A cross-referenced guide to the contents of safety data sheets (SDSs) in Europe, based on the requirements of the REACH Regulation (1907/2006), Annex II.
Check out our handy glossary of definitions and abbreviations of technical terms used in this article.
Mandatory headings and sub-headings are given in bold for Sections 1 to 16. The Annex is required if Exposure Scenarios are available for the substance, or the substance in a mixture where: (a) the mixture requires and SDS; and (b) the substance is present in the mixture above cut-off levels referred to in the REACH Regulation (1907/2006), Article 14.
New EU requirements apply from 1 January 2021. These are specified in Regulation 2020/878 of 18 June 2020, and are indicated below with ‘[from 1 Jan 21]’.
Date of issue of the particular revision.
Can also add information to indicated which revision or version has now been superseded.
Guidance recommends using versions numbered in units and decimals. Units for major changes, requiring re-issue to previous recipients, and decimals for minor changes, eg Version 1.1.
All pages, including any Annexes, should be numbered, and indicate the length of the safety data sheet (eg ‘page 1 of 10’) or an indication whether there is a page following (such as ‘continued on next page’ or ‘end of safety data sheet’).
|Alchemy recommends the product name is given in the header, in case printed pages of the SDS become separated.|
SECTION 1: Identification of the substance/mixture and company/undertaking [back to Sections]
Substance: name (IUPAC or other official chemical name); identification number (eg EC number); REACH Registration number if available.
If the safety data sheet pertains to one or more nanoforms, or substances that include nanoforms, this shall be indicated by using the word ‘nanoform’ [from 1 Jan 2021].
Or mixture: trade name.
Where a mixture has a unique formula identifier (UFI) indicated in the safety data sheet, then provide it here [from 1 Jan 2021].
|1.2||Relevant identified uses of the substance or mixture and uses advised against|
Identified uses: brief description of what the product is intended to do (eg antioxidant) and if applicable the types of use (eg lubricants) and recipient (eg industrial use). Do not list use descriptor system codes, although a reference to exposure scenario short titles in the Annex may be appropriate.
Uses advised against: These are usually derived from the Chemical Safety Assessment. Such uses cannot be shown to be safe. Reasons for the inclusion of a use-advised-against should be given.
|1.3||Details of the supplier of the safety data sheet|
Name, address and telephone number of an EU supplier. The supplier can be a manufacturer, importer, only representative, or downstream user. The supplier must be based in the EU, so that the authorities can contact them.
An email address for someone responsible for the SDS (guidance recommends using a dedicated company email address, eg SDS@chemicalcompany.com).
The SDS author can also add the contact details of non-EU manufacturer or a responsible person in a particular EU Member State.
|1.4||Emergency telephone number|
Some EU countries have mandatory poison centre telephone numbers that must be included, usually only after a notification of product formulation details. For other countries, the inclusion of the poison centre number is optional. This situation is currently undergoing harmonisation up until 2024, and a central EU web-portal is available.
A company number may be given, but callers to the emergency number should receive health information on the product in the language of countries in which the product is marketed.
REACH does not mandate a 24 h number, although provision of 24 h cover may be part of good product stewardship. If not 24 h, then state the hours that the service is available. There are companies who specialise in providing such services.
SECTION 2: Hazards identification [back to Sections]
|2.1||Classification of the substance or mixture|
Hazard classification according to Regulation (EC) No. 1272/2008. This consists of the hazard classes, hazard categories, and hazard statements, often in a codified form, eg Flam Liq 2, H225; Acute Tox 3, H302. If the codified form is used, then a full explanation of terms should be given, usually in Section 16.
Guidance recommends giving a M-factor for products with an Aquatic Acute 1 or Aquatic Chronic 1 hazard classification.
If a product does not meet the criteria for classification, it is advised to state this, along with a reason for providing the SDS, eg ‘this product does not meet the criteria for classification in any hazard class according to Regulation (EC) No 1272/2008, but a safety data sheet is being supplied as it contains useful information on safe handling.’
The label elements as indicated in this Section are usually the same as those on the actual product container. Some variation is possible, particularly in the precautionary statements, for example where the SDS covers a range of pack sizes or types of recipient (eg industrial vs consumer use).
|Pictograms: the hazard classification determines hazard pictograms (using the CLP Regulation, Annex I), for example Carc 2, H351 requires:|
The pictogram may be replaced with a black and white version, or with the inner symbol only.
|Signal word: the signal word ‘danger’ or ‘warning’ is determined by the severity of the hazard classification. Use only one signal word.|
|Hazard statements: these form part of the hazard classification, but are here given in full. So for our Carc 2, H351 product, the associated hazard statement is: H351: Suspected of causing cancer.|
It is not necessary to use the code (H351), but it may be helpful as shorthand or in translation work.
All of the hazard statements identified for the product should be listed, unless there is clear redundancy or duplication.
|Precautionary statements: these are assigned on the basis of the hazard classification (using the CLP Regulation, Annex I). A maximum of 6 is recommended, and the advice on the selection is given in ECHA Guidance on Labelling and Packaging, which grades the precautionary statements for a particular hazard class as ‘highly recommended’, ‘recommended’, or ‘optional’, but also use knowledge of your product to select the best precautionary statements. They can also be combined for greater flexibility.|
|Supplemental information: The EU specifies several types of supplemental label elements, such as: (i) EUH hazard phrases specified in the CLP Regulation, Annex II [eg EUH208 ‘contains (name of sensitising substance). May produce an allergic reaction’]; (ii) the unique formula identifier (UFI); and (iii) a statement for hazardous plant protection products.|
The statements for the percent of the product with unknown acute toxicity and aquatic toxicity should be given (CLP Regulation, Annex I, Sections 126.96.36.199.2.2. and 188.8.131.52.1.).
