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Introduction

This article is an overview on the content, use and legal context of Safety Data Sheets (SDS). Safety Data Sheets are a key element for information on chemical substances and mixtures. They are especially relevant in the context of employers´ risk assessments in the framework of occupational safety and health[1][2]. SDS are also used to convey REACH[3] information down the supply chain. For substances registered under REACH, exposure scenarios describing the conditions of safe use shall be attached to the SDS (extended SDS), in case such exposure scenarios have been elaborated in the course of a Chemical Safety Assessment (CSA). SDSs are also part of the Globally Harmonised System (GHS) for Classification and Labelling of Chemicals[4].

What is a SDS?

The Safety Data Sheet (SDS) is a comprehensive information document about a chemical substance or mixture. It is meant as an additional source of information that goes beyond information available through classification and labelling and is predominantly intended for employers. Employers use SDS as a source of information about hazards, including environmental hazards, and advice on safe use at work. In the EU, SDS as specified in Article 31 of the REACH regulation (Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH))[3] are legally required for chemical products. SDS-like information is often available even when it is not legally required.

What is the relevance of a SDS?

Safety Data Sheets are intended to enable users to take the necessary measures relating to the protection of human health and safety at the workplace and protection of the environment. They should provide information on the hazards of a substance or a mixture and on safe storage, handling and disposal. The information provided by safety data sheets should also meet the requirements set out in Council Directive 98/24/EC on chemical agents at the workplace[1]. In particular, the safety data sheet should enable employers to determine whether any hazardous chemical agents are present in the workplace, and to assess any risk to the health and safety of workers arising from their use. SDS are also used to convey REACH information down the supply chain.

However, the SDS provides only information that is available for the compiler (e.g. manufacturer). Therefore, though it is the most important starting point for risk assessment in the workplace, the SDS does not necessarily fulfil all information needs or guarantee compliance with other substance related legislation.

Addressees of SDS information

Safety Data Sheets basically address employers and the workplace and also cover effects on environment. The employer has a responsibility to evaluate the information obtained from the SDS for the chemicals that are used and provide the information to the workers in an appropriate manner. This may vary from oral communication to individual instruction and training supported by information in writing, depending on the nature and degree of the risk revealed by the assessment. Information from SDS may also be relevant for poison centres, emergency responders, occupational physicians, and professional use of biocides and medical products and for the transport of dangerous goods. However, some of these target groups may receive additional information from a variety of other sources such as the emergency response information notified to the poison centres under CLP, UN Recommendations on the Transport of Dangerous Goods [5]  or regulation (EC) 648/2004 on detergents[6] .

Safety data sheets are intended for the professional and industrial users of chemicals, not for consumers. Consumers are informed by labelling and package inserts. Although the SDS are aimed at the professional or industrial user (employer), workers and their representatives must be given access to the SDS of the products they use or may be exposed to (Article 35 REACH[3]  and Article 8 Directive 98/24/EC[1].

Legal framework and responsibility for SDS

Legal basis for SDS

The legal basis for the Safety Data Sheet (SDS) in the European Union is provided by the Art.31 of the REACH Regulation “Requirements for safety data sheet" . The content of SDS is described in REACH Annex II "Requirements for the compilation of Safety Data Sheets". The Annex II has been aligned to annex 4 of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) [7]which is the international framework for SDS. The non-binding “Guidance on the compilation of safety data sheet“ is provided by the European Chemicals Agency (ECHA), and aims to provide the industry with guidance[8].

There is also an international ISO standard (ISO 11014:2009)[9], which defines the general content and order of sections of a Safety Data Sheet (SDS) but does not define a fixed format or include a blank SDS document template.

For which products must SDS be provided?

SDS must be provided to any member of the supply chain without prior request (see Article 31(1) REACH for the following substances that are classified as hazardous according to the EU Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures, amending (CLP)[4]. Hazard classes according to CLP:

