Co-written by Pradip Suwal and Hannah Rubery.
On November 20, 2024, the European Union announced a pivotal update to chemical regulations, publishing Regulation (EU) 2024/2865 in the Official Journal. This amendment revises the Classification, Labelling, and Packaging (CLP) Regulation (EC) No 1272/2008, introducing substantial changes to how chemical substances and mixtures are classified and labelled across the EU, with many of these changes looking to take effect in 2026.
Key Updates:
1. Classification of Substances with Multiple Constituents:
Regulation (EU) 2024/2865 introduces key updates to the classification of complex substances, requiring hazard assessments to be based on individual components rather than their overall composition. This approach prevents the under-classification of substances where hazardous ingredients may be diluted or blended.
The regulation also mandates the evaluation of endocrine-disrupting (ED) and persistent, bioaccumulative, and toxic (PBT) properties using constituent-level data. Notably, plant-derived substances are granted a temporary exemption to allow for further scientific research. By addressing regulatory gaps, these changes aim to ensure more accurate hazard classifications while enhancing protections for both consumers and the environment.
2. Labelling Requirements:
(i) Digital Labelling: The regulation introduces the option for digital labels, allowing certain label elements to be provided in digital form via a data carrier on the physical label or packaging. However, this is voluntary and complements the physical label.
(ii) Fold-Out Labels: Fold-out labels are now permitted for all products, provided they meet specific formatting and content requirements. This flexibility allows for the inclusion of necessary hazard information without compromising label readability or design.
(iii) Mandatory EU-based suppliers for online sales: One of the key enforcement measures in Regulation (EU) 2024/2865 is the requirement for a mandatory EU-based supplier for online sales of hazardous substances and mixtures. This change closes a major regulatory gap that previously allowed non-EU sellers to bypass CLP compliance when selling chemicals directly to EU consumers.
(iv) Minimum Dimensions and Font Sizes: The regulation specifies the following minimum dimensions for labels and pictograms, along with the minimum font sizes based on the capacity of the package:
| Package Capacity | Minimum Label Dimensions (mm) | Minimum Pictogram Dimensions (mm) | Minimum Font Size (x-height in mm) |
| ≤ 0.5 litres | If possible, at least 52 × 74 | Not smaller than 10 × 10 If possible, at least 16 × 16 | 1.2 |
| > 0.5 L ≤ 3 L | At least 52 × 74 | At least 16 × 16 | 1.4 |
| > 3 L ≤ 50 L | At least 74 × 105 | At least 23 × 23 | 1.8 |
| > 50 L ≤ 500 L | At least 105 × 148 | At least 32 × 32 | 2.0 |
| > 500 litres | At least 148 × 210 | At least 46 × 46 | 2.0 |
Note: For packages not exceeding 0.5 litres, the specified dimensions should be applied if possible. If not, the pictogram dimensions should be no smaller than 10 × 10 mm.
Additional Formatting Requirements:
To further ensure label readability, the regulation mandates:
- Text Colour and Background: Text must be printed in black on a white background.
- Font Style: A single font that is easily legible and without serifs shall be used
- Line Spacing: The distance between two lines of text must be at least 120% of the font size.
- Letter Spacing: Adequate spacing between letters to ensure the selected font is easily readable.
3. Poison Centre Notifications (PCN):
The updated regulations impose new responsibilities on distributors, requiring them to submit poison centre notifications when selling hazardous mixtures across borders or rebranding them. Furthermore, ECHA now has the authority to store and manage emergency response data on behalf of Member States. Unlike the 2008 CLP regulations, which only required manufacturers and importers to submit notifications, these updates address regulatory gaps and ensure poison centres receive accurate and complete information.
4. Promotion of Non-Animal Testing:
The updated regulations encourage the adoption of new approach methodologies (NAMs), including in vitro techniques and computational models, for hazard classification. This marks a significant shift away from the heavy reliance on animal testing seen under CLP 2008. By prioritizing modern, ethical alternatives, the changes reflect the EU’s commitment to eventually phasing out animal testing in favour of more advanced and humane methods.
5. New Hazard Classes:
The updated classification criteria introduce two important hazard categories: Endocrine Disruptors (EDs) and Persistent, Mobile, and Toxic (PMT) substances, along with Very Persistent, Very Mobile (vPvM) substances. Endocrine Disruptors are further divided into Categories 1 and 2, addressing risks to both human health and the environment. PMT and vPvM substances, on the other hand, pose a significant threat to water resources.
These revisions fill critical gaps left by the 2008 CLP regulation, which did not specifically account for these classes. By aligning EU legislation with the latest scientific advancements, the updates strengthen chemical risk assessments and promote better protection for people and the planet.
6. Advertising and Distance Selling:
The revised rules for advertising and distance selling now enforce stricter standards. Ads for hazardous chemicals must prominently display hazard pictograms, signal words, and hazard statements. Additionally, misleading terms such as “non-toxic” or “eco-friendly” are prohibited when referring to hazardous substances.
Unlike the previous CLP 2008 regulation, which only required hazard categories to be mentioned in advertisements, the new guidelines provide clearer, more detailed hazard information across both traditional and digital platforms, ensuring greater transparency and consumer safety.
Conclusion
Compliance with CLP regulations is crucial for E-liquid manufacturers to ensure product safety and meet legal requirements. Nicotine-containing E-liquids, in particular, demand meticulous attention to classification, labelling, and packaging according to nicotine strength. Adhering to these guidelines not only safeguards consumers but also helps manufacturers avoid legal risks and foster trust in their brand.
Most of these amendments will come into effect from the 1st July 2026, with some rules like those on formatting, applicable from 1st January 2027. Products which have been placed on the market within these periods do not need to be re-labelled and re-packaged based on the new rules, but they can continue to be in the supply chain until 1 July 2028 and 1 January 2029 respectively.