Chemical regulations are constantly evolving, with new hazards being identified and included in the regulations. Over the decades, we have seen new and evolving criteria for many health and environmental hazards as our knowledge and understanding of the science has increased. The potential endocrine disrupting properties of some chemicals, and the contamination of our environment with persistent chemicals that may have long-term and as yet unidentified effects have been causing increasing concern in recent years.
The EU Commission has committed to increasing sustainability and tackling pollution from chemicals through the European Green Deal and Chemicals Strategy for Sustainability. One of the measures they are taking to help progress these ideals is the introduction of new hazard classes for endocrine disruptors and persistent chemicals to facilitate the identification of chemicals with these properties and to improve the communication of their hazards, providing customers with the information needed to make appropriate purchasing decisions and to take suitable risk management measures when using them.
The new hazard classes have been introduced in Regulation (EU) 2023/707, which was published on 31st March 2023 and entered into force on 20th April 2023. The new legislation provides for the addition of four new hazard classes to the CLP Regulation
3.11 Endocrine Disruption for Human Health
4.2 Endocrine Disruption for the Environment
4.3 Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties
4.4 Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties
For help with the technical criteria, see the page CLP Hazard Criteria for endocrine disruption and persistence (vPvB, vPvM, PBT and PMT)
It is important to remember that no new testing is required under CLP for health and environmental hazards. However, where there is data available, suppliers will need to assess this and come to a conclusion on whether or not to classify for these hazards, as they currently do for all of the other hazard classes in CLP.
Testing and assessment may of course be required by other regulations such as the REACH, Biocidal Products, and Plant Protection Products Regulations, and there may be a need to review and update dossiers for these hazards in the future.
Timescales
Recognising that the chemical industry will need some time to adapt to and implement these new hazard classes, the Delegated Act includes transitional measures for the classification of substances and mixtures.
The new classification and labelling criteria will apply to all substances being placed on the market from 1 May 2025. For substances already placed on the market before 1 May 2025 (i.e. those substances already in the supply chain), the new classification and labelling criteria will apply from 1 Nov 2026.
The new classification and labelling criteria will apply to all mixtures being placed on the market from 1 May 2026. For mixtures already placed on the market before 1 May 2026 (i.e. those already in the supply chain) the new classification and labelling criteria will apply from 1 May 2028.
What to do now
The introduction of the new hazard classes will require a considerable effort for many companies. Planning for the implementation of them will help make the process go more smoothly. Some actions that can be taken now include:
- Start identifying raw materials and products that may be affected
- Check the Candidate List of SVHC to see if any of the substances you use are listed there as endocrine disruptors, PBT, vPvB, PMT or vPvM (you should already be aware of these!!)
- Under REACH, substances registered in the ≥ 10 tpa bands will have undergone a formal PBT and vPvB assessment. This should be communicated on SDS, and you can also check the registration dossiers on the ECHA website to see this.
- If in the check above, the substance is not classified as PBT or vPvB, but the criteria for “P” and “T”, or “vP”, are fulfilled, check if the substance may also be of concern for mobility (M). Some registration dossiers may include log Koc values, if not, simple predictions using QSAR tools can be made which may highlight concerns for further investigation.
- Check screening lists to see if a chemical may be of concern (just because a chemical is on such a list does not automatically mean it is a problem, but there should either be data available, or data will be being generated to help make assessments in future). Some useful lists include:
- A list of PBT/vPvB assessments made under the previous EU chemicals legislation on the ECHA website at https://echa.europa.eu/information-on-chemicals/pbt-vpvb-assessments-under-the-previous-eu-chemicals-legislation and a list of substances undergoing assessment for endocrine disrupting properties at https://echa.europa.eu/ed-assessment
- Endocrine Disruptor Lists (collaboration of some EU Member State national authorities) https://edlists.org/the-ed-lists
- US EPA screening lists for endocrine disruptors (https://www.epa.gov/endocrine-disruption)
- US EPA PBT List https://www.epa.gov/toxics-release-inventory-tri-program/persistent-bioaccumulative-toxic-pbt-chemicals-covered-tri
- UN list of identified endocrine disruptors (included in this report) https://wedocs.unep.org/bitstream/handle/20.500.11822/25634/edc_report2.pdf?sequence=1&isAllowed=n
- Japan List of Suspected Endocrine Disruptors https://www.env.go.jp/en/chemi/ed/speed98/sp98t3.html
- CHEMSEC SIN List https://sinlist.chemsec.org/
- If you are a formulator, you will be dependent on receiving information on the new classifications of your raw materials from your suppliers. This could leave you with a very short timescale to implement the new rules, especially if you are producing mixture-in-mixture products. Talk to your suppliers to see how quickly they anticipate implementing the new classification and labelling criteria, and if there are any products that they expect will be affected.
- Consider how changes in classification may affect pre-printed label stocks, packaging, etc. and manage stocks accordingly.
- A change to the classification and labelling of a product may trigger other obligations, e.g., the need to update a safety data sheet or to provide a new safety data sheet for a previously unclassified product, to make or update a notification to the Classification and Labelling Inventory for a substance, or to make or update a Poison Centre Notification for mixtures. Make sure your plan includes the necessary resources to manage these additional obligations.
What about the GHS? What about the UK?
In response to feedback from stakeholders who would like to see high and consistent standards worldwide for identification and communication of chemical hazards, the EU Commission has proposed the adoption of the new hazard classes to the GHS Sub-Committee of Experts, who agreed at their Dec 2022 meeting to form a working group with the aim of developing criteria for inclusion into the GHS in future. The EU Commission hopes that this work will be completed within the next biennium, for inclusion into the 11th Revised Edition in 2025.
For classification and labelling in the UK, you will need to consider the requirements for Northern Ireland and for Great Britain. In Northern Ireland, EU CLP remains in force under the Northern Ireland Protocol, and products placed on the NI market will need to be classified and labelled in accordance with the new requirements. In Great Britain, EU CLP no longer applies, and instead GB CLP is to be used. The UK Government has issued an Explanatory Memorandum which states that it has no plans to establish similar hazard classes into the GB CLP Regulation without consensus at UN GHS and will consider its position and feed into discussions at UN GHS in the first instance.
On a practical note, the HSE have previously said that they have no objection to additional useful information, such as GHS hazard categories not adopted in CLP, being included on SDS and labels, provided that it does not contradict or distract from the legally required information. It could be expected that a similar approach may be adopted in relation to these new hazard classes.
Page last updated January 2024