Safety Data Sheets
A Safety Data Sheet (SDS) needs to be supplied with hazardous substances and mixtures and made available for the supply of mixtures containing hazardous substances above thresholds of concern.
For substance REACH Registered and with a Chemical Safety Report (CSR), an extended SDS (eSDS) is expected which incorporates descriptions of uses and the risk management measures (RMM) considered necessary as a result of the Chemical Safety Assessment.
Note that the format and technical content of EU and GB SDS remain the same in most part.
However, from January 2021, the EU SDS needed poison centre details [link] (including UFI) and the EU format also suggests more details in Section 3 on ingredients plus other minor changes.
It is recommended to keep EU and GB SDS aligned as closely as possible and it is generally accepted that EU format is acceptable in the UK (despite minor differences in legal texts).
Note also that US SDS formatting is also possible to align to provide a single document that covers most of the World to GHS requirements. Local requirements will still need to be referred to, including names of suppliers /importers, local exposure limits and national requirements (eg California Prop 65)
Introduction to SDS / MSDS (e-SDS)
Globally, the production, transport, storage and supply of chemicals are covered by a number of national and international regulations with the objective of protecting man and the environment from potentially hazardous chemicals that are essential to our standard of living. It is not just the chemical industry that is affected by these regulations – any organisation using chemicals, including printing, electronics, textiles, motor trade, health care etc. needs to be aware of chemical safety issues.
For those of us working with chemicals, it is important that we know how to recognise those that are hazardous, how to reduce exposure and ultimately to reduce any risk to ourselves, our colleagues and to the environment. The term ‘Risk Management Measures’ or ‘RMM’ is used to describe the recommendations for handling and use to keep exposure levels below thresholds considered to be hazardous.
In Europe, there is a requirement to identify chemical substances and to understand their hazards so that products can be classified, labelled with suitable risk and safety phrases and packaged in an appropriate manner. To communicate hazards and to help identify potential risks, a Safety Data Sheet (SDS) needs to be provided to commercial users so that they in turn can ensure suitable protection to their own staff.
EU / GB Regulatory framework
The REACH and CLP Regulations are the basis for the regulatory framework in Europe (including the UK) and there is greater international consistency with adoption of the Global Harmonisation System (GHS) for classification and labelling throughout most of the World. Note that GHS refers to the ‘Safety Data Sheet’ or SDS and the word ‘Material’ is not required and we should be using SDS and not MSDS. However, when considering how serious a topic hazard communication is, one questions whether the use of ‘M’ or not is really worth worrying about – the quality of information communicated is of far greater importance than the title.
Annex II of REACH (and being such a big Annex, it has its own Regulation), describes the requirements for SDS preparation and dictates when an SDS is needed, the language, formatting etc. The CLP Regulations cover the details on how to classify a substance or mixture and also covers labelling requirements. Labelling is covered on another page [link].
The process of chemical control was first set out in Directive 67/548/EEC (the Dangerous Substances Directive) and almost all pieces of EU legislation relating to the chemical industry since then referred back to the principles laid out in this Directive including REACH. Being. Directives, these were all subject to implementation though national legislation and with the withdrawal of the UK from the EU, the UK has reverted to National Regulations based on the EU.
The Science
Despite the focus of many on the precise wording of Regulations the concepts and science have not changed since the original 16-point SDS format was introduced in 1991.
The three objectives are:
- Identity of the material and identification of key properties and hazards
- Instructions and guidance on use to minimise risk
- Remedial action in case things go wrong
All the amendment and changes in GHS and REACH has not changed this principle.
National legislation
SDS provision in the EU is linked to REACH and being an EU Regulation and should (in theory) result in a more unified approach to chemical legislation in Europe (including Norway, Iceland and Liechtenstein).
The UK and Switzerland follow GHS (CLP), but are not part of EU Regulations and have national laws.
Even in the EU, national inspection units are responsible for local interpretation of the Regulation and this is varies around Europe, with some agencies taking a pragmatic view that hazard and risk communication is the most important objective and other agencies being more concerned with format and procedure.
If you get the easy task of formatting right, then you can concentrate efforts on what really matters.
Supply of the SDS
A Safety Data Sheet (SDS) must be prepared for chemical products considered hazardous to health or the environment (as defined in CLP / GHS). REACH expands on the meaning of ‘dangerous’ to include Persistent, Bioaccumulative, Toxic (PBT) and very Persistent, very Bioaccumulative (vPvB) materials and substances of ‘equivalent concern’.
