On June 9, 2022, the UK released an independent report entitled "Phasing Out Smoking: An Overview", which not only showcases future tobacco harm reduction plans, but also highlights the increased promotion of e-cigarettes.
The MHRA is the competent authority for the e-cigarette and refill notification scheme in Great Britain and Northern Ireland and is responsible for enforcing Part 6 of the Tobacco and related Products Regulations (TRPR) and the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 most of the regulations.
TRPR has established rules to ensure
All e-cigarettes and filled containers (also known as e-liquids) meet minimum standards for safety and quality;Provide this information to consumers to enable them to make informed choices;Protect the environment in which children do not start using these products.
TRPR specific requirements
Limit the capacity of electronic cigarette cans to no more than 2mL;
Limit the maximum volume of nicotine-containing e-liquids sold in one filled container to 10mL;
Limit the nicotine content of e-liquid to no more than 20mg/mL;
Require nicotine-containing products or their packaging to be child- and tamper-resistant;
Certain ingredients are prohibited, including pigments, taurine;
Includes new labelling regulations and warnings;
Require all e-cigarettes and e-liquids to notify MHRA before they are sold.
The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 have been published.
The 2020 Regulations set out the requirements for notification of new products from 1 January 2021. This will mean:
1. Manufacturers placing products on the Northern Ireland market will be required to use the European Union Common Entry (EU-CEG) system for notification of tobacco and vaping products.
2. Manufacturers placing products on the UK market will be required to notify the UK domestic system.
Notifiers will be required to pay a fee if they place products in one of the Great Britain or Northern Ireland markets, and the same fee if they place products in both markets.
A producer is someone who makes or imports these products, or rebrands any product as their own.
Manufacturers must submit information on their products to MHRA for supply across the UK via the MHRA submission portal and the Common European Entry (EU-CEG) notification portal. From 23 August, products that have successfully submitted notifications through MHRA will be directly formulated on MHRA.
Manufacturers of new e-cigarette and refill container products must submit a notification to MHRA 6 months before they intend to place their products on the UK and/or Northern Ireland market. Once your notice is posted on MHRA's website, you can launch products in the notice area. If the notification has been issued, there is no need to wait for the remainder of 6 months before placing the product on the market in the notification area.
Note: Supply of products to the UK market requires separate product notification submissions through EUCEG (Northern Ireland) and the MHRA submission portal (UK). That is, if you need to sell at the same time in Great Britain and Northern Ireland, you need to submit information notices in the two systems.
If the manufacturer has submitted both Great Britain and Northern Ireland notices for the specific product you are importing, then you do not need to submit duplicate notices. Likewise, if the manufacturer has notified you of the details of the relabeled product and your brand name is listed on the manufacturer's notice, then you do not need to submit a duplicate notice.
The TRPR does not include any requirements for where e-cigarettes and refill container products must be tested. Notifying parties are required to ensure that the product meets the standards of any testing carried out, so they must submit a statement stating that they are solely responsible for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions.
Manufacturers, importers and distributors of e-cigarettes are also required to comply with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulations (RoHS) 2012. These regulations limit the levels of certain harmful substances in certain electronic devices, e-cigarettes being one of them. They impose obligations on manufacturers, importers and distributors of e-cigarette models.
UK e-cigarette registration MHRA process
1. The specific situation of the product (whether it has e-liquid, how many flavors and models);
2. Determine the cost of product testing and the number of samples;
3. Sign the contract;
4. Send samples and fill in the application form;
5. Dezewei receives samples for testing;
6. Issue a draft report after passing the test;
7. Confirm the draft report and make MHRA notification materials;
8. Register MHRA system account;
9. Upload the test report and other notification materials, and pay the notification fee;
10. After the notification is passed, the product will be displayed on the MHRA website.
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