Writing an SDS according to the new requirements of Annex II of REACH

December 20, 2022

The Regulatory Context

As announced in our last article on the update of Annex II of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation and Authorisation of Chemicals (REACH), new requirements have been established for elaboration within Safety Data Sheets (SDS).

This regulation has been applicable since January 1, 2021. However, the regulation allowed SDSs prepared in accordance with Regulation (EU) 2015/830 to be provided until the 31st of December, 2022 (if the Unique Formula Identifier- UFI number was included in the SDS). This means that as of January 1, 2023, any manufacturer, importer, distributor or downstream user is obligated to use SDSs that comply with the new requirements. All SDS, without exception, must be re-issued in 2023.

What are the new requirements in 2023 for SDSs?

Previously, when a substance didn’t contain nanoforms or endocrine disruptors, it wasn’t necessary to specify this in the SDS. However, with the new SDS template, you are obliged to provide all information about the substance, including substances it doesn’t contain.

From our previous article on all the new SDS requirements, SDSs must now:

  • Take into consideration the Unique Formulation Identifier (UFI) of each product
  • Implement new information requirements in accordance with the 6th and 7th revisions of the GHS (sections 9 and 14)
  • Include information additional information on nanoforms (Regulation 2018/1881)
  • Communicate on endocrine disruptors throughout the supply chain (Regulation (EC) No 1907/2006)
  • Provide specific concentration limits, multiplication factors, and acute toxicity estimates (Regulation (EC) No 1271/2008)

The new requirements will change the following 9 of the 16 total SDS sections:

  • Section 1 : Identification of the substance/mixture and of the company
  • Section 2 : Identification of hazards
  • Section 3 : Composition/information on ingredients
  • Section 9 : Physical and chemical properties
  • Section 10 : Stability and reactivity
  • Section 11 : Toxicological information
  • Section 12 : Ecological information
  • Section 14 : Transport information
  • Section 15 : Regulatory information

How do I update all my SDSs according to the requirements of REACH Annex II?

EcoMundo proposes to edit all of your SDSs in accordance with the new requirements of annex II of the REACH regulation. The SDS Factory software has been updated with the new SDS template, offering you the possibility to update all of your existing SDSs as required in just a few simple clicks. 

Want to know more about SDSs?

For more information, don’t hesitate to contact one of our SDS and SDS Factory experts below: Contact us!

Encore +

Articles similaires

Autorisation Reach

Postponement of the DEHP ban in medical devices: new dates

The European Commission recently announced a postponement of the ban on the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices (MDs).

The European Commission Approves Chrysanthemum cinerariaefolium Extract for Use in Biocidal Products of Type 18

The approval of Chrysanthemum cinerariaefolium extract by the EU for type 18 biocides is a significant milestone in the fight against pest insects. This decision will come into effect on February 1, 2025.

The European Union Approves Formic Acid for Biocidal Products: Conditions and Implications

The European Parliament and the Council have approved formic acid as an existing active substance for use in biocidal products of product types 2, 3, 4, and 5, in accordance with Regulation (EU) No. 528/2012. This decision includes formic acid among the approved active substances for biocidal products and comes with specific conditions and considerations aimed at ensuring effectiveness and safety for users, as well as environmental concerns.