Add other statutory warning, such as ‘Restricted to professional users’ for CMRs (REACH Regulation, Annex XVII).
Also add the authorisation number, if applicable.
The Hazard Classes of the CLP Regulation do not cover all types of hazard, and others should be mentioned here, such as dust explosion, photo-sensitisation, or PBT/vPvB properties.
SECTION 3: Composition/information on ingredients [back to Sections]
Only one heading, 3.1 or 3.2, should be used in the SDS.
|Constituent identities: for mono-constituent substances, this would be the main constituent of the product. For multi-constituent substances, the legislation asks for the identity of constituents that contribute to the hazard classification. Relevant impurities should also be listed.|
Usually the product identifiers required for each constituent are the chemical name and an identification number, such as the EC number, but other numbers such as the CAS number (or commonly both) can be used.
Nanoform particle characteristics, as described in REACH Annex VI, should be given [from 1 Jan 2021].
|Concentration: the concentration of constituents and impurities is not mandatory, but is commonly added (eg >95 wt%).|
|Supplemental hazards (eg EUH066: repeated exposure may cause skin dryness or cracking), ATE, M-factor, and specific concentration limits [from 1 Jan 2021]|
|Deciding which components of a mixture should be listed is complicated.|
For mixtures with a hazard classification: any of the following: (i) components with a health or environmental classification and presents above generic cut-off values or specific concentration limits given in the CLP Regulation (taking into account the M-factor for environmental classification); (ii) components with an EU Occupational Exposure Limit Value (no concentration limit) (see Section 8); (iii) PBT or vPvB substances present at ≥ 0.1%.
For mixtures not meeting the criteria for classification: any of the following: (i) components with a health or environmental classification and presents above 1% (0.2% for gases); (ii) components with an EU Occupational Exposure Limit Value (no concentration limit); (iii) PBT or vPvB substances present at ≥ 0.1%.
For each component identified above, the information below is required. It is possible to claim some information as confidential in some limited circumstances (CLP Regulation, Article 24).
It is often useful to include other components, such as water, and Alchemy recommends the SDS author to format this Section so it is clear which ingredients are mandated and which are not. If you voluntarily list a component, then you are obliged to also give its chemical name, hazard classification and REACH Registration Number.
|Component identities: Usually the product identifiers required for each component are the chemical name and the EC number. Other numbers such as the CAS number can also be listed.|
|Concentration: exact weight percentages or ranges can be given. Components should be listed in decreasing order of percentage. If ranges are used, then the product classification should be based on the highest value of the range for each component.|
|REACH Reg. No.: the REACH Registration Number should be given, if available.|
|Classification: the hazard classification, usually in coded form (eg Carc 2, H351) for brevity. The Section should contain a cross-reference to Section 16 with a listing of the full hazard statements (eg H351: suspected of causing cancer). Guidance recommends that M-factors are also given, if applicable.|
If a mandated component is not classified, then the reason it is mandated should be stated (eg EU OEL, or PBT).
Supplemental hazards (eg EUH066: repeated exposure may cause skin dryness or cracking), ATE, M-factor, and specific concentration limits should be added if available [from 1 Jan 2021].
SECTION 4: First aid measures [back to Sections]
|4.1||Description of first aid measures|
This Section advises the first-aider on dealing with minor medical issues, or in more serious cases when to get professional medical help, and how to stabilise a patient until it arrives. The advice should be on what symptoms may be expected from the product (immediate and delayed), and the priority and speed of actions required, following accidental exposure via inhalation, skin, eye or ingestion.
The SDS author should emphasise any product-specific advice or treatment, particularly if antidotes should be given.
The response precautionary statements associated with the hazard classification of the product can be helpful start for this sub-section.
|Inhalation: Standard treatments are: (i) remove exposed person to fresh air; (ii) keep warm and at rest in a position comfortable for breathing; (iii) for more serious effects (eg respiratory irritation or difficulty in breathing), getting professional medical attention.|
|Skin: Standard treatments are: (i) quickly remove contaminated clothing; (ii) wash affected area (eg with soap and water, depending on solubility of product); (iii) for more serious cases (eg signs of skin irritation or skin corrosion, or dermal absorption), getting professional medical attention; (iv) washing contaminated clothing before re-use.|
|Eye: Standard treatments are: (i) irrigate affected eye with room-temperature water or eyewash solution for several minutes; (ii) possibly removing any contact lens; (iii) for more serious cases (eg signs of eye irritation or serious eye damage), getting professional medical attention.|
|Ingestion: Standard treatments are: (i) rinse mouth; (ii) give water to drink; (iii) for more serious cases (eg ingestion of toxic product, ingestion of significant quantities), getting professional medical attention. |
Ingestion is particularly serious for product that may be an aspiration hazard (low-viscosity products, often hydrocarbons, that can enter the lung after swallowing and cause lung damage).
|4.2||Most important symptoms and effects, both acute and delayed|
This sub-section can re-iterate the main hazards as given by the hazard classification, such as acute toxicity or eye irritation. Better, is to give more specific information on symptoms following human exposure.
|4.3||Indication of any immediate medical attention and special treatment needed|
This specialist sub-section can cover: (i) medical monitoring for long-term effects in the workplace; (ii) specialist treatments and training required in case of workplace exposures; (iii) explanation of the medical treatments specific to the product; (iv) notes for medical professionals.
SECTION 5: Firefighting measures [back to Sections]
|Suitable: give recommended firefighting media, preferably relating to both small and larger fires. Common extinguishants include water spray, foam, carbon dioxide, powder, and sand.|
|Unsuitable: give any firefighting media that are considered unsafe to use, eg because of reaction. Water-jet is commonly given, because it may spread fires or cause dust clouds.|
|5.2||Special hazards arising from the substance or mixture|
Commonly includes: (i) flammability of product; (ii) explosivity of vapours, dust cloud, or heated containers; (iii) oxidising products that may intensify a fire; (iv) hazardous decomposition products.
|5.3||Advice for firefighters|
Commonly, only basic advice is given, relating to: (i) wearing specialist protective clothing (eg self-contained breathing apparatus, SCBA); (ii) removing product from fire, or cooling containers with water spray; (iii) preventing run-off water from entering water-courses or drainage system.
