Analysis of the core points of the latest revised draft of the Czech Electronic Cigarette and Related Products Law (No. 37/2017)

Revision Background and Purpose

The Czech Ministry of Health recently released a revised draft of the regulations on electronic cigarettes and herbal smoking products, aiming to further strengthen product safety, ingredient control, and labeling standards; The scope of application of electronic cigarettes has been extended for the first time to nicotine free products.

The following are the main revision requirements for electronic cigarette products in this draft

Part 1: Ingredients and Product Requirements

1. Ingredient control

1) Explicitly added requirements for prohibited and limited ingredients in e-liquid

2) Prohibited from containing: sugar (except for characteristic flavors), mineral oil, vegetable oil, cannabinoids, and psychoactive substances listed in the Addictive Substances Act.

3) Nicotine salts are subject to regulation, with limits calculated based on effective nicotine.

2. Product appearance and structural requirements

The product shall not imitate food, toys, or cosmetics.

It shall not have any function other than generating steam.

Disposable electronic cigarettes are only allowed to contain one oil tank or cartridge, and refillable electronic cigarettes can contain up to three oil tanks or cartridges.

3. Requirements for nicotine free electronic cigarettes:

The volume of nicotine free electronic cigarettes shall not exceed 2mL

The volume of nicotine free supplementary containers cannot exceed 10mL

The volume of the refillable electronic cigarette oil tank shall not exceed 2mL.

Electronic cigarettes or refilling containers that do not contain nicotine need to be notified through EU-CEG

Part 2: Requirements for Labels and Packaging

1. Health Warning:

Nicotine free products need to be labeled as "Pou ž í v á n í tokoto v ý robku š kod í Va š emu zdrav í" ”.

2. Add prohibited elements:

Packaging and advertising must not involve illegal or dangerous substances, imply social success, vulgar content, or target individuals under the age of 18.

3. New label requirements:

18 year old prohibited icon: diameter ≥ 1 cm, with the text "V ý robek nen í ur č en osob á m mlad ší m 18 let

Other warnings: "V ý robek nen í ur č en t ě hotn ý m a koj í c í m ž en á m." and "Uchov á vejte MIMO dosah osob mlad ší ch 18 let

Product flavor description: must start with "p ří chu ť".

Barcode/QR code: It is allowed to indicate a barcode or QR code on the packaging, but it cannot replace legal information, and its pattern must not imitate any other symbol.

Part Three: New Requirements for Registration Procedure

1. Provide information on responsible parties in the Czech market (legal or natural persons)

2. Products containing e-liquid must submit a safety data sheet SDS that complies with EU regulations.

3. The manufacturing process must describe technical and hygiene specifications, as well as product transportation, storage, and handling, covering at least the general principles specified in Czech standard Č SN EN 17647.

Part Four: Effectiveness and Transition Period

1. Re notification: Product registration must be completed within 3 months before the law takes effect.

2. Sales of old inventory: Products that comply with old regulations can be sold out within 7 months after taking effect.

3. Implementation date: Effective from the first day of the month following the announcement (announcement date to be determined).

suggestion

It is recommended that relevant enterprises immediately initiate gap analysis for the new regulations and plan compliance plans in advance. If you have any questions about the content of the draft or the subsequent compliance process, we are always ready to provide you with the latest regulatory interpretations and professional testing and certification services support.