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Regulatory context for Safety Data Sheets (SDS)
Safety Data Sheets (SDSs) are a key tool for communicating information on the safe use of hazardous substances and mixtures throughout the supply chain.
In the European Union, the requirements for compiling an SDS are set out in Annex II to Regulation (EC) No 1907/2006 (REACH).
The latest major revision of Annex II was introduced by Commission Regulation (EU) 2020/878, which replaced the previous requirements established by Regulation (EU) 2015/830. The new requirements have applied since 1 January 2021, with a transitional period allowing SDSs prepared under the previous requirements to continue to be supplied until 31 December 2022. Since 1 January 2023, SDSs supplied on the EU market must comply with the requirements of Regulation (EU) 2020/878.
However, SDS compliance is not a one-off exercise. Under Article 31(9) of REACH, suppliers must update SDSs without delay when, for example, new information becomes available concerning hazards or the need for more stringent risk management measures, or when an authorisation has been granted or refused or a restriction has been imposed. ECHA
This means that companies should maintain a continuous SDS review process rather than simply updating their documents once.
What changed with Regulation (EU) 2020/878?
Regulation (EU) 2020/878 introduced a number of additional information requirements and brought Annex II of REACH into line with the 6th and 7th revisions of the UN Globally Harmonised System (GHS). It also introduced specific requirements concerning nanoforms and endocrine-disrupting properties.
Among other requirements, SDSs must address:
- Nanoforms: where relevant, the SDS must indicate which nanoforms are covered and link the relevant safety information to those nanoforms.
- Endocrine-disrupting properties: information on endocrine-disrupting properties must be communicated where applicable.
- Unique Formula Identifier (UFI): where applicable, the UFI must be included in the SDS in accordance with the CLP Regulation and the requirements for hazardous mixtures.
- Specific concentration limits, M-factors and acute toxicity estimates (ATEs): these values may be relevant for the classification of substances and mixtures and must be reflected where applicable.
- Updated physical and chemical information: additional information may be required in Section 9.
- Updated transport information: Section 14 contains additional requirements intended to improve the consistency of transport-related information.
- Updated regulatory information: Section 15 must contain relevant information concerning applicable EU chemical legislation.
The regulation therefore affects a number of sections and subsections of the SDS, rather than introducing an entirely new 16-section structure.
Which SDS sections are affected?
The requirements introduced by Regulation (EU) 2020/878 have implications for several parts of the SDS, including:
Section 1 – Identification of the substance/mixture and of the company/undertaking
Additional information may be required, including relevant identifiers and, where applicable, the Unique Formula Identifier (UFI).
Section 2 – Hazards identification
The hazard classification and other relevant hazard information must be consistent with the applicable version of the CLP Regulation.
Information concerning endocrine-disrupting properties may also need to be communicated where relevant.
Section 3 – Composition/information on ingredients
The composition information must reflect the applicable classification and identification requirements and, where relevant, information concerning nanoforms and other properties affecting the hazard assessment.
Section 9 – Physical and chemical properties
This section contains additional information requirements introduced to improve the description of the physical and chemical properties of substances and mixtures.
Section 10 – Stability and reactivity
Additional information may be required concerning hazardous reactions, conditions to avoid and incompatible materials.
Section 11 – Toxicological information
The section must provide relevant information supporting the hazard classification and assessment, including applicable information concerning acute toxicity.
Section 12 – Ecological information
Additional information may be relevant to environmental hazards, including information concerning persistence, bioaccumulation and other properties where applicable.
Section 14 – Transport information
The requirements for transport information have been expanded and clarified to improve the quality and consistency of transport classifications.
Section 15 – Regulatory information
This section must reflect relevant regulatory information applicable to the substance or mixture, including information on authorisations, restrictions and other applicable EU chemical legislation.
New CLP hazard classes: another important SDS update
The regulatory landscape has continued to evolve since Regulation (EU) 2020/878 entered into application.
In 2023, Commission Delegated Regulation (EU) 2023/707 introduced new hazard classes under the CLP Regulation for:
- endocrine disruption for human health;
- endocrine disruption for the environment;
- persistent, bioaccumulative and toxic (PBT) and very persistent, very bioaccumulative (vPvB) properties;
- persistent, mobile and toxic (PMT) and very persistent, very mobile (vPvM) properties.
The transitional provisions are particularly important for companies placing mixtures on the EU market.
For substances, the new classification requirements generally applied from 1 May 2025, with transitional provisions for substances already placed on the market before that date.
For mixtures, the new hazard classes generally apply from 1 May 2026. Mixtures placed on the market before 1 May 2026 benefit from transitional provisions until 1 May 2028.
Consequently, companies supplying mixtures in the EU should now ensure that their classification, labelling and SDSs have been reviewed against these new hazard classes where relevant.
Why should companies review their existing SDSs?
An SDS should not be treated as a static document.