SECTION 6: Accidental release measures [back to Sections]
|6.1||Personal precautions, protective equipment and emergency procedures|
This Section gives advice to non-emergency personnel on minimising damage to people, property and the environment from spills and leaks.
This sub-section commonly advises on measures regarding: (i) requirements for PPE; (ii) control of ignition sources, particularly control of static sparking; (iii) requirements for ventilation; (iv) control of dusts and vapours; (v) need for evacuation; (vi) the need to report to local authorities.
These measures often depend on the size of spill, and it is common to split sub-sections accordingly, ie for small spills and large spills (with ‘small’ and ‘large’ dependent on the hazard and context of the spill).
The legislation also requires advice in this sub-section for emergency personnel on suitable fabrics for PPE, although this is frequently omitted, or simply refers to Section 8.
This sub-section commonly advises to: (i) prevent product from entering water courses; (ii) not flush spills to sewer.
|6.3||Methods and material for containment and cleaning up|
Appropriate methods depend on the size of the spill, its physical state (liquid, solid, gas), and the context (industrial or professional use).
This sub-section is commonly divided into: (i) stopping the source of the spill; (ii) containing the release (eg through bunding); (iii) cleaning-up the spill (eg through absorption of liquids; vacuuming of dusts); (iv) decontamination procedure (eg washing with water and detergent); (v) special considerations from the hazard of the product (eg for volatile liquids, flammable products).
|6.4||Reference to other sections|
This sub-section cross-references Section 8 (exposure controls/personal protection), for further information on PPE, and Section 13 for disposal considerations for the product and contaminated wastes.
SECTION 7: Handling and storage [back to Sections]
|7.1||Precautions for safe handling|
This sub-section provides information for safe handling, and provides help in protecting users, particularly workers, and the environment. As such, it should facilitate the workplace risk assessment (eg under UK COSHH Regulations). The operational conditions and risk managements measures recommended in this sub-section should be consistent with any exposure scenarios in the Annex.
The SDS author should add useful information regarding: (i) containment measures (eg ventilation, dust control) (see Section 8); (ii) fire prevention; (iii) general occupational hygiene measures, such as hand washing; (iv) measures for protecting the environment (eg avoiding release; cleaning spills); (v) special measures appropriate to the product, depending on the hazard and context in which it is handled.
The prevention precautionary statements associated with the hazard classification of the product can be helpful start for this sub-section.
|7.2||Conditions for safe storage, including any incompatibilities|
This sub-section should specify any conditions which impact the safe storage (rather than product quality, which could be additionally added and identified), for example: (i) physical parameters (temperature range, humidity, light sensitivity); (ii) incompatible materials (see Section 10) and required separations; (iii) inert atmospheres; (iv) container materials or packaging; (v) storage room ventilation; (vi) special electrical equipment and prevention of static electricity.
Any storage quantities requiring regulatory action (eg under Seveso III) may also be given.
Also note any hazards that may arise during storage, such as pressured containers.
|7.3||Specific end use(s)|
This sub-section should specify handling and use recommendations for specified uses, often those in the chemical safety assessment and the associated exposure scenarios in the Annex. In this case, the SDS author can reference the identified uses in Section 1.2, and the exposure scenarios in the Annex.
For some products and specific uses, eg biocides, further detailed use recommendations will be given elsewhere (eg in product leaflets, or in web documents), and can be referenced if they are readily available.
SECTION 8: Exposure controls/personal protection [back to Sections]
|EU limit values: these are not mandated in this Section, but Alchemy recommends adding any available EU occupational exposure limit values (OELs) to avoid confusion. |
Oddly, substances with an EU limit value have to be listed in Section 3, but not in Section 8, although all EU OELs should be adopted into the national legislation.
Conversely, a substance with a national (but not an EU) OEL in countries in which the product is supplied should be given in this Section, but its listing is not mandatory in Section 3.
|National limit values: The national occupational exposure limit values (eg UK, Workplace Exposure Limits, WELs) and any biological limit values should be given for substances or mixture components where they are available. The national legislation concerning OELs should be given here, or in Section 15.|
The GESTIS database, available freely online, is a good resource for EU national OELs.
|Monitoring procedure: For relevant substances or components of mixtures, the recommended workplace monitoring procedures should be given. Advice on monitoring in the UK is given in: BS EN 14042:2003; Workplace Atmospheres; Guide for the Application and Use of Procedures for the Assessment of Exposure to Chemical and Biological Agents.|
|Other: human health (DNELs, DMELs): These are safe limits for human health derived in the Chemical Safety Assessment of substances, and should be given for relevant routes (eg inhalation and dermal exposure), and user types (industrial or consumer). |
Section 15 states whether a CSA is available. If the CSA is not available, the DNEL or DMEL values are publicly available for substances registered at >10 t/a at the ECHA ‘search for chemicals’ webpage.
|Other: environmental (PNECs): The predicted no-effect-concentrations are the limit values for protection of the environmental. PNECs are derived in the Chemical Safety Assessment of substances, and should be given for relevant environmental compartments (eg freshwater, marine, sewage-treatment plants, sediment, soil).|
Section 15 states whether a CSA is available.
If the CSA is not available, the PNEC values are publicly available for substances registered at >10 t/a at the ECHA ‘search for chemicals’ webpage.
|Engineering controls: This sub-section usually relates to the type of ventilation: (i) general, but giving a recommended number of air changes per hour (eg minimum of 3); (ii) local exhaust ventilation to remove dust, fume and vapours at source; (iii) whether use in a closed system is recommended. |
For certain products and processes, the SDS author can give more specific advice on risk management measures, including separation in time or place of workers from the product (administrative controls).
