Last reviewed 10 August 2023
In this feature, Mark Selby of Denehurst Chemical Safety Ltd describes why it is important that checks are made on incoming safety data sheets (SDSs), many of which, unfortunately, cannot be considered reliable.
When receiving an SDS from an EU supplier, there is a legal requirement on the supplier to meet certain standards. However, this requirement does not apply to non-EU suppliers, where the information supplied can vary considerably. Although the EU obligation is only for the positive supply of SDSs for hazardous substances or mixtures, EU suppliers can be asked for and must then supply SDSs for mixtures that are not classified as hazardous but contain hazardous ingredients above thresholds of concern. There is no obligation for the supplier to provide SDSs if none of the ingredients are hazardous.
If receiving an SDS that is mandated, the standards need to meet those outlined in Annex II of EC Regulation 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as a minimum. Note that Annex II of REACH was recently updated by EU regulation 2020/878, which required all SDS to be updated by the end of December 2022. Note that this regulation has not been adopted in Great Britain. Ideally, the SDS will exceed these legal requirements and will actually be useful to the recipient with details of the chemical composition, classification, advice on safe handling, etc.
Where a substance has been registered under REACH and a chemical safety report (CSR) has been prepared, the supplier should pass on the conclusions as an annex to the SDS; this is the “extended SDS (eSDS)”, that contains details of the scenarios for exposure or “exposure scenarios (ESs)” and ideally will contain specific risk management instructions for these specific uses.
Even if the SDS received appears to meet the legal requirements in terms of formatting and even if it looks professionally prepared, the quality of the document needs to be checked in terms of technical content. Checking the quality of the information is a requirement because the recipient is liable for the protection of its workers or, if selling on (in a new formulation or as received), the onus for ensuring accuracy and suitability of data passes to the onward supplier.
Systems also need to be in place to collate incoming SDSs and to demonstrate that the recommendations have been considered by the recipient. These systems should also demonstrate whether other sources of information have been checked and whether there is confidence that the incoming SDS is suitable.
Summary of checks
While remembering the obligation to ensure correct information is held on a substance or mixture by each supplier or user in the supply chain, it is clearly important that checks are made on received SDSs. As will become apparent, it is possible to spend a lot of time on making these checks, asking questions of suppliers and looking for independent verification.
In a world where time is limited and there are not the resources to spend hours making checks, it is instead important to concentrate on a few key areas.
This report outlines the key areas to check and if at any stage it is found that the SDS from an EU supplier contains errors or has key information missing, it may be a good use of your time to send the SDS back, point out errors seen and ask that the document is checked and all errors corrected (remembering of course, that what you may think is “wrong” is perhaps only a “difference of opinion”). Non-EU suppliers may update errors as part of their service to you, but there is no legal requirement to do this. If importing chemical products, the “importer” takes all the legal responsibility.
A summary of recommended checks is as follows.
Confirm who is supplying the product and whether the SDS reflects who you think the supplier is. This indicates where the legal responsibility lies.
Verify that the labelling matches SDS. If the product has not yet been received, this step will need to wait and instead, move on to check “3”.
Simple regulatory check, including uses. In the case of a non-EU supplier, it is a bonus if this is correct.
Simple technical check. Do sections 2 and 3 match? And are these consistent with the hazard data in sections 9, 11 and 12?
Risk management check. Are the recommended risk controls appropriate for the uses and for the properties of the material?
Full technical check. If all is good so far, it is very unlikely that this will be a problem, but if there are reasons to doubt the accuracy of data, cross referencing with other sources such as the European Chemicals Agency (ECHA) website will be useful.
Responsibility: legal requirements
European suppliers (in the European Economic Area (EEA)) of hazardous substances and mixtures have a legal obligation for the supply of SDSs free of charge before or at the time of supply. There are legal requirements set out in Annex II of REACH that dictate the format to follow and with all the attendant headings and subheadings, it is relatively easy to determine if an incoming SDS meets these requirements.
It is unfortunate that many complaints are heard from EU recipients claiming that the SDSs (and also labelling) are not compliant. However, on further investigation, it appears that the complainant is actually the “importer”. This gives rise to the concern that many recipients are not always aware of the full demands of being the “importer”.
The defining status of an “importer” or a “shipping agent” or a “sales facilitator”, etc is not covered by legal text. So, a company in the EU that helps broker a deal with a non-EU supplier and an EU customer may not actually be the “importer”. Sometimes, it may take on the role of an importer, sometimes it may be a REACH “Only Representative (OR)” or sometimes it may just be a facilitator.