Changes in the classification of a substance or mixture, new hazard information, changes to the Candidate List, new restrictions or authorisations, updated composition information, or new regulatory requirements can all trigger the need to review and potentially update an SDS.
ECHA's enforcement activities have also demonstrated the importance of SDS quality. A major enforcement project conducted across the EEA in 2023 examined SDS compliance and identified shortcomings in both the implementation of the updated requirements and the correctness of information provided in SDSs. ECHA
For manufacturers, importers, distributors and downstream users, maintaining accurate and up-to-date SDSs is therefore an ongoing regulatory responsibility.
How can you ensure that your SDSs remain compliant?
A comprehensive SDS compliance review should typically include:
- verification of the applicable REACH requirements;
- verification of the classification under the latest applicable CLP requirements;
- review of substance identifiers and composition information;
- verification of nanoform information, where applicable;
- assessment of endocrine-disrupting properties, where relevant;
- verification of PBT, vPvB, PMT and vPvM information, where applicable;
- review of specific concentration limits, M-factors and acute toxicity estimates;
- verification of UFI information for applicable hazardous mixtures;
- review of Sections 9, 10, 11, 12 and 14;
- review of regulatory information in Section 15;
- verification of consistency between the SDS, classification and labelling, registration information and, where applicable, exposure scenarios;
- monitoring of regulatory changes that may trigger future SDS updates.
Where an exposure scenario is required, the information in the SDS should also be consistent with the relevant registration and Chemical Safety Report, and the applicable exposure scenarios should be communicated with the SDS.
How can EcoMundo help you draft and update your SDSs?
EcoMundo supports companies in the drafting and review of Safety Data Sheets for the European market.
Our SDS services can help you:
- assess your existing SDS portfolio against the latest REACH and CLP requirements;
- update SDSs according to Annex II of REACH;
- integrate the latest CLP classification requirements;
- assess the impact of the new hazard classes introduced by Regulation (EU) 2023/707;
- manage UFI and other relevant information;
- prepare SDSs in the required European languages;
- ensure consistency between SDSs, product classifications and regulatory data;
- maintain your SDS portfolio as regulatory requirements evolve.
With the regulatory requirements continuing to evolve, reviewing your SDS portfolio now can help ensure that your products remain compliant with the latest EU chemical legislation and that accurate safety information is communicated throughout your supply chain.
Want to know more about SDSs?
For more information, don't hesitate to contact one of our experts below: Contact us!
Regulatory context for Safety Data Sheets (SDS)
Safety Data Sheets (SDSs) are a key tool for communicating information on the safe use of hazardous substances and mixtures throughout the supply chain.
In the European Union, the requirements for compiling an SDS are set out in Annex II to Regulation (EC) No 1907/2006 (REACH).
The latest major revision of Annex II was introduced by Commission Regulation (EU) 2020/878, which replaced the previous requirements established by Regulation (EU) 2015/830. The new requirements have applied since 1 January 2021, with a transitional period allowing SDSs prepared under the previous requirements to continue to be supplied until 31 December 2022. Since 1 January 2023, SDSs supplied on the EU market must comply with the requirements of Regulation (EU) 2020/878.
However, SDS compliance is not a one-off exercise. Under Article 31(9) of REACH, suppliers must update SDSs without delay when, for example, new information becomes available concerning hazards or the need for more stringent risk management measures, or when an authorisation has been granted or refused or a restriction has been imposed. ECHA
This means that companies should maintain a continuous SDS review process rather than simply updating their documents once.
What changed with Regulation (EU) 2020/878?
Regulation (EU) 2020/878 introduced a number of additional information requirements and brought Annex II of REACH into line with the 6th and 7th revisions of the UN Globally Harmonised System (GHS). It also introduced specific requirements concerning nanoforms and endocrine-disrupting properties.
Among other requirements, SDSs must address:
- Nanoforms: where relevant, the SDS must indicate which nanoforms are covered and link the relevant safety information to those nanoforms.
- Endocrine-disrupting properties: information on endocrine-disrupting properties must be communicated where applicable.
- Unique Formula Identifier (UFI): where applicable, the UFI must be included in the SDS in accordance with the CLP Regulation and the requirements for hazardous mixtures.
- Specific concentration limits, M-factors and acute toxicity estimates (ATEs): these values may be relevant for the classification of substances and mixtures and must be reflected where applicable.
- Updated physical and chemical information: additional information may be required in Section 9.
- Updated transport information: Section 14 contains additional requirements intended to improve the consistency of transport-related information.
- Updated regulatory information: Section 15 must contain relevant information concerning applicable EU chemical legislation.
The regulation therefore affects a number of sections and subsections of the SDS, rather than introducing an entirely new 16-section structure.
Which SDS sections are affected?