The information should be sufficiently detailed for recipients of the SDS to use in a workplace risk assessment.
|Personal protective equipment: PPE is the ‘last-resort’ in the hierarchy of chemical control. |
The legislation calls for more detail on the PPE than is commonly available to the SDS author, because of the variety of workplace scenarios for most chemical products. PPE manufacturer’s websites give useful guidance on suitable materials and design for PPE.
Give reference to PPE standards (CEN).
Eye/face: Safety glasses or face shield.
Glove: give recommendations on: (i) glove material; (ii) thickness; (iii) breakthrough time. Also whether thermal protection is relevant, for example with molten plastics.
Clothing: any recommendation for wearing further skin protection, such as overalls, sleeves, boots.
Respiratory protection: detailed recommendations for RPE should be given: (i) for dust, vapour, or gas; (ii) filter types; (iii) the assigned protection factor, if available; (iv) if air-supplied respirator is recommended.
|Environmental exposure controls: Give any recommendations concerning process water-treatment or ventilation exhaust scrubbing should be given, especially if detailed in the exposure scenarios of the Annex.|
SECTION 9: Physical and chemical properties [back to Sections]
|9.1||Information on basic physical and chemical properties|
The SDS author should not leave any of the properties blank, and distinguish between ‘no information available’, and ‘not relevant’ for the product. Some estimation is often useful, for example using QSARs such as the US EPAs ECOSAR. For mixtures, it is often useful to indicate properties of main components and those contributing to the product hazard classification in Section 2 of the SDS.
Units should be those given in Directive 80/181/EEC, ie SI units.
Testing is not mandated specifically for SDS purposes, but Alchemy recommends testing for key parameters, particular where the classification or safe handling may be affected, such as a flash point where it cannot be predicted.
The method of determination shall be provided, including measurement and reference conditions [from 1 Jan 2021].
The sub-headings below change from 1 Jan 2021.
Add particle characteristics [for solids], including particle size, or size distribution. Add description of nanoforms [from 1 Jan 2021].
|Appearance: physical state (eg solid, liquid), colour, and other descriptors (powder, paste, viscous liquid).|
|Odour: Often given as ‘characteristic’, but a few products have distinctive odours that can be given here.|
|Odour threshold: rarely available, but relevant for some toxic substances such as thiols.|
|pH: a scale of roughly 0 to 14. A product with pH value lower than 7 are acidic, pH 7 is neutral, and and higher than 7 is alkaline. Not relevant for substances that do not dissociate (ie split into ions) in water. Extreme pH products usually regarded as classified for skin corrosion and serious eye damage.|
|Melting/freezing point: usually not relevant for liquids with Mp < – 20 °C or solids with Mp > 300 °C.|
|Initial boiling point/range: usually not relevant for solids with Mp >300 °C or those that decompose before boiling.|
|Flash point: relevant for liquids and low-melting-point solids. Used to determine flammable liquid classification. EU has classification of products with Fp ≤ 60 °C. UN GHS, and countries such as the USA that implement Flammable Liquid, Category 4, classify liquids with Fp > 60 but ≤ 93 °C as combustible liquids. Not relevant for inorganic substances. Give the method (eg closed-cup), as it can affect the measurement.|
|Evaporation rate: rarely available, but gives evaporation rate compared to a standard substance, such as butyl acetate. Should be closely related to vapour pressure.|
|Flammability (solid, gas): these classifications are determined by specialised testing, and not ‘common sense’, so charcoal is not classified a flammable solid, but can be described as combustible.|
|Flamm. or expl. limits: Give the concentration limits for flammability or explosion, either for vapour or dusts. If dust explosion information is available, the minimum ignition energy is a useful parameter.|
|Vapour pressure: The vapour pressure is a measure of the volatility and therefore the likelihood of inhalation or flammable vapours. The temperature of measurement is important, eg n-butanol, 626.6 Pa at 25 °C.|
|Vapour density: rarely available, but gives an indication of whether vapours can form a flammable/explosive atmosphere or asphyxiation hazards by collecting in low-lying areas.|
|Relative density: this parameter usually relates to the density of a liquid compared to water, but can also be the density of gas compared to air. The bulk density of solids may also be given here.|
|Solubilities: this mainly relates to the solubility in water. Alchemy recommends giving quantitative data where possible, as qualitative statements (eg moderately soluble) are open to mis-interpretation.|
|Partition coeff. (log Kow): the octanol–water partition coefficient is a measure of the substance’s affinity for water vs fat. As such, it is a key parameter in the Chemical Safety Assessment, as it gives an indication of a substance’s ability to cross biological membranes and accumulate in tissue. This parameter only applies to substances, so for a mixture report as the components, or as a range.|
|Auto-ignition temp.: note the REACH SDS requirements (Annex II) use the term auto-ignition, but the testing requirements of REACH (Annex VII) uses self-ignition temperature. The Test Method Regulation (440/2008) use auto-ignition for liquids and gases, and relative self-ignition temperature for solids. |
Both are the lowest temperature at which the test substance will ignite under the standard conditions of the tests.
|Decomposition temp.: this is most frequently found for substances during the tests for melting, boiling, or auto-ignition points.|
|Viscosity: This is a measure of the ‘thickness’ or flow of a liquid, and is mainly used to indicate whether the substance or mixture is an aspiration hazard.|
|Explosive properties: usually this gives re-assurance that the product is not explosive, from consideration of the chemical functional groups (eg absence of chlorates, azides), oxygen balance (CLP Regulation, Annex I, 184.108.40.206.), and experience in use. If explosive properties are possible, then Alchemy recommends testing as good product stewardship.|
|Oxidising properties: usually this gives re-assurance that the product is not oxidising, from consideration of the chemical functional groups (eg absence of peroxides, chlorates) in the product, oxygen balance, and experience in use. If oxidising properties are possible, then Alchemy recommends testing as good product stewardship.|
Any other physico-chemical properties that may be useful to the user for safe handling or particular uses, such as fat and other solvent solubility, redox potential, acid/alkali reserve.