The legal obligation is on the recipient; the company that takes the goods and “processess” (uses, repacks, relabels, puts into store for its own sales, etc) them. This is the true “importer” and unless someone else in Europe has declared that they have taken care of specific importing roles, then the recipient must do this.
The role of the “importer” includes:
REACH Registration of substance(s) if applicable — this can be covered by OR
notification under EC Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) of any hazardous or even non-hazardous substance of less than one tonne. REACH ORs may include others in a “group” but “importers” must be part of this
notification under Annex VIII of EC Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) to the relevant poison centre
correct CLP labelling on goods once received, they may require relabelling when off loaded on site (even if they are only used on site and not onward supplied)
correct SDS for own use and/or any onward supply
correct worker safety assessment (in the UK, under Control of Substances Hazardous to Health Regulations 2002 (COSHH) (as amended) and Dangerous Substances and Explosive Atmospheres Regulations 2002 (DSEAR)).
Requirements such as customs duties and other taxes are not relevant and just because someone else in the supply chain does this, this does not make them the “importer” for REACH or CLP.
If there is a REACH OR, there is no legal requirement for them to provide SDS or CLP labelling. However, they do need to provide all the necessary information to enable correct SDS and CLP labelling and for this reason, most ORs will provide an SDS to EU requirements.
In the case of mixtures, where there may be more than one OR, each covering different components, none of these representatives need to provide any details on the safety of the mixture — the “importer” is on its own (but hopefully with a helpful and responsible non-EU supplier).
Subsection 2.2 of the SDS is supposed to reproduce many (but not all) of the labelling details on the product itself. As we have moved fully into the requirements for CLP labelling, this should include at least the following.
The hazard pictogram(s) if/as applicable. This/these may be shown as either the full-colour diamond framed pictogram or on the SDS only with a black rather than red outer frame line, or simply as the graphic symbol only.
Signal word if/as applicable (DANGER or WARNING or in some cases no signal word).
Hazard (H) statements applicable.
Precautionary (P) statements chosen for use on the CLP label.
The product description (name of substance and applicable reference number or trade name of the mixture), ingredients to be named (in the case of some mixtures) and the supplier’s name/address and telephone number and quantity (for products sold by retail) are not required to be given.
Either way, the product label and the SDS must match or, if not, the supplier should be questioned about the discrepancy. Clearly, if the SDS is received in advance of the product, this check will need to be made later.
The old orange and black symbols as required under the 67/548/EEC Dangerous Substances Directive (DSD) or 1999/45/EC Dangerous Preparations Directive (DPD) (implemented in the UK by the now essentially revoked Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (SI 2009 No. 716) (CHIP4)) should no longer be seen.
This important check does raise another issue. It is unfortunately common practice in many organisations for the SDS to be received by the safety management or purchasing personnel in their comfortable offices and for the product to be received in a warehouse that may be at a different location to the office. It is essential that those in their offices should either make the effort to obtain details of the labelling or at least ensure that those receiving and storing the product see the SDS immediately, and verify that the SDS and label are consistent.
Sometimes the P statements on the labelling will not precisely match those on the SDS and this is because the SDS must cover all important P statements for any use or for any sized container, but the product label need only include P statements that are relevant; for example, a 10t Isotank for industrial use need not include “keep away from children”, but if selling the same to the consumer in one litre bottles, this becomes an important statement. However, it should be possible to find all the labelling P statements on the SDS (labels are limited to 6 precautionary statements).
Goods will often be received with only transport labels (transport class hazard diamonds), for example, if corrosive or flammable, the transport labels are sufficient to cover CLP requirements for the display of the CLP pictograms in the case of single skin packs (drums, bulk bags, etc). In these cases, checks with section 14 are needed to confirm if there are any obvious discrepancies between the SDS and the label and also to check for discrepancies between section 2 of the SDS (CLP classification and labelling) and section 14 (transport information).
If the labelling and SDS match, then this is good and there will be comfort that the supplier, whether EU or non-EU, has taken some care over its communication. The next parts are to confirm that these are correct.
The actual format and legal status of the SDS is actually not very important from a scientific or health and safety perspective and if a supplier has decided not to list every irrelevant subheading in section 9, then this need not be a reason to reject its SDS; life is bad enough without customers starting to take on the role of the inspector.
