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Product Stewardship

New European Regulation n. 2020/878 about compilation of safety data sheets

News in the Safety Data Sheets world

Recently it has been published the new Regulation (UE) 2020/878, which amends Annex II of REACH, about compilation of safety data sheets (SDS).

The main changes concern the presence of the new UFI code (Annex VIII of the CLP regulation), new features on section 3 and section 9, the information requirements about nanoforms and the inclusion of information relating to endocrine disruptors. Some section and subsection titles will be changed and two new subsections will be introduced.

In this news, we have described below the main new features:

1. UFI Code

UFI (Unique Formula Identifier) shall be provided in section 1.1 of the safety data sheet, ​ in accordance with section 5, part A of Annex VIII of the CLP Regulation.

2. Section 3
  • Compared with currently in force regulation requirement (Reg. (UE) 2015/830), shall be indicated specific concentration limits,
  • M-factors,
  • acute toxicity estimates  

for substances included in Part 3 of Annex VI or else determined in accordance with Annex I to Regulation (EC) No 1272/2008. Moreover, if a substance is registered and covers a nanoform, the particle characteristics that specifies the nanoform, as described in Annex VI, shall be indicated.

The concentration limits for which a substance must be listed in section 3.2 shall be updated and changed accordingly.

3. Section 9

A new and interesting modification will affect all the endpoints of this section. For each of them the required information, definitions, cases of applicability and non-applicability and in some cases the appropriate temperatures to indicate in the SDS are specified and described.

4. Section 11

Information on adverse health effects caused by endocrine disrupting properties shall be provided in subsection 11.2, where available, for the substances identified as having endocrine disrupting properties in Subsection 2.3.

 

This new regulation shall apply from 1 January 2021, however the update of the SDS to new information requirements may take place after a transitional period that will end on 31 December 2022. Thus, Safety data sheets not complying with the Annex to this Regulation may continue to be provided until this date.

Source: Eur-Lex

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