Safety Data Sheet – regulations, what do you need to know about the EU legislation?
Everyone who works in the chemical products industry will sooner, or later, encounter a document called a Safety Data Sheet. Moreover, even if your company is not directly related to the chemical industry, but you use products such as detergents, lubricants or manufacturing aids in your workplace, it is also possible that Safety Data Sheets are not completely unfamiliar to you.
Regulation on Safety Data Sheets
Of course, knowing that such a document exists is one thing, but it is worth considering where the need to prepare it comes from. As far as the European Union market is concerned, this duty results from the REACH Regulation, specifically from Article 31. Detailed requirements for Safety Data Sheets are described in Annex II to the REACH Regulation (Regulation 2020/878/EU or the "Safety Data Sheet Regulation").
The development of a Safety Data Sheet requires complying with the provisions specified in the regulations. The Regulation on Safety Data Sheets establishes the format and expected content of such a document, starting from determination of the order of all 16 sections, ending with detailed requirements related to the disclosure of relevant substances in the Safety Data Sheet.
Safety Data Sheets for Substances and Mixtures
Will all chemical products require the preparation of a Safety Data Sheet? Definitely not, it will depend on their form, whether they are considered a substance, a mixture or an article under the REACH regulation, as well as on their hazard classification.
A Safety Data Sheet will need to be prepared when:
- The substance is classified as hazardous
- The substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria in Annex XIII of the REACH Regulation
- The substance is on the list drawn up in accordance with Art. 59 section 1 for reasons other than those specified in point a) and b).
A Safety Data Sheet for the mixture must be prepared for:
- Mixtures that are classified as hazardous, but also when:
- the mixture contains, in specified concentrations, substance(s) posing a threat to human health and the environment or substances that are carcinogenic, mutagenic or toxic to reproduction;
- the mixture contains substance(s) for which occupational exposure limits have been defined in the Community
The Regulation on Safety Data Sheets specifies in detail for which substances and mixtures a Safety Data Sheet should be provided to the recipient. Sometimes however, assessing the need to prepare a document may pose some difficulties. The regulation also provides provisions on timing of the SDS delivery - no later than on the day of the first delivery of the goods. The Regulation on Safety Data Sheets is therefore the best source of knowledge on when and how to prepare such a document, but its preparation also requires specialized knowledge that goes beyond the scope of Regulation 2020/878/EU.
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