SDS compliance with a clear technical and regulatory structure
The Safety Data Sheet (SDS) is one of the most relevant regulatory documents for placing chemical substances and mixtures on the European Union market. At SHAPYPRO, we support companies and laboratories in the preparation, review, and updating of SDSs according to REACH and Regulation (EU) 2020/878, with a focus on technical consistency, regulatory compliance, and clear hazard communication.
Key compliance pillars for SDS preparation
A compliant SDS must combine legal accuracy, technical reliability, and consistency with the broader regulatory framework.
REACH Annex II
The structure, format, and content of the SDS must follow the legal requirements established under Annex II of REACH.
CLP alignment
Hazard classification, labelling elements, and risk communication must remain consistent with CLP requirements.
Technical accuracy
The SDS must be based on reliable, up-to-date technical, toxicological, and environmental information.
Ongoing updates
The document must be reviewed and updated without delay when relevant new information becomes available.
The SDS as a technical and regulatory document
An SDS is not a purely administrative document. It must accurately and consistently reflect all available information on a substance or mixture. The article stresses that the information included must be clear and understandable, consistent with other regulatory documentation, and based on reliable and up-to-date data. Vague expressions that minimise risk are not acceptable unless supported by robust technical evidence.
This means that SDS preparation requires more than completing a template. It requires interpretation of regulatory obligations, review of source data, and consistency across hazard communication, composition, toxicology, ecotoxicology, and supplier information.
Why SDS quality matters
- Supports hazard communication across the supply chain
- Helps prevent regulatory deficiencies
- Improves consistency with REACH and CLP documentation
- Reduces inspection and compliance risks
Mandatory structure of the SDS
Every safety data sheet must contain 16 mandatory sections, even when one of them is not applicable. In those cases, the reason must be explicitly stated. The length of the document is not fixed, but it must remain proportionate to the hazardous properties of the product and to the information available.
- Identification of the substance or mixture and of the supplier
- Hazard classification and communication according to CLP
- Composition and information on ingredients
- Physical and chemical properties
- Toxicological and ecotoxicological information
- Labelling elements and UFI where required
- Consistent information across all mandatory sections
A well-prepared SDS must also remain coherent with the REACH registration, where applicable, and with other regulatory documentation linked to the substance or mixture.
What changed with Regulation (EU) 2020/878?
The update to Annex II introduced several changes that directly affect how an SDS should be prepared or reviewed. The article specifically highlights the need to address nanoforms, endocrine disruptors, improved consistency with REACH registration data, and greater precision in the description of physical and chemical properties.
Competence in SDS preparation
The REACH Regulation states that SDSs must be prepared by competent persons. This implies appropriate training, up-to-date knowledge of the applicable legislation, and the ability to interpret technical and toxicological data. A poorly prepared SDS may create both regulatory non-compliance and direct consequences for user safety and supplier liability.
Updating and maintaining the SDS
SDSs must be updated without delay when new hazard information becomes available, when CLP classification changes, when restrictions or authorisations under REACH are introduced, or when new risks to human health or the environment are identified. Each update should be clearly indicated, preferably in section 16.
SHAPYPRO support in SDS preparation and review
The article explains that SHAPYPRO supports companies and laboratories through technical content review, verification of compliance with REACH and Regulation (EU) 2020/878, and identification of potential deficiencies from a quality and regulatory compliance perspective.
Need support with SDS preparation or review?
If you need to prepare, review, or update a Safety Data Sheet according to REACH and Regulation (EU) 2020/878, SHAPYPRO can help strengthen both the technical quality and the regulatory reliability of the document.