Safety Data Sheet Preparation and Review under REACH
SHAPYPRO supports companies in preparing, reviewing and updating Safety Data Sheets for substances and mixtures placed on the European Union market.
The service integrates REACH requirements, CLP classification and labelling, toxicological and ecotoxicological information, physicochemical properties, transport, exposure and risk-management measures to produce clear and consistent documents adapted to the product.
- REACH · Annex II
- CLP
- Regulation (EU) 2020/878
- Hazard communication
When a Safety Data Sheet Is Required
The Safety Data Sheet is the main instrument for communicating hazards and safe-use measures between suppliers, distributors, professional users and other actors in the supply chain.
The duty to provide an SDS depends on product classification, composition, recipient and other REACH conditions. Each substance or mixture should therefore be assessed before deciding whether the sheet is mandatory, available on request or replaced by other safe-use information.
Hazardous Substances or Mixtures
An SDS must be supplied to professional recipients where the substance or mixture meets the criteria for classification as hazardous under CLP.
PBT, vPvB or Candidate List Substances
It is also required for substances that are persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, or included in the Candidate List of substances of very high concern.
Non-Hazardous Mixtures Containing Relevant Components
Certain mixtures not classified as hazardous may require an SDS on request when specified concentration thresholds are exceeded.
Products Supplied to the General Public
The sheet does not always have to be supplied automatically to consumers, although it may be required when requested by a downstream user or distributor.
Safe-Use Information without an SDS
Where REACH does not require a sheet, the supplier may still have communication duties to enable appropriate risk management.
SDS Preparation, Review and Update Services
The service is adapted to the product, the available documentation and the company’s role in the supply chain.
SHAPYPRO can prepare a new sheet, review an existing document, adapt an SDS from another market or update it when classification, composition, uses or regulatory requirements change.
New SDS Preparation
Preparation based on composition, specifications, analytical data, supplier information and the intended uses and markets.
Technical and Regulatory Review
Assessment of all 16 sections to identify omissions, inconsistencies, outdated data or unsupported statements.
Classification of Substances and Mixtures
Review of CLP classification using available data, harmonised classifications, concentration limits and mixture rules.
Adaptation to the European Union Market
Conversion and review of documents from other regulatory systems to comply with REACH, CLP and the European format.
Translation and Language Review
Preparation or control of language versions while maintaining chemical terminology, classification and safety measures consistently.
Updates and Version Control
Review following changes to formula, supplier, classification, uses, restrictions, authorisations or hazard information.
Consistency with Labels and Related Documentation
Alignment between the SDS, CLP label, technical data sheet, transport information, poison-centre notification and other documents.
Extended SDSs and Exposure Scenarios
Review and integration of exposure scenarios or safe-use information where applicable to the substance or mixture.
REACH and CLP Compliance Pillars
A compliant SDS is not produced by simply completing a template. It requires interpretation of technical data and legal duties, justification of classification and consistency across all sections.
REACH Annex II
The structure, order, content and drafting criteria must comply with the requirements established for Safety Data Sheets.
CLP Classification and Labelling
Sections 2, 3 and 15, together with the rest of the document, must be consistent with the applicable classification, pictograms, signal words and hazard statements.
Reliable Technical Data
Information should come from identifiable and appropriate sources such as REACH dossiers, suppliers, studies, regulatory databases, literature and product documentation.
Real Product and Composition
The sheet must represent the substance or mixture placed on the market, including concentrations, impurities, properties and conditions of use.
Clear Risk Communication
Prevention, first aid, protection, storage, transport and disposal measures must be understandable and proportionate to the identified hazards.
Competent Person
Preparation and review should be performed by professionals with sufficient training and experience to interpret the data and applicable legislation.
The 16 Mandatory SDS Sections
A Safety Data Sheet must retain the structure of 16 sections and the required subsections. Where specific information is not applicable, the relevant section should remain and the absence of data should be appropriately explained.
Consistency between sections is as important as the information itself. Classification in Section 2 should not conflict with composition, properties, toxicology or risk-management measures elsewhere in the sheet.
Identification
Product identifier, identified and advised-against uses, supplier details, emergency contact and UFI where applicable.
Hazard Identification
CLP classification, label elements, other hazards and relevant properties such as PBT, vPvB or endocrine disruption where applicable.
Composition and Information on Ingredients
Substance identities, concentrations or ranges, component classifications and information needed to interpret hazards.
First-Aid Measures
Measures by exposure route, key symptoms and effects, immediate medical attention and special treatment.
Firefighting Measures
Extinguishing media, specific hazards and recommendations for firefighters.
Accidental Release Measures
Personal precautions, environmental protection, containment, cleaning and references to other sections.
Handling and Storage
Safe-use conditions, incompatibilities, storage requirements and specific end uses.
Exposure Controls and Personal Protection
Exposure limits, DNELs, PNECs, engineering controls, protective equipment and environmental measures.
Physical and Chemical Properties
Relevant information on state, colour, odour, pH, flammability, solubility, viscosity and other properties, including conditions and methods where relevant.
Stability and Reactivity
Reactivity, chemical stability, hazardous reactions, conditions and materials to avoid and decomposition products.
Toxicological Information
Health hazard classes, likely routes of exposure, symptoms, immediate or delayed effects and other relevant information.
