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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]

·         Page numbering – the SDS must also indicate the page number, and whether all pages are present, e.g. Page X of Y

 

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1  Product Identifier

For substances, 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, as well as providing a ‘plain English’ explanation

 

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 a 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 Number

Specify when it is available, if not 24 hours.

 

SECTION 2:  Hazards Identification

2.1 Classification of the substance or mixture

Give the classification of the substance 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.

 

For mixtures, you can continue to use the DPD classification until 1 June 2015. If still labelling using DPD, and you want to give the CLP classification in advance for information, it is recommended to indicate this with a phrases such as “proposed CLP classification from 1 June 2015” or by putting the CLP classification in section 16.

 

2.2 Label elements

Consistent with the label.  Pictograms must be shown, but can be in black and white – it is not necessary to print SDS in colour.

 

2.3 Other hazard information

An overview of key hazards –

Ingestion

 

Skin Contact

 

Eye Contact

 

Inhalation

 

Environment (vPvB / PBT)

 

Additional Information [anything else likely to cause a problem, such as dust explosion hazards, cold hazards for liquefied gases, etc.

 

SECTION 3:  Composition

For section 3, only one of these sub-sections need appear:

 

3. 1 Substances

For substances, indicate the purity and any other substance present that may impact on classification 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. 1 Acute or chronic aquatic toxicity.  Annex II gives the full 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. Components should be listed in order of their concentration.

 

Confidentiality can be sought for components and application can be made to use generic names for ‘generic’ hazards such as corrosivity, flammability etc.]

 

SECTION 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 any 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.

 

SECTION 5:  Firefighting 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.

 

SECTION 6:  Accidental Release Measures

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?]

 

6.4 References to other sections

References to section 8 for further advice on protective clothing and to section 13 for further advice on disposal.

 

SECTION 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

 

SECTION 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.

 

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

 

SECTION 9:  Physical and Chemical Properties

9.1 Information on basic physical and chemical properties

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 dust particle size, 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.

 

SECTION 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

Inherently reactive properties, e.g. oxidisers and reducers

 

10.2 Chemical stability

 

10.3 Possibility of hazardous reactions

Reactive with other chemicals if mixed or used at the same time? Possibility of hazardous polymerisation

 

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. Products of combustion should be given in section 5.

 

SECTION 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

 

SECTION 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 .

 

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 no 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.

 

SECTION 13:   Disposal Considerations

Consistent with Exposure Scenarios

 

13.1 Waste treatment methods

 

Do not simply state ‘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.

 

SECTION 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.

 

SECTION 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]

 

SECTION 16:  Other Information

 

 

ANNEX

Addition of Exposure Scenarios as applicable

 

Exposure Scenario 1

 

Exposure Scenario 2

 

etc

 

Further information on writing Exposure Scenarios is available.

 

For a copy of this document in Word format, please contact info@denehurst.co.uk

Denehurst Chemical Safety Ltd

Denehust offers an SDS advisory service that includes review and training.  As well as acting as trainers for courses run by CHCS and REACHReady and other organisations, Mark and Gill also run in-house training tailored to the specific demands of the client in their industry. 

 

Although a SDS writing service is offered, this is typically in the context of preparing small numbers of SDS to demonstrate how it should be done, allowing the client to start working these by themselves.

 

Denehurst has links with organisations that can provide software, that can work with larger numbers of routine SDS or provide services for translation.