- A TPD/TRPR vape product notification is the submission of all required product information to the regulatory authority within the country you would like to market your vape product.
Regulatory Support for Nicotine
Our specialised team provides end-to-end regulatory services for Nicotine; a naturally occurring chemical compound found in tobacco products.
Nicotine Explained
Nicotine is a naturally occurring chemical compound found in tobacco plants. It is a highly addictive substance that stimulates the central nervous system. Nicotine is the main addictive component in tobacco products like cigarettes, cigars, and smokeless tobacco, as well as in nicotine replacement therapies like patches and gums.
Regulatory
Services
TPD/TRPR
Vape Product Notifications
TPD/TRPR Vape Product Notifications
- Under the Tobacco Products Directive (EU Member States) and the Tobacco and Related Products Regulations, 2016 (UK – GB & NI), all tobacco products, including vape products, must be notified to the relevant authority within the countries which the product will be marketed. No vape product can be legally placed on the market until a product has been notified and subsequently approved by the relevant authority.
- The Tobacco Products Directive (Directive 2014/40/EU) is the primary legislation regulating vape products in the EU. Individual member states have implemented this directive into their national law and so the TPD forms the basis of vape product requirements and restrictions. There are some differences between individual member states, but as a whole, the requirements (such as maximum permitted nicotine strength, the inclusion of a health warning, etc.) remain consistent between all EU members.
- The Tobacco and Related Products Regulations, 2016 (TRPR, 2016), is the UK specific implementation of the TPD. The TRPR applies to Great Britain (England, Scotland & Wales) and Northern Ireland. The requirements and restrictions specified in the TRPR remain mostly aligned with those in the TPD. The primary difference being that a vape product intended for the GB market must be notified through a separate notification system (The MHRA notification portal), whereas notifications to EU member states and Northern Ireland can be sent through a centralized system, known as the EU-CEG system (EU – Common Entry Gate system).
- We offer a comprehensive vape product notification service. From initial consultation, where we outline all the necessary requirements for a successful product notification, through to complete product submission on behalf of the client.
- If required, we offer initial client set-up on the EU-CEG and MHRA portals. Through an initial client meeting and ongoing consultancy meetings, we will then ensure that all the necessary requirements are outlined for a successful notification, each step of the way, until the product is successfully published by the relevant authority.
- We will review all documentation and product information required to support a successful notification, advising on amendments and changes if necessary and, once all documentation and information has been confirmed to meet the requirements for a successful notification, we will complete all product submissions on your behalf.
Nicotine Product Pre-Market Packaging,
Labelling and Leaflet Review
Nicotine Product Pre-Market Packaging, Labelling and Leaflet Review
- A pre-market packaging, labelling and leaflet review is a comprehensive review of the compliance of your products packaging and leaflets, whether that be for a vape product, a nicotine pouch product, a heat-not-burn product, etc.
- A packaging review is necessary to ensure your product packaging meets all the requirements for legal sale in your target market.
- The TPD/TRPR, CLP Regulation and GPSR (General Product Safety Regulations) regulate the requirements and restrictions for nicotine product packaging.
- The TPD/TRPR both describe very specific requirements and restrictions for tobacco product packaging (which includes vapes and heat-not-burn products). For example, under the TPD/TRPR a health warning must be affixed to the product packaging and feature specific text, such as “This product contains nicotine which is a highly addictive substance”, these warnings can differ between European markets, but the specifications of the warning and how it must be presented remains largely aligned. In addition to this, the TPD/TRPR calls for other mandatory information, such as ingredients lists and the nicotine content of the product. The TPD/TRPR also list certain packaging restrictions which must be adhered to.
- The CLP regulation requires that specific information be presented on the product packaging and effectively communicate the hazards of the product to the consumer. This includes mandatory pictograms depending on the hazard of the product, such as the “Skull and crossbones” or “Exclamation mark” pictograms, signal words, such as “Danger” or “Warning” and hazard/precautionary statements.
- The GPSR requires information which conveys safety information, usage instructions and product traceability on the product packaging. The TPD/TRPR and CLP regulations already cover a lot of these information requirements, but the GPSR (particularly GPSR 2023:988, EU GPSR) requires information such as Manufacturer/Importer/Responsible Person details and batch codes be displayed on product packaging to aid in product traceability.
- We provide a comprehensive packaging, labelling and leaflet review service. We can review your initial packaging designs and leaflets, providing feedback on the corrections, advisories and recommendations required. We also review subsequent iterations made to packaging designs and leaflets, guiding you along each step of the way until we can confirm your packaging and leaflet files meet all the necessary requirements for legal sale in your target market.
Safety Data Sheet Generation
and Translation
Safety Data Sheet Generation and Translation
- A Safety Data Sheet (SDS) is a comprehensive document which provides information about a chemical products (substance or mixture) composition, physical and chemical properties, health and environmental impacts and the potential hazards it poses. Safety data sheets also provide information on the safe handling, first aid requirements, correct use, storage and disposal of the chemical product.
- Safety Data Sheets are a legal requirement under the UK & EU REACH Regulations for any hazardous chemical products. In the case of nicotine products, such as vapes, nicotine pouches, etc. a safety data sheet must be generated (in the official language of the intended market) and be kept on file.
- Under the EU REACH and UK REACH regulations, any hazardous substance or mixture (chemical product) must include a Safety Data Sheet. The REACH regulation dictates a specific format which the safety data sheet must follow and adhere to, along with all the necessary information which must be presented in the safety data sheet.
- We can generate and translate safety data sheets for your entire product range. All we require is the ingredient disclosure for your product and a few extra chemical/physical specifications and our regulatory team will cover the rest.
TPD/TRPR
Toxicology Report Generation
TPD/TRPR Toxicology Report Generation
- Toxicological profiles for ingredients which are part of a nicotine products formulation are required as part of the notification process and are used by the responsible authority within each market to determine the safety and compliance of the product.
- Under the TPD & TRPR, toxicological data must be provided for each ingredient during the product notification process. The report must cover specific areas of an ingredient’s toxicology profile such as Carcinogenicity, Mutagenicity, Reproductive Toxicity, Cardiopulmonary Toxicity, etc.
- Regulation 31. (3)(c) of the TRPR 2016 and Article 20 2. (c) of Directive 2014/40/EU both require the toxicological data regarding a products ingredients and subsequent emissions as part of a product notification.
- We generate all toxicology reports in house to support TPD & TRPR product notifications. We currently have a library of hundreds of toxicology reports, covering all the major components and common ingredients found in e-liquid product formulations, and the capability to generate new toxicology reports if a client brings us a formulation which contains an ingredient for which we do not currently have a toxicology report on file.
- Toxicology reports are included as part of our TPD/TRPR product notification services but are also available for individual purchase.
TPD/TRPR
Annual Reporting Services
TPD/TRPR Annual Reporting Services
- TPD/TRPR Annual reporting is the submission of mandatory annual information required under the TPD/TRPR regulations.
- Regulation 32 of the TRPR 2016 and Article 20 Part 7 of Directive 2014/40/EU both require comprehensive annual data. This includes annual sales data and the modes of product sales.
- We can perform this annual duty on your behalf, where we enter and ensure all your annual product data is submitted before specific deadlines. As part of this service, we provide timely reminders as deadlines approach and guide you on what information we require before you provide us with this data which we will then submit on your behalf.
Responsible Person
(Authorized
Representative) Service
Responsible Person (Authorized Representative) Service
- A Responsible Person is an appointed legal authorized representative that acts on behalf of a business within a specific region in relation to a products safety and compliance requirements.
- Under regulation 31. (3)(a) of the TRPR 2016 (UK – GB & NI), Article 20 Part 2. (a) of Directive 2014/40/EU (EU Member States) and Article 16 of the GPSR 2023:988 (EU Member States), a responsible person is required within the region where the product shall be marketed, if the manufacturer/importer is not based within that region.
- For example, a GB based manufacturer which wishes to market a product in an EU member state, such as France or Germany, must appoint a responsible person within an EU member state under the requirements of the TPD (Directive 2014/40/EU) and the GPSR 2023:988.
- We can act as your Responsible Person for both UK markets (the GB market and NI market) and the EU/EEA markets, with offices in Liverpool, England, for the GB market, and Barcelona, Spain, for the NI/EU/EEA markets.
- As your responsible person, we undertake all duties which this entails, such as ensuring product compliance, maintaining your technical documentation, advising on product testing requirements if necessary, undertaking corrective actions and liaising with regulatory bodies.
TPD/TRPR Heated Tobacco
Product Notifications
TPD/TRPR Heated Tobacco Product Notifications
- A TPD/TRPR Heated Tobacco Product notification is the submission of all required product information to the regulatory authority within the country you would like to market your HTP.
- Heated Tobacco Products, such as Heat Not Burn products, are classified as novel tobacco products under the TPD/TRPR and are required to be notified to the regulatory authorities in advance of being placed on the market(s) for sale.
- Article 19 of Directive 2014/40/EU and Regulation 22 of the TRPR 2016, both require the mandatory notification of novel tobacco products to the regulatory authority overseeing the market where the product will be sold. This includes product information, ingredients information, emissions information, toxicological assessments of the ingredients and subsequent emissions, etc.
- We offer a comprehensive HTP notification service. From initial consultation, where we outline all the necessary requirements for a successful product notification, through to complete product submission on your behalf.
- If required, we offer initial client set-up on the notification portals. Through an initial client meeting and ongoing consultancy meetings, we will then ensure that all the necessary requirements are outlined for a successful notification, each step of the way, until the product is successfully published by the relevant authority.
Poison Centre Notification
& UFI Code Generation
Poison Centre Notification & UFI Code Generation
- A poison center notification (PCN) is the submission of information about a hazardous chemical product to the designated poison control centers in the countries where the product will be marketed.
- A PCN provides information on the hazardous products composition, hazards, classifications, physical/chemical properties, toxicological information, first aid requirements and contact information of the manufacturer/importer etc. PCN’s enable poison control centers to provide appropriate medical advice in the event of accidental exposure or poisoning incidents with the hazardous product.
- PCN’s are mandatory under the EU CLP Regulation (Regulation (EC) No 1272/2008).
- In conjunction with this, the product must also be assigned a UFI code (Unique formula identifier) which is specific to the hazardous product. The UFI code is a mandatory requirement under the EU CLP Regulation and must be displayed on the product packaging/label. The UFI code is linked to the product during the PCN submission process and can be quoted to a poison control center during an emergency, where it will used to retrieve product specific information and enable poison control centers to provide timely medical advice.
- We provide a comprehensive PCN submission and UFI code generation service to all EU/EEA markets for nicotine containing products. All we require is product formulations disclosures and safety data sheets and we will take care of the rest.
- If necessary, we can even provide the SDS for your specific product, making the process even more streamlined on your behalf.