Ecological Information
Ecotoxicity, persistence, degradability, bioaccumulation, mobility, PBT or vPvB assessment, endocrine-disrupting properties and other effects.
Disposal Considerations
Waste-treatment methods for the product and packaging, taking account of applicable rules.
Transport Information
ADR, RID, ADN, IMDG and ICAO/IATA classification where applicable, together with special precautions.
Regulatory Information
Product-specific health, safety and environmental legislation, restrictions, authorisations and chemical safety assessment.
Other Information
Changes from the previous version, abbreviations, sources, classification methods, full texts and training advice.
Regulation (EU) 2020/878 and CLP Developments
Regulation (EU) 2020/878 amended Annex II to REACH and strengthened the level of detail required in Safety Data Sheets.
Developments under CLP may also change product classification and require updates to the SDS, label and other hazard-communication elements. Applicable transition periods should be considered when planning an update.
Nanoforms
Identification of nanoforms and connection of safety information to their specific characteristics where applicable.
UFI
Inclusion of the unique formula identifier in the relevant section where the regulatory scenario requires it to appear in the SDS.
Endocrine Disruptors
Communication of relevant information on endocrine-disrupting properties for human health or the environment.
Sections 9, 11 and 12
Greater detail in physicochemical, toxicological and ecotoxicological information, including effects not always reflected in traditional classification.
New CLP Hazard Classes
Review of endocrine disruption, PBT, vPvB, PMT and vPvM classes according to the applicable criteria and transition periods.
Consistency with Classification and Labelling
Coordinated update of the SDS, label and related documentation when classification changes.
An SDS correctly drafted several years ago may no longer be compliant if classification, composition, regulatory obligations or available information have changed. It is a living compliance document, not a decorative PDF filed and forgotten.
Extended SDSs and Exposure Scenarios
Where a chemical safety assessment has been carried out and exposure scenarios developed for a substance, relevant information should be communicated to downstream users through an extended Safety Data Sheet.
Exposure scenarios describe operational conditions and risk-management measures that control exposure of workers, consumers and the environment during identified uses.
Use Coverage
Verification that the recipient’s actual use is covered by the communicated exposure scenario.
Operational Conditions
Review of quantities, duration, frequency, temperature, ventilation and other conditions affecting exposure.
Risk-Management Measures
Verification of engineering controls, personal protection, emission treatment and other necessary measures.
Consistency with the Main SDS
Alignment between annexed scenarios and Sections 1, 7, 8, 9, 11, 12 and 15.
Information for Mixtures
Selection and integration of safe-use information from ingredient substances so that it is useful to recipients of the mixture.
Language, Supply and Consistency across the Supply Chain
The SDS must be provided in the language or languages required by the Member State where the product is placed on the market, unless national rules permit another option.
Translation is not a word-substitution exercise. It must preserve substance identity, regulatory phrases, safety measures and consistency between classification, label and sheet.
Supply to the Recipient
The sheet must be provided free of charge on paper or electronically no later than the date of first supply where the duty applies.
Language Versions
Each version should use correct chemical and regulatory terminology for the country of supply.
Consistency with the Label
Identifiers, classification, pictograms, hazard statements, precautionary statements and supplier details should match.
Supplier Data
Information received for raw materials should be critically reviewed before it is transferred to the SDS of a mixture.
Document Traceability
Sources, classification criteria, versions, dates and changes should be recorded and retained.
Working Methodology
Each project begins with a review of the available information and the purpose of the document. The quality of the result depends on the source data and on identifying contradictions or missing information before drafting.
1
Information Collection
Composition, specifications, raw-material SDSs, properties, uses, markets, supply format and existing documentation.
2
Regulatory Assessment and Classification
Review of REACH, CLP, harmonised classifications, specific limits, M-factors, acute toxicity estimates and mixture rules.
3
Preparation of the 16 Sections
Structured drafting and selection of information relevant to the product and its recipients.
4
Cross-Consistency Review
Checks across composition, classification, label, transport, properties, toxicology, ecotoxicology and risk-management measures.
5
Client Validation
Resolution of questions and confirmation of uses, suppliers, contact details, markets and actual supply conditions.
6
Issue and Version Control
Delivery of a dated document, identification of the version and record of changes from earlier editions.
Safety Data Sheet Updating and Maintenance
The initial issue does not close the process. An SDS should be updated without delay when new information affects hazards or risk-management measures, when an authorisation is granted or refused, or when a restriction is imposed.
A review may also be required after changes to composition, supplier, harmonised classification, CLP rules, identified uses, transport data or toxicological and environmental information.
The new version should be dated, identify the changes and be supplied to previous recipients where required under REACH.
Periodic Review
Planned control of the document against new data sources and regulatory changes.
Change Assessment
Evaluation of the impact of a change in formula, raw material, supplier, use or market.
Classification and Label Update
Coordinated review of CLP classification, Section 2 and label elements.
Revision History Control
Record of dates, versions, changes and recipients who should receive the updated document.
Support with Findings
Review of comments from customers, inspectors, authorities, distributors or occupational safety services.
Support for Safety Data Sheet Preparation or Review
Each substance or mixture requires its own assessment. SHAPYPRO adapts the service to the product, available information, the company’s role in the supply chain and the markets where the product is supplied.
The objective is to provide a technically consistent SDS that is understandable to recipients and aligned with REACH, CLP and the real product documentation.
