New Proposal to Harmonize Classification and Labeling: What It Means for Businesses

The European Commission has introduced a new proposal aimed at harmonizing chemical classification and labeling across the EU. This initiative is part of the broader EU Chemicals Strategy for Sustainability, which seeks to improve both human health and environmental protection while also encouraging innovation within the chemical industry. The proposal, which amends the existing Classification, Labeling, and Packaging (CLP) Regulation, brings substantial changes that will impact chemical manufacturers, importers, and downstream users. This blog explains what’s changing, why it matters, and how companies should prepare. Why Harmonization Matters Chemicals are used in nearly every industry—cosmetics, cleaning products, paints, plastics, electronics, and more. Although the EU already has strict CLP regulations, inconsistent classification and labeling practices can lead to: A harmonized approach ensures chemicals are assessed and labeled consistently across all EU member states, increasing transparency, supporting the single market, and better protecting public health. Key Elements of the New Proposal 1. New Hazard Categories Introduced The updated CLP Regulation proposes new hazard classes, including: These additions reflect advancements in scientific understanding and increased concern about long-term and low-dose chemical exposure. 2. Broader Use of Harmonized Classifications The proposal aims to expand the scope and frequency of harmonized classification decisions at the EU level. More substances will receive official classifications, reducing the need for inconsistent self-classifications by companies. 3. Stricter Self-Classification Rules Companies will face stricter requirements when self-classifying substances, including stronger scientific justification and improved documentation—helping to increase accountability and data quality. 4. Digital Labeling Options The new regulation includes provisions for digital labelling, allowing key product information, such as multilingual safety instructions, to be accessed via QR codes or links. This reduces packaging waste and improves accessibility for users. 5. Faster Updates and Streamlined Processes The proposal seeks to accelerate the update process for classifications and labels in response to new scientific data, ensuring regulations remain timely and responsive to emerging risk Business Implications The proposed regulation could significantly affect how chemicals are assessed, labelled, and marketed in the EU. Key impacts for businesses include: How Businesses Can Prepare 1.Review Your Product Portfolio Assess whether your substances or mixtures fall under the new hazard categories. 2.Communicate with Suppliers Ensure upstream partners are aware of the changes and are reviewing their chemical inventories. 3.Upgrade Compliance Systems Update internal systems for classification, labeling, and chemical safety reporting. 4.Train Key Teams Regulatory, R&D, and marketing teams should understand the updated CLP rules and their implications. 5.Stay Informed Track developments from ECHA and the EU Commission, including guidance documents, deadlines, and stakeholder consultations. The EU’s proposal to harmonize classification and labeling is a forward-thinking move toward a safer, more sustainable chemical industry. While it introduces new compliance challenges, it also offers greater clarity, consistency, and a foundation for innovation and consumer trust. Businesses that act proactively will not only ensure compliance but also gain a competitive edge in a marketplace where safety and sustainability are growing priorities. FAQs: 1. What is the goal of the proposed classification and labeling framework? The proposal aims to align the classification and labeling of hazardous substances across the EU. It seeks to reduce inconsistencies, enhance consumer protection, and simplify compliance by ensuring chemicals are properly identified and hazards are communicated effectively. 2. Why is harmonization important? Currently, some substances are classified differently by various companies, creating confusion and potential safety risks. Harmonization promotes consistent, science-based classifications, minimizing discrepancies and providing better protection for workers and consumers.

Everything about – New Intension for Harmonized classification and labelling (CLH)

Manufacturers, importers or downstream users will (self)classify and label hazardous substances and mixtures in order to ensure the protection of human health and the environment. To ensure an adequate risk management for hazards like carcinogenicity, mutagenicity, reproductive toxicity (CMR) and respiratory sensitizers, classification and labelling should be harmonized throughout the EU. This is done through harmonized classification and labelling (CLH), that are listed in Annex VI to the CLP Regulation. The CLH can be proposed for substances that do not have an entry in Annex VI of the CLP, or for substances with an existing harmonized classification that needs to be modified due to the availability of new information or the emergence of new scientific or technical developments, or for substances that need to be reevaluated based on existing data. The CLH proposals can be submitted to ECHA by either a state competent authority (MSCA) or a manufacturer, importer, and downstream user. The CLH process get initiated when ECHA receives an intention to prepare a CLH dossier by an MSCA or manufacturer, importer or downstream user. After the receival of intention, a substance identity check is performed, after which ECHA publishes the intentions on the Registry of Intentions on its website. The CLH is designed to prevent situations in which two or more parties submit proposals for the same substance at the same time. During the early stages of the process, anyone can provide information relevant to the proposed risk classification for a substance or provide that information during the consultation process. Interested parties can follow the progress of a proposal through the CLH process, starting from the notification of the intention to the adoption of the opinion of the Committee for Risk Assessment (RAC). The advance notice allows interested parties to prepare and plan for future comments. Those who know something about the identity or hazard properties of a substance are encouraged to provide this information to the dossier submitter during the early stages of the process, or at the very least during the consultation phase. The status of an opinion adopted by RAC is indicated as ‘Opinion Adopted’. Recently two intentions have been received for: piperonal (EC 204-409-7, CAS 120-57-0): Intention was created on 6th Jan 2022. Submission date is expected on Sep 30, 2022. Intention was submitted by Ireland. Dossier submitter has proposed harmonized classification for reproductive toxicity. Piperonal is also called heliotropin, and it is an organic compound. This can be commonly found in fragrances and flavors. ethane-1,2-diol (EC 203-473-3, CAS 107-21-1): Intention was created on 22nd Nov 2021. Submission date is expected on Dec 01, 2023. Intention was submitted by Netherlands. Dossier submitter has proposed harmonized classification for reproductive toxicity, H361d.At the time of proposal, the classification was Acute Tox. 4.

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