Consultation on the updated requirements for the compilation of SDS

Annex II to REACH: requirements for the compilation of SDS

Annex II represents one of the most significative parts of regulation 1907/2006 (REACH Regulation). It sets out the requirements that each supplier must fulfil for the compilation of a safety data sheets for a substance or a mixture in accordance with Article 31. Annex II provides important information on how to fill out every section and subsection of the SDS in compliance with REACH Regulation.

The most recent modification to Annex II is Regulation 2015/830, which came into force on June 1^st 2015. However, the draft regulation that has undergone this consultation is a first step towards a futher modification. The public consultation ended in October 10^th 2019.

Update of SDS requirements: proposed changes

The draft preparation and the following consultation derives from the necessity to adapt the SDS to the recent European requirements regarding nanoforms and the 6^th and 7^th revision of United Nations’ GHS.

Furthermore, Annex VIII to CLP regarding the harmonized information relating to emergency health response and the European initiative about the communication along the supply chain of endocrine disruptors have determined the necessity to modify the requirements for SDS compilation.

The major proposed changes include:

• Modification of the criteria for selecting substances to report in Section 3 of the mixture’s SDS.
• Additional information required in Section 9 of the SDS
• Two new subsections relative to endocrine disruptors
• The addition of information about nanoforms

Update of SDS requirements: deadlines

As stated in the draft, the new regulation will come into force on January 1^st 2020.

Furthermore, a transitional period is predicted: Safety Data Sheets provided to a recipient before January 1^st 2020 may continue to be used until 31^st December 2022.

However, this transitional period cannot be applied in cases where the SDS needs to be updated as provided in Article 31(9) of REACH Regulation or if a UFI code has to be added to the SDS.

Many associations of the chemical industry and related branches, such as FEDERCHIMICA, VCI, DUCC, CEFIC, and many other stakeholders (including Trace One), have already pointed out that the implementation deadline contained in the draft would be much too short.

Trace One is following the development of this situation with maximum attention and we will keep you updated as it develops.

To access the DRAFT update of Annex II to REACH regulation, please use the following links:

• DRAFT update of Annex II to REACH regulation

Newsletter 125