Introduction to SDS / MSDS
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 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 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, the provision of the SDS there is a general 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 Regulatory framework
REACH and CLP Regulations have created a new regulatory framework in
Europe 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 – therefore, in theory, even US ‘Material Safety Data
Sheets’ will be SDS without the ‘M’ in future. 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 describes the requirements for SDS preparation and dictates
when an SDS is needed, the language, formatting etc. CLP Regulation EC (no.)
1272/2008 covers the details on how to classify a substance or mixture and also covering labelling requirements.
Labelling is covered on another page.
Annex II has already been revised and the revised version was finalised in late 2009.
This guide is based on the revised Annex II.
Background to European chemical supply regulations
Along with most of the World, legislation has been enacted in Europe to control the supply of dangerous chemicals.
In Europe, the system is based on hazard identification (classification based on hazards) and the control of particular chemicals
is set according to the hazard with the objective of reducing risk.
The process of chemical control was first set out in Directive 67/548/EEC 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 National There were new Directives over
the years changing the SDS and classification requirements, but from June 2007, REACH (Regulation (EC) No 1907/2006) has been
the EU legal basis.
Confusingly,
the final transition to CLP will not be seen until 2015 (for mixtures) and the phase-in period for REACH registration ends
May 2018. Until then, there will be dual standards.
The information provided in the SDS is part of the requirements of Directive 98/24/EC
covering supply of chemical safety in the workplace (eg. UK COSHH) and the change to the new Annex II under REACH does not
replace existing workplace or consumer safety legislation.
The Science
Despite new Regulations and hazard classification systems, the concepts and science have not changed.
The first stage in the reduction of risk is to ensure that
the potential hazards of the chemical product (either a single substance or a mixture) are suitably identified and then communicated
to those in contact with the product. In Europe, the identification of hazards under Directive 67/548/EEC was formalised
into symbols and numbered Risk and Safety phrases. Anyone in Europe can therefore look at a pictogram symbol and associated
Risk and Safety phrase numbers and know the potential hazard of the chemical and be advised on the basics of safe handling
or disposal.
GHS,
and in the EU, CLP, is not changing this principle, but uses a slightly different set of symbols and phrases for communicating
hazard. Over time with adoption of GHS globally, the symbols (pictograms) and phrases (statements) will be used
universally.
National legislation
Pre-REACH
SDS legislation was based on Directives and these needed enacting through national legislation in Member States. REACH
is based on a Regulation and should (in theory) result in a more unified approach to chemical legislation in Europe (including
Norway, Iceland and Liechtenstein). Switzerland will follow GHS, but is not signing up to REACH.
National inspection units are responsible for local interpretation of the Regulation
and this is still varying 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.
Supply of the SDS
A Safety Data Sheet (SDS) must be prepared for chemical products
considered dangerous to health or the environment. ‘Dangerous’ is defined in Directive 67/548/EEC and subsequent
amendments – REACH does not change this requirement, but does expand the meaning of ‘hazardous’ to include very
Persistent, very Bioaccumulative (vPvB) materials (under CLP, the term 'dangerous' is replaced by the term 'hazardous'
with very similar scope).
However,
anyone being supplied a chemical 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 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 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 UK sales office and asks to buy the product, it
is not being placed on the French market and English language and UK contact details are OK, but if they advertise in French
in French journals, that is considered placing on the market and contact details must be made available in French language,
whether that person is in the UK or France. A sales agent in France counts as placing on that market and that agents
contact details needs to be given.
Effectively, none of this has changed from the old pre-REACH and pre-CLP process,
except that SDS were national laws and under that system, a UK exporter could not be prosecuted by the French inspectors for
failing to provide local contact details; only the French importer or sales office could be prosecuted for failing to provide
a suitable SDS. It is no different now in that the French inspectors need someone in France to complain to if it is
placed on the French market.
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. 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, 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.
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. GHS changed this slightly, with sections 2 and 3 changing position.
The content of an SDS must reflect
all information available to the supplier, relating to the hazardous chemical, that is considered necessary to provide adequate
warning and advice on safe handling to the users.
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 and R phrases assigned. Suppliers must be able to justify their data sheets
and retain records of how decisions were made to classify (or not classify).
