Safety data sheets (SDS) are an essential element allowing the dissemination of information along the supply chain, as well as to the final user (professional user). The SDS assures that manufacturers and importers communicate the necessary information along the entire supply chain, which in turn, ensures that substances and mixtures are used safely.
Besides the SDS, the labels are the second important source of information regarding the hazards linked to substances and mixtures that users (including workers and consumers) have access to.
Safety data sheets contain various types of information such as the substance properties, hazards, and instructions on how to properly use it, its disposal, and its transport. They also specify the proper conditions of use and how to manage the risks involved (so as to assure environmental and health protection).
Regulatory provisions (Article 31 REACH)
All regulatory provisions linked to SDS are specified in the Regulation (EC) No 1907/2006 (REACH) and its amendments.
When to supply a SDS?
- A SDS is mandatory (Article 31(1)) when:
- A substance or mixture fulfils the classification criteria as a dangerous product according to the CLP Regulation, or;
- A substance is persistent, bio-accumulative and toxic, or very persistent and very bio-accumulative, according to the criteria in Annex XIII REACH, or;
- A substance is included in the list of substances that are candidates for Authorisation (SVHC) which could possibly be subjected to Authorisation in the future according to Article 59(1) REACH.
- In the case of articles, it is not necessary to supply a SDS
- For hazardous substances and mixtures made available to the general public (Article 31(4)), it is not necessary to supply a SDS if the information for a safe use of the substances or a mixture is sufficient
- A SDS must be supplied on request (Article 31(3)) for certain mixtures that are not classified but contain at least one substance:
- That presents a danger for health or the environment, in an individual concentration:
o ≥ 1 % by weight for non-gaseous mixtures;
o ≥ 0.2 % by volume for gaseous mixtures;
- Being PBT, vPvB, or SVHC in an individual concentration ≥ 0.1 % by weight for non-gaseous mixtures;
- Having an EU workplace exposure limit.
SDSs are to be provided free of charge on paper, or in electronic format (Article 31(8)) and in the official language of the Member State in which the substance is being placed on the market (Article 31(5)).
In Luxembourg, SDS must be supplied in French or in German (Article 4 of Paquet REACH). Information on the required languages of the SDS for each Member State is accessible in a document made available on ECHA’s website.
Update obligations (Article 31(9) REACH)
SDS must be updated (Article 31(9)):
- As soon as new information which can affect the management of risks or new information regarding hazards are made available;
- Once an authorisation (under REACH) is granted or denied;
- As soon as a restriction (under REACH) has been adopted;
In addition, it is recommended to regularly review and update a SDS.
The updated SDS is disseminated free of charge to all the former recipients for whom the providers have supplied the substance or mixture within the last 12 months.
SDS content (Annex II REACH)
The content of a SDS is defined in Annex II REACH and is divided into 16 sections:
- 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
Annex II REACH has been modified twice, respectively by:
- Regulation (EU) 453/2010 which takes into account the different classification and labelling criteria of the CLP regulation,
- Regulation (EU) 2015/830 which adapts the requirements linked to SDSs with the 5th review of GHS (Globally Harmonised system) rules.
The Guidance on the compilation of safety data sheets, which is available on ECHA’s Website, supplies the practical details on data that must be included in each section of a SDS.
Extended Safety Data Sheet (eSDS) (Article 31(7) REACH)
The concept of exposure scenarios have been introduced with the REACH Regulation and more precisely, in the registration procedure. They describe all the possible conditions for which a substance (as is or in a mixture/article) can be used throughout its entire life cycle without presenting risks.
The creation of an exposure scenario is required for all substances that have been registered with a tonnage of more than 10 tonnes per year and for which a chemical safety report (CSR) has been completed (Article 14), and covers all of the identified uses of a given substances. The exposure scenario uses key data from the CSR and must contain information on the operational conditions of use of a substance and the risk management measures aimed at reducing or avoiding exposure of humans or the environment to the substance. The exposure scenarios are attached to the Safety Data Sheet and are transmitted to the downstream users through the so called Extended Safety Data Sheet (eSDS) (Article 31(7)).
Upon receiving the extended safety data sheet, the downstream user must verify that the use and conditions of use of the substance are covered by the exposure scenarios in the Annex (Article 37(5)).
Reminder: If the uses and the conditions of use of the substance are not covered by the received exposure scenario, the downstream user may be required to create his own chemical safety report.
- ECHA Guidance on the compilation of safety data sheets
- ECHA E-guide “Safety data sheets and exposure scenarios – Advice for recipients”
- ECHA Questions and Answers on safety data sheet
- ECHA webpage on communication in supply chian
- ECHA Practical guide 13 “How downstream users can handle exposure scenarios”