In this informative article, we take a deep dive into the chemical safety requirements for vape devices (ENDS) and e-liquids, covering Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification, Labelling, and Packaging (CLP) regulations, as well as what a Globally Harmonized System (GHS) and Safety Data Sheet (SDS) are. This is not intended to constitute legal advice.

The chemical safety of ENDS and e-liquids must be ensured for the product to be sold to consumers, as it is possible that such products may contain potentially harmful and/or toxic substances. They are therefore highly regulated and must comply with REACH regulations.

The regulatory body that is responsible for REACH in the EU is The European Chemical Agency (ECHA). Each substance that passes evaluation and authorization is considered fully registered with REACH and is given a REACH registration number.

CLP: Packaging, Use, and Disposal of ENDS in the European Union (EU)

There are several pieces of legislation that cover packaging, use, and disposal of ENDS in the European Union (EU). In the EU, chemicals, including nicotine, are subject to the requirements of REACH and CLP (a regulation resulting from REACH).

The CLP Regulation aims to ensure a high level of health and environmental protection, as well as the free movement of substances, mixtures, and products. This applies to e-cigarettes, concentrated flavours, and e-liquids, including those that are nicotine-free. The EU CLP Regulation adopts the UN GHS of classification and labelling of chemicals across all EU countries.

Under the requirements of CLP, each unique formulation must be provided with a unique formulation identifier (UFI). This is a 16-digit alpha-numeric code that is used to identify the formulation. The UFI must be submitted along with information on the composition of the formulation to the Poisons Centre Notification (PCN) system. This allows a poisons specialist to advise health care professionals in the event of adverse exposure to the product.

What is a Globally Harmonized System (GHS)?

GHS is a system for classification, labelling, and packaging of chemicals adopted by the UN in 2001. Its purpose is to provide a universal harmonised system for the communication of chemical safety information. 

Despite its aim that all countries worldwide should implement the system in order to ensure uniform methods for evaluation and communication of hazards, it can be confusing and, at times, might not seem to be harmonized at all. An example of this is that different countries may classify the same chemical in different ways; for some countries, one chemical can be classified as being toxic while in others that same chemical could be considered harmful, non-toxic, or not dangerous.

It is important to note that your labelling must be correct for each country you wish to sell your product in, as a different hazard classification would require different labelling. Further, information on the classification of a chemical substance or mixture must be provided by the manufacturer when transporting material.

What is a Safety Data Sheet (SDS)?

Regulated by REACH and CLP, the SDS is the main hazard communication tool and must accompany hazardous chemicals. It is articulated in 16 sections and provides information regarding, for example, composition (section 3), physical and chemical properties (section 9), and toxicological and ecological properties (sections 11 and 12) of the product. An integral part of the SDS is a CLP classification of the mixture, which is entirely devoted to section 2: Identification of hazards.

EU Nicotine Classification & Labelling

The EU harmonized classification for nicotine, depending on the concentration, is typically acute category 2: toxic for skin contact, ingestion, and inhalation. Consequently, nicotine products must be labelled with the danger phrases “Fatal if swallowed,” “Fatal by skin contact” and “Fatal by inhalation.” It is important to note that the manufacturer must classify their products in accordance to CLP. These hazards need to be communicated via the label.

Additionally, CLP labels for nicotine-containing products must include:

• The product identifiers – this can include trade names or other designations of the product as well as the EC number for nicotine (EC 200-193-3)
• The correct hazard and precautionary statements
• A ‘toxic’ hazard pictogram
• A signal word (either ‘warning’ or ‘danger’)
• The name, full address, and telephone number (landline, not mobile) of the supplier
• The nominal quantity of the substance or mixture in the package made available to the public (unless this is specified elsewhere on the package)
• Identification of the hazardous constituents of the preparation. The nicotine content, as a percentage of weight by volume, must be clearly displayed
• Batch numbers, expiry dates, and the nominal volume of the content

The design of the label must ensure that the hazard pictogram and hazard and precautionary statements stand out clearly and are easy to read. Warnings must read horizontally when the package is set down normally.

All other hazardous substances in addition to nicotine must be defined. It is important not only for the end-user but for everyone who might have to deal with the substance, for example, producers, distributors, transporters, or consumers. Besides nicotine, e-cigarettes can also contain other potentially harmful ingredients, including ultrafine particles that can be inhaled deep into the lungs, flavourings (e.g., diacetyl- linked to serious lung disease), volatile organic compounds, heavy metals, and others. The safety of each ingredient must be evaluated separately, and any potential risk should be communicated.

Simplifying Global Regulation and Compliance

We understand that the numerous requirements when preparing for a TPD/TRPR submission can feel overwhelming, which is why we created a team of regulatory and testing experts – we take care of the process for you, assisting with all aspects of your submission, from chemical safety for ENDS and e-liquids, to ensuring packaging and labelling is correct. Contact us today to hear how we can help you get your vaping product on the market!