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News | MHRA Electronic Cigarette Group August Briefing Explanation
Author.
LCS
Source:
Post time:
2024-08-21
Recently, the Electronic Cigarette Notification Group of the Medicines&Healthcare Products Regulatory Agency (MHRA), a government agency under the Department of Health&Social Care (DHSC) in the UK, released its monthly briefing for August.
The briefing covers three topics: how to bring security products into the UK market, notification requirements for Novel Products, and marketing statements.
one
How to bring security products into the UK market?
MHRA encourages companies to adhere to the PAS 7050:2022 standard. Because this specification provides a comprehensive code of conduct for manufacturers, importers, distributors, and retailers to ensure product safety; At the same time, the specification also provides detailed recommendations to assist companies in developing Product Safety Management Plans (PSMPs). MHRA recommends that companies ensure that their products comply with all applicable relevant legislation, maintain safety procedural documents, and strengthen employee training on the importance of product safety.
All these guarantee programs and files are not only necessary for protecting consumers, but also for enterprises to protect themselves.
two
Announcement of New Product
（Novel Product notifications）
The implementation of The Tobacco and Related Products Regulations (TRPR) in the UK is jointly supervised by multiple agencies. MHRA is only responsible for notifying compliance approvals.
The novelty of new products mainly lies in product design. Given the emergence of a large number of new designs, MHRA will continue to collaborate with the Chartered Trading Standards Institute Vaping Expert Panel (CTSI VEP), as well as legislators and industry, to provide guidance and feedback to applicants of new products.
1) What is a new product?
The MHRA and electronic cigarette expert group believe that the product has the following characteristics:
The equipment can accommodate more than one tank/truck/pod at the same time and make the total liquid volume of the product exceed 2mL (such as N in 1 product)
The device does not include rechargeable batteries or charging ports (such as large batteries or replaceable battery products)
Rechargeable device, but the product is sealed - that is, it cannot be oiled or refilled
In terms of equipment design, oil tanks can be filled with oil through refill containers (whether using specialized docking systems or universal oil filling designs), and even oil bottles can directly deliver oil to cores, cotton, heating wires, or similar structures
The oil bottle is designed to interface with other products or inject oil into them
Special note:
MHRA points out that it is necessary to recognize that the term "rechargeable" used in the notification submission for product types 2 (Electronic cigarette – Rechargeable, placed on the market with one type of e-liquid (fixed combination)) and 3 (Electronic cigarette – Rechargeable, device only) does not refer to rechargeable batteries, but rather to replaceable fuel tanks/cartridges or equivalent components. So,
a) If a device comes with several fixed and non replaceable oil tanks/smoke bombs, it is considered a disposable product
b) If a device is designed to interface with an oil bottle, but the oil tank (or heating wire) of the device itself cannot be replaced, it is considered a disposable product
c) The oil bottles designed to be used in conjunction with the product must be separately announced and must comply with the requirements of the announcement and the supply of oil bottles
2) Necessary documents for new products
a) Opening and Filling Files
For new products, reasonable guidance (including schematic diagrams) must be provided in the instruction manual for consumers to use (including oil injection and ammunition replacement)
b) Production file
√ The technical product schematic diagram should include all relevant components
√ It should include a Bill of Materials (BOM) document and their use in the production of finished products
√ Explain the standards or Publicly Available Specifications (PAS) followed in ensuring Quality Management (QM), Quality Assurance (QA), and Quality Control (QC). Examples include ISO 9001:2015, PAS 8855:2024, PAS 7050:2022, etc
√ Product images (including all relevant components designed and used together with the product)
If the products announced separately are intended to be sold as kits, they need to be explained in the production documents when announced separately, listing the ECIDs of the relevant products and annotated pictures
√ PDF format labels, packaging, and instructions (can be uploaded as a single file to the production file, no need to upload again in the leftlet file)
three
Packaging, Display, and Marketing Statement
MHRA does not endorse any product safety.
Prohibit the use of "MHRA Approved", "TPD Compliant", "TRPR Compliant", "Harm reduction technology platform", "Harm reduction innovation" or any similar statements. Such practices do not comply with the Consumer Protection from Unfair Trading Regulations 2008 (CPRs) and are explicitly prohibited, including certain provisions in Regulation 38 of the TRPR.
Additional explanation:
CTSI, as a licensed trade standards association, has released numerous guidelines that can serve as a reference for the safety and compliance of electronic cigarette products. Refer to the following link:
https://www.businesscompanion.info/focus/chemical-safety-of-vapes
https://www.businesscompanion.info/focus/vaping-products
As a well-known institution in China that has been deeply involved in testing for 20 years, Lixun Testing (www.lcs-Cert. com) has obtained CMA or CNAS qualification recognition in many fields. At the same time, a series of testing methods have been developed for electronic cigarette products, which can provide authoritative electronic cigarette product testing reports.
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