SECTION 10: Stability and reactivity [back to Sections]
The reactivity of the product should be given. Commonly, commercial products will show no special reactivity. For products known to have reactive functions, especially that may cause hazards during foreseeable use, describe the reactivity and resulting hazard (eg secondary amines, may form carcinogenic nitrosamines with nitrites; strong acids forming flammable hydrogen with some metals).
Commonly, commercial products are stable, and bland statements are given in this sub-section: ‘product is stable at ambient temperatures up to 50 °C’.
For products known to have the potential to spontaneously decompose or polymerise, especially that may cause hazards during foreseeable use, describe stabilising agents that may affect the stability and the significant changes in the product that may indicate instability.
|10.3||Possibility of hazardous reactions|
For products that may spontaneously decompose or polymerise, or have hazardous reactions, particularly that create heat or pressure, describe the reaction and the conditions under which it occurs, eg strong acid, reacts violently with alkaline substances; pyrophoric substance, spontaneously combusts if exposed to air.
|10.4||Conditions to avoid|
These are physical conditions, such as light exposure, ignition sources, or humidity, that may cause the product to develop increased hazard. Also describe precautions to manage such risk.
There is potential for overlap of contents with sub-section 10.3. This sub-section usually lists types of chemical that have reactivity with the product. Standard incompatible materials for many products are ‘strong acids, alkalis, and oxidising agents’, but more specific information should be given if available, for example if the product may corrode certain containers or equipment.
|10.6||Hazardous decomposition products|
This sub-section should be used to describe hazardous decomposition products that may form during foreseeable use, and not for those formed during fire (given in Section 5). So examples would include isopropyl ether that may form peroxides on storage. Often bland statements are sufficient: ‘no know hazardous decomposition products.’
SECTION 11: Toxicological information [back to Sections]
|11.1||Information on toxicological effects|
This Section is aimed at medical and occupational health professionals, and can contain technical health information.
Information should be presented on the health hazard classes below.
The SDS author is expected to search for available information to include in this Section.
Usually health effect information is obtained on neat substances from animal studies, although if it is available for mixtures or from human data, then this takes precedence.
Structure–activity relationships and other sources may provide useful data.
If human data is available, give the expected symptoms or adverse effects, eg from epidemiological studies, at different doses.
The SDS author for mixtures can combine component information to give an overall description for the hazard class, or present information, as appropriate, on main components and those that contribute to the hazard classification.
Alchemy recommends reporting a brief description of test method (eg Guideline number, duration, dosing, and species) and key results. For any numerical data (eg LD50, NOAEL) give an interpretation, and any resulting hazard class, eg LD50 (oral, rat, Method OECD 423) 200 mg/kg (toxic if swallowed) (classified as toxic by the oral route, Category 3).
If data is available, but results in no classification, the guidance advocates the convoluted phrase: ‘based on available data, the classification criteria are not met.’ State ‘no data available’ (and you are supposed to say why), rather than ‘not classified’ to avoid confusion.
|Acute toxicity: How poisonous is the product? Acute toxicity is the short-term harm, usually after exposure to a single, high dose of the product by the oral, dermal or inhalation route. The information is often presented as an ‘acute toxicity estimate‘ (ATE), or in older tests as an LD50 (for oral and dermal routes), and LC50 (for the inhalation route). Alchemy recommends giving the information by route.|
|Skin corrosion/irritation: Does the product cause skin inflammation or burns? Skin irritation and skin corrosion data can be obtained from in vitro or in vivo tests, or from the pH, and describes the effects likely from a 4 hour exposure to the skin. Irritation is redness and swelling, and corrosion is destruction of the skin.|
|Serious eye damage/irritation: Does the product cause eye irritation or blindness? Eye irritation and serious eye damage data can be obtained from in vitro or in vivo tests, or from the pH, and describes the likely effects from exposure of the eye (without rinsing or treatment). Irritation is reversible redness, swelling, and opacity, whereas eye damage is irreversible.|
|Respiratory sensitisation and skin sensitisation: |
Does the product cause asthma or skin allergy? Respiratory sensitisers are identified from experience in use, and occasionally from functional groups (particularly isocyanates). They are of concern for causing asthma.
Skin sensitisation is allergy that causes dermatitis. There are several ex vivo or in vitro tests for skin sensitisers (notably the local lymph node assay, LLNA) that have superseded the in vivo maximisation and Buehler tests.
|Germ cell mutagenicity: Does the product cause fetal malformation? Germ cell mutagens are able to cause genetic harm to the offspring of exposed parents. The strategy to detect germ cell mutagens comprises in vitro and in vivo tests, including the Ames and chromosome aberration tests, to detect gene mutation and chromosomal defects.|
|Carcinogenicity: Does the product cause cancer? Carcinogens increase the incidence of cancer. The strategy to detect them comprises in vitro and in vivo tests. Several influential organisations (IARC, NTP, ACGIH) produce lists of carcinogens, and it may be useful to reference these lists.|
|Reproductive toxicity: Does the product harm fertility and reproduction of parents, or the development of the offspring? Reproductive effects are usually investigated in repeated-dose studies in animals.|
|STOT-single exposure: Specific target organ toxicity (single exposure) relates to the products capability to cause adverse effects in particular organs after a single dose. It is an uncommon effect, but a well-known example is methanol’s ability to cause blindness. |
STOT-SE, Category 3, covers two common effects: respiratory irritation, and ‘drowsiness and dizziness’.
|STOT-repeated exposure: Can long-term exposure lead to chronic health effects? This information is critical to evaluate long-term effects of the product. Usually the information is derived from repeated-dose studies on animals (varying in duration from 28 d to lifetime). It gives key parameters such as the NOAEL for determining safe levels of use, as part of the chemical safety assessment. |
Epidemiological data or other human data is occasionally available, and can be reported.
|Aspiration hazard: this is a serious health hazard posed by low-viscosity products, often hydrocarbons, that can enter the lung after swallowing, and cause lung damage.|
|11.2||Information on other hazards|
From 1 Jan 2021, the Sections above refer only to the hazards in the EU classification system (in CLP Regulation 1272/2008), and this new Section is added. All other health hazards should be mentioned here, specifically including endocrine disrupting properties.
