Vaping compliance

ABOUT LIQUA 

We only use USP standard, Kosher certified PG and VG in our e-liquids. These provide minimum odor, which can influence the overall taste. Most manufacturers are not concerned with the smell of these ingredients, but we think it’s very important as these odors interfere with the taste perception of the e-liquid. We also never use materials of animal origin or VG from palm trees, which often have traces of allergens in them.

Our cleanroom environment is GMP food industry level and ISO Level 7. Certified to ISO9001 standards. We wash all of our bottles, nozzles, and caps in 5 stages of ultrasound cleaning and ultra pure compressed air drying.

Different materials require different storage solutions. Most of them are contained in industrial refrigeration units with specific, ideal temperatures for each ingredient. We use a Zero Cross Contamination protocol for all materials to ensure 100% quality during the entire manufacturing process. That protocol ensures that different products never contact same surface, tubings or tools. Dispensing is is done through gravimetric measurements with 0.1% USP precision levels. Mixing results are controlled by multi-sampling from batches to ensure an even spread of material across the batch.

TPD/CLP Vaping Compliance

The E-Cigarette industry is now entering a new, more professional era. New regulations will place large demands on e-cigarette and e-liquid producers. Many, who are not able to comply with such strict product, packaging and promotional restrictions, will cease to exist. Ritchy is one of the key players in the e-cigarette industry and we take these regulatory requirements seriously. We therefore have a dedicated compliance team to guide us and our partners successfully through changes in their markets as they take place.

From 20th of November 2016 Ritchy supply TPD/CLP compliant product to all EU markets

Ritchy ensure timely notification of all products supplied and fully support our trade partners during transitional period

4pillars of our regulatory / compliance system

Monitoring of latest and upcoming compliance requirements in every market through:
    • contact with authorities (local and EU level);
    • contact with distributors and trade partners;
    • involvement in associations, participation on industry conferences;
    • cooperation with independent experts, agencies (chemical, law, etc.);
    • contact with business intelligence agencies.

R&D and Quality / Product management:
    • close cooperation of our R&D, supply chain, quality and legal teams along with thorough testing and verification protocols assure superb quality and compliance of our products;
    • packaging and product compliance.

System that ensures timely notifications of products in every market through:
    • internal databases/content management systems;
    • IT tools directly working with the EU-CEG system.

Risk management / benchmarking:
    • best practice and competition monitoring;
    • claims and vigilance management;
    • Internal quality management system.

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.

TOBACCO PRODUCTS DIRECTIVE (2014/40/EU) OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

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:
  1. Vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks.
  2. Caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality.
  3. Additives with colouring properties for emissions.
  4. 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.

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.

Information provided by Ritchy Group Ltd and can be found here:

https://www.ritchy.com/tpd-clp-vape-compliance/


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