New Regulations, New Packaging – What has changed?

As part of the Tobacco and Related Products Regulations (TRPR) 2016, there is now a requirement that all nicotine containing e-liquids and hardware which can hold such e-liquids i.e. Tanks, either manufactured or imported into the UK after the 19th November, must comply with strict labelling regimes. Although such products manufactured or imported prior to this date can continue to be sold, by the 19th May 2017 all such items must legally be in compliant packaging. So, what does this mean in reality and what should we expect to see when we purchase such items, either on-line or from a store in future?

It is assumed that more and more products in compliant packaging will arrive on the market as the May 2017 deadline approaches, but as yet it seems there are very few examples of fully compliant packaging in stores or being purchased from eCommerce sites. The main requirements are set out below with examples of packaging:

Labelling Requirements – E-liquid

– Health Warning – ‘This product contains nicotine which is a highly addictive substance’ must be present covering at least 30% of the 2 largest surfaces of the unit package.

– Ingredients must be declared on the packaging in descending order of weight, with the nicotine content clearly visible.

– Indication of the nicotine delivery per  dose which the e-liquid will provide to the user.

– Details on the flavourings contained in the e-liquids, as this is not always obvious from the flavour name.

– Directions for use, including advise on the nozzle width of the bottle to allow consideration for the device it is suitable for filling, and also disposal of the contents and container.

– Batch coding must be present with details of the manufacturer/ importer for traceability.

– Storage instructions and shelf life of the product.

– Other relevant information relating to who the product is suitable for and any known side effects.

Other e-liquid regulations

The fact that an e-liquid is purchased and received in packaging including all of the above provides a clear visible indicator that the manufacturer/ importer has taken some action to comply with the requirements of TRPR, however there are several other key requirements which contribute to a product which is fully compliant and need to be considered:

– E-liquid cannot be supplied in bottles greater than 10ml.

– E-liquid cannot be supplied in a strength greater than 20mg/ml (2.0%)

– Emissions testing and toxicological reviews pertinent to the e-liquid must be carried out at significant cost.

– Products must be notified to the Medicines and Healthcare Products Regulatory Agency (MHRA), providing details on ingredients, emissions tests and toxicological reviews.

– E-liquids must be high purity and not contain certain chemicals.

– Bottles should be child resistant and tamper evident, and protected against breakage and leakage, including when filling a device using the bottle.

– Declaration that the manufacturer/importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.

Labelling Requirements – hardware

– Health Warning – ‘This product contains nicotine which is a highly addictive substance’ must be present covering at least 30% of the 2 largest surfaces of the unit package. However, this health warning will be accompanied by the text, ‘This warning only applies once the product has been filled with nicotine containing e-liquid’ when relevant.

– The indicative dosage of nicotine which the product can provide to the user, under normal or reasonably foreseeable conditions, must be displayed. The indicative dose is determined by standardised laboratory emission analysis of the hardware device, using a 1.8 % nicotine strength test e-liquid. If a device is to be used with lower nicotine strength e-liquid, then the user can determine the indicative dose by a simple ratio calculation.

– Batch coding must be present with details of the manufacturer/ importer for traceability.

– Other relevant information relating to who the product is suitable for, any known side effects and safe storage conditions.

– The instructions provided with the product must detail the maximum refill bottle nozzle diameter to ensure leak free filling can be achieved.

The fact that a tank is purchased and received in compliant packaging including all of the above provides a clear visible indicator that the manufacturer/ importer has taken some action to comply with the requirements of TRPR, however there are several other key requirements which contribute to a product which is fully compliant and need to be considered:

– Tanks must have a maximum refill capacity of 2ml.

– Products must be notified to the Medicines and Healthcare Products Regulatory Agency (MHRA), providing technical details on product manufacture, emissions tests, consistency of nicotine dose, declaration of full responsibility for the quality and safety of the product and that the product does not pose a risk to human health under normal conditions of use. 

– Packages must be child resistant and tamper evident.

There is much still to be done in policing the new regulations if we are to see full sets of compliant products available by May 2017. To ensure as a customer you know what you are purchasing it is vital that suitable questions are asked and answers sought from your supplier to confirm the product you are purchasing, or intend to purchase, meets all of the requirements of the regulation. This is not something that should be dismissed as not particularly relevant, or simply ignored; all products are not of the same quality, nor will they all meet the necessary legal requirements as we move into 2017.

Let us know what you think of the new packaging requirements in the comments below.

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