Safety Data Sheets
Safety Data Sheets
REACH is strict for Safety Data Sheets. Correct content, languages and distribution are strongly enforced. When substances have been registered under REACH, Exposure Scenarios must be attached, producing ‘Extended Safety Data Sheet’. GHS Classification is rapidly introduced. Sitmae offers a complete SDS service. See our dedicated webpage 'One-Stop REACH shop'.
Learn more: • Languages and distribution • REACH and Safety Data Sheets (SDS) • REACH Exposure Scenario’s • Extended Safety Data Sheets • Globally Harmonised System • REACH Registration numbers • Information for non-dangerous substances
Under REACH, Safety Data Sheets must be provided, free of charge, upon first delivery. Also when an SDS is updated it must be sent to all who have received the substance or mixture over the last twelve months. Safety Data Sheets need not be provided to the general public if there is otherwise enough information available for safe use. The SDS must be in an official language of the Member State where the substance or mixture is placed on the market. With over twenty-five different languages in the EU, this may pose a logistical problem.
Automatic translation of Safety Data Sheets is however possible when only standard phrases are used. Safety Data Sheets may be distributed in digital form. It is possible to place the Safety Data Sheets on a web site for customers to download. There must however be a system that ensures and documents that the customers actually have received the documents.
Under REACH, the European Safety Data Sheets have not changed much. Their required content is described in REACH Annex II. Safety Data Sheets are required for substances and mixtures that are classified as dangerous. REACH Enforcement authorities tend to check the availability and correctness of Safety data Sheets wherever possible.
Safety Data Sheets must be provided to all recipients of dangerous substances and mixtures. Free of charge and in the official language of the Member State where the product is marketed. New under REACH are the ‘Extended Safety Data Sheets’. They are SDS with as attachments so called ‘Exposure Scenarios’. Please see the dedicated section below.
REACH Exposure Scenario’s (ES) for dangerous substances are excerpts of the Chemical safety Report that is part of the registrations dossier. The Exposure Scenario’s list and address all the known uses of the dangerous substance. They often differentiate between industrial, professional and consumer use of the substance.
The REACH Exposure Scenario’s describe how the substance is manufactured and used during its life cycle. It describes and recommends measures to control exposure of humans and the environment. Exposure Scenario’s are complex documents. Sitmae REACH Services is one of the very few that can produce these in almost all European languages. Other service providers are often limited to English only.
An ‘Extended’ Safety Data Sheet is an SDS to which REACH Exposure Scenario’s are attached. For dangerous substances ‘Extended Safety Data Sheets’ are obligatory under REACH, as soon as a substance has been registered.For dangerous mixtures a ‘normal’ Safety Data Sheet is generally sufficient.
The system in Europe for classification and labelling of dangerous substances and mixtures is in the process of being replaced. The Globally Harmonised System is taking its place rapidly. The symbols and Risk Phrases are different. In some cases the criteria differ slightly: a substance can for example be ‘Eye irritant’ under GHS and not under the old EU system.
The REACH registration number of a substance must feature on its Safety data Sheet. The REACH registration number identifies both the substance and the registrant. The registrant is identified in the last four digits of the Registration number.
On Safety Data Sheets for mixtures, the REACH registration numbers of the dangerous ingredients must be listed. In this case however, the last four digits of the number (identifying the substance manufacturer) may be omitted. The producer, importer or Only Representative of the mixture must be able to provide the full registration number of the substances to the authorities.
Under REACH, non-dangerous substances and mixtures do not require an SDS. There is however a need to provide information such as the registration number, the presence of Candidate List substances, details of restrictions etc.
In general, SDS-lookalike documents are produced for this purpose. These documents need not necessarily be distributed in all EU languages. But of course they should be understandable to the recipient of the chemicals.