New SDS in 2023
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Some people working with SDSs may not have noticed it yet, but we are currently in the transition period to a new SDS format. For the second time, Annex II of the REACH Regulation [1] has been amended. This directly changes the requirements for a safety data sheet. I will describe the results of these changes in this and the following articles.
Legal source and exact transition period
Regulations are adapted by amending regulations, which may change or delete parts of the legal text or add new content. Creating a legally compliant safety data sheet therefore also means taking into account all legally relevant amending ordinances. In order to maintain an overview, legal texts are also often published in consolidated versions. These include the described adaptations from amending ordinances. While consolidated versions are much easier to read, only the official text and amending ordinances compose the actual legal text.
The amending regulation in this context (amending Annex II of the REACH reg.) is Regulation (EU) 2020/878 [2]. The described amendments have been active since 01.01.2021 and apply to all safety data sheets beginning with January, 2023. Therefore, both variants, with and without consideration of the amendment regulation mentioned, are still usable at this point in time.
How can old and new SDSs be recognised?
In the case of safety data sheets, the exact headings of the individual sections are specified. Thankfully, rewordings in these headings make it easy to distinguish between safety data sheets in the old format and the ones that already take the amendment regulation into account.
Two examples:
- Section 12 has been given another subsection. 12.6 now deals with “Endocrine disrupting properties” and the old section 12.6 is now 12.7 “Other adverse effects”.
- 14.7 has been renamed “Maritime transport in bulk according to IMO instruments”, previously “Transport in bulk according to Annex II of Marpol and the IBC Code”.
Further adjustments have also been made to Section 9, which I will go into detail in another post.
Content adjustments
Not only have sections been renamed or newly added, there have also been adjustments to the required content. These can be summarised in three larger areas: Endocrine disrupting properties, nanoforms and adjustments to the requirement for information in section 9 (PC hazards).
Significance for SDS creators
If you carry out substance registrations yourself, then the information on endocrine effects and nanoforms from the chemical safety report should also appear in the safety data sheet. Section 9.2 offers further possibilities to provide details on certain PC classifications in a structured way with new, optional subsections.
As a formulator and thus downstream user who uses substances and mixtures for their own products, the new information must be passed on accordingly along the supply chain from the preceding safety data sheets. If own nanoforms are produced, then the resulting hazards must also be included in the corresponding product safety data sheet.
Meaning for SDS receivers
It is not always easy to see whether a safety data sheet is still up to date or already out of date. An amending regulation such as this one offers the opportunity to ask the supplier whether the amendments by Regulation (EU) 2020/878, which are mandatory starting with January 2023, are already taken into account. In addition, the state of the safety data sheets can be identified more easily through the changed section headings.
The amending regulation has already been known for years (2020), which gave the SDS compilers time to update their safety data sheets according to the new requirements. Our software GeSi³ for the creation of safety data sheets has also already implemented the changes at the start of 2021 to facilitate a seamless transition to the new requirements.