  • Hazard class 1: free
  • Hazard class 2: Physical hazards
    • 2.1 Explosives
    • 2.2 Flammable gases
    • 2.3 Flammable aerosols
    • 2.4 Oxidising gases
    • 2.5 Gases under pressure
    • 2.6 Flammable liquids
    • 2.7 Flammable solids
    • 2.8 Self-reactive substances and mixtures
    • 2.9 Pyrophoric liquids
    • 2.10 Pyrophoric solids
    • 2.11 Self-heating substances and mixtures
    • 2.12 Substances or mixtures which in contact with water emit flammable gases
    • 2.13 Oxidising liquids
    • 2.14 Oxidising solids
    • 2.15 Organic peroxides
    • 2.16 Corrosive to metals
    • 2.17 Desensitised explosives
  • Hazard class 3: Health hazards
    • 3.1 Acute toxicity
    • 3.2 Skin corrosion /irritation
    • 3.3 Serious eye damage/eye irritation
    • 3.4 Respiratory or skin sensitation
    • 3.5 Germ cell mutagenicity
    • 3.6 Carcinogenicity
    • 3.7 Reproductive toxicity
    • 3.8 Specific target organ toxicity (single exposure)
    • 3.9 Specific target organ toxicity (repeated exposure)
    • 3.10 Aspiration hazard
    • 3.11. Endocrine disruption for human health
  • Hazard class 4: Environmental hazards
    • 4.1 Hazards to the aquatic environment
    • 4.2. Endocrine disruption for the environment 
    • 4.3. Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties 
    • 4.4. Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties 
  • Hazard class 5: Additional hazards
    • 5.1 Hazardous to the ozone layer

Safety Data Sheets must be provided irrespectively of the quantity that is supplied but only if the product is supplied to a third party. Companies that produce or formulate chemicals for their own use do not need to compile SDS.

For which products are SDS not required?

SDS do not have to be provided for articles. REACH defines an article as an object which during production is given a special shape, surface or design that determines its function to a greater degree than its chemical composition. In a general sense, an article can usually be considered to be a finished product e.g. clothing, flooring, furniture, jewellery, newspapers and plastic packaging[10]. Although the SDS format may be used to convey safety information for articles, there is no legal requirement to provide safety data sheet for articles. Safety data sheets only have to be provided for pyrotechnic articles for vehicles (components of safety devices in vehicles which contain pyrotechnic substances)[11].

Safety data sheets are not required for:

  • Radioactive substances,
  • Waste,
  • Substances that are subject to customs supervision or in transit,
  • Non-isolated intermediates,
  • During carriage by rail, road, inland waterway, sea or air.

SDS are also not required for the following types of preparations in the finished state, intended for the final user and covered by specific regulation:

  • Cosmetic products,
  • Medicinal products for human or veterinary use,
  • Medical devices that are invasive or used in direct physical contact with the human body in so far as sufficient information is provided by other means,
  • Food or additives or flavouring in foodstuffs,
  • Feeding stuffs or additives in feeding stuffs,
  • Animal nutrition.

Though not being accompanied by SDS these substances and mixtures are subject to employers´ risk assessment if they are used in workplaces[1][2].

Who is entitled to receive an SDS?

Any member of the supply chain and distributors must be provided with Safety Data Sheet (SDS). Consumers are not legally entitled to require SDS.

If a product for which a SDS must be compiled is available in a retail store to consumers and to members of the supply chain, the latter are entitled to receive a SDS on request. Workers are not entitled to request SDS. However, workers and their representatives are to be granted access by their employer to the SDS related to the substances or mixtures that they use or may be exposed to in the course of their work (Article 35 of REACH and Article 8 of Directive 98/24/EC ). SDS are also available on a voluntary basis on various internet homepages. Information and data that are available in a SDS cannot be claimed as confidential.

Responsibility to compile and provide SDS

The initial responsibility for drawing up a Safety Data Sheet lies with the manufacturer, importer or with the sole representative appointed by a non-Community manufacturer.

The actors further down the supply chain also have to provide a Safety Data Sheet to customers, either by forwarding the safety data sheet received from the supplier or by compiling their own. In all cases the supplier of a substance or a mixture who provides the Safety Data Sheet is responsible for its contents, even though he/she may not have prepared the Safety Data Sheet him/herself.

Ways of providing SDS

Safety Data Sheets are to be provided free of charge on paper or electronically before or when the substance or mixture is first supplied. The supplier has to actually deliver the Safety Data Sheet, which is more than just making it available. For example sending an e-mail with a link to a general web-site where the SDS needs to be laboriously searched for and downloaded by the customer would not be sufficient. Options including a specific link leading directly to the SDS may be acceptable if this method of providing the Safety Data Sheet is voluntarily accepted by the customer.