SECTION 12: Ecological information [back to Sections]
Information should be presented for all sub-headings.
The SDS author is expected to search for available information to include in this Section.
Usually environmental toxicity information is obtained on neat substances, although if it is available for mixtures, then this takes precedence. Fate and degradation data applies only to substances.
Structure–activity relationships and other sources may provide useful data.
The SDS author for mixtures usually presents information, as appropriate, on main components and those that contribute to the environmental hazard classification.
Alchemy recommends reporting a brief description of test method (eg Guideline number, duration, test concentrations, and species) and key results. For any numerical data (eg LC50) give an interpretation, and any resulting hazard class, eg LC50 (fish, 96 h, Method OECD 203), 624 mg/L (harmful to aquatic life with long lasting effects).
The information determines process control measures, waste-treatment and dealing with spills.
Is the product toxic to environmental organisms? Toxicity usually relates to the aquatic environment, and initial testing is commonly conducted on fish, Daphnia (crustacea), and algae, representing vertebrate, invertebrate, and plant species (and a small part of a food chain). Add information on toxicity to sewage-sludge microorganisms, important for protection of sewage treatment plants, and terrestrial organisms (eg worms, bees) if available.
Information from reliable models shall be provided if experimental data not available [from 1 Jan 2021].
|12.2||Persistence and degradability|
Does the product persist in the environment?
A product that is rapidly biodegradable by micro-organisms can disappear from the environment. Initial testing usually relates to transformation of organic products to carbon dioxide and water (mineralisation) in 5 to 28 days. More sophisticated testing can track the disappearance of a substance (primary biodegradation), and over longer periods.
Hydrolysis in water and photo-transformation in air may also be important.
Can the product accumulate in aquatic organisms? Bioaccumulation is often estimated from the log Kow (> 4 indicates bioaccumulation potential). More sophisticated testing involves measuring the bioconcentration factor in aquatic organisms (usually fish).
|12.4||Mobility in soil|
Can the substance migrate from the site of a spill on soil to groundwater or water courses? The mobility is usually estimated as the soil adsorption coefficient (Koc), calculation from the octanol–water partition coefficient (log Kow). More sophisticated tests use HPLC, or full equilibrium experiments.
|12.5||Results of PBT and vPvB assessment|
The PBT (persistent, bioaccumulative and toxic) and vPvB substances remain in the environment and can accumulate, sometimes to toxic levels, in the food chain. The criteria for these effects are given in REACH Annex XIII. PBT and vPvB substances are uncommon (more information: Persistent Organic Pollutants), and often this sub-section gives a bland statement, eg ‘the product does not contain any substances assessed to PBT or vPvB.’
|12.6||Other adverse effects|
Many products have information on aquatic hazards, as outlined in previous sub-sections, but if there is further hazard information, eg on ozone depletion or environmental endocrine effects, then the SDS author should give details here.
From 1 Jan 2021, this Section will be renumbered 12.7, and Section 12.6 will be titled ‘endocrine disrupting properties’.
SECTION 13: Disposal considerations [back to Sections]
|13.1||Waste treatment methods|
This section contains information on recommended disposal methods. It frequently contains bland statements: ‘disposal must be in accordance with current national and local regulations,’ ‘use a licensed waste contractor’, and ‘containers of this material may be hazardous when emptied due to product residue – all hazard precautions given in this data sheet must be observed for used containers.’
Add more specific advice if available. The main routes of disposal are:
(i) incineration, suitable for organic products, particularly solvent-based or hydrocarbon products. Not suitable for inorganic products;
(ii) landfill, only suitable for less hazardous products;
(iii) disposal via drains may be suitable for some products, particularly in small quantities if rapidly biodegradable. But it is generally discouraged.
The method should be chosen on the basis of risk assessment, particularly the Chemical Safety Assessment, if available.
The waste classification code (also referred to as List of Waste or European Waste Catalogue code) may be useful for some products.
The principles of hazardous waste management are given in the Waste Framework Directive (2008/98/EC), and reference to it may be useful to recipients of the SDS.
SECTION 14: Transport information [back to Sections]
|This section gives the transport classification of the product, based on the Dangerous Goods List in the UN Recommendations on the Transport of Dangerous Goods. The details by mode of transport should also be given: (i) road (ADR); (ii) rail (RID); (iii) inland waterways (ADN); (iv) sea (IMDG); (v) air (ICAO).|
The criteria for hazard transport classification has largely been harmonised with the CLP hazard classes for supply classification, but there are differences in detail, and the transport classification does not cover as many hazards as the CLP Regulation.
The UN Number is the four digit number used in the Dangerous Goods List, eg UN 1993.
|14.2||UN proper shipping name|
The proper shipping name is given with the UN Number in the Dangerous Goods List, plus any technical name, eg FLAMMABLE LIQUID N. O. S. (contains diisopropyl ether).
|14.3||Transport hazard class(es)|
The hazard class and any subsidiary class, as given in the Dangerous Goods List for the chosen UN Number, eg Class 3 for flammable liquids for UN 1993.
