MHRA June News

This includes guidelines for electrical waste recycling, warning requirements and standards, adverse reaction reports, and product identification.

Waste Electrical Equipment Recycling (WEEE) Regulations

Electronic cigarette belongs to EEE products. The 2013 WEEE regulation required EEE producers to assume a series of responsibilities and play a role in protecting natural resources and managing EEE appropriately when it becomes waste, including registering as EEE producers and providing funding for WEEE collection and disposal. If the manufacturer puts more than 5 tons of EEE into the English Market within a year, it must add the Producer Compliance Plan (PCS); If less than 5 tons of EEE are put into the English Market within a year, they can directly register as small producers with the environmental regulatory authority.
 

Battery regulations

Electronic cigarette contains portable battery. The 2009 Regulations on Waste Batteries and Batteries require battery manufacturers to take responsibility and minimize the harmful effects of waste batteries on the environment. This includes registering as a portable battery manufacturer and providing funding for the collection and disposal of discarded portable batteries. Therefore, Electronic cigarette manufacturers need to ensure that they are registered and comply with battery regulations. If the portable batteries put on the English Market by the battery manufacturer exceed 1 ton per year, the battery compliance plan (BCS) must be added; If less than 1 ton of portable batteries are put into the English Market within a year, they must be registered directly with the environmental regulatory authority.
 

Packaging regulations

The Producer Responsibility Obligations (Packaging Waste) Regulations of 2007 require packaging manufacturers who have obligations to bear the responsibility of reducing packaging production and increasing recycling. This includes registering as a packaging manufacturer and providing funding for the collection and disposal of waste packaging. Electronic cigarette manufacturers may need to ensure that they are registered and comply with packaging regulations.
 

Compliance and Execution

Warning requirements and standards

Manufacturers and producers should note that under the 2016 Tobacco and Related Products Regulations (TRPR), they are responsible for ensuring that products supplied to the UK comply with regulatory requirements. Due to recent non-compliance incidents, MHRA will work with the Trade Standards Authority and other UK law enforcement agencies to take measures to ensure compliance with these standards.
 

2023 Autumn Multi institutional Network Seminar

The result of this work is that MHRA will hold a regulatory webinar, providing all submitters, importers, and distributors with the opportunity to participate in guidance demonstrations and engage in Q&A with many UK institutions.

Production document guidance

During 2023, MHRA has been reviewing the standards for production document documentation. MHRA will consult regulatory and industry experts to develop guidelines that clarify the notification requirements for submitting these documents. This guide will be released by the end of 2023 and will provide sufficient time for submitters to meet the requirements.

Adverse reaction report

MHRA will write to all producers and designated UK responsible persons (subsidiaries) to request information related to all suspected adverse reactions reported between January 1, 2021 and June 30, 2023. The information provided should be anonymous to protect the confidentiality of patients and reporters, but should include as many details as possible. This includes but is not limited to patient characteristics (age, gender), detailed information on adverse reactions, time of onset (including degree of use) results, and type of reporter (public or healthcare professionals).

Product identification - brand and sub brand

Delete Non compliant Registration - Product Name and Brand

The unit package and any outer package of the Electronic cigarette and supplementary container as well as the label of the product itself shall not contain any of the following elements or characteristics: (a) promote the product or encourage its consumption, risk or emission by creating a false impression of the product's characteristics and health effects; (b) Claiming that using this product is beneficial for health. The submitter should pay attention to the benefit statement of using the product or its ingredients, including any suggestions on energy or health effects (and related terminology). The registrant needs to check for such issues and update them.
 

Product identification

The submitted content clearly identifies the product, including brand, flavor name, and nicotine concentration under the brand and sub brand headings (see figure below).