New Regulation on EU Safety Data Sheet Formatting

23/11/2022

Chemical regulation is often subject to change as new classifications and hazards arise, which can be complex and confusing to navigate.

The European Chemicals Agency (ECHA) regularly updates their regulations according to evolving information on chemical effects, with the newest changes to safety data sheets (SDS) having been adopted in 2020 and fully enforced from 1 January 2023.

Read on to find out what’s changing and what that means for your business.

Regulatory context

ECHA is the primary body for chemical regulation with the European Union, facilitating both the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Classification, Labelling, and Packaging (CLP) regulations.

Annex II to REACH details the requirements for safety data sheets, in order to provide sufficient information on chemical substances and mixtures to distributors and users.

This change to REACH is applicable to all manufacturers, distributors, importers, or downstream users placing substances on the EU market.

What’s different

Annex II to REACH has been updated as of 18 June 2020, and will be fully enforced from 1 January 2023, meaning that all SDS must be compliant to these updates before the deadline of 31 December 2022.

The Unique Formula Identifier (UFI) is now a mandatory inclusion in section 1 of the SDS, in addition to its presence on PCN dossiers and product packaging. This helps with the notification of products to poisons centres when handled in bulk.

New warnings have also been introduced for nanoforms and endocrine disrupting chemicals in various sections within the SDS.

Nanoforms are substances or materials with particle sizes between 1 to 100 nanometres in at least one dimension. The small size can cause these particles to have different characteristics as larger materials of the same composition, and while these differences are often advantageous, they can also cause different types of harm depending on the substance.

Endocrine disrupting chemicals (EDCs) are substances that alter the hormonal and homeostatic systems of living organisms. This in turn interferes significantly with primary regulatory processes of the body like metabolism, stress response, and reproduction, by producing hyperactivity of certain hormones in the body. Known EDCs present in a concentration of equal to or greater than 0.1% must now be declared within the updated SDS.

Section 3 (“Composition/information on ingredients”) requires more compulsory information regarding M-factors and acute toxicity limits, if known, as well as the nanoform particle characteristics and endocrine disrupting characteristics, if applicable.

Section 9 (“Physical and chemical properties”) has expanded sub-section 2 (“Other information”) to include more parameters relating to physical hazards and other safety characteristics.

Sub-headings have been changed in the following sections:

Section 11.1 has been amended to be more specific, now stating, “Information on hazard classes as defined in Regulation (EC) No 1272/2008.”
For Section 12.6, the old “Other adverse effects” section is replaced by “Endocrine Disrupting Properties”, with respect to environmental effects. Where possible information on ED properties of ingredients must be stated.
Section 14.7 has been reworded with respect to the instruments of the International Maritime Organization, rather than Marpol

Who is affected by this change

This change to REACH is applicable to all manufacturers, distributors, importers, or downstream users placing substances on the EU market—including non-EU states within the European Economic Area, as well as Northern Ireland while the Northern Ireland Protocol remains in force.

With the legislative changes brought about by Brexit in full effect, EU law (including REACH) no longer applies to substances on the market within Great Britain.

What do you need to do to be compliant

Businesses must adopt all described changes to their SDS to comply by the 31 December 2022 deadline. This may include the adjusted subheadings, additional information about endocrine disrupting substances and nanoforms, or the addition of a UFI to aid poisons centres in the case of a chemical emergency.

By 1 January 2023, all SDS for substances on the European market must comply with the new regulations.

In anticipation of this change, Chemwatch has already begun implementing these changes on in-house authored SDS. This includes automatically updated templates and chemical information to comply with the requirements of the jurisdiction. To check whether your vendor SDS are compliant, or for any questions or concerns regarding this change, speak to your customer service representative or contact re*********@ch*******.net.

Further information about your SDS obligations and REACH compliance can be found in our Webinar catalogue, including a more in-depth overview of UFI’s, guidance on PCN submissions, and more.

Chemwatch is here to help

If you have any questions about regulatory compliance, SDS authoring, chemical risk assessment, or inventory management, talk to the Chemwatch team today! We’re informed by over 30 years of chemical expertise and well equipped to help you with hazard identification and risk control. Contact us today at sa***@ch*******.net.

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