Updates of SDS

If the Safety Data Sheet has been revised, the new version has to be provided when the substance or mixture is supplied after the revision. Revisions must be identified as such on the first page and information on the changes must be given either in section 16 or elsewhere in the SDS. Intervals for a regular revision of Safety Data Sheets are not defined in the REACH regulation.

In specific cases (see Article 31 (9) of REACH) Safety Data Sheets must be revised without delay and updated versions are required to be provided to all recipients who have received the substance or mixture within 12 months before the revision. Revision is necessary if: (a) New information, that may affect the risk management measures, or new information on hazards, has become available; (b) An authorisation has been granted or refused; (c) A restriction has been imposed.

Management and record keeping of SDS

Article 36(1) of REACH requires that "each manufacturer, importer, downstream user and distributor shall keep available all the information he requires to carry out his duties under REACH for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or mixture."

Safety Data Sheets that have been compiled and provided as well as the information gathered in order to do so should be regarded as such information. There is no specification how these requirements are to be fulfilled. Downstream users in particular who only receive SDS will mostly use them for workplace risk assessment. They may find other ways of record keeping than storing individually copies of SDS and/or outdated versions thereof.

Content of SDS

Gathering data for SDS

The safety data sheet (SDS) is not an instrument to generate information, but rather an instrument to structure and make available the relevant data and to propose appropriate safety measures for workplace and environment.

Information required in the SDS should be available because it is needed as part of other legislation (e.g. registration under REACH or classification under CLP or transport classification[5]). If data/information that is requested in the SDS is not provided the reason (not available/not relevant) must be given in the appropriate sub-section of the SDS. Testing need not be initiated in order to “fill-in empty fields" in a SDS.

If some data are not readily available to the compiler of an SDS he/she may also consult literature or publicly available databases for relevant information. These may be consulted either to seek data that is otherwise not available or to check data supplied from upstream that seems inconsistent or implausible. Relevant information may for example be found in the ECHA database on registered substances[12] . More databases are available in section 2.25 of the Guidance on Compilation of Safety Data Sheets[8]. Sources that were used for compilation of SDS should be indicated in section 16 of the SDS.

Formal requirements for SDS

The required format and content of an SDS within the EU Member States (and in other countries that have adopted the REACH Regulation) are defined in Annex II of REACH. Formal requirements are also aligned with the Global Harmonised System for Classification and Labelling (UN GHS).

SDS are to be provided free of charge on paper or electronically in the language required by the EU Member State where the product is placed on the market. An SDS contains the following 16 sections and their subsections. No subsection may be empty.

  • Section 1: Identification of the substance/mixture and of the company/undertaking
  • Section 2: Hazards identification
  • Section 3: Composition/information on ingredients
  • Section 4: First aid measures
  • Section 5: Firefighting measures
  • Section 6: Accidental release measures
  • Section 7: Handling and storage
  • Section 8: Exposure controls/personal protection
  • Section 9: Physical and chemical properties
  • Section 10: Stability and reactivity
  • Section 11: Toxicological information
  • Section 12: Ecological information
  • Section 13: Disposal considerations
  • Section 14: Transport information
  • Section 15: Regulatory information
  • Section 16: Other information

Content of SDS by sections

Section 1 – Identification of substance/mixture and of the company/undertaking

Section 1 comprises the identification of the product, contact details of the supplier and emergency contact. If the SDS refers to one or more nanoforms, or substances that include nanoforms, this must be indicated by using the word ‘nanoform’.

Section 1 also includes the relevant identified uses of the substance or mixture and uses advised against. This is a brief description of the identified uses with a generic list of applications and, in case of an eSDS (see below) a reference to the exposure scenarios. The information on the ‘uses advised against’ must also include the reason why.

Section 2 – Hazards identification

Section 2 conveys the classification of the substance or mixture i.e. based on the CLP-classification. Classification is a most important starting point for risk assessment, especially if control banding approaches[13]  are followed for risk management. An example of a control banding approach is COSHH Essentials, developed by the HSE (Health and Safety Executive, UK)[14].

Subsection 2.2 provides the labelling of the product in accordance with CLP. These label elements include[8]:

- Hazard pictogram(s)
- Signal word (danger or warning);
- Hazard statement(s), H and EUH
- Precautionary statement(s), P
- Any additional applicable label elements

Subsection 2.3 must information whether a substance meets the criteria for PBT or vPvB in accordance with REACH Annex XIII and, more importantly for OSH, on other hazards that do not result in classification but nevertheless require risk assessment. Such hazards are for example formation of air contaminants during hardening or processing, dustiness, dust explosion hazards, cross-sensitisation, suffocation, freezing, high potency for odour or taste, or environmental effects such as hazards to soil-dwelling organisms or photochemical ozone creation potential.

