Important New Updates for Safety Data Sheets in 2021 – What You Need to Know

 

REACH UPDATE

The European Commission has amended Annex II of REACH, concerning the compilation of Safety Data Sheets (SDSs).

Safety Data Sheets don’t change very often – this is an uncommon and important update.

The regulation aligns REACH Annex II with the 6th and 7th revisions of GHS, and brings in a number of modifications to SDSs.  The latest amendment to Annex II was published in the Official Journal on 26th June 2020 (Regulation (EU) 2020/878).

 

DEADLINES

The regulation will apply from 1st January 2021, which means that all new SDSs, authored after this date, must take into account the new requirements.

All existing SDSs, authored before January 2021, will still be valid until the grace period ends on 31st December 2022 (except for bulk mixtures requiring an UFI).

After this date, all SDSs will need to be updated to the new requirements. 

Organisations should start the process of updating their SDSs now.

 

THE CHANGES IN SDS REQUIREMENTS

The main provisions of the new revised Annex II are:

  • The alignment of Safety Data Sheets with UN GHS Revisions 6 & 7.
     
  • The alignment with requirements for nanomaterials.
     
  • To clarify requirements related to Poison Centres (Unique Formula Identifiers (UFIs)).
     
  • Additional information for substances and mixtures with endocrine-disrupting properties.
     
  • The addition of Specific Concentration Limits (SCLs), M-factors and Acute Toxicity Estimates.
     

The main sections of the SDS which have undergone revision are 1, 2, 3, 9, 11 and 12, with sections 3 and 9 seeing the biggest changes.

Visit our Hibiscus site to see the list of updates by SDS Section.

 

WHO DO THE AMENDMENTS APPLY TO?

Relevant UK authorities have indicated that the UK will not be adopting this update to Annex II after the UK leaves the EU (31 December 2020). This means that one SDS will not be compliant for UK REACH and EU REACH.

If you are a manufacturer or importer of chemical substances in the UK, it is critical that you put a plan in place to ensure that your SDSs are compliant according to the regulations in both places, and that you can continue trading your products in the UK and EU from 1 January 2021.

 

WHAT YOU NEED TO DO

  • You should start preparing for the changes now – make sure you’re ready for the implementation date on  January 1st 2021.
     
  • Begin to gather the relevant information to update your SDSs.
     
  • Ensure that any NEW SDSs, created from 1st January meet the new requirements.
     
  • Ensure that you update your EXISTING SDSs in good time for the 31 December 2022 deadline.

 

HOW CAN HIBISCUS HELP? – PROMETHEUS UPDATED FOR REACH 2020

Hibiscus have designed the Prometheus SDS software package to simplify and streamline the Safety Data Sheet process, saving you time and money; Prometheus is a simple, flexible and affordable solution to the problem of creating, storing and distributing your own SDSs.

Prometheus has now been updated in order to help you comply with the latest REACH 2020 requirements:

  • The mandatory headings in templates for safety datasheets have been updated to conform to REACH 2020. The big changes are in section 9, where it is now obligatory to list nine physical properties, and section 11, where 11.1 is now divided into subsections based on route of exposure. There are also small changes to various headings in most languages. Acute toxicity estimate, M-factor, and specific concentration values for substances have been added – they are now required in section 3.
     
  • Automatic creation of tables has been changed significantly because REACH 2020 makes it obligatory to list many more properties for substances in section 3. Column widths are now minimised automatically and tables are split if necessary when they are generated automatically.
     
  • The template for poisons centre sheets has been updated to include product category name and product category code. Automatic checks have been added to ensure that concentrations of components are given as exact values and add up to 100%.
     
  • Extra components that are not listed in the associated SDS can now be added to a poison centre sheet.
     
  • The phrase “This Safety Data Sheet is provided in compliance with the EC Regulations 1907/2006, 1272/2008, 2015/830 and 2020/878” is now available for use in SDS headers and section 15.1.
     
  • The templates for non-EU datasheets remain the same, except for minor updating of the text of some headings. Automatic “translation” in either direction between REACH 2020 datasheets and earlier and non-EU ones, moves phrases appropriately between subsections that have changed.

CALL 0113 242 4272 FOR FURTHER DETAILS, OR CONTACT US AT ENQUIRIES@HIBISCUS-PLC.COM