Understanding CLP Regulation for E-Liquid Manufacture

Co-written by Pradip Suwal and Hannah Rubery.

The Classification, Labelling, and Packaging (CLP) Regulation (EC) No 1272/2008 establishes a unified framework across the European Union for classifying, labelling, and packaging chemicals. Aligned with the United Nations’ Globally Harmonized System (GHS), it ensures chemical hazards are communicated clearly and consistently. By mandating accurate warning labels and comprehensive safety information, the regulation aims to protect individuals and promote the safe handling, transport, and use of chemicals.

Importance of CLP Compliance for E-Liquid Manufacturers

The CLP Regulation is a critical framework for e-liquid manufacturers, governing the classification and labelling of nicotine and other components like propylene glycol, glycerol, and flavourings. Its purpose is to ensure consumers are fully informed of any potential risks associated with these products.

Compliance with CLP is not just a legal requirement—it’s essential for building consumer trust and maintaining market access. Failure to comply can lead to heavy penalties, reputational damage, and restricted market opportunities. Here’s why the CLP Regulation plays a vital role for e-liquid manufacturers:

• Ensuring Consumer Safety: CLP regulations provide clear and accurate hazard information, enabling consumers to use e-liquids safely. This is especially important for nicotine-containing products, where risks like toxicity or irritation need to be clearly communicated.
• Meeting Legal Obligations: Compliance with CLP is mandatory for manufacturers operating within the EU. Non-compliance can result in severe consequences, including fines, product recalls, or outright bans.
• Securing Market Access: Aligning with CLP standards allows manufacturers to sell their products in the EU and other markets with similar regulations. This not only ensures legal market entry but also boosts credibility and expands global reach.
• Protecting the Environment: CLP encourages manufacturers to assess and minimize the environmental impact of their products, including the safe handling and disposal of chemicals to prevent harm to ecosystems.

For E-liquid manufacturers, adherence to the CLP Regulation is more than just a procedural necessity—it’s a cornerstone of safe practices, legal compliance, and long-term success in a competitive and regulated market.

Implementing CLP Regulations in E-Liquid Manufacturing

E-liquids containing nicotine are regulated under the CLP Regulation, requiring manufacturers to accurately classify and label their products. This process is based on the nicotine concentration and any other hazardous properties. It involves identifying appropriate hazard categories, selecting relevant pictograms, assigning signal words, and crafting precise hazard statements.

1.   Classification

The Tobacco Products Directive (TPD) mandates that e-liquids must contain only high-purity ingredients, with the exception of nicotine. All other components must be safe for human health in both their heated and unheated states. Consequently, the acute toxicity classification of e-liquids is primarily determined by their nicotine content. In some cases, certain flavouring ingredients may also influence this classification. However, when evaluating e-liquids, the concentration of all ingredients should be taken into account.

This article provides general guidance on the CLP classification of e-liquid mixtures, with a particular emphasis on nicotine content. The impact of flavouring ingredients is beyond the scope of this document. Instead, the acute toxicity of e-liquid formulations will be assessed solely based on their nicotine concentration.

Nicotine (CAS No. 54-11-5) is classified under Annex VI of the CLP Regulation with the following hazard categories:

Using the ATE values provided by ECHA’s Committee of Risk Assessment Experts (RAC) and the formula outlined in Annex 1 of the CLP Regulation:

• ATEmix represents the estimated acute toxicity of the mixture, while ATEi refers to the acute toxicity of each individual component. The classification of refill liquids is determined based on the nicotine concentrations they contain.

Table below shows the classification of refill fluids according to CLP Regulation, based on the harmonized classification approved for the 13th ATP.

2. Labelling

Once E-liquids are classified, they must be labelled according to CLP guidelines. Labels must include:

• Product Name: The exact name of the E-liquid.
• Hazard Pictograms: Relevant symbols, such as the skull and crossbones for toxicity or the exclamation mark for irritants.
• Signal Word: “Danger” or “Warning,” depending on the hazard severity.
• Hazard Statements: Specific dangers, e.g., “Toxic if swallowed” or “Causes skin irritation.”
• Precautionary Statements: Safe handling instructions, e.g., “Keep out of reach of children” or “Wear protective gloves.”
• Nicotine Content: The nicotine concentration in mg/ml.
• Supplier Information: The manufacturer’s or supplier’s name, address, and contact details.

3. Packaging

E-liquids with high nicotine concentrations must comply with CLP guidelines for safe packaging. To prevent accidental exposure, particularly for children, child-resistant packaging is mandatory for all nicotine-containing products, significantly reducing the risk of poisoning.

Additionally, E-liquids must be stored carefully to minimize chemical degradation, fire hazards, or accidental spills. Proper storage involves using well-suited containers that are clearly labelled and fully compliant with CLP standards for safe handling.

Conclusion

Adhering to the guidelines for E-liquid labelling and packaging is essential to ensure consumer safety and compliance with legal standards. Proper labelling, child-resistant packaging, and careful storage all play a vital role in minimising risks associated with these products.

It is important to note that the regulations governing E-liquids and nicotine-containing products have been updated as of November 2024, reflecting the latest safety and compliance measures. All manufacturers and suppliers are urged to review these changes thoroughly to guarantee full compliance with current standards.