E-liquid Regulations and Labelling Requirements
The Medicines and Healthcare products Regulatory Agency – MHRA is an UK agency responsible for implementing the rules for any vaping products with nicotine, and creating guidelines for both consumers and manufacturers.
MHRA’s Tobacco and Related Product Regulations took effect in 2016 in UK and made Tobacco Products Directive as a priority for e-cigarette manufacturers. Any vaping device with nicotine sold by the e-cig manufacturers and suppliers should be in compliance with the new set of rules and regulations to be able to survive in the UK e-cig market after 20 May 2017.
Although the new regulations have been thought to protect public health, the whole community is in disagreement and concerned about current and further limitations which could put at risk business future and freedom to customize individual vaping experiences.
Below are some changes to the rules to be followed by the e-cigarettes industry from the 20th May 2017.
- Strengths of nicotine e liquid
The highest nicotine strength to be sold in the market cannot exceed 20mg/ml.
Although it could be a good idea to avoid nicotine overdose, this decision limits a portion of the vaping communities who prefers e-liquid customization. To customize e-liquids a person needs PG/VG bases of nicotine higher than 24mg/ml, to be able to dilute it to 6, 8 or 12mg/ml.
- Regulations to tanks and bottles
The maximum capacity of tank/ cartridge/ clearomizer has been reduced to 2ml. This includes both prefilled, refillable tanks and disposable electronic cigarettes.
Manufacturers and suppliers should also limit the size of the bottles where they supply the nicotine e-liquids to 10ml capacity maximum.
Moreover, the devices should be tamper-proof, child-resistant and protected against breakage and leakage.
Safety measures are great idea to avoid accidents and to protect children and consumers. However the volumetric limitations to 2ml tanks and 10ml bottles not only will make it tedious for consumers who consume more than 2 ml a day, but for manufacturers which production costs will be affected pushing the price per ml of e liquids higher.
- Quality compliance
The TPD compliant e-liquids should not contain artificial colorings and prohibited additives, also must be manufactured only using ingredients of high quality and purity. The e juice must also be free from ingredients that could pose some health risks to the consumers.
This measure could cut down a lot of overseas suppliers which ingredients and manufacturing practices are below quality standards or unknown.
- Labelling information
The labels on the 10ml bottles should look a lot different than they are used to. Any TPD compliant e-liquid should display the following details on the label.
- Brand & e-juice name should be mentioned
- Ingredients must be mentioned clearly on the package along with their weight.
- Nicotine content should be clearly visible.
- The amount of nicotine delivered per dose must be indicated.
- Details on the flavouring substances should be stated.
- Directions for use and advice on the disposal of the contents and contained should be mentioned.
- Batch coding along with the name, address, phone number and website of the importer/manufacturer/supplier must be present.
- Shelf life and storage instruction of the product must be stated.
- Information related to any known side effect must be explained.
- Health Warnings “Product not to be sold to people under the age of 18 – Keep out of reach of children and animals – Nicotine is a highly addictive substance – Not recommended for use by non-smokers – Not to be used during pregnancy” must be present covering at least 30% of the unit package.
This measure is a positive step, as customers should be informed about the product to feel safer when using it, although it is a bit contradictory, as there is not much area in a 10ml bottle for a label displaying the whole information listed and still letting visible what is contained inside the bottle.
Without a doubt, 2017 will be the year of change for electronic cigarettes not only in the UK but across the globe as well. There can be a massive shakeup of the industry and enormous reduction of product offerings.