do not carry sufficient information about their effects on human health and the environment. Several hundred different chemicals have been found to cause skin or respiratory diseases; in 2001, it was estimated that between 18 and 30 per cent of such diseases were related to occupational exposure. Even more serious, it has been estimated that 32 million people are exposed to substances that cause cancer at levels above those considered as safe, and that between 35,000 and 45,000 deaths occur in the EU each year as a result of such exposure.1
The Control of Substances Hazardous to Health Regulations 2002 (COSHH) require employers to assess the risks of substances used in their workplace, and prevent or adequately control exposure to them. Risk assessments for the use of chemicals in the workplace are generally reliant for information on the relevant Safety Data Sheet (SDS) for the substance. Article 6(2) of COSHH specifically requires the risk assessment to consider information on health effects provided by the supplier, including information contained in any relevant SDS.
The aim of the original EU directive on SDS (1991/155/EEC) was to provide professional users of substances and preparations with sufficient information to take the necessary measures to ensure protection of health and the environment. Information was given on the hazards inherent in a chemical substance, or preparation, as was guidance on how the substance or preparation should be handled, stored, and disposed of, together with advice on what to do in case of an accident. (See panel overleaf for the mandatory information required in the sheets.)
However, many people have found SDSs incomprehensible, or even inaccurate, and various studies have been carried out on them. In one such study, out of 150 SDSs only 37 per cent were found to have accurate health-effects data (chronic health information was the most inaccurate), and only 47 per cent were accurate regarding personal protective equipment, or correct occupational exposure limits.2
Consequently, a number of changes has been made over the last 10 years to try to improve the situation, including changes to the relevant legislation and, most recently, the introduction of the Globally Harmonised System of Classification and Labelling (GHS).3
The directive was first amended in 1993 to implement necessary changes related to substances, and again in 2001 to implement the requirements of the environmental classification of preparations. In 2006, the requirements for SDS were incorporated into REACH.4 The key difference between the SDS requirements under REACH and those in the directive is that exposure scenarios (ES)5 generated under REACH must be contained in the annex to SDS for relevant identified uses. This gives users of the substances vital information on how to control the substance in terms of specific risk management measures (although as the ES are provided for each substance, this makes the information for mixtures quite voluminous).
There were certain other changes under REACH:
- Section 1: the e-mail address and registration number of the person responsible for the SDS should be included;
- Sections 2 and 3 were reversed, in order to improve comprehensibility by providing information on the hazard before the composition of mixtures (if relevant);
- Section 3 (information on ingredients): persistent, bio-accumulative and toxic (PBT) substances and very persistent and very bio-accumulative (vPvB) substances should be mentioned if present in volumes of > 0.1%; registration numbers of substances registered under REACH should also be given, when available (each substance gets a unique number linking the substance identity and the manufacturer/importer of the substance);
- Section 8: where a chemical safety report is required, the relevant Derived No Effect Levels (DNELs) for health effects and Predicted No Effect Concentrations (PNECs) for the environment related to a substance shall be given for the exposure scenarios set out in the annex to the SDS; a summary of the risk management measures (RMMs) relating to both health and the environment is required; for preparations, it is useful to provide values for constituents required to be listed in section 3;
- Section 11: information on toxico-kinetics, metabolism and distribution should be included, as should a statement on the carcinogenic, mutagenic and reproductive toxicity (CMR) category-1 or 2 status of the substance or mixture.
- Section 12: results of the PBT/vPvB assessment, and the emission characterisation (only required if the PBT and vPvB conditions are met) should be included, as should information – if available – on endocrine-disrupting potential;
- Section 15: if a chemical safety assessment (CSA) has been carried out for the substance, or a substance in the preparation, this must be indicated; relevant information on authorisation or restriction for a substance under REACH, as well as relevant national measures (e.g. occupational exposure limits) for the substance should be mentioned;
- Section 16: full risk and safety phrases related to classification should be included, as should information on where use is advised against (e.g. recommended restrictions on use, and non-statutory recommendations by the supplier).