Packing Groups are assigned according to the criteria of the regulations, largely harmonised with the hazard classes of the CLP Regulation, with PG I for severe hazards, and III for less severe hazards, eg for UN 1993, FLAMMABLE LIQUID N. O. S., PG II applies to products with a flash point < 23 °C and initial boiling point > 35 °C (same criteria as CLP for flammable liquid, Category 2).
The criteria for environmentally hazardous for transport corresponds with the following CLP Hazard Classes: Aquatic Hazard (Acute), Category 1; and Aquatic Hazard (Long-Term), Categories 1 and 2 (ie those which require the GHS09 ‘dead fish, dead tree’ hazard pictogram).
Marine pollutants according to the IMDG Code should also be identified.
|14.6||Special precautions for user|
The SDS author should add any special precautions relating to handling and storage during transport operations. Reference to Section 8 may be useful.
|14.7||Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code|
This sub-section is rarely used, but applies only for cargoes that are carried in bulk by sea, eg oil or fuel.
No sub-sections should be left blank, and a statement such as ‘this product is not intended to be transported by sea in bulk containers’ may be used.
From 1 Jan 2021, the title of this subsection will be: ‘Maritime transport in bulk according to IMO instruments’.
SECTION 15: Regulatory information [back to Sections]
|15.1||Safety, health and environmental regulations/legislation specific for the substance or mixture|
This sub-section should give the important EU legislation that is relevant for the product, or its use.
It is not clear which legislation should be referenced, or how long the list of legislation should be.
Alchemy recommends referencing general chemical control legislation (eg Chemical Agents Directive, 98/24/EC; Seveso III (96/82/EC), or the PIC Regulation (649/2012), legislation on the product type (eg detergents, biocides, aerosols) and any other legislation that specifically refers to the product or its components (such as occupational exposure limit values).
There are many other possibilities, such as regulations on: (i) emissions (to air and water); (ii) environmental quality standards; (iii) persistent environmental pollutants (iv) waste management and disposal; (v) workplace monitoring; (vi) PPE; (vii) storage and segregation; (viii) explosive atmospheres; (ix) young or pregnant workers; (x) persistent environmental pollutants.
Add details if the product or any component is on the Candidate List of Substances of Very High Concern, or subject to REACH Authorisation or restriction.
There is also a requirement to add national legislation. It is not clear which legislation should be listed, and some Member States require long lists, which can quickly lead to unhelpful wordage, particularly if multiple countries are covered. Most countries have legislation for occupational exposure limit values. Germany has a unique requirement for the water-hazard class (WGK; given in ordnance AwSV).
|15.2||Chemical safety assessment|
This sub-section states whether a chemical safety assessment is available for the product.
SECTION 16: Other information [back to Sections]
|Revisions: If the SDS has been revised (see Header information), then the SDS author can give the main revisions and the affected sub-sections here. Alternatively, the revisions can be marked directly in the body text with the explanation here, eg ‘Hazard classification updated to include eye irritation. Revisions to the text are indicated in the SDS by a sidebar.’|
|Abbreviations: All abbreviations used in the SDS should be explained, eg technical terms, and organisations.|
|References: Key sources of information should be given, such as the ECHA ‘search for chemicals,’ IARC monographs, GESTIS database.|
|Basis of classification: The SDS author should give the basis for the hazard classification of mixtures, eg: (i) testing or human experience; (ii) bridging from similar product, or other structure–activity relationship; (iii) calculation method for mixtures, using special or generic concentration limits for components.|
|List of hazard statements: Give the full hazard statements where codes have been used in hazard classifications, eg Section 2.1 and Section 3.2.|
|Further information: any other information regarding safe handling, use, training requirements, etc, not covered in the other Sections. |
If an Annex includes numerous exposure scenarios, then a table of contents may be added in this sub-section.
Some suppliers like to add a disclaimer from liability for use of the product, although the utility and appropriateness of such a statement is questionable.
ANNEX: Exposure scenario and risk management measures [back to Sections]
|What is in the SDS Annex?|
The SDS Annex contains exposure scenarios (ie operational conditions and risk management measures recommended for safe use), which may be required for substances as part of the Chemical Safety Assessment (CSA) for REACH Registration at >10 tonnes/year.
When is the SDS Annex required?
If an actor in the supply chain conducts a CSA, then they should put any exposure scenarios in the Annex.
Downstream users who have not carried out the CSA, but formulate mixtures using a substance with exposure scenarios, should include the information in the exposure scenarios in their own SDS if: (i) the mixture requires and SDS; (ii) the component is present above specific or generic cut-off limit concentrations in the mixture.
In this case, the downstream user SDS compiler can: (i) add the relevant substance exposure scenarios as an Annex to the mixture SDS; or (ii) incorporate the information from the substance exposure scenario(s) into the main text of the mixture SDS.
It is also possible to develop CSAs and exposure scenarios directly for mixtures, but there is limited guidance on how to do this.
Format of the Annex
The format is not specified in the legal text, but the recommendation below is accepted practice, and shows the type of information typically required.
An ES for communication typically consists of 4 sections: (i) title; (ii) conditions of use affecting exposure; (iii) exposure estimation (health and environment); and (iv) guidance for Downstream Users working within the exposure scenario.
The complexity of actual use of chemical product often requires multiple ‘contributing scenarios’ (eg mixing, transferring, dipping, equipment cleaning) for each exposure scenario (eg coating of machine parts), and multiple exposure scenarios within the Annex, so the Annex comprehensibility is a great challenge for both the SDS author and user.
|EXPOSURE SCENARIO 1|
|1||Short title of exposure scenario 1|
A brief description of the exposure scenario (eg industrial coating of metal machine parts by dipping).
