Article

New Draft Version of REACH Annex II on the Format of the SDS Released

Posted on: September 19, 2019

by Dr. Eleanor Grimes

Image of chemicals in a lab - Learn more about the New Draft Version of REACH Annex II on the Format of the SDS ReleasedAnnex II of REACH, which sets out the required structure and content for a safety data sheet (SDS), has had a new draft version released that is open for comment until midnight Brussels time on the 10th October 2019.

The main sections of the SDS that have undergone revision are 1, 2, 3, 9, 11 and 12, with sections 3 and 9 undergoing the most significant changes.

If the current version of the draft regulation is implemented into law, then section 3 of the SDS will require considerably more information for each of the substances that are required to be disclosed, and additional substances may also need to be listed. This is because there would be a mandatory requirement to include details such as specific concentration limits, M-factors and ATE values where applicable for each substance listed, and the disclosure limit for sensitisers will be lowered by a factor of 10 compared to the current requirements.

Other factors affecting section 3 include the need to take into account nanoforms and endocrine disruptors. These are both topics that have featured heavily in ECHA’s chemical management plan, through additional updates to the REACH programme. Information on both nanoforms and endocrine disrupters will also need to be included in other sections of the SDS, so they can be fully assessed for their hazardous properties.

Section 9 has also undergone a complete overhaul in the updated draft version of Annex II, with the section now requiring a lot more detail; additionally, information with regards to physical hazards will now have to be addressed within subsection 9.2.

Whilst many of the changes currently in the draft result in a modification to the SDS, there are also some changes designed to provide further clarification on the points already addressed; for example, section 14 has undergone a significant text change in the legislation, but only minor changes with regards to the overall meaning.


How we can help?

Our regulatory experts can provide global SDS authoring, SDS consulting and SDS training services for your entire product inventory and/or intermediates. We have professional knowledge and skill in the Globally Harmonized System (GHS), ISO and ANSI formats. With our sophisticated software, SDSs are prepared in HTML and/or PDF formats and can be translated into multiple languages.

Your UL SDS author can also perform ongoing review and updates of your existing SDSs or those we have created for your company. Read more about Hazard Communication Advisory Services.


Resources

Draft Regulation: https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2018-5250193_en

Current legislation: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1568726936965&uri=CELEX:32015R0830

Related Articles

REACH Amendment To Include Extended Coverage for Nanomaterials

Endocrine Disrupting Chemicals (EDC) in EU Chemical Regulations


DISCLAIMER

The views, opinions and technical analyses presented here are those of the author, and are not necessarily those of UL LLC. All content is subject to copyright and may not be reproduced without prior authorization from UL. While the editors of this site may verify the accuracy of its content from time to time, we assume no responsibility for errors made by the author, editorial staff or any other contributor.