The safety data sheet (SDS) is one of the most relevant regulatory documents in the placing of chemical substances and mixtures on the European Union market. Its primary function is to ensure clear and effective communication of hazards, as well as the measures required to protect human health, workplace safety, and the environment throughout the entire supply chain.
The preparation of SDSs is regulated by Regulation (EC) No 1907/2006 (REACH), specifically Article 31 and Annex II. This annex was substantially updated by Regulation (EU) 2020/878, which introduced new technical and content requirements that must be complied with in all SDSs prepared or updated since its application date.
Understanding these requirements and applying them correctly is essential to avoid frequent deficiencies that may lead to inspection findings, regulatory non-conformities, or difficulties in the marketing of chemical products.
Regulatory Framework Applicable To Safety Data Sheets
Annex II of the REACH Regulation sets out in detail the mandatory structure, format, and content of safety data sheets. This is not a recommendation, but a legal requirement applicable to manufacturers, importers, only representatives, and, in certain cases, downstream users.
The amendment introduced by Regulation (EU) 2020/878 aims to:
- Adapt SDSs to the latest revisions of the Globally Harmonised System (GHS).
- Align their content with Regulation (EC) No 1272/2008 (CLP).
- Introduce specific requirements for nanoforms.
- Improve communication of emerging hazards, such as endocrine disruptors.
- Increase consistency between the SDS and information registered under REACH.
From a regulatory perspective, the use of SDSs that do not comply with the updated Annex II is no longer acceptable, once the transitional periods have elapsed.
The SDS As A Technical And Regulatory Document
An SDS is not an administrative document nor a mere formality. It is a technical and regulatory document that must accurately and consistently reflect all available information on a substance or mixture.
The Regulation requires that the information included be:
- Clear and understandable.
- Consistent with other regulatory documentation.
- Based on reliable and up-to-date data.
Vague or risk-minimising expressions such as “safe product” or “no adverse effects” are not acceptable unless supported by robust technical evidence.
Mandatory Structure Of The SDS
Every safety data sheet must contain 16 mandatory sections, which must always be included, even when a specific section is not applicable. In such cases, the reason must be explicitly stated.
Although the length of an SDS is not fixed, it must be proportionate to the hazardous properties of the product and the amount of information available.
Identification Of The Substance Or Mixture And Of The Supplier
Section 1 is essential for traceability and correct product identification. It must include:
- Clear identification of the substance or mixture.
- Identified uses and uses advised against.
- Full details of the supplier responsible for the SDS.
- An emergency telephone number, where applicable.
For registered substances, the information must be consistent with the REACH registration, and where required, the registration number must be included.
For hazardous mixtures, correct inclusion of the UFI is mandatory where required by the CLP Regulation.
Hazard Classification And Risk Communication
Section 2 must accurately reflect the classification according to the CLP Regulation. Where a substance or mixture is not classified as hazardous, this must be adequately justified.
In addition to formal classification, the SDS must include information on:
- Other relevant hazards not covered by CLP classification.
- PBT or vPvB properties, where applicable.
- Endocrine disrupting properties, in line with the criteria introduced by Regulation (EU) 2020/878.
Composition And Information On Ingredients
Section 3 is one of the most sensitive sections from a regulatory standpoint. For mixtures, hazardous components must be declared in accordance with the applicable thresholds, including:
- Chemical identity.
- Concentration or concentration range.
- CLP classification.
- Specific concentration limits, where applicable.
The use of alternative chemical names is only permitted when duly authorised under the applicable legislation.
Changes Introduced By Regulation (EU) 2020/878
The update of Annex II introduced substantial changes that must be considered when preparing or reviewing an SDS.
Nanoforms
Where a substance is placed on the market in nanoform, the SDS must clearly identify this form and link the safety information to the specific characteristics of the nanoform.
Endocrine Disruptors
Clearer communication of potential endocrine disrupting effects is required for both human health and the environment, where data are available.
Toxicological And Ecotoxicological Information
Sections 11 and 12 must be aligned with the information included in the REACH registration, avoiding internal inconsistencies and relevant omissions.
Physical And Chemical Properties
Greater precision is required in the description of properties, including units, test conditions, and methods used, where relevant.
Competence In SDS Preparation
The REACH Regulation explicitly states that safety data sheets must be prepared by competent persons. This implies:
- Appropriate training.
- Up-to-date knowledge of applicable legislation.
- The ability to interpret technical and toxicological data.
A poorly prepared SDS not only represents a regulatory non-compliance, but may also have direct consequences for user safety and the legal liability of the supplier.
Updating And Maintaining Safety Data Sheets
SDSs must be updated without delay when:
- New relevant information on hazards becomes available.
- Classification under CLP changes.
- Restrictions or authorisations under REACH are introduced.
- New risks to human health or the environment are identified.
Each update must be clearly indicated, specifying the revision date and the changes made, preferably in section 16.
The Importance Of A Systematic Approach
In a constantly evolving regulatory environment, preparing an SDS in accordance with REACH and Regulation (EU) 2020/878 must be understood as a continuous process, not a one-off action.
A systematic approach, based on periodic review of available information and document consistency, is essential to ensure regulatory compliance and effective communication of chemical risks.
SHAPYPRO Support In SDS Preparation And Review
The correct preparation and maintenance of safety data sheets requires not only regulatory knowledge, but also technical expertise to interpret toxicological, physico-chemical, and environmental data, as well as to ensure consistency across regulatory documentation.
In this context, SHAPYPRO supports companies and laboratories in key aspects related to SDSs, such as technical content review, verification of compliance with REACH and Regulation (EU) 2020/878 requirements, and identification of potential deficiencies from a quality and regulatory compliance perspective. This support helps strengthen document reliability and alignment with the expectations of competent authorities.
Conclusion
Preparing a safety data sheet in accordance with the REACH Regulation and the requirements introduced by Regulation (EU) 2020/878 requires a rigorous, consistent, and technically sound approach. A properly developed SDS not only ensures regulatory compliance, but also serves as an essential tool for the safe management of chemical substances and mixtures throughout the supply chain.
Correct interpretation of Annex II requirements, consistency with CLP classification and REACH registration data, and continuous updating of available information are key elements to avoid regulatory deficiencies and ensure effective hazard communication. In an evolving regulatory context, the SDS must be regarded as a living document, closely linked to the overall management of chemical safety.