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;
1 Identification of the substance/mixture and the company/undertaking
2 Hazards identification (assessment)
3 Composition/information
on ingredients
4 First aid measures
5 Fire fighting measures
6 Accidental release measures
7 Handling and storage
8 Exposure controls / personal
protection
9 Physical and chemical properties
10 Stability and reactivity
11 Toxicological information
12 Ecological information
13 Disposal considerations
14 Transport information
15 Regulatory information
16 Other information
This ‘16-point’ format, based on GHS recommendations, will be acceptable
throughout the world. A specimen format is given below and is available in Word on request.
Changes in the new Annex II of REACH
- The extended SDS (e-SDS)
The key changes are a more prescribed set of sub-headings aimed to make the SDS more
consistent and to prompt the writers with more headings. REACH itself will make more data available to
the writers, but inputs such as the Derived No Effect Level (DNEL) need to be added.
The biggest problem
is the addition of the Exposure Scenarios; these are short guides describing the envisaged routes of exposure and how the
use may lead to exposure to workers, public users and the environment. It is essential that the contents of the SDS reflect
real use patterns and that readers of the SDS can look at what the authors had in mind when writing risk management measures
and precautions.
The Exposure Scenarios (ES) are effectively ‘justification’ documents that
justify that certain uses of the substances and their mixtures have been considered and that potential exposure has been assessed
in terms of risk. However, the ES added to the SDS need to be concise and readable to the intended user;
avoid complicated text and mathematics, and instead provide easy to follow text. Note that the ES is part
of the SDS and will need translation – many organisations will be using standard phrsed in the ES so that they can be
translated automatically.
The REACH Only Representative
The OR does not really need to have
a part to play in SDS, unless they are the EU office or the exporter / importer. REACH registration is about import
and manufacture, but CLP and SDS is about placing on the market and unless the OR is placing on the market themselves, they
need not get involved in EU SDS.
Where there is an OR, the importers are DUs in terms of registration, but they
are placing on the EU market and therefore must take full responsibility for the SDS and have their names and contacts consistent
with the supply route. The OR / exporter can obviously help them in this and the obligations set out in Part A of the
CSR make this obligation very clear (ie communicating RMM) and the OR must supply the importers with all available information
to allow the importer to prepare their own SDS.
The reference to registrants in the legal text is if the importer is the registrant,
but this is an 'if' and the idea is to tidy up contacts so that customers can find out who is responsible for RMM
and use patterns covered by the registration etc.
***************************************************
Example format :
SAFETY DATA SHEET
Issue Date: [this is not the ‘printing date’
(as seen on some SDSs), but is the date that the current version was issued]
Version number:
Revision / Cancels: [this needs to identify the previous version to enable version control.
Old versions need to be retained on file and revisions given to customers who had previously received the hazardous
substance/ mixture. Changes need identifying in Section 16]
1 IDENTIFICATION OF THE SUBSTANCE/MIXTURE
AND OF THE COMPANY/UNDERTAKING
1.1
Product Identifier
[For substance,
include registration number and name used for registration. Must be consistent with the label.
One SDS can be used to cover a range of similar mixtures, but in this case, all names of these mixtures must be included
]
1.2
Relevant identified uses of the substance or mixture and uses advised against
[Use
codes found in Chapter R-12 of ECHA guidance – see Exposure Scenario guide]
1.3 Details of the
supplier of the substance or mixture
[Address of responsible EU supplier and/or local address in Member State
if being placed on the market in other member states. Note, that this may also require translation to the
appropriate local language.
This includes importers, even if an Only Rep has made the registration.
The non-EU supplier may be identified for information, but responsible EU legal entity must be given.]
1.4
Emergency Telephone (out of office hours):
For Technical Queries contact: [include e mail that will
be checked by competent people, but does not have to give name of person]
2 HAZARDS IDENTIFICATION
2.1
Classification of the substance or mixture [CLP classification]
2.2 Label elements [Consistent with the label.
Pictograms may be used (in black and white if necessary), but this is not obligatory. It is recommended.]