Section 3 – Composition/information on ingredients

Section 3 gives information on composition/information on ingredients. For a substance the identity of impurities is to be provided. For mixtures those ingredients that are hazardous for health or environment are indicated with their name, identification number, registration number (abbreviated), classification and concentration range. Cut-off limits in section 3 are lower than those for classification, mostly 1% or 0.1%. Information on ingredients can be very informative for identifying those components that determine the risk or to check the plausibility of the classification of a mixture.

Section 4 – First aid measures

Section 4 on first aid measures should describe initial care in such a way that it can be understood and given by an untrained responder. Most important symptoms and effects should be indicated. Particular notes for the physician may be added. Special attention should be given to special installations that might be required for first aid (e.g. emergency showers, eye-wash bottle). The first aid measures have to be organised by relevant routes of exposure (inhalation, skin contact, eye contact, ingestion. Information on how the first responder can protect him or herself should also be indicated.  

Section 5 – Firefighting measures

Section 5 “Firefighting measures" should describe the requirements for fighting a fire caused by the substance or mixture, or arising in its vicinity. It warns against specific hazards (e.g. decomposition products, explosion) from the substance and gives advice to fire fighters. Employers must ensure that suitable extinguishing media are available and unsuitable extinguishing media are removed from the workplace. 

Section 6 – Accidental release measures

Section 6 gives advice on how to prevent adverse effects from spills, leaks, or releases on persons, property and the environment. It should distinguish between responses to large and small spills if different equipment or procedures are required. Reference should be made to section 13 “Disposal considerations" if necessary.

Section 7 – Handling and storage

Section 7 provides information on provide advice on safe handling practices[8]:
- containment and measures to prevent fire as well as aerosol and dust generation;
- prevent handling of incompatible substances or mixtures;
- draw attention to operations and conditions which create new risks by altering the properties of the substance or mixture, and to appropriate countermeasures; and
- reduce the release of the substance or mixture to the environment, such as avoiding spills or keeping away from drains.

The section also provides information on conditions for safe storage[8]:
- specific design for storage rooms or vessels (e.g. retention walls, ventilation);
- incompatible materials;
- conditions of storage (humidity limit/range, light, inert gas, etc.);
- special electrical equipment and prevention of static electricity.

Also advice, if relevant, on quantity limits under storage conditions should be included.

This information helps the employer in elaborating suitable working procedures and organisational measures according the Chemical agents Directive[1] and the CMR Directive[2]. Sufficient detail and targeted information is essential for workplace risk assessment and the selection of appropriate prevention measures.

Section 7 should also include advice on general occupational hygiene for example how to deal with contaminated personal protection devices and clothing.

If available, additional reference should be made to industrial sector specific solutions (approved codes of practice, factsheets and brochures from sectoral social partners, labour inspection guidance, etc.) 

Section 8 – Exposure controls/personal protection

Section 8 describes the applicable occupational exposure limits and necessary risk management measures. The section conveys parameters to verify whether measures for prevention and control provided in section 7 have been successfully applied. Such control parameters are national occupational exposure limit values OELs and national biological limit values for the substance or the relevant ingredients of a mixture and also for air contaminants that are foreseeably formed during use. The information must also include  recommended monitoring procedures. Such monitoring methods can be personal air monitoring, room air monitoring, biological monitoring etc according to agreed standards.

Where a chemical safety report is required, those DNELs and PNECs relevant for exposure scenarios in the annex to the SDS must be given. DNEL and PNEC (Derived No Effect Level and Predicted No Effect Concentration) are reference values for harmful toxicological and environmental effects derived from REACH registration.

REACH also requires “Appropriate engineering controls" to be indicated in subsection 8.2 1. Special reference is made to the specific conditions that have to be communicated if a substance has been registered as an isolated intermediate or if the registrant has made use of “exposure based waiving" of tests in the registration under REACH. Reference is also made to control banding approaches that may be used to assign appropriate measures based on classification if OEL are not available.

