TPD Compliance

T.P.D. Regulations article 20: “electronic cigarettes and e-liquids”

Comes in to law 20th May 2016

Products that contain less than 20 mg/mL of nicotine and that have not opted electronic cigarettes under the EU TPD. The EU TPD also includes a number of medicinal regulations, i.e., do not wish to make claims relating to smoking cessation, which come under the TPD. These products will be regulated as consumer products. Regulatory officers will be responsible for ensuring:

1.  Products are child and tamper proof.

2. Health warnings, instructions for use, and information on addictiveness and toxicity appear on the packaging and any accompanying information leaflet.

3. There are no promotional elements on the packaging.

4. All substances contained in the product and information on the product's nicotine content are listed.

5. Existing rules regarding cross-border advertising and promotion of tobacco products, which will apply to electronic cigarettes, are adhered to.

6. Manufacturers inform Member States before placing new products on the market and that they report annually to Member States.

7. That a size limit for e-liquids of 10 ml for dedicated refill containers and 2 ml for electronic cigarette cartridges and tanks is adhered to. Products containing more than 20 mg/ml of nicotine or that make smoking cessation claims will be prohibited unless they are licensed as medicines.

These products will require authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, and this will be enforced by the MHRA.

European Union, EU: Permitted.

Import, sale, use and advertising are permitted.

At March 2014: it appears that the new TPD (see below) will implement a range of restrictions that, depending on how they are interpreted, could mean a ban on all current hardware, all refills over 20 mg strength, all advertising, and international (but not within-country) web sales. Such restrictions will be in place by 2016, although earlier is a possibility (and a probability in some countries).

Currently, at Q1 2014, individual countries have their own regulations. One vendor tells us: "In practice, only three EU countries are problem-free for import for us: UK, Germany, and Italy" (note this refers to commercial imports for vendors). We think this may be a slight exaggeration, as for example, Holland and Czech Republic are (in theory) unrestricted. Many vendors say postal supplies to customers are hardly ever problematic.

The EU, in Q2 2013, attempted to implement a two-tier system with additional restrictions based on a tobacco product classification (perhaps describable as a three-tier system, as they tried to impose medical licensing on some products and tobacco classification on some/all others). This failed as medicalization was rejected by vote in the EU Parliament.

EU law is superior to national law within the 28 countries. An EU directive must be transposed into individual national law before it can be implemented in any given country. This can take two years, though it may be pushed through more quickly. Below, we have left the time-related commentary at each stage as a reference. Please scroll down to the final update to see the current situation.

1.            nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml. 

2.            The nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml  

3.            The nicotine-containing liquid does not contain additives listed

1.            Vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks,

2.            Caffeine, taurine or other additives and stimulant compounds that are associated with energy and vitality,

3.            Additives having colouring properties for emissions,

4.            For tobacco products for smoking, additives that facilitate inhalation or nicotine uptake, and

5.            Additives that have CMR properties in unburnt form.

4.            Only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients referred to in paragraph 2(b)                   of this Article are only present in the nicotine-containing liquid in trace levels if such traces are technically unavoidable during manufacture.

5.            Except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form;

6.            Electronic cigarettes deliver nicotine doses at consistent levels under normal conditions of use;

7.            Electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling                    without leakage.

8.            Carry one of the following health warnings:

               “This product contains nicotine, which is a highly addictive substance. It is not recommended for use by non-smokers.”

                Or “This product contains nicotine, which is a highly addictive substance.”

9.            Must carry the correct labelling (EC Label)

               EC 200-193-3: This is the European Commission chemical code for nicotine.

               And display the warning sign according to the E.U.regulations.

General Information

An E-Liquid is a combination (a mixture) of a number of components, All our e-liquids will contain flavorings, Propylene Glycol, Aqueous Vegetable glycerine (in varying degrees depending on flavours and ratios), and a percentage of Nicotine (if selected), up to a maximum of 2.0% (20 mg strength).

1.            All the Hangsen E-Liquids are made from the highest, purest components available.

2.            We do not and will not knowingly sell or supply e-liquid to anyone under the age of 18.

3.            Our E-liquid is only intended to be used with electronic cigarette products / vaporizers by persons over the age of 18.

Storage Advice

1.            The storage life of unopened bottles is in excess of 18 months.

2.            Store e-liquid upright, in a cool, dark but well-ventilated area, in a locked cupboard or drawer, out of reach from any children or pets and away from food and drink.

3.            Keep away from naked flames or sources of heat.

4.            Store away from incompatible substances.

5.            We always supply a child-resistant cap with every bottle of E-Liquid and strongly recommend that this be used when the bottle is being stored

Warnings & Safety Advice

1.            Nicotine is a Toxin.

2.            Nicotine, in its pure form and taken in high enough doses, can kill.

3.            It is classified as TOXIC, hence the need for a toxic warning label.

4.            It is addictive

E-liquid will contain nicotine (if you have selected anything above 0 mg).

Although it is only a small constituent part of your chosen e-liquid, we are required to give the following warnings:

1. may cause respiratory tract irritation.

2. may be fatal if swallowed. Harmful if inhaled.

3. may be fatal if absorbed through the skin.

4. May cause central nervous system effects.

5. May cause adverse reproductive effects based upon animal studies.

6. may cause eye and skin irritation.

7. Target Organs: Central nervous system, lungs, skeletal muscle.

We also offer the following advice on handling.

1.            Wash hands thoroughly after handling.

2.            Remove any contaminated clothing and wash before reuse.

3.            Use with adequate ventilation.

4.            Avoid contact with eyes, skin, and clothing.

5.            Keep container tightly closed.

6.            Avoid ingestion

7.            All our bottles of e-liquid are supplied with child-resistant caps and carry CHIP-compliant labelling, tactile hazard warnings, appropriate safety warnings, information on ingredients, etc.

We are constantly updating to ensure compliance.

Please read all the labels and warnings on our e-liquid bottles.

Health Advice

We advise that before use, you talk to your doctor, especially if you are pregnant and/or breast feeding or if you have (or think you have) any of the following:

1.            Any allergy to PG/VG/peg 400 or nicotine;

2.            A weak immune system;

3.            A heart disease, an irregular heartbeat, high blood pressure or chest pain;

4.            A jaw condition called TMJ (tempura mandibular joint) disease;

5.            An over-active thyroid;

6.            Diabetes;

7.            Pheochromocytoma (tumour of the adrenal gland);

8.            Liver or kidney disease;

9.            A stomach ulcer;

10.          Asthma or chronic pulmonary disease.

The above is not a full list; if you have an illness, please talk to your doctor before using any e-liquid.

Also remember there are many drugs that can be affected by nicotine, including prescription and over-the-counter medications, they include vitamins, minerals, herbal products, etc.; please ask your doctor if you are unsure.

Should you require further information before making a purchase, please enquire through our contact form on the contact page or via email

Disclaimers

Be advised that some flavours may not be suitable for use in polycarbonate tanks as they may cause cracks in the plastic.

We will not be held responsible for damaged equipment; you use the e-liquids in your vape equipment at your own risk

The use of E-Liquids and "Vaping" is a relatively new concept; time trials and medical studies are few and far between, and quantified results and information about any potential risks are therefore hard to find.

There is much speculation about the safety concerns of using E-Liquid and the components that are used to make it.

We advise that you carry out your own research on the subject and make up your own mind.

If you decide to use our E-Liquid, you agree that you do so at your own risk.