List of ‘contributing scenarios’, that together describe the process of the exposure scenario. Each contributing scenario is usually presented as: (i) short description of the contributing scenario; (ii)
using codes of the use descriptor system, particularly the process category (PROC) (ie the tasks or techniques, eg PROC8a ‘transfer of mixture at non-dedicated facilities) and environmental release category (ERC) (the activity type for the environment, eg ERC2 ‘formulation into mixture’).
Other codes of the use descriptor system can be added if relevant to define the exposure scenario: (i) Sector of Use (SU); (ii) Product Categories (PC); (iii) Article Category (AC).
|2||Conditions of use affecting exposure|
This section includes the operational conditions and risk management measures for each contributing scenario given in Exposure Scenario 1, Section 1, divided into Environmental and Human Health (Worker), as given below.
|2.1||Environment contributing scenario|
This sub-section is repeated for all contributing scenarios.
For each repeat, give the contributing scenario ‘short description’ and ERC Code.
Physical form: solid, liquid or gas.
Any maximum concentration of the substance in a mixture may be useful.
|Amount used, and frequency and duration of use|
Example: maximum daily amount per site: 0.2 tonnes/day; maximum annual amount per site: 50 tonnes/year; or maximum number of emission days, 250/year.
|Technical and organisational conditions and measures|
Include different measures to reduce environmental emissions from processes to air and water, eg use air filtration with removal efficiency of >95%; or process water wastes through on-site microbial treatment plant before discharge to surface water.
|Conditions and measures related to sewage treatment plant|
Give any specific type of treatment required, or the minimum capacity, eg estimated substance removal from wastewater via municipal sewage treatment 20% (assumed STP flow > 2000 m3/d).
|Conditions and measures related to treatment of waste|
Give the appropriate disposal route or any need for special treatment of waste, eg dispose of wastes and residues from cleaning as hazardous waste for incineration.
|Other conditions affecting environmental exposure|
Give any other key operational conditions that have been used in the assessment, eg receiving surface water flow > 18000 m3/d; or the emission factor to air, water and soil used in calculations of the PNEC.
|Additional good practice advice|
Further advice representing good practice for the environment, rather than mandated minimum standards. This sub-section is not mandatory for the exposure scenario.
|2.2||Worker Contributing Scenario|
This sub-section is repeated for all contributing scenarios.
For each repeat, give the contributing scenario ‘short description’ and PROC Code.
Give product characteristics relevant for the worker/human health exposure assessment, eg physical form (solid, liquid, gas), dustiness, vapour pressure, and any maximum concentration of the substance in a mixture.
|Amount used, frequency and duration of use/exposure|
Give any time or frequency limits for use required in the Chemical Safety Assessment, eg covers daily exposures up to 8 hours; or mixing in open vessels restricted to one 15 minute exposure per day.
|Technical and organisational conditions and measures|
Give the exposure controls required, eg need for closed system; or the efficiency requirements for local exhaust ventilation; or the need for training in glove use.
|Conditions and measures related to personal protection, hygiene and health evaluation|
Give risk managment measure related to personal protective equipment (PPE) for workers, eg wear gloves (compliant with EN374). Reference to the SDS Section 8 can be given, which contains more detail.
Give any health surveillance programmes recommended for the workplace.
|Other conditions affecting workers exposure|
Other operational conditions that have been used in the chemical safety assessment can be given here, eg indoor use, process temperature < 40 °C.
|Additional good practice advice|
Further advice representing good practice for worker safety, rather than mandated minimum standards. This sub-section is not mandatory for the exposure scenario.
|3||Exposure estimation and reference to its source|
This part gives the exposure scenario gives the details of the software or estimation method used in the chemical safety assessment, and some of the key output values. Any details not considered relevant for the downstream user recipient of the SDS may be omitted.
|3.1||Environment Contributing Scenario|
This sub-section is repeated for all contributing scenarios. For each repeat, give the contributing scenario ‘short description’ and ERC Code. An RCR <1 indicates acceptable ‘safe’ use.
For example: CS 01: Industrial application of coatings in industrial setting (ERC 5: use at industrial site leading to inclusion into/onto article).
All estimates based on Chesar 3.5.
• to water, 1.5 kg/d;
• to soil, 0.0 kg/d;
• to air 2.1 kg/d.
Freshwater: 0.04 mg/L; PNEC 0.1 mg/L; RCR 0.4.
Freshwater sediment: 0.4 mg/L; PNEC 1.2 mg/L; RCR 0.33.
Sewage treatment plant: 0.8 mg/L; PNEC 18 mg/L; RCR 0.04.
|3.2||Worker Contributing Scenario|
This sub-section is repeated for all contributing scenarios. For each repeat, give the contributing scenario ‘short description’ and PROC Code. An RCR <1 indicates acceptable ‘safe’ use.
For example: CS 01: Industrial application of coatings in industrial setting (PROC 7: industrial spraying).
All estimates based on Chesar 3.5.
Worker, inhalation, systemic, long-term: 15 mg/m3; DNEL 55 mg/m3; RCR 0.27.
Worker, inhalation, systemic, short-term: 45 mg/m3; DNEL 110 mg/m3; RCR 0.41.
Worker, dermal, systemic, long-term: 5 mg/kg/day; DNEL 12 mg/kg/day; RCR 0.42.
Combined routes, systemic, long-term, RCR 0.69.
|4||Guidance to the downstream user as to whether they are in compliance with the exposure scenario.|
|For the environment: the SDS author should give advice to the downstream user (DU) on whether their use fits into the exposure scenario, when certain parameters of the operational conditions or risk management measures are different from the assumptions in the exposure scenario (so-called scaling options). This is particularly helpful if the DU uses smaller amounts than anticipated in the exposure scenario. The advice can be given as a reference to the exposure model, if the DU has the expertise to use it, or to a company-specific website, or more simple instructions if only a small number of parameters are critical (eg neutralisation of product and waste-waters to pH 7 leads to non-hazardous waste).|
|For human health: see above.|