Recently, I have received 6 questions about safety data sheets. Since the answers are quite extensive, I would like to share with you the first three of them. And the next three will be answered in a couple of days ...
- When does a supplier have to submit a safety data sheet?
The REACH Regulation (Article 31) stipulates: "The supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II. The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or preparation is placed on the market, unless the Member State(s) concerned provide otherwise."
The safety data sheet therefore must be submitted to place a chemical on the market. Placing a product on the market comprises the supply or handover to a third party against payment or without any charge. Import is considered as placement on the market.
- Does the Slovenian version of a safety data sheet have to be an accurate translation of the English version or should it be adapted to Slovenian legislation?
The Guidance on the Compilation of Safety Data Sheets stipulates:
"Where there is a chain of supply, the requirements of REACH in relation to the provision of safety data sheets apply at each stage of the supply chain.
The initial responsibility for drawing up the safety data sheet falls on the manufacturer, importer or only representative who should anticipate, so far as it is reasonably practicable, the uses to which the substance or mixture may be put.
Actors further down the supply chain should also provide a safety data sheet, drawing on, checking the adequacy of, and adding to, the information provided by their suppliers to cater for the specific needs of their customers.
In all cases, suppliers of a substance or a mixture which requires a safety data sheet have the responsibility for its contents, even though they may not have prepared the safety data sheet themselves. In such cases the information provided by their suppliers is clearly a useful and relevant source of information for them to use when compiling their own safety data sheets. However, they will remain responsible for the accuracy of the information on the safety data sheets they provide (this also applies to SDSs distributed in languages other than the original language of compilation)".
The Slovenian version of the safety data sheet is therefore not a word-for-word translation of the English version, but a document, harmonised with the Slovenian legislation.
- Does the header of the document (safety data sheet) have to contain the following: SDS is in accordance with regulation (EC) No 1907/2006?
No, this indication in the header is not necessary. The following shall apply: "The required format and content of an SDS within the EU Members States in which the REACH Regulation directly applies (and in other countries which have adopted the REACH Regulation) is defined in Annex II of the REACH."
The content and format must therefore be harmonised with the REACH Regulation, but it is not necessary that the text, e.g. "Safety Data Sheet is in accordance with the REACH Regulation No. 1907/2006" is included in the header of the safety data sheet.
As already mentioned, the answers to other three questions will follow soon.