E-cigarettes regulation in Europe
There are many laws and regulations that affect the e-cigarette industry in Europe. Some come directly from EU institutions which impact all members states. Others are on the national level and their impact is limited only to the respective country. The key message of all regulations is that only safe products should be available on the market.
The 2 major regulations for vaping products across the whole of the EU are:
Regulation and Tobacco
Products Directive
The European Union’s Tobacco Products Directive (TDP2) came into effect on 20th May 2016; it applies specifically to the block of 28 member countries within the European Union. Manufacturers and importers must comply with a profound list of different requirements in each country, adding to the cost of doing business.
For this reason we are continually reviewing national transposed TPD legislation to ensure we have our products compliant with TPD for each EU country. Adoption of TPD2 in local regulations might vary while key deadlines are:
- 20th May 2016
TPD2 took effect in EU. - 19th Nov 2016
last non TPD compliant product could have been produced - 19th May 2017
last non TPD compliant product could have been sold in the retail.
A transitional clause permits non-compliant products manufactured or marketed before 20th November 2016 to be sold until 20th May 2017.
What does TPD Regulate?
- Product restrictions
- Packaging and labelling restrictions
- Obligation to notify
- Advertising, promotion and sponsorship
- Sales channels
Classification, Labelling and Packaging
This European legislation on the classification, labelling and packaging of substances and mixtures came into force in January 2009. It sets out the exact risk and safety phrases and warning symbols that potentially harmful consumer chemicals must be labelled with, and how they must be packaged. It also establishes classification and labelling inventory of substances with which e-liquid manufacturers have to comply.
As of 4th May 2017 Commission Regulation (EU) 2017/776 amends the CLP legislation. It changes rules for the classification and labelling of e-liquids as well as the hazard classification of nicotine. For oral toxicity the new hazard classification is stricter than before, for dermal toxicity based on the latest scientific research milder.
As a result based on the overall classification of our mixtures for all nicotine containing liquids in our portfolio (3, 6, 12,18mg), the labelling will bear the exclamation mark in the red square sign, accompanied with appropriate Risk and Safety Statements. Compliance with the new harmonised classifications is not required immediately and transitional period until December 2018 allows to sell out existing stocks.
How Ritchy meets TPD requirements?
Product compliance
Based on our analysis of the legal framework and its practical implementation in each country, we make sure our existing products meet those requirements for product
E-liquid nicotine concentration is limited to 20 mg/ml (2%)
Tanks / clearomisers / prefilled cartridges cannot contain more than 2 ml of liquid
E-liquid bottles cannot contain more than 10 ml
Products (including devices and bottles) must be child-proof and tamper-proof
Bottle possess securely attached nozzle at least 9 mm long
Flow control mechanism emits no more than 20 drops of refill liquid per minute
The TPD prescribes that nicotine-containing liquid does not contain any of the following substances:
- Vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks.
- Caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality.
- Additives with colouring properties for emissions.
- Additives that have CMR (carcinogenic, mutagenic, reprotoxic) properties in unburnt form
Purity of e-liquid
Through close cooperation of our R&D, operations, design, and legal teams and thorough testing and verification protocols, we make sure that our formulations are safe and do not contain any substances banned by the TPD.
TPD Package Compliance
While perfecting the product internally we also focus on packaging. We check that we have all locally required market information on every pack (CLP, TPD ) and that the product presentation is compliant.
The TPD establishes a series of requirements that affect certain aspects of the labelling and packaging of e-cigs, including an obligation to include a health warning on unit packets and any outside packaging of e-cigarette products. All products must be sold with information on packages, leaflets and health warning refill containers include appropriate instructions for refilling, including diagrams.
The nicotine delivery per dose.
A list of all ingredients contained in the product in descending order of weight.
Possible adverse effects.
A recommendation to keep the product out of reach of children.
Contra-indications.
Warnings for specific risk groups.
Contact details of the manufacturer or importer and a legal or natural contact person within the EU.
Addictiveness and toxicity.
A health warning, shall appear on 2 largest surfaces of the unit packet and any outside packaging and cover >30% of the surface of the unit packet
Instructions for use and storage of the product.
An indication of the nicotine content.
The batch number.
TPD Notifications
The TPD imposes an obligation to provide detailed product information to the competent authorities of each member state in which an e-cig product that contains or could contain nicotine will be placed on the market. No product is allowed onto the market unless it has been notified in the member state where it is distributed.
Frequently Asked Questions
Do I need to notify your products in my country?
No, all notifications are submitted via a Common Entry Gate by Ritchy.
Have you notified all LIQUA products in my country?
We have submitted product notifications to all markets we do business in. The number of products notified in each country varies based on our portfolio strategy. Please consult your local Ritchy sales manager for specific information on which products have been notified in your country.
Who is responsible for the compliance of our products?
Ritchy bears full responsibility for the compliance, quality and safety of our products.
Can you provide me with notification confirmation of products you supply to me? Can you provide confirmation stating that all p products you supply me are TPD compliant?
Yes, we can provide you confirmation stating that all products that we supply are TPD compliant and notified. However please note that some countries still do not have 100% of legislation in place, so requirements may change.
Is your hardware (vape kits) TPD compliant?
Yes, our vape kits are fully TPD compliant. We include a leaflet with requested information and health warnings where required by EU member states.
