Advanced Search

About Electronic Cigarettes And Herbal Products For Smoking

Original Language Title: o elektronických cigaretách a bylinných výrobcích ke kouření

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
37/2017 Sb.



DECREE



on 2 December. February 2017



about e-cigarettes, refill containers into them and herbal remedies

products for smoking



The Ministry of health shall, pursuant to section 19 para. 4 of law No.

110/1997 Coll. on foodstuffs and tobacco products and amending and supplementing

some related laws, as amended by Act No. 180/2016 Coll. (hereinafter referred to

"the Act"):



§ 1



The subject of the edit



This Decree incorporates the relevant provisions of the European Union ^ 1) and

modifies the



and composition,) the requirements for appearance, quality and characteristics of the electronic

cigarettes and refill containers into them,



b) marking of electronic cigarettes and refill containers into them and

herbal products for smoking, including prohibited elements and features



(c)) the way of the period and scope of notification requirements manufacturers and importers

electronic cigarette refill containers into them and herbal products

for smoking and



(d)) the extent of the data required for registration with the cross-border sales

electronic cigarette and refill containers into them at a distance and the way

its implementation.



§ 2



Definition of terms



For the purposes of this Ordinance, means the



and) common electronic gateway for submission of information

information electronic portal established and administered by the European Commission to

to ensure the uniform method of reporting electronic cigarettes and

refill containers into them and herbal products for smoking,



(b) the health warning warning) concerning the adverse effects

electronic cigarettes or refills, or herbal product

intended for smoking on human health,



c) retailer, any natural or legal person,

that States the electronic cigarette or refills or

herbal products for smoking on the market.



§ 3



General requirements for electronic cigarettes and refills them



(1) the electronic cigarette and refills them must be



and) secured against tampering on the part of children and any adverse

handling, which would erode the integrity of the product and, in particular, was in

contrary to the purpose for which they are electronic cigarettes and refills

designed,



b) protected against breakage and leakage of fluid and



(c) a mechanism ensuring that recurring) performance without leakage

fluid according to § 4, in the case of reusable electronic

cigarettes.



(2) electronic cigarettes containing nicotine dose must be released

nicotine under normal conditions of use.



(3) the production of liquid filling must be in electronic cigarettes

only used folders with high purity. Substances other than folders

included in the list pursuant to section 6 (1). 1 (b). and) may be included in

liquid filling in trace amounts, only if such trace

the amount of technically unavoidable during the manufacture of liquid fillings

electronic cigarettes.



(4) a liquid electronic cigarette cartridges can contain only

substances, which in a heated or unheated form do not constitute a risk to the

human health, and nicotine.



(5) Liquid electronic cigarette cartridges must not contain



and) vitamins or other additives, which create the impression that the liquid filling

is the health benefit or that it represents a reduced risk to health,



(b)), caffeine, taurine or other ingredients and stimulating ingredients that are

associated with energy and vitality,



c) ingredients whose properties cause coloring of the emissions, and



d) ingredients, which have, in the form of unburnt carcinogenic,

mutagenic or toxic to reproