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EU TPD&UK MHRA Notice
The EU issued the Tobacco Products Directive 2014/40/EU (TPD II) in 2014 to regulate the manufacturing, display, and sales of E-cigarettes circulating in the EU market. According to Clause 2 of Article 20 of Title III of TPD II, “Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended placing on the market.” Under the Commission Implementing Decision (EU) No. 2015/2183, the notification shall include a test report on E-cigarette emissions, a list of e-liquid ingredients, and toxicological information on each ingredient.
The UK officially completed Brexit on January 1, 2021, and the notification for e-cigarettes was transferred to the official website of the UK Medicines and Healthcare products Regulatory Agency (MHRA). MHRA is the competent authority for the E-cigarette and refill Container Notification Program in the UK, responsible for implementing most of the provisions of Part 6 of the Tobacco and Related Products Regulations (TRPR) and the 2020 Tobacco Products and Nicotine Inhalation Products (Amendment) (EU Exit) Regulations.
TPD Notification Information
- The name and contact details of the manufacturer;
- The name and contact details of the importer or legal representative if applicable;
- The list of all ingredients contained in the product and toxicological data on the ingredients and
emissions of the product;
- The emissions resulting from the use of the product by brand name and type;
- The description of the components of the product;
- The description of the production process;
- The declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product.
Core requirements of TPD II
TPD II aims to protect public health, particularly by preventing adolescents from being exposed to tobacco and nicotine products. The main requirements for electronic cigarette products include:
Composition and emission restrictions:
The nicotine concentration in the cigarette liquid shall not exceed 20mg/mL.
The capacity of e-liquid shall not exceed 10mL, and the capacity of e-cigarette cartridges shall not exceed 2mL.
Prohibit the use of certain additives (such as vitamins, caffeine, etc.).
Packaging and labeling requirements:
The packaging should have anti child opening function.
The label should include health warnings, nicotine content, and ingredient information.
Advertising restrictions:
It is prohibited to advertise electronic cigarettes on television, radio, and print media.
Pre listing notice:
Electronic cigarette products need to submit a notice to the target member country before being launched.
Premarket Notification
According to Article 20 (2) of TPD II, electronic cigarette products must submit a pre-market notification to the target Member State through the EU-CEG portal before entering the EU market. The notice must be submitted at least 6 months before the planned listing date.
Main content of the announcement
Product Information
Product name, model, and category.
Detailed information of manufacturers and importers.
Composition Table of Smoke Liquid:
List all the components and their concentrations of the tobacco liquid.
Toxicological information:
Provide toxicological data for each component, especially for the evaluation of released substances after heating.
Emission testing report:
Provide a testing report on the emissions of electronic cigarettes, including the amount of nicotine released, the content of harmful substances such as formaldehyde and acetaldehyde.
Production process description:
Describe the production process and quality control measures of the product.
Packaging and labeling information:
Provide samples of product packaging and labeling to ensure compliance with TPD II requirements.
Submission process of notice
Preparation stage:
Collect product composition, toxicology data, and emission testing reports.
Register an EU-CEG account:
Register an account on the EU-CEG portal.
Fill out the notification form:
Fill out and submit the notification form in the EU-CEG portal.
Submit supporting documents:
Upload documents such as the smoke liquid composition table, toxicology information, and emission testing report.
Waiting for review:
The target member country may need to review the notification and provide additional information.
Approved:
After passing the review, the product can be launched in the target member country.
Requirements for emission testing reports
The emission testing report is an important component of the pre-market announcement and should include the following content:
Nicotine release amount:
Measure the nicotine release of electronic cigarettes under different usage conditions.
Hazardous substance detection:
Detect harmful substances (such as formaldehyde, acetaldehyde, acrolein, etc.) in the emissions of electronic cigarettes.
Detection method:
Use standardized testing methods (such as ISO 20768:2018).
Testing agency:
The testing must be conducted in a laboratory that meets the ISO 17025 standard.
Composition Table and Toxicological Information of Smoke Liquid
Ingredient List:
List all the components and their concentrations of the tobacco liquid.
The ingredients must meet the limit requirements of TPD II (such as nicotine concentration not exceeding 20mg/mL).
Toxicological information:
Provide toxicological data for each component, especially for the evaluation of released substances after heating.
Including information on acute toxicity, irritability, sensitization, etc.
Your company's TPD II compliance services
Your company can provide the following services to customers to help them meet TPD II and pre-market announcement requirements:
Regulatory Consultation:
Provide detailed interpretation and compliance guidance for TPD II.
Composition analysis:
Assist clients in analyzing the composition of cigarette liquid to ensure compliance with TPD II requirements.
Emissions testing:
Contact a laboratory that meets the ISO 17025 standard for emissions testing.
Toxicological assessment:
Provide toxicological data support for the components of tobacco liquid.
Notice submission:
Assist clients in submitting pre-market announcements on the EU-CEG portal.
Continuous support:
Provide regulatory updates and notification maintenance services.
summary
TPD II and pre-market announcements are key requirements for electronic cigarette products entering the EU market. Your company's professional services can help customers efficiently complete compliance processes, ensure that products meet TPD II requirements, smoothly enter the EU market, and achieve compliant operations. Through component analysis, emission testing, toxicological assessment, and notification submission, your company can provide comprehensive support to customers and assist in their global business development.
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