With the publication of the implementation plan, last week, MHRA has been designated as the competent authority for implementing the majority of provisions under Article 20 and published a guidance to inform producers, retailers and consumers.
The authority defines a PRODUCER as anyone who manufactures or imports vapor products or who re-brands any product as their own, in opposition to a RETAILER who sells e-cigarettes and/or e-liquids by retail to the general public. Not that a retailer may also be a producer and vice versa.
What should producers know?
Only Producers must notify MHRA about their products and use the European portal (EU CEG). The TPD does not cover nicotine-containing products that fall into medicines.
One of the particularity of the British TPD implementation plan relies in the transition periods for notifying products. A diagram was issued by MHRA to simplify the understanding of the procedure.
Hence, as a producer, you DO NOT NEED to notify if:
- the manufacturer has submitted a UK notification for the specific product you import,
- the manufacturer has notified details of a product that you have re-branded
Then MHRA evaluated whether product notification is complete and complies with the TPD, and publishes all non-confidential information (what is considered confidential is defined by producers during the notification process).
A notification to MHRA is expected 6 months before a new product is intended on the UK market. But between 20 May to 19 November 2016 applications for new products must be made at least one day before they are sold for the first time.
A product which has been substantially modified will count as a new product and must also follow this process. Substantially modified refers to a change that may have an effect on the human body and include one or more of the following:
- any change to the qualitative or quantitative composition of the nicotine-containing liquid;
- any change to the volume of a refill container, tank or cartridge;
- any change to the composition or power output of a device which would be likely to affect emissions.
What should retailers know?
A retailer does not need to submit information for any products on sale unless he also qualifies as a producer.
A retailer has until May, 20, 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD.
Between November 20, 2016 and May 19, 2017 a retailer is allowed to distribute its remaining stock but must enquire before the suppliers about the compliance of the products with the requirements of the TPD and whether the supplier notified its products to MHRA.
Beyond May 20, 2017, only products notified to MHRA will be allowed for sale, they must be listed on the MHRA website.
For cross-border sales
Businesses selling to consumers need to be registered (in possession of a confirmation of registration) for cross-border distance sale (online sale) from May 20, 2016:
- UK business → European Economic Area (EEA, 28 Member states + Iceland + Liechtenstein + Norway)
- EEA or 3rd country business → UK market
Labelling of products
The UK’s government has interpreted the TPD requirements for labelling of products. It particularly defines the terms Unit Pack, Container Pack and Outside Packaging and, based on a few examples, demonstrates how to comply with the European requirements.
Producers are invited to include information on the bottle to identify the product and ensure it can be used safely even if it is not a TPD requirement, especially if the bottle is presented in a cardboard.
- Bottle of e-liquid with no further packaging other than an information leaflet attached to the bottle via tag or other → The labelling requirements must be applied to the bottle, via label, pull-out label or other means.
- Bottle of e-liquid and information leaflet placed within a cardboard box/sleeve → The cardboard box/sleeve is considered the smallest individual packaging. TPD labelling must be applied to the cardboard box/sleeve. The bottle does not have to carry this information.
- Multipack of 2 or more bottles of e-liquid or e-liquid included in a presentation box or starter kit
- → If the individual bottles are placed in a cardboard box/sleeve (as in point 2) TPD labelling must be applied to both the individual cardboard box/sleeve and each subsequent layer of packaging (container pack).
- →Where the individual bottles not packaged and are aggregated in a multipack or presentation box, the multipack or presentation box would be considered the unit pack. Only the multipack or presentation box would require TPD labelling.
Reporting of issues
Consumer, retailer → Producer → MHRA
From 20 May 2016, producers should inform MHRA of any issue with a product (unsafe, not of good quality or not compliant with TPD regulations) and provide details of the risk to human health and safety. The corrective action(s) taken must also be reported.
Consumers can also contact Citizens Advice to report any problems.