Understanding the Product Risk Assessment (PRA) Model Developed in Collaboration with Bibra Toxicology Advice and Consulting Ltd
As the vaping industry continues to evolve, ensuring the safety of e-liquids and vaping devices has become paramount. To address this need, EL-Science worked with Bibra Toxicology, a leading toxicology consultancy, to develop a comprehensive Product Risk Assessment (PRA) model. This model aims to systematically identify, evaluate, and mitigate potential risks associated with vaping products, ensuring they meet the highest safety standards. In this article, we explore the key components and benefits of the PRA model developed through this collaboration.
What is a Product Risk Assessment (PRA)?
A Product Risk Assessment (PRA) is a systematic process used to identify potential hazards associated with a product, evaluate the risks these hazards pose, and implement strategies to mitigate these risks. The goal of a PRA is to ensure that a product is safe for consumer use, complies with regulatory standards, and meets industry best practices.
Key Components of the PRA Model
The PRA model developed by EL-Science and Bibra Toxicology incorporates several critical components to ensure a thorough evaluation of vaping products. These components include:
1.
Hazard Identification
Hazard identification involves a detailed analysis of all substances used in vaping products, including nicotine, propylene glycol, vegetable glycerin, and flavouring agents. The process leverages Bibra Toxicology’s extensive toxicological data library and TRACE, their in-house toxicology databank, to identify any potentially harmful chemicals.
2.
Exposure Assessment
Exposure assessment determines the levels of exposure to various chemicals during typical usage of vaping products. This assessment considers factors such as the amount of e-liquid consumed, frequency of use, and the efficiency of the vaping device. Accurate exposure assessments are crucial for evaluating the risk associated with each chemical.
3.
Dose-Response Assessment
Dose-response assessment examines the relationship between the exposure level of a substance and the magnitude of its toxic effect. This step involves reviewing scientific literature and toxicological studies to establish safe exposure limits for each chemical.
4.
Risk Characterisation
Risk characterisation integrates the information from hazard identification, exposure assessment, and dose-response assessment to evaluate the overall risk posed by the product. This step involves comparing estimated exposure levels to established safety benchmarks to determine the likelihood and severity of adverse health effects.
5.
Risk Management and Mitigation
Based on the risk characterisation, appropriate risk management strategies are developed and implemented. These strategies may include reformulating e-liquids to eliminate or reduce harmful chemicals, improving manufacturing processes, and enhancing quality control measures to ensure product safety.
Collaboration with Bibra Toxicology: Leveraging Expertise
Bibra Toxicology’s involvement in developing the PRA model brings significant expertise and resources to the table. Bibra’s team of toxicologists has extensive experience in conducting hazard characterisations and risk assessments across various industries, including nicotine products. Their systematic approach to toxicology, combined with their comprehensive data resources, ensures that the PRA model is both robust and reliable.
Benefits of the PRA Model
The PRA model offers several key benefits for the vaping industry, including:
1.
Enhanced Product Safety
By systematically identifying and mitigating potential risks, the PRA model ensures that vaping products are safe for consumer use. This proactive approach helps prevent adverse health effects and enhances consumer confidence in the safety of vaping products.
2.
Regulatory Compliance
The PRA model helps manufacturers meet stringent regulatory requirements set by bodies such as the European Union’s Tobacco Products Directive (TPD) and Classification, Labelling and Packaging (CLP) regulations. Compliance with these regulations is essential for legal market access and consumer protection. Particularly, CLP regulations require the listing of chemical sensitisers on product packaging to inform consumers about potential allergens and other risks.
3.
Improved Product Quality
Implementing the PRA model leads to higher product quality by identifying and addressing potential issues during the development and manufacturing processes. This results in more consistent and reliable vaping products.
4.
Competitive Advantage
Manufacturers that adopt the PRA model demonstrate a commitment to safety and quality, which can provide a competitive advantage in the market. Consumers are more likely to trust and choose products from companies that prioritise safety and regulatory compliance.
CLP Regulations: The Need for Listing Sensitisers on Packaging
The Classification, Labelling and Packaging (CLP) regulation is a European Union standard that aligns with the United Nations’ Globally Harmonised System (GHS) of classification and labelling of chemicals. It requires that any substance or mixture classified as hazardous must be labelled to inform users of the risks.
A crucial aspect of CLP is the requirement to list sensitisers on product packaging. Sensitisers are substances that can lead to allergic reactions following skin contact or inhalation. In the context of vaping products, this means that any identified chemical sensitisers in e-liquids must be clearly listed on the packaging. This transparency is vital for protecting consumers, particularly those with sensitivities or allergies to specific chemicals.
Conclusion
The Product Risk Assessment (PRA) model developed in collaboration with Bibra Toxicology represents a significant advancement in ensuring the safety of vaping products. By systematically identifying, evaluating, and mitigating potential risks, the PRA model provides a comprehensive framework for producing safe and compliant e-liquids and vaping devices. This proactive approach not only enhances consumer safety but also helps manufacturers navigate complex regulatory landscapes and improve product quality. As the vaping industry continues to evolve, the adoption of robust risk assessment models like the PRA will be crucial in maintaining high standards of safety and quality.
The commitment of EL-Science to commission Bibra Toxicology for an £800,000 toxicological study underscores the industry’s dedication to safety. This initiative has set new standards in toxicological research, providing the most comprehensive set of data and risk assessments available within the e-liquid market. By leveraging this data, manufacturers can not only meet regulatory requirements but also build trust with consumers, ultimately contributing to a safer and more sustainable vaping industry.