The wording of the legislation states that “This information on engineering control shall complement that already given under Section 7". Therefore, technical measures to control exposure will mostly be found in section 7 while section 8 will provide instead detailed specifications (including appropriate CEN standards) on personal protection equipment. If personal protection equipment (PPE) is specified in section 8 this does not insinuate, that PPE is a preferred risk management measure. Technical and organisational control measures proposed in the SDS shall be designed in a way that PPE, especially respiratory protection, is not necessary for routine operations. In case specific tasks still require PPE, these tasks should be clearly addressed and distinguished from other tasks.

Sections 9 to 12 – data on properties

Sections 9 to 12 provide data on chemical, physical and toxicological and ecotoxicological properties. Information on physical and chemical properties in section 9 (pH, explosion limits, boiling/freezing point, dustiness, combustible dusts) may be of immediate relevance for risk assessment. However most of the other data are not immediately relevant for employers but are of value for experts who want to check the plausibility of classification and measures. Section 10 should give data or qualitative description of stability and reactivity. Information expected in this section might also be placed in sections 2, 5, 6, 7 or 9, so referencing or cross-checking is recommended.

Sections 13 to 16 – other relevant information

Section 13 covers disposal considerations and precautions for the safe handling of waste, especially calling attention to wastes that are more hazardous than the initial product.

Transport information in section 14 is relevant, if the product is to be returned to sender of be transported further down the supply chain.

Section 15 should inform about the most relevant EU- and national regulations applicable to the product amongst which references to authorisations and/or restrictions on use are most important. Specific national legislation, especially national provisions on occupational safety and health including European and national legislation protecting vulnerable groups, e.g. young workers and pregnant and breastfeeding women should be provided, if relevant.

Section 16 may contain any other information the supplier wants to provide. It should include indication of changes made to the previous version of the safety data sheet, a legend for abbreviations and acronyms, literature references and sources for data.

Extended SDS (eSDS)

Legal basis for eSDS

In the EU, Safety Data Sheets are also used to transmit information generated during the registration of substances under the REACH Regulation. A large part of the information is integrated in the different sections of the SDS, e.g. identified uses and uses advised against by the registrant, registration numbers, data on toxicological, ecotoxicological and physical properties resulting from tests for registration. However this information included in the body of the SDS does not yet result in what is called an “extended SDS". The term “extended SDS" or “eSDS" refers to a safety data sheet that has one or more exposure scenarios annexed to its body (REACH, Art.31(7)).

Exposure scenarios are the outcome of a chemical safety assessment (CSA) that is required under REACH. Exposure scenarios provide information on the operational conditions and risk management measures that are required for safe use of the substance or mixture. A CSA must be performed for any substance that is produced or imported in quantities bigger than 10 tons/year per producer/importer. If such substance is classified as hazardous or is assessed as being a PBT or vPvB substance the registrant has to establish and document the conditions for safe use in exposure scenarios and place these (as a minimum those relevant for the recipient of the substance) in an annex to the SDS (REACH Art. 31(7). Such SDS are termed “extended SDS".

What type of information is to be expected in an Exposure Scenario

There will in general be several exposure scenarios (ES) each with a “free text" title, such as" use in paints and coatings" or “use in cleaning products". For each ES there will be “contributing scenarios" describing conditions of safe use for the environment, workers and consumers (where applicable).

The worker exposure section should incorporate product characteristics (such as concentration of substance in mixture, viscosity, form [powder/-granular/pellet], general ventilation conditions, processes and working technologies, including provisions to control the release of the substance into the working environment (such as containment or application techniques). If required for safe use, risk management measures should also be indicated such as local exhaust ventilation (LEV) and personal protective equipment (PPE) and possibly organisational measures, such as training, supervision and maintenance. Practical examples of exposure scenarios are available at the ECHA homepage[15].

Safe conditions of use by consumers are described in the consumer section. These are determined by product characteristics (such as identified uses / product types, concentration in product, package design) and plausible assumptions on the operational conditions. These include aspects such as indoor / outdoor use, method of application and application form (spray, liquid, powder) amount, frequency and duration of application (for each event, number of events per day, duration per event). Specific PPE or hygiene instructions may be added in recommended “instructions for use".

The environmental section will for example specify safe daily and annual amounts of release, environmental risk management measures (RMM) such as waste water treatment processes, filters, air abatement systems, including their effectiveness.

