Regulatory Updates with Dr. Filippo Busolo
Welcome back to Chemistry Under the Lens, our blog series dedicated to the latest regulatory developments in the chemical industry. Today, we sit down with Dr. Filippo Busolo, an expert in chemical substance management and dangerous goods transport safety, to discuss the recent updates introduced by Regulation (EU) 2024/2865. This new regulation brings significant changes to labeling requirements and poison centre notifications. Let’s dive in!
Label Updates: What’s Changing?
Let’s start with label updates. What are the main changes companies need to be aware of?
Dr. Filippo Busolo: “The new regulation sets strict deadlines for updating labels. If a substance or mixture is reclassified with a new hazard class, a stricter classification, or requires new hazard statements (EUH) under Article 25, the supplier must update the label without delay and within six months of receiving or being informed of the new evaluation. For other types of changes, the deadline is 18 months. However, if the modification is due to a harmonized classification and labeling set out in a delegated act, the update must be implemented by the specified date in the act itself. These obligations take effect on July 1, 2026.”
Digital vs. Physical Labels
How will the integration of digital information impact product data communication?
Dr. Filippo Busolo: “The regulation introduces the possibility of providing some information in digital format. All label elements must still be physically present on the packaging, but certain supplementary details, as outlined in Section 1.6 of Annex I, may be provided exclusively in digital form. Companies may also opt for dual-format labeling, both physical and digital. In this case, they must ensure that the information is accessible free of charge and independently of purchase—whether through an oral or written request or in case of temporary unavailability of the digital label.”
New Requirements for Physical Labels
Are there new requirements regarding physical labels?
Dr. Filippo Busolo: “Yes, the regulation establishes minimum dimensions for labels, pictograms, and text to enhance readability and consistency. Here’s a breakdown of the new provisions:
- For packages up to 0.5L: Labels should be at least 52×74 mm, pictograms at least 10×10 mm (preferably 16×16 mm), and a minimum font size of 1.2 mm.
- For packages between 0.5L and 3L: Labels should be at least 74×105 mm, pictograms at least 23×23 mm, and a minimum font size of 1.4 mm.
- For packages between 3L and 50L: Labels should be at least 105×148 mm, pictograms at least 32×32 mm, and a minimum font size of 1.8 mm.
- For packages between 50L and 500L: Labels should be at least 148×210 mm, pictograms at least 46×46 mm, and a minimum font size of 2.0 mm.
- For packages over 500L: Labels must be at least 148×210 mm, pictograms at least 46×46 mm, and a minimum font size of 2.0 mm.
Additionally, text must be printed in black on a white background, with line spacing at least 120% of the font size and using a sans-serif font for maximum clarity. Foldable labels will be allowed, provided they meet the criteria set out in Annex I of the CLP Regulation. These provisions will apply starting January 1, 2027.”
Poison Centre Notifications: What’s New?
Let’s talk about poison centre notifications. What changes does the new regulation introduce?
Dr. Filippo Busolo: “One of the most significant changes concerns the notification obligations for distributors. Previously, only importers and downstream users were required to provide information on hazardous products. Under the new regulation, distributors selling in other Member States or relabeling hazardous mixtures must also submit notifications to poison centres. This change aims to minimize information gaps in the supply chain, ensuring poison centres have access to accurate and complete data to respond effectively to health emergencies.”
Are there any exemptions for distributors?
Dr. Filippo Busolo: “Yes, distributors may be exempt from the notification requirement if they can demonstrate that the relevant information has already been submitted to authorities by importers or downstream users. This provision takes effect on January 1, 2027.”
How Should Companies Prepare?
What advice would you give companies to ensure compliance with these new regulations?
Dr. Filippo Busolo: “Compliance with the new rules is crucial not only to avoid penalties but also to ensure worker and consumer safety. I strongly recommend that companies start reviewing their label compliance and notification procedures now. Proactive adaptation will not only prevent legal risks but also enhance their reputation and build trust with customers.”
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