However, a poorly formatted SDS that has clearly not been prepared with consideration of current guidelines will raise a concern that the rest of the SDS may be below expected standards as well. Likewise, typing errors and other mistakes immediately visible will reduce the reader’s confidence in the quality of information in the document. This is made worse when the supplier has claimed compliance with REACH on the SDS. These compliance statements are not needed and are actually meaningless.
For substances that have been REACH registered, a REACH registration number should be provided and in the case of mixtures, registration numbers for the components listed in section 3 should be included. If a mixture contains non-hazardous components, there is no requirement to list these components and therefore no need to list their registration numbers. These non-hazardous components can be kept confidential and even though recipients can ask if they are REACH registered, the supplier does not have to divulge anything confidential. There is certainly no need to know if substances are preregistered and asking for preregistration numbers is completely pointless.
Once registered, the supplier of a substance (whether as a substance or in a mixture) supplied by it in excess of 10t per year, needs to pass on relevant details of the CSR in the SDS. This may be in the form of an SDS extended with ESs or for mixtures with single intended uses, these details may be incorporated into the SDS. The registered uses of the substance/substances need to be indicated.
However, unless the supplier has provided this information, there is no legal requirement for you to acquire it and unless your own customers have made a specific request, there is no need to insist that your supplier provides such detail. The obligation is to pass on the details received. However, if an eSDS has not been received and it is known that the supplier has registered under REACH for supply in excess of 10t per year, it will cast doubt on the ability of the supplier to meet regulatory demands.
If in doubt whether uses are covered by REACH registrations, a simple check is to consult the disseminated REACH dossiers if registered, and if the information is indeed published, a list of uses and sectors of use will provide reassurance ( echa.europa.eu).
Do not take these too literally though and look for generic sectors of use such as “professional” or “consumer” that can cover a wide range of industry sectors. Another tip is to remember that the term “processing aid” includes cleaning products; for full guidance on this, ECHA has provided a good guidance in Chapter 12 of “Information Requirements for Chemical Safety Assessment” ( here).
The first check is therefore to confirm that the legal requirements appear to be understood by the European supplier and that formatting and content is up to standards expected. If the document is clearly substandard and sections have been left blank or missing completely, then return to the sender asking for an immediate update. Failure to do so should be reported to the competent authorities. In theory, this is reported to the competent authority of the recipient who will then pass on the complaint to colleagues in the Member State of the supplier (if being supplied from another part of Europe) but in reality, a threat to complain to the competent authority of the supplier will normally provoke some action.
If importing and the supplier is non-European, there is nothing to be done and the onus rests entirely on the “importer” to meet all legal requirements.
Simple technical check — contents of the SDS
The content itself is, of course, more important than the form-filling exercise of having correct headings and something to fill those sections. It is unfortunate that many authors of SDSs focus on the number of words they have managed to include in any given section rather than actually deciding if these words are useful or if the technical content is correct.
Although the contents of the SDS are set out in the respective 16 sections, starting at section 1 and working through is not necessarily the best method. The reasoning behind the order prescribed for the various sections of the regulations has been lost in the mists of time, but an efficient review of an SDS will necessitate jumping around between the sections.
A quick check of section 3 will give an immediate indication of what to expect. First, only either subsection 3.1 should be shown if the product being supplied is a substance or only subsection 3.2 shown if the product is a mixture.
Under subsection 3.2, the classification of hazardous ingredients should be indicated in this section and this in turn will allow a quick sanity check with section 2 and section 14; for example, if there are no flammable components entered in section 3, it is very unlikely that the mixture will be flammable; this may seem like an obvious statement, but is sadly a common error and some software authoring systems make mistakes that get missed.
The next check is to examine the properties in section 9 (physico-chemical properties), section 11 (health effects) and section 12 (environmental fate and effects).
Simple questions include the following.
Appearance: does the physical form, colour, etc entered in section 9 match what is in the container (again, it is essential that those handling the product make the check, those stuck in their office will not get to see the material)?
Classification check #1: if classified for a particular effect (eg irritating to eyes) is this reflected in section 11? If classified as flammable, is the flash point in section 9 consistent with this?
Classification check #2: if only classified in subsection 2.1 as flammable, but section 11 states “may have sensitising properties” or suggests “causes irritation to eyes”, then should the material be classified accordingly for these hazards? Often, the word “irritant” is used to describe something that is annoying if in the eye, but not actually “irritant” by definition of CLP. The SDS needs to clarify this.