The ES should also inform about the risk coefficient resulting from the exposures that are predicted under the conditions described in the ES and the assessment values for “safety" applied in REACH (DNEL and PNEC). It should also describe how some conditions may be modified or adapted to on-site or practical requirements.

For which products must eSDS be provided?

Extended SDS must only be provided for a substance, but not for a mixture or an article. The substance must be registered (see registration number) and produced or imported in quantities in excess of 10 tons/year per producer/importer and be classified as hazardous (humans, environment) or be a PBT or vPvB substance.

Exposure scenarios must be attached for those uses that are nominated under “identified uses" in section 1 of the SDS. As the number of exposure scenarios may be very high, the supplier may choose to attach only those ES that are relevant for the specific branch or field of application he supplies. Practical examples of exposure scenarios are available at the ECHA homepage. If a downstream user of a substance was legally obliged or has chosen to perform a CSA of his own for a specific use and if he is required to provide an SDS to his customers he shall attach a resulting exposure scenario to the SDS of the substance and also to the mixture containing that substance.

For which products are eSDS not required?

Extended SDS do not have to be provided for mixtures. For substances that do not need to be registered (substances used only in plant protection products and active substances in biocidal products) or which are produced or imported in quantities lower than 10 tons/year and per producer/importer there is no obligation to draw up exposure scenarios nor to provide extended SDS. Irrespectively of the tonnage that is registered any substance that is not classified as hazardous and is not assessed as a PBT or vPvB will not need an eSDS.

Addressees and relevance of eSDS information

Downstream users in their role as employers as well as in their role as members of the supply chain have to comply with the conditions described in the exposure scenario. If they do not comply they shall in a first step contact the supplier of the substance for clarification. Additional legal obligations such as a downstream user report or even a downstream user chemical safety assessment might arise for them in the context of REACH (see Art. 37 and 38)[16] .

Exposure scenarios describe the conditions under which substances that are hazardous for humans or environment can be used safely. Exposure scenarios cover parameters such as nature of the process, operational conditions, safe quantities of the substance, frequency and duration of use, technical and personal risk reduction measures. They are derived for specific processes in the workplace, for consumer uses and for the release of the substance into the environment during its lifecycle[15].

Formulators of consumer products shall take into account the exposure scenarios they have received for consumers and environment when deciding on composition, type of application, packaging and advice on use for consumer products.

Employers who handle substances must assess whether the conditions in the exposure scenario are compatible with the conditions in the workplace[16]. Normally they will already operate in accordance with workplace and environmental legislation. They will be used to identifying, assessing and controlling exposure and emissions and may hold permits or licences issued by competent authorities. Therefore, in most cases, they should also comply with the conditions required in the exposure scenario they receive. The entry into force of REACH does not affect existing legislation, which remains applicable. From the angle of workplace legislation and occupational safety and health it might not be sufficient to comply with REACH exposure scenarios. Employers always have to take into account the specific conditions of the workplace (use of other substances and mixtures, temperature and ambient conditions, ignition sources and machinery, vulnerable groups (young workers, pregnant and breastfeeding women), increased uptake of a substance through the skin or under high physical strain). In addition, they may be confronted with several chemical agents in a workplace and will have to balance the information to set the right measures.

With regard to workplace exposure, the Advisory Committee on Safety and Health at Work (ACSHW) issued a guidance document in 2009[17] , that provides an overview of the interface between the Chemical Agents Directive 98/24/EC (CAD) and REACH. It demonstrates that one process of assessing risks can often meet the relevant requirements of both REACH and CAD. However, in most cases employers will use mixtures and not substances, so they will mostly not receive eSDS with exposure scenarios but “normal" SDS.

An ECHA-based Exchange Network on Exposure Scenarios (ENES) aims to identify good practices on preparing and implementing exposure scenarios, and to develop an effective communication exchange between supply chain actors[18] .

Relation of eSDS for substances and SDS for mixtures

Formulators use substances to produce mixtures that they deliver to their customers. For each substance that they use as an ingredient of the mixture they have to take into account the exposure scenarios they have received. For example: if a formulator of a paint wants to propose natural ventilation as a safe condition of use in section 7 “Handling and storage" of the SDS, he has to make sure that this matches the measures in the relevant exposure scenarios that he has received for each ingredient. Formulators need not attach the exposure scenarios from the ingredients to the SDS of the mixtures. They are also not obliged to generate an “exposure scenario" or an extended SDS for the mixture. However, when they prepare the SDS for a mixture, they are obliged to include, i.e. consider and take into account, the relevant exposure scenarios and other relevant information from the SDS supplied to them.