2.3
Other hazard information: [overview of key hazards]
Ingestion
Skin Contact
Eye
Contact
Inhalation
Environment (vPvB / PBT)
Additional Information [anything
else likely to cause a problem]
3 INFORMATION ON THE INGREDIENTS
3. 1 Substances [For substances,
indicate the purity and any other substance present such as additives. Should be consistent with REACH
registration where appropriate]
3.2 Mixtures [For mixtures, components considered hazardous need to be listed if above their relevant thresholds
of concern. These are 1% for lower classes of hazard or 0.1% for sensitisers, Cat. 1 acute toxic, CMR,
PBT, vPvB and Cat. Acute of chronic aquatic toxicity. Annex II gives the fill details.
The concentrations of these
components needs to be given and each correctly named with correct identifiers (eg EC number); ranges of concentrations can
be given, but the classification of the mixture needs to relate to the highest concentration levels in the range.
Confidentiality can be sought
for components and application can be made to use generic names for ‘generic’ hazards such as corrosivity, flammability
etc.]
4 FIRST AID MEASURES
4.1 Description of first aid measures [make sure these
are sensible, appropriate and achievable by the skill of the anticipated user. Do not suggest ‘medical
attention’ all the time for low hazard materials].
Ingestion
Skin
Eyes
Inhalation
4.2
Most important symptoms and effects, both acute and delayed
Ingestion
Skin
Eyes
Inhalation
4.3
Indication of immediate medical attention and special treatment needed
[Consider specific
instructions that relate to the hazardous properties, and can help first aid to be directed at the most important symptoms.
Especially important for STOT (systemic toxic) materials]
5 FIRE-FIGHTING
MEASURES
5.1 Extinguishing media
Small
fires [define ‘large and small]
Large fires
[Select extinguishing media appropriate to surrounding
area.
Extinguishing media considered incompatible with product]
5.2
Special hazards arising from the substance or mixture
[Specific chemical hazards, such as oxidising or
if the material produces hazardous gases or by-products from combustion]
5.3
Special protective actions for fire-fighters
[Specific procedures or requirements, bearing in mind
professional fire-fighters will have their own agenda for tackling major incidents]
6 ACCIDENTAL RELEASE OF MATERIAL
6.1 Personal precautions, protective equipment and emergency procedures
[Consider appropriate
action for professional emergency services or for user to clean up. This may relate to large or small spills
(define, for example < 5 litres) and to the type of use and users. If used by professionals outside
chemical factories, the skill of the user at cleaning hazardous chemicals need to be considered]
6.2 Environmental Precautions
[Again, relate to the size and nature of spill in relation
to exposures defined in the ES.]
6.3 Methods and material
for containment and cleaning up
[Needs to be practical for users identified in the ES and may differ between
identified users and size of containers. Specify if special cleaning methods are needed or neutralising
agents are needed. Any special training?]
7 HANDLING AND STORAGE
[Section must be consistent with Exposure Scenarios
and CSR (where needed for substances) and relate to the uses identified in Section 1. Note that Section
7 provides an overview to safe handling, where-as Section 8 goes into more detail for control measures and exposure limits.
There is some overlap but general statements can go into Section 7 and details in Section 8]
7.1 Precautions for safe
handling
[Include precautions such as prevention of dust, loss to the environment, and if specific
handling controls are needed.
Consider general hygiene such as washing hands, clothing
and equipment]
7.2 Conditions for safe storage, including any incompatibilities
[Consider
physical (flammable) hazards as well as safety and the environment. May need to consider storage away from
general public depending on the type of use (specified in Exposure Scenarios).
If oxidising or reducing
agent, special storage conditions are needed]
7.3 Specific end uses
[May be sufficient
to refer to attached Exposure Scenarios; chance to add any specific comments on specific uses]
8 EXPOSURE CONTROLS
/ PERSONAL PROTECTION
[Consistent with Exposure Scenarios]
8.1 Control parameters
[Enter workplace exposure limits and for registered substances
with agreed Derived No Effect Levels (DNEL or DMEL) and environmental Predicted No Effect Concentrations (PNEC). EC
occupational exposure limit values are defined in Article 2(d) of Directive 98/24/EC and need to be checked for current figures.
National limits may be added here or in Section 15 ‘Regulatory Information’.
For mixtures, the
limits and DNEL / PNEC must be reported for each hazardous substance present that contribute to the hazard of the mixture.
Biological
limit values need to be considered to determine if the components are above or below any such limits.]
8.2 Exposure controls
[Typically, reference to attached Exposure Scenarios will be sufficient for detailed
information, but add key details in this section – it is likely that many readers will quickly get bored and fail to
wade through Exposure Scenarios.
