Hazardous substances safety data sheets: new EU Regulation 2020/878

On June 18, 2020, the EU Regulation 878/2020 was published, which amends Annex II of the REACH Regulation on Safety Data Sheets. This new regulation applies from 1 January 2021 and will repeal the current EU Regulation 830/2015. This is the third update of Annex II of REACH, after Reg. 453/2010 and the aforementioned Reg. 830/2015.

By way of derogation, SDSs that do not comply with EU Regulation 878/2020 can continue to be provided until 31 December 2022.

Among the most impactful innovations introduced by this new regulation are:

- Some subsections have been redefined, for example Section 11, where subsection 11.1 has changed its name and a new subsection 11.2 Information on other hazards has been introduced. In section 12 the 12.6 Property of         interference with the endocrine system has been inserted;
- Among the product identifiers, the need to report, where necessary, the unique formula identifier (UFI) * is specified;
- Amendment to section 3 of the SDS
 - the specific concentration limit, the M factor ** and the acute toxicity estimate for the substances included in Annex VI of Regulation (EC) 1278/2020 must be indicated;
 - if they stop it registered and refers to a nanoform (https://echa.europa.eu/it/regulations/nanomaterials) it will be necessary to indicate the characteristics of the particles that make up the nanoform (EU regulation 1881/2018);
    Changed some concentration limits for which a substance must be listed as a substance of a mixture in subsection 3.2.1. (table 1.1 CLP Regulation);

    The information on physical and chemical properties has been specified to be reported in section 9. Unlike the current regulation, the new one specifies exactly how to describe the various properties.

*: The unique formula identifier, known by the acronym UFI, is a code that will be mandatory to indicate on the label of products that contain a dangerous mixture. The UFI and other information provided will be used mainly by poison centers in the event of an emergency call. For example, the UFI can be read directly from the label of a product to the operator of a poison control center, in addition to the trade name, to accurately identify the product affected by the accident.

**: For the "hazardous to the aquatic environment" hazard class, the concept of multiplying factors (M factors) is used instead of specific concentration limits. The M factors have been defined to attribute a greater weight to substances classified as dangerous for the aquatic environment.

Basically, up to 31/12/2022 the SDS can still run with the old references which, moreover, are not explicitly indicated (mention is made of the CLP Regulation which, in fact, does not change). Rather, the customer should be advised to check, with their supplier, the need to adapt to the new EU Regulation 878/2020 (as a visual "impact", the possible inclusion of the UFI).

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