Références

[1] Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work. Available at: https://osha.europa.eu/en/legislation/directives/75 

[2] Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work. Available at: https://osha.europa.eu/en/legislation/directive/directive-200437ec-carcinogens-or-mutagens-work 

[3] Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Available at: https://osha.europa.eu/en/legislation/directives/regulation-ec-no-1907-2006-of-the-european-parliament-and-of-the-council 

[4] Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures, amending (CLP). Available at: https://osha.europa.eu/en/legislation/directives/regulation-ec-no-1272-2008-classification-labelling-and-packaging-of-substances-and-mixtures

[5] UN Recommendations on the Transport of Dangerous Goods. Available at: https://unece.org/rev-21-2019 

[6] Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents. Available at: http://data.europa.eu/eli/reg/2004/648/oj 

[7] UNECE - United Nations Economic Commission for Europe. Globally Harmonized System of Classification and Labelling of Chemicals (GHS, Rev. 10, 2023). Available at: https://unece.org/info/Transport/Dangerous-Goods/pub/381478 

[8] ECHA – European Chemicals Agency, Guidance on the compilation of safety data sheet, Version 4.0., December 2020. Available at: https://echa.europa.eu/documents/10162/2324906/sds_en.pdf/01c29e23-2cbe-49c0-aca7-72f22e101e20 

[9] ISO – International Organisation for Standardization, ISO 11014:2009 Safety data sheet for chemical, Content and order of sections, 2009.

[10] ECHA – European Chemicals Agency. Candidate List substances in articles. Available at: https://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles 

[11] Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles. Available at: http://data.europa.eu/eli/dir/2013/29/oj 

[12] ECHA – European Chemicals Agency. Database on registered substances. Available at: http://echa.europa.eu/de/information-on-chemicals/registered-substances 

[13] Zalk, D. M., West, E., & Nelson, D. I. Control banding: background, evolution, and application. Patty's Industrial Hygiene, 2021, 1-37.

[14] ECHA – European Chemicals Agency. How to undertake a qualitative human health assessment and document it in a chemical safety report Available at: https://echa.europa.eu/documents/10162/17250/pg_15_qualitative-human_health_assessment_documenting_en.pdf 

[15] ECHA - European Chemicals Agency. Practical examples of exposure scenarios. Available at: https://echa.europa.eu/support/practical-examples-of-exposure-scenarios 

[16] ECHA – European Chemicals Agency, How downstream users can handle exposure scenario. Practical guide 13, 2016. Available at: https://echa.europa.eu/documents/10162/17250/du_practical_guide_13_en.pdf 

[17] EC – European Commission DG Employment, Social Affairs and Equal Opportunities, Guidance for employers on controlling risks from chemicals - Interface between Chemicals Agents Directive and REACH at the workplace, Social Europe, 2010. Available at: https://osha.europa.eu/en/legislation/guidelines/guidance-employers-controlling-risks-chemicals-interface-between-chemicals-agents-directive-and-reach-workplace 

[18] ECHA – European Chemicals Agency. Exchange Network on Exposure Scenarios (ENES). Available at: https://echa.europa.eu/about-us/exchange-network-on-exposure-scenarios 

Lectures complémentaires

EU-OSHA – European Agency for Safety and Health at Work, Practical tools and guidance on dangerous substances. Available at: https://osha.europa.eu/en/themes/dangerous-substances/practical-tools-dangerous-substances

EU-OSHA – European Agency for Safety and Health at Work, Info sheet: Legislative framework on dangerous substances in workplaces, 2018. Available at: https://osha.europa.eu/en/publications/info-sheet-legislative-framework-dangerous-substances-workplaces 

EU-OSHA – European Agency for Safety and Health at Work, Info sheet: Substitution of dangerous substances in the workplace, 2018. Available at: https://osha.europa.eu/en/publications/info-sheet-substitution-dangerous-substances-workplace 

EU Commission. How REACH works. Available at: https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/how-reach-works_en 

ECHA, European Chemicals Agency https://echa.europa.eu 

Contributeur

Eva Lechtenberg-Auffahrt

German Federal Institute for Occupational Safety and Health (BAUA)

Karla Van den Broek

Prevent, Belgium