If area needs to be ‘well ventilated’, specify conditions for
ventilation (air exchanges etc) that is consistent with DNELs for inhalation for workplace use.
Eye
/ face protection
Skin protection
Respiratory protection
Other
Thermal
hazards
Personal hygiene precautions such as gloves, coveralls, goggles etc. Where
appropriate, consider the materials for gloves etc. and try to avoid use of trade names. Help in determining
the type of glove may include help in the type of material (eg ‘resistant to organic acids’ etc)
Consider
‘thermal’ hazards if exposure scenarios predict use of heated material.]
8.3 Environmental exposure controls
[Add any specific environmental controls (eg, bunding, intercept of waste
water etc) consistent with the Exposure Scenario and Section 13 covering disposal]
9 PHYSICAL AND
CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical
properties
[delete those not applicable or add new parameters if needed.
Use correct EU units
and avoid vague descriptions such as ‘poorly soluble’, ‘high melting point’, ‘not very viscous’]
Appearance
[at temperatures of use, defined in exposure scenarios]
Odour
Odour threshold
pH
[concentration in water?]
Freezing/Melting Point (degree C)
Initial boiling point and boiling range
Flash
Point (degree C)
Evaporation rate
Flammability (solids and gases)
Upper/lower flammability
or explosive limits
Vapour Pressure, Pa at temperature degree C [for mixtures, consider presence of solvents
and water]
Relative Density (at degree C)
Solubility in water and solvents (mg/l)
Partition
coefficient [for mixtures, it may be appropriate to report partition coefficients for key components]
Autoignition
temperature (degree C)
Decomposition temperature (degree C)
Viscosity (at degree C)
Explosive
properties
Oxidising properties
9.2 Other information
Other physical and
chemical parameters such as miscibility, fat solubility (solvent – oil to be specified), conductivity, or gas group
[The
data in this section needs to relate to the substance or mixture being supplied. For substances, these
properties will relate to those determined for registration and used for the CSR (if appropriate). For
mixtures, the properties of the mixture must be reported. For example, an aqueous solution will take on
many properties of water, including vapour pressure, partition coefficient, boiling point, and special care is needed to ensure
that the correct physical properties are reported]
10 STABILITY
AND REACTIVITY
[This section is less to do with shelf-life
than dangerous decomposition and hazards from breakdown and reactivity. The Exposure Scenarios will need
to take all this into account. The precautions need to be practical and relevant for identified uses and
the skill levels of users.]
10.1 Reactivity
[Reactive with other
chemicals if mixed or used at the same time?]
10.2 Chemical stability
10.3
Possibility of hazardous reactions
10.4 Conditions to Avoid
[Consider sparking
for organic powders that may have a risk of explosion]
10.5 Incompatible materials
10.6
Hazardous decomposition products
[Such as flammable gases, toxic materials etc]
11. TOXICOLOGICAL INFORMATION
[For substances, this
is consistent with the data for registration (if applicable) and should agree with harmonised classification and labelling
or at least consistent with industry agreed classification. For mixtures, the acute toxicity and irritation
/ corrosion of the mixture may be more relevant to the reader than the properties of the components, but for longer-term toxicity
(including CMR effects) and systemic effects (STOT and sensitising) the properties of the specific components may be more
relevant.
If there is no data on the mixture, end points must be estimated; it is not sufficient
to state that ‘no data are available’.]
11.1 Information on toxicological effects
[The
use of units and terminology must be precise and phases such as ‘low toxicity’ need to be avoided unless fully
qualified. If the substance or mixture is not classified in relation to a specific end-point, any hazards
below the threshold for classification need to be put into context; eg mild irritant to eyes, but not sufficient
to cause classification’. This will avoid confusion to the reader.]
(a) acute toxicity
[Oral,
dermal and inhalation or other routes as appropriate for Exposure Scenarios for the substance or mixture- note that exposure
to formulated product may be different to the exposure to the substance]
(b) skin corrosion/irritation
(c) serious eye damage/irritation
(d) respiratory or skin sensitisation
[Convention is that skin sensitisers should be considered an inhalation sensitiser if there is a risk
of inhalation; for mixtures, consider enhanced risk of inhalation as a result of formulation changes]
(e) germ cell mutagenicity
[Data may be limited and assumptions may need to be made according to mutagenicity endpoints
or reference to class of substance]
(f) carcinogenicity
[Data
may be limited and assumptions may need to be made according to mutagenicity endpoints or reference to class of substance]
(g) reproductive toxicity
[Data may be limited and assumptions may need to be made through reference to class
of substance]
(h) STOT-single exposure
[Specific
organ effects from acute studies]
(i) STOT-repeated exposure
[Specific
organ effects from repeat exposure studies]
(j) aspiration hazard.
[Only relevant for low viscosity organic substances]
[If
data is missing, justification is needed and best-estimates should be made, giving a justification for that estimate]
12. ECOLOGICAL INFORMATION
[For
substances, this is consistent with the data for registration (if applicable) and should agree with harmonised classification
and labelling or at least consistent with industry agreed classification. For mixtures, the acute toxicity
and irritation / corrosion of the mixture may be more relevant to the reader than the properties of the components, but for
persistent substances or those showing chronic effects, the properties of the specific components may be more relevant.
If
there is no data on the mixture, end points must be estimated; it is not sufficient to state that ‘no data are available’.]
12.1
Toxicity
[Key organisms such as fish, Daphnia, algae, sludge bacterial inhibition, earthworms, higher plants
etc. Use correct units and check against reported water solubility. Estimate effects
of mixtures or diluted materials. If solubility in water is < 100 mg/l, water accommodated fraction
.
PNECs need to be added for each key component with a potential for biological impact].
12.2
Persistence and degradability
[Biodegradation data and other breakdown processes. For mixtures,
each component will need separate consideration]
12.3 Bioaccumulative potential
The partition coefficient
may give an indicator if now specific test data available. For mixtures, each component will
need separate consideration]
12.4. Mobility in soil
The partition coefficient
and adsorption coefficient may give an indicator if now specific test data available. For mixtures, each
component will need separate consideration]
12.5. Results of PBT and vPvB assessment
[The
PBT / vPvB potential must be assessed for substances being registered and for mixtures, each component will need
separate consideration]
12.6. Other adverse effects
[For mixtures, each component
will need separate consideration]
13. DISPOSAL CONSIDERATIONS
[Consistent with Exposure Scenarios]
13.1 Waste treatment
methods
[Do not simply sate ‘in accordance with local regulations’ but give positive suggestions
in agreement with the conditions of the Exposure Scenarios. Quantify disposal in accordance with use patterns
(eg. If sold in 5 litre packs, disposal of 5 litres will be of interest). Remember that sending for ‘chemical
waste disposal and incineration’ is expensive not practical for non-industrial or domestic settings.
Consider
recycling or recovery.]
14. TRANSPORT INFORMATION
[For substances, these are identified in the Registration and may already
be published in Transport legislation. For mixtures, key components may take priority for identification
for transport; if multiple hazardous components, consider the properties of the mixture and classify accordingly]
14.1
UN Number
14.2 UN Proper Shipping Name
14.3 Transport hazard class(es)
14.4 Packing group
14.5
Environmental hazards
14.6 Special precautions for user
14.7. Transport in bulk according to Annex II of MARPOL73/78
and the IBC Code
[In many cases, the SDS author may wish to confirm these with qualified transport specialists
and must agree with their organisation’s Dangerous Goods Safety Advisor (DGSA) who will be taking legal responsibility
for transport labelling]
15. REGULATORY INFORMATION
15.1. Safety, health
and environmental regulations/legislation specific for the substance or mixture
[Include national regulatory
status where different Community laws exist in various Member States]
15.2 Chemical Safety Assessment
[Indicate if a full
CSA / CSR is available (noting that the Exposure Scenario attached to the SDS will be an abridged easy-to-read version)]
[Note
that the label elements that used to go in Section 15 are now in Section 2]
16. OTHER INFORMATION
Date
of compilation and revision details, including key changes since last revision
Literature sources
and references where needed
List of abbreviations used in the SDS
Explanation
of risk phrases and/or hazard statements from Sections 2 and 3
Note that these classifications relate to the pure forms
of the components listed in Section 3.
ANNEX
Addition of Exposure Scenarios as applicable
Exposure Scenario 1
Exposure Scenario
2
etc
Further information on writing Exposure Scenarios is available.