Non-classification check: if not classified in subsection 2.1 as an environmental hazard, for example, but section 12 states “no data” then how is it possible to be sure it does not need classification; it may be perfectly justifiable as to why there is no data on a new substance or one at low volume that is not REACH registered, but if the suppliers decide it does not need classification, this decision needs to be based on a good reason. Such a reason may be comparison with similar substances or computer modelling, but if this has been done, the supplier should communicate this.
Component check: if a mixture contains hazardous components (for example, a potential sensitiser), then the mixture will need to reflect this and if this component is present at over 1%, there needs to be good reasons given if the mixture is not classified as such. Likewise, if a component is classified as dangerous for the environment, but section 12 of the mixture SDS states “no data” this is clearly wrong. Data on components need to be communicated if no assessment of the mixture has been possible.
Transport labelling check: as well as transport classification, does the dangerous goods name used match the declared components and does the UN number relate to the key component.
These checks are easily performed once the criteria for CLP classification is fully understood and assuming some basic knowledge of chemistry, toxicity and environmental fate and effects, as well as knowledge of CLP and transport of dangerous goods labelling. Checking an incoming SDS is not just an administrative exercise, it does need technical skills. These skills can be easily learned and in-depth knowledge is not required, but sometimes it is worth asking for a second opinion. Your own Dangerous Goods Safety Adviser, (DGSA) if one is required, is an obvious person to ask if there is any uncertainty about section 14.
Risk management check
It is common for those writing SDSs to add lots of apparently irrelevant risk management measures or, more worryingly, to not really understand the uses of the product they are selling. Many authors of SDSs are unaware of the practical issues relating to the product being sold. Examples seen in SDSs have included the use of local exhaust ventilation for a product used outdoors, or recommending evacuating a building, in case of spillage of an alcohol-based hand cleaner used in hospitals.
The P statements, first aid measures and conditions of use must reflect the end product and recommended uses. Most of this is common sense, but the problem faced by many suppliers is that software authoring systems guess phrases to add to the SDS based on properties, for example, spilling a flammable liquid may mean that evacuating a building is a good idea, especially if the flammable liquid is in a very large container. However, spilling a 200ml hand sanitiser hardly warrants emptying a building. Software does not know this, but the authors should. If you find inappropriate statements, then confidence in the quality of the SDS will be reduced and it is a good chance that it was written with no thought concerning the final uses.
The legal requirement for safe use of chemical products rests with the user, or more specifically, with the senior management at the site of use. Therefore, when receiving an SDS that provides insufficient or incorrect risk management measures, the blame will lie with the recipient. Checking that the risk management measures are appropriate is therefore very important.
If the SDS is incorrect, the fault may not always lie entirely with the supplier. Does the supplier know the intended use by the recipient? If a product is sold as “lubricant for industrial machinery” by professional and industrial users in closed systems, then the supplier should provide sufficient details in the SDS to help these intended users. If a recipient decides to use the product manually in servicing bicycles or decanting into small containers to sell to the general public, then the initial supplier cannot be held responsible for these downstream uses. In such cases, the recipient will need to decide on appropriate risk management for its own workers and for the consumer labelling on small packs.
However, if the initial supplier makes a claim on its website or sales literature that its product is ideal for use on bicycles, then its SDS must cover it. The need to describe a use for REACH registration or substances and for subsequent SDSs depends on the product’s claims and intentions. If a product is being sold for a specific use and the SDS does not help in that scenario of use, then the purchaser must ask the supplier for more details.
Conversely in the case of a product being sold to a private consumer who will not get an SDS, the retailer may take some responsibility, but any blame will lie largely with the organisation whose name is on the label.
Full technical check
If by this stage the recipient is satisfied that the supplier of the SDS understands regulatory requirements for SDS formatting and has ensured that the product label and SDS section 2 match, and if the recipient is satisfied that the substance has been covered through REACH registration requirements by the upstream suppliers and that uses are described that are applicable to the intended use and that risk management is appropriate for its uses, then it is likely that this will be the end of the basic checks.
The next level of checking will be for technical content.