However, anyone being supplied a chemical product can demand an SDS even if it is not hazardous if the mixture contains hazardous components above certain thresholds. This requirement applies to all chemical products, unless being supplied for non-professional use, such as retail sales.
The threshold of concern is typically 1% w/w (solids or liquids) or 0.2% v/v (gas) for hazardous substances or where the substance has a defined Community exposure level, or 0.1% for substances of higher concern including Cat. 1 sensitisers, CMR, vPvP, PBT and others meeting the definition in Article 59 of REACH.
Language
The EU Regulation states that the supplier placing a hazardous substance or mixture on the market in a specific Member State must provide the SDS (including Exposure Scenario) in the official language(s) of that Member State. Placing on the market is considered pro-active selling in that market; therefore, if a French company goes to a German sales office and asks to buy the product, it is not being placed on the French market and German language will suffice.
With the UK not in the EU, there is no need to provide SDS in any language other than English, except of course (important) customer service. A UK company with a distributor or saes office in the EU will need to ensure that their EU colleagues have EU SDS in correct languages.
Note that advertisements are considered ‘placing on the market’, so an advert in a French language journal or web-site is considered placing on the market in France, and the SDS must be made available in French language.
Internet selling has made this very difficult to pin down, but ultimately, it is good practice to help customers.
Competence and training
The legislation uses the word ‘competent’ to describe the person preparing the SDS or labelling. This is not clearly defined, but the text goes on to suggest training and refresher training work. From this, it can be inferred that unless there is evidence of training or suitable alternatives, competence will be difficult to demonstrate if the quality of the SDS is ever questioned by a regulator.
The lack of definition of ‘competence’ will give the authorities flexibility in using inadequate competence as a reason for failure to comply with the Regulation.
The Chemical Hazard Communication Society (CHCS) [link]) provide training courses to cover all parts of SDS writing. In-house training by Denehurst can be provided (link to training page)
Safety Data Sheet – SDS format
The European SDS was formalised in the ‘16-point’ format in Directive 91/151/EEC and amended significantly by Directive 2001/58/EC and was based on the UN International Labour Organisation (ILO) format, also used in other parts of the World and replaced by GHS
Current format is based on REACH Annex II and updates are issued as new Directives from time to time.
Although suppliers are not expected to conduct extensive testing on their products to generate data for safety data sheets, there should be sufficient data on the product (or derived from similar materials) to enable a suitable classification to be made. Suppliers must be able to justify their safety data sheets and retain records of how decisions were made to classify (or not classify).
The UK HSE are wanting to enhance the justifications for SDS to include hazard information profiles explaining how the conclusions were derived and also want the SDS to contain useful information for the recipient and not just treated as a form to fill in. Sometimes, with use of software, a well-formatted and ‘compliant’ SDS can be generated with very little thought – a good SDS will have had a lot of thought put in to it and unfortunately, even the best software cannot do that for you.
Ultimately, the function of the SDS is to communicate potential hazards and it is unacceptable to supply a material if those hazards are not known.
Format
Headings to be used in European SDS are as follows;
Section 1 Identification of the substance/mixture and the company/undertaking
Section 2 Hazards identification (assessment)
Section 3 Composition/information on ingredients
Section 4 First aid measures
Section 5 Fire fighting measures
Section 6 Accidental release measures
Section 7 Handling and storage
Section 8 Exposure controls / personal protection
Section 9 Physical and chemical properties
Section 10 Stability and reactivity
Section 11 Toxicological information
Section 12 Ecological information
Section 13 Disposal considerations
Section 14 Transport information
Section 15 Regulatory information
Section 16 Other information
This ‘16-point’ format, based on GHS recommendations, will be acceptable throughout the world. Note that the word ‘Section’ must now form part of each heading.
As already indicated, formatting is the easy part and is a major advantage of good software systems that provide the correct format in a consistent manner.
The REACH Only Representative
Only Representatives (more details here [link]) have specific obligations under the REACH Regulation, including keeping records of the supply of the substance. They also have an obligation to provide ‘necessary safety data and risk management details’ to those importing the substances covered by the OR Registration. This can be done by the SDS and a good OR will advise the non-EU / non-GB supplier to ensure a valid SDS is provided.
However, Only Representatives need not be identified in Section 1 of the SDS (although is optional)
Where Downstream Users (ie importers reliant on an OR) wish to forward the substance to their own customers, they will need SDS and labelling in their own names.
Training
Denehurst can provide training in the (extended) SDS, including understanding and writing the exposure scenarios.
Specimen training programmes for basic and advanced SDS writing or for e-SDS / exposure scenarios (extended-SDS page [link] can be provided on request.