Regulation (EC) No 1272/2008 has been recently agreed, and implements the GHS in the EU. The GHS was developed under the auspices of the United Nations to harmonise classification systems across the world, including the requirements for SDS. However, during the negotiations on Regulation 1272/2008, Annex II of REACH, dealing with SDS, was not amended, meaning it now needs to be updated.
Several features of the updated SDS requirements are worth highlighting. Firstly, the requirements are better structured, with the division into part A (Requirements for the compilation of safety data sheets) and part B (List of headings/sub-headings). Paragraph numbers and sub-headings have been introduced, and blank sub-headings are not allowed.
Secondly, the GHS content related to SDS has been incorporated into Annex II of REACH (but adapted to Community requirements, where necessary).
Thirdly, references in the text have been updated to reflect Regulation 1272/2008 rather than the old directives on classification. The REACH text on SDS has also been clarified in places.
The new provisions will be phased in, with the requirements for substances applying from 1 December 2010, and for mixtures from 1 June 2015. However suppliers may, on a voluntary basis, include both the classification and the labelling in accordance with the CLP Regulation 1272/2008 earlier, as long as they also provide the classification in accordance with Directives 67/548/EEC and 1999/45/EC. Suppliers of substances or mixtures may apply the new SDS requirements immediately, if they so choose.
In the case of substances already on the market before 1 December 2010 and which do not need to be relabelled and repackaged, an updated SDS will not be required until 1 December 2012. For mixtures already on the market before 1 December 2015 and which do not need to be relabelled and repackaged, an updated SDS will not be required until 1 June 2017.
From 1 December 2010 until 1 June 2015, suppliers of mixtures may apply the new SDS requirements providing they include the classification of the mixture in accordance with both Directive 1999/45/EC and Regulation (EC) No 1272/2008, and provide the classification of the component substances in accordance with Directive 67/548/EEC and Regulation (EC) No 1272/2008.
A key issue that has also been dealt with is the very controversial requirement to include the REACH registration number for a substance, or components of a mixture. The concern was related to confidentiality, as part of the registration number relates to the identity of the supplier. The solution proposed is that the part of the number referring to the individual registrant of a joint submission may be omitted by a supplier, provided that the supplier assumes the responsibility to provide the full registration number, upon request for enforcement purposes, to the recipient, or to the member-state authorities responsible for enforcement.
Health and safety practitioners who need to use SDS will potentially have more information, both on the substance or mixture itself and on the risk-management measures that are needed to protect workers from the chemical. However, the sheer amount of information contained in the SDS may make accessing the relevant details problematic, despite the new structure. There are numerous training courses and guidance documents available to assist users, including on the HSE website.6
In essence, section 2 contains information on the hazards of the substance, and sections 7 and 8 detail how to control the substance. Further information or assistance can also be obtained from the supplier (whose details will be contained in section 1 of the SDS) or the user’s trade association.
Nevertheless, there are likely to be complications related to the new classifications that might not be easily recognised by users. Practitioners who have to produce SDS for their company will have extra work to do to produce compliant sheets by the end of this year, in addition to any registration under REACH and reclassification of their substances under the new CLP Regulation.
1 ‘Commission consults workers and employers on reducing exposure to substances that cause cancer and reduce fertility’ – Press release IP/04/391, Brussels, 26 March 2004
2 Kolp, Williams and Burtan (1995): ‘Assessment of the Accuracy of Material Safety Data Sheets’, in J Am Ind Hyg Assoc, Volume 56, Issue 2, pp178-183
3 For an earlier feature by the author on the GHS, see SHP November 2007 – ‘Sweet harmony’, Vol.25, No.11 or visit www.shponline.co.uk/features-content/full/sweet-harmony
4 For an earlier feature by the author on REACH, see SHP June 2007 – ‘Within REACH’, Vol.25, No.6 or visit www.shponline.co.uk/features-content/full/within-reach
5 An exposure scenario for a substance sets out the risk-management measures that will ensure the substance is safe for a particular set of operational conditions
Mark Blainey is a biochemist and toxicologist and an author of the original REACH proposals.