The requirements introduced by Regulation (EU) 2020/878 have implications for several parts of the SDS, including:
Section 1 – Identification of the substance/mixture and of the company/undertaking
Additional information may be required, including relevant identifiers and, where applicable, the Unique Formula Identifier (UFI).
Section 2 – Hazards identification
The hazard classification and other relevant hazard information must be consistent with the applicable version of the CLP Regulation.
Information concerning endocrine-disrupting properties may also need to be communicated where relevant.
Section 3 – Composition/information on ingredients
The composition information must reflect the applicable classification and identification requirements and, where relevant, information concerning nanoforms and other properties affecting the hazard assessment.
Section 9 – Physical and chemical properties
This section contains additional information requirements introduced to improve the description of the physical and chemical properties of substances and mixtures.
Section 10 – Stability and reactivity
Additional information may be required concerning hazardous reactions, conditions to avoid and incompatible materials.
Section 11 – Toxicological information
The section must provide relevant information supporting the hazard classification and assessment, including applicable information concerning acute toxicity.
Section 12 – Ecological information
Additional information may be relevant to environmental hazards, including information concerning persistence, bioaccumulation and other properties where applicable.
Section 14 – Transport information
The requirements for transport information have been expanded and clarified to improve the quality and consistency of transport classifications.
Section 15 – Regulatory information
This section must reflect relevant regulatory information applicable to the substance or mixture, including information on authorisations, restrictions and other applicable EU chemical legislation.
New CLP hazard classes: another important SDS update
The regulatory landscape has continued to evolve since Regulation (EU) 2020/878 entered into application.
In 2023, Commission Delegated Regulation (EU) 2023/707 introduced new hazard classes under the CLP Regulation for:
- endocrine disruption for human health;
- endocrine disruption for the environment;
- persistent, bioaccumulative and toxic (PBT) and very persistent, very bioaccumulative (vPvB) properties;
- persistent, mobile and toxic (PMT) and very persistent, very mobile (vPvM) properties.
The transitional provisions are particularly important for companies placing mixtures on the EU market.
For substances, the new classification requirements generally applied from 1 May 2025, with transitional provisions for substances already placed on the market before that date.
For mixtures, the new hazard classes generally apply from 1 May 2026. Mixtures placed on the market before 1 May 2026 benefit from transitional provisions until 1 May 2028.
Consequently, companies supplying mixtures in the EU should now ensure that their classification, labelling and SDSs have been reviewed against these new hazard classes where relevant.
Why should companies review their existing SDSs?
An SDS should not be treated as a static document.
Changes in the classification of a substance or mixture, new hazard information, changes to the Candidate List, new restrictions or authorisations, updated composition information, or new regulatory requirements can all trigger the need to review and potentially update an SDS.
ECHA's enforcement activities have also demonstrated the importance of SDS quality. A major enforcement project conducted across the EEA in 2023 examined SDS compliance and identified shortcomings in both the implementation of the updated requirements and the correctness of information provided in SDSs. ECHA
For manufacturers, importers, distributors and downstream users, maintaining accurate and up-to-date SDSs is therefore an ongoing regulatory responsibility.
How can you ensure that your SDSs remain compliant?
A comprehensive SDS compliance review should typically include:
- verification of the applicable REACH requirements;
- verification of the classification under the latest applicable CLP requirements;
- review of substance identifiers and composition information;
- verification of nanoform information, where applicable;
- assessment of endocrine-disrupting properties, where relevant;
- verification of PBT, vPvB, PMT and vPvM information, where applicable;
- review of specific concentration limits, M-factors and acute toxicity estimates;
- verification of UFI information for applicable hazardous mixtures;
- review of Sections 9, 10, 11, 12 and 14;
- review of regulatory information in Section 15;
- verification of consistency between the SDS, classification and labelling, registration information and, where applicable, exposure scenarios;
- monitoring of regulatory changes that may trigger future SDS updates.
Where an exposure scenario is required, the information in the SDS should also be consistent with the relevant registration and Chemical Safety Report, and the applicable exposure scenarios should be communicated with the SDS.
How can EcoMundo help you draft and update your SDSs?
EcoMundo supports companies in the drafting and review of Safety Data Sheets for the European market.
Our SDS services can help you:
- assess your existing SDS portfolio against the latest REACH and CLP requirements;
- update SDSs according to Annex II of REACH;
- integrate the latest CLP classification requirements;
- assess the impact of the new hazard classes introduced by Regulation (EU) 2023/707;
- manage UFI and other relevant information;
- prepare SDSs in the required European languages;
- ensure consistency between SDSs, product classifications and regulatory data;
- maintain your SDS portfolio as regulatory requirements evolve.
With the regulatory requirements continuing to evolve, reviewing your SDS portfolio now can help ensure that your products remain compliant with the latest EU chemical legislation and that accurate safety information is communicated throughout your supply chain.
Want to know more about SDSs?
For more information, don't hesitate to contact one of our experts below: Contact us!
