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
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