The safety data sheet is the most important instrument for communication within the supply chain. It is intended to inform professional users within the supply chain of the data and recommendations they require for handling the dangerous substance or mixture such that the measures necessary for protection of health, occupational safety and protection of the environment can be taken for each use.
The legal arrangements concerning the safety data sheet can be found in Article 31 of the REACH Regulation.
The requirements concerning preparation of the safety data sheet are governed by Annex II of the REACH Regulation. The safety data sheet must be prepared in plain and easily understandable language by a competent person. Annex II sets out the required structure of the safety data sheet precisely in individual sections and subsections.
A sample safety data sheet with comments is provided by the Federal Institute for Occupational Safety and Health (BAuA). The BAuA also provides a list of service providers and software to assist you in preparing safety data sheets.
When must a safety data sheet be prepared?
You must prepare a safety data sheet when, as a manufacturer, formulator or importer, you supply a substance or mixture to a downstream user and at least one of the following criteria applies:
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the substance or mixture is dangerous (in accordance with the CLP Regulation);
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the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB);
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the substance appears on the candidate list of substances subject to authorisation (REACH, Article 31 (1)).
Obligations of suppliers within the supply chain
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Supply of a dangerous substance or mixture (REACH, Article 31 (8))
As a supplier, you must make the safety data sheet of a dangerous substance or mixture available free of charge to the recipient, either on paper or electronically, at the latest on the day on which you first supply the substance or mixture to the recipient. The safety data sheet must be written in one of the official languages of the Member State in which the recipient is established.
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Supply of a non-dangerous mixture (REACH, Article 31 (3))
As the supplier, you must make a safety sheet available to the recipient at his request when the mixture does not satisfy the criteria for classification as dangerous, but:
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contains at least one substance hazardous to health or the environment in an individual concentration:
of ≥ 1% by weight (for non-gaseous mixtures), or
of ≥ 0.2% by volume (for gaseous mixtures); or
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at least one PBT or vPvB substance or substance on the candidate list in an individual concentration of:
0.1% by weight (for non-gaseous mixtures); or
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contains a substance for which Community workplace exposure limits exist.
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Obligations regarding updates (REACH, Article 31 (9))
As the supplier, you must update the safety data sheet without delay in the following circumstances:
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as soon as new information which may affect the risk management measures or new information on hazards becomes available;
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once an authorisation has been granted or refused;
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once a restriction has been imposed.
You must mark the new, dated version of the safety data sheet as "Revision: (date)". You must include the registration number on any updates to the safety data sheet following registration (REACH, Article 31 (9)).
Should you as the supplier be in possession of an updated version of a safety data sheet, you must make the updated version available free of charge in paper or electronic form to all former recipients to whom you have supplied the substance or mixture in the preceding twelve months.
Obligations of downstream users
A downstream user is any party who purchases a substance, on its own or in a mixture, from a supplier and uses it in the course of his commercial or industrial activities.
Should you be a downstream user, you have the following obligations under REACH with respect to the safety data sheets received:
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As part of the hazard assessment at the workplace, you must take into account the risk management measures communicated in the safety data sheet.
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Should you determine that the risk management measures described in the safety data sheet are not sufficient (e.g. because you have acquired new information on the hazardous properties of a substance), you must report this information back to your supplier (REACH, Article 34).
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Should you produce formulations yourself, you must prepare a safety data sheet for them yourself where applicable and pass it on down the supply chain.
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As an employer, you must provide your employees with access at all times to information on the substances they use and/or may be exposed to (REACH, Article 35). This information particularly includes the relevant safety data sheets.
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In accordance with REACH, Article 36, you as a downstream user are obliged, like manufacturers, importers and distributors, to retain all information required under REACH for fulfilment of your tasks for a period of at least ten years after the last use of the substance/mixture. You must consequently also retain the relevant safety data sheets for at least ten years and present them to a competent authority on request.
