Regulations to watch in 2024: GHS updates

Welcome to the first of five episodes in our 2024 blog series, “Regulations to watch.” Today, we’re unpacking all you need to know about the upcoming GHS updates. 

[What you need to know]   

Ensuring compliance: A guide to the updated GHS regulations 

The implementation of the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was an achievement. Countries were willing to compromise on a regulatory framework to aid in the communication of hazards all over the world.  

The GHS was not perfect, and not all countries implemented it in the same way, but it was a vast improvement over the very different ways of determining hazards that we had in the past.  It also allowed countries that did not already have a regulatory framework for hazard communication to implement a plan more easily than starting from the beginning. 

However, it does seem as if a shift is going on; regulators now appear more willing to move away from the harmonization model. This individuality in the regulations makes sense. Different countries have different priorities, concerns and governmental structures that dictate what and how they can define their regulations.  

As such, countries are increasingly willing to move out of the GHS framework, which allows for specific differences, and into an area where they can create new hazard classes ahead of U.N. implementation within the GHS framework.  

This has already occurred in the EU, which has moved away from only adding supplemental label information and is now adding additional hazard classes. Canada and the U.S. did this in their original implementations by adding entirely new hazard classes, including combustible dust, simple asphyxiants, pyrophoric gases and more.  

This post explores these changing regulations in greater detail and provides the information you need to ensure a smooth transition in 2024. 

[What you need to do]  

Essential information for businesses regarding the EU CLP update 

Regarding classification, labeling and packaging (CLP), the EU CLP Regulation has been revamped with significant additions, including new hazard classes for endocrine disruptors for health and the environment, as well as for PBT, vPvB, PMT and vPvM. This is crucial for businesses that place chemicals on the EU market. The table below shows the basic information on the implementation of these new hazard classes. Businesses will need to reclassify their substances according to these new categories. 

Label elements are different than in earlier implementations of the CLP, where additional hazards were addressed as a part of supplemental label information with an EUH phrase. In this case, even while an EUH code is assigned, the hazard statement is to be treated as a traditional hazard statement and not supplemental label information.  

Precautionary phrases have also been assigned, although no new phrases were created. In addition, no symbols were assigned to these hazards, as authorities did not want to cause confusion with other hazards prior to these being adopted by the U.N. 

Endocrine disruptors in REACH vs. CLP SDS requirements 

Endocrine disruptors are substances that interfere with hormonal systems and which are potentially harmful to human health and the environment. They are not completely new to the Safety Data Sheet (SDS), as they have been addressed since the REACH Annex II update.  

However, in comparing the implementations for REACH and CLP, we can see that they are not identical. CLP has implemented two categories for these hazard classes, but only category 1 aligns with the REACH criteria.  

In addition, Annex II requires that certain information be output on the SDS. If you currently have negative endocrine statements on your SDS, you should evaluate how they are being used, as these could be negative for the REACH criteria, but still regulated under CLP. Clear methods of communication are also needed. You should also identify the regulation under which the evaluation was conducted. 

The same issue also occurs for PBT and vPvB, where the criterion for T is different between REACH and CLP.   The table below compares the two sets of criteria. Here, you can see that the CLP has added criteria for endocrine disrupting materials. 

Depending on how you output information on your SDS, you may run into the same issues as with endocrine disruptors. The ECHA has indicated that there were plans to align the requirements between the regulations, but that this would only be done when the new EU commission is formed. 

Changes are already being made to the labeling requirements for these new hazard classes. Here they are shown in both the original and revised text. 

The EU CLP also added notes to Annex VI for substances in ATPs 19 and 20. These new notes provide instructions on how to classify materials when a substance listed in Annex VI can be associated with more than one line in the table. 

Note X states that the information contained in that line of the table is only evaluating the hazards associated with that part of the substance. If your substance is applicable to multiple lines in the table, you must evaluate all the hazard classes applicable and assign the classification appropriately. 

Notes 11 and 12 both give criteria regarding how to assess whether a hazard is applicable based on the classification limits for the hazard. In both cases, the sum of the individual substances must be used to determine the overall classification. Note 11 applies specifically to boron compounds, whereas note 12 applies more broadly and the note itself is not specific to a substance.  

[Additional information]  

The U.S. and Canada catch up: Proposed regulations align U.S. with U.N. Revision 7 

In February 2021, the U.S. Occupational Safety and Health Administration (OSHA) proposed a significant update to the Hazard Communication Standard (HCS) to align with the U.N.’s GHS Revision 7. This move aims to streamline communication of chemical hazards in the workplace and across international borders. 

The proposed revisions focus on several key areas: classification updates, labeling enhancements and SDS. As of April 2024, the proposed U.S. regulation is still with the Office of Management and Budget. 

In Canada, the Hazardous Products Regulations (HPR) was published January 4, 2023, with a three-year transition period. The HPR has been updated to align with U.N. GHS Revision 7. It also refers to U.N. GHS Revision 8 specifically related to the implementation of Chemicals Under Pressure. OSHA also implemented Revision 7 but did not implement Chemicals Under Pressure.  

As mentioned earlier, pyrophoric gases had been implemented for the U.S. and Canada prior to their inclusion into GHS. Both countries have decided to align their implementation of this hazard with the U.N. criteria. 

Canada had previously implemented requirements for materials that are water reactive and release toxic gases. This requirement is still applicable, but additional clarification was provided.  

According to the Regulatory Impact Analysis, the amendment made to “water reactive, emits toxic gases” was to clarify that the selection of the supplemental label element is based on the toxicity of the gaseous substance: 

• If a hazardous product does not meet the classification due to its LC50 value (8.1.1 (1)) and releases a gaseous substance that has an LC50 that falls into one of the acute toxicity ranges, then the hazardous product must be classified in the appropriate Acute Toxicity category. 

If a hazardous product does not meet the classification due to its LC50 value and releases a gaseous substance, then the following hazard statement must be included in the supplemental label elements: 

• Cat 1 & 2: “In contact with water, releases gases which are fatal if inhaled.” 

• Cat 3: “In contact with water, releases gases which are toxic if inhaled.” 

• Cat 4: “In contact with water, releases gases which are harmful if inhaled.” 

• Furthermore, for those hazardous products, which meet the criteria of 8.1.1 (2), then the hazard statement “Fatal/toxic/harmful if inhaled” is not required on the SDS and label. 

In the U.S., OSHA is planning to implement the desensitized explosive categories, which are not included in the Canadian regulation. 

[What happens next] 

Keeping up with global regulations 

GHS revisions and country implementations will continue for quite some time. We know that countries including China and Malaysia are making updates to their regulations and India is still planning to implement requirements for hazard communication.  

It remains to be seen whether regulators will work more toward convincing the U.N. to add additional hazard classes, or whether they will continue to add what they need to their regulations and work with the U.N. later. In any case, Sphera will continue to watch these and other regulations to help you through the upcoming transition.  

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