Home | Contact Us | REACH - CSR | Policy | Profile | REACH | IUCLID guidance | e-SDS / MSDS | CLP | Services | Site map | Training

Denehurst Chemical Safety Ltd

Extended Safety Data Sheets (e-SDS) and Labelling

Development of the Extended Safety Data Sheet (e-SDS)
REACH Annex II revision
 

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.  Between now and 2018, as REACH phase-in substances are registered, there will be a transition to the extended SDS (eSDS) that incorporates descriptions of uses and the risk management measures (RMM) considered necessary as a result of the Chemical Safety Assessment / Report (CSA / CSR).  These descriptions of use and RMM are known as the Exposure Scenario (ES).

Links to other pages:

CLP
REACH basics

The CSR



Update June 2011

Annex II format SDS is provided below.
For this in Word Document, please contact info@denehurst.co.uk

Training is provided in the extended SDS, including understanding and writing the exposure scenarios

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 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 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 covers labelling requirements.  Labelling is covered on another page.

A revision to Annex II is currently in the process of being adopted. This guide is based on the final draft of the revised Annex II, which was published at the beginning of 2010.

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 implementation though National legislation. 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 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. 

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 phrases in the ES so that they can be translated automatically.

The REACH Only Representative

Only Representatives have specific obligations under the REACH Regulation, including keeping records of the supply of the latest SDS. Under the proposed revision to Annex II, Only Representatives may also be identified as the Supplier in section 1 of the SDS, with the option to also include details of the non-EU company who has appointed them.


Where Downstream Users wish to forward on the SDS they have received from an OR to their own customers, then they will need to make suitable arrangement s with the OR in the same way that they would need to do so with any other EU based supplier.


***************************************************


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: 

Supercedes / 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.]
For Technical Queries contact: [include e mail that will be checked by competent people, but does not have to give name of person]

1.4 Emergency Telephone

Specify when it is available, if not 24 hours.

2  HAZARDS IDENTIFICATION

2.1 Classification of the substance or mixture [CLP classification]
Give the classification of the substance or mixture according to CLP.
Until the end of the transitional arrangements in 2015 it will also be necessary to give the classification of a substance in accordance with the Dangerous Substances Directive 67/548/EEC.

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.

Back to home page
For a Word Document of this text, pleased contact info@denehurst.co.uk