Checking the content of the data in sections 9, 11 and 12 requires more time and for a complex mixture with many declared hazardous components, this can take an hour or more to perform to any degree of reliability. For simple mixtures or where only one or two components are clearly contributing to the potential hazard, these checks will take a lot less time. It is therefore advisable to put the greatest effort into key components and assess how they contribute to the properties of the whole product.
The first check is to look at the (ECHA website) and search under the “information on chemicals” section at top right. It is best to search by EC or CAS number, but name searches are possible, even though the name used by ECHA needs to be known or else the search may not result in any returns. Caution is also needed if using the CAS number. The CAS system is not as robust as the EU numbering system and sometimes a single CAS number can relate to more than one substance.
If the substance is not found on the ECHA database, it means that either the wrong details were entered or it means that the substance should not be on the market. However, some polymers are not listed.
If found, the website will provide information on various lists where further details can be found. Of most interest are the Classification and Labelling Inventory (CLI) and Registered Substances lists. Other entries can indicate whether substances are on the Candidate List or are restricted in their uses — these are worth a check and details should be provided in the SDS (in section 15 “Regulatory Information”).
The CLI will provide details of and official (but partial) harmonised classification and labelling (CLH) (reflecting CLP Annex VI) and this needs to be reflected in subsection 2.1 (if the product is a substance) or 3.2 (for constituents of a mixture) of the SDS. Even if not listed with a CLH, if hazardous, there should be details of the full classifications as determined by manufacturers and “importers” of the substance(s). For many common substances, there has been some evaluation and a green tick may appear in the “Joint Entries” column. A green tick is very likely to be the correct classification and is typically based on the results of REACH registration. It should match the CLH (Annex VI entries), but there can be discrepancies — if there is a difference, the more severe classification should have been used.
Many software systems are often not kept up to date with the ECHA database and incorrect classifications are given — it is essential that these are corrected by the supplier.
In the Registered Substances section, it is possible to check data such as the Acute Toxicity Estimate (ATE) or the older LD50 figures. Again, many SDS authoring software systems rely on old and less reliable data and there can be differences. Authors or recipients of SDSs should not rely on the software, but instead make checks. These can in turn change classifications and it is possible to find many examples of incorrect mixture classifications caused by over-reliance on software systems and no cross checks being made with real data. The classification findings need to relate to data in sections 9, 11 and 12, and if data are available on components, then the statement “no data” should not appear.
It does take some degree of technical knowledge to read the disseminated REACH dossiers and to make interpretations of these data in relation to mixtures and classification. The authors of SDSs should be doing this and it will be quickly apparent if the suppliers have failed to take such steps themselves.
If the first two or three components are checked and found to be correct, then further checks may be less important.
Those who are familiar with SDSs and their contents will find that the checks indicated above can be completed very quickly and with experience, a five-minute look through will give a reasonable indication if it is adequate or will need to be returned to sender. Considering the importance of getting it right to ensure safety of your own workers and legal requirements for onward supply in your own products, it is worth taking more time to make the necessary checks if required.
When carrying out these checks, make a record and keep these records on file. This is good practice and will provide a personal record of checks made as well as providing a degree of protection in case it all goes horribly wrong and there is an accident in which workers or customers are harmed. These checks can only demonstrate best practice and will act in defence that due diligence was shown by the recipient if the supplier has incorrectly declared ingredients or provided misleading information.
There is no fixed system for making and keeping these records, but they should at least be dated; the main reason for this to validate information taken from a public data source, such as ECHA, against a particular date. When receiving an SDS, classifications may appear correct against public sources of data, but a week later, ECHA (as an example) could update the disseminated dossier with new data. The supplier should also be checking for changes in data sets and should provide an updated SDS.
If major issues are found with the incoming SDS, then it is important to inform the supplier and failure by EU suppliers to respond with correct information should be reported to inspecting competent authorities. If the SDS is from another EU Member State, such complaints are still made to your own national agency who will then inform its colleagues in the corresponding Member State.
Certain minor errors, such as typographical, would not necessarily be enforceable by regulatory agencies or cases where the supplier has missed out information that would be helpful or has not fully covered all relevant uses. However, it is still important to point these out to the supplier and as part of the administration, keep records of such correspondence.
Preparing good SDSs is difficult and ultimately those in industry must work together and help each other to the benefit of everyone involved. Such help should be in the form of constructive (but not too pedantic) comments. A lot of time can be wasted complaining to suppliers when the issue is often a matter of opinion so it is important to be realistic when making suggestions of changes or improvements.