SDS: update of REACH Annex II

November 18, 2022

Definition of Annex II

When a supplier prepares a Safety Data Sheet for a substance or a mixture, they must comply with certain requirements. These requirements are listed in Annex II of REACH.

The information provided during registration and in the Chemical Safety Report (CSR) shall be consistent with that provided in the SDS (when the SDS is to be provided). The annex of the SDS shall contain the exposure scenario(s), if a Chemical Security Report (CSR) is established.

Finally, each section of the SDS shall indicate whether it concerns nanoforms. If so, the relevant information about these nanoforms must be provided.

Requirements for preparing an SDS

The Safety Data Sheet must inform users of the hazards that a substance or mixture may present. It allows users to take the necessary measures (storage, handling, disposal of the substance/mixture) to protect human health and the environment, but also to ensure safety in the workplace.

Thus, an SDS makes it possible to determine the presence of hazardous chemical agents in a workplace and the associated risks. For this, the information available on an SDS must comply with the requirements of Directive 98/24/EC.

The person authoring an SDS must be competent and trained. The information must be provided in a clear, simple manner, without specialized language and the SDS must display its date of writing.

What are the changes?

On June 18, 2020, the European Commission published the text on Commission Regulation (EU) 2020/878, amending Annex II of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).

The revision of Annex II of REACH concerns the requirements surrounding the content of Safety Data Sheets (SDS). Thus, the regulation introduces new requirements for the preparation of SDSs. Specifically, companies must:

  • 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 regulation is applicable as of January 1, 2021. 

Note that there is a grace period allowing SDSs prepared in accordance with Regulation (EU) 2015/830 to be provided until December 31, 2022. This grace period only applies to SDSs that include a UFI number.

The 16 sections of an SDS

Section 1 : Identification of the substance/mixture and of the company/undertaking

Section 2 : Hazards identification

Section 3 : Composition/information on ingredients

Section 4 : First aid measures

Section 5 : Firefighting measures

Section 6 : Accidental release measures

Section 7 : Handling and storage

Section 8 : Exposure controls/personal protection

Section 9 : Physical and chemical properties

Section 10 : Stability and reactivity

Section 11 : Toxicological information

Section 12 : Ecological information

Section 13 : Disposal considerations

Section 14 : Transport information

Section 15 : Regulatory information

Section 16 : Other information

EcoMundo's solution for the creation and management of your SDSs

Combining service and software solutions, EcoMundo supports you throughout the process of creating and managing your SDSs

The SDS Factory software is an integrated solution for managing Safety Data Sheets. It allows you to create your SDSs automatically, optimize them, and to digitize your data

Create, translate, and distribute your SDSs in just a few clicks, while taking into account the most up-to-date international regulatory requirements.

The advantages of the SDS Factory software :

SDS Factory has a complete worldwide hazard classification database of over 300,000 substances, allowing you to create fully compliant SDSs in a matter of minutes. It also functions as a regulatory watch, automatically alerting you in case of any regulatory changes internationally concerning your specific products/mixtures. Moreover, it is possible to interface your information system (ERP, PLM, LIM, etc.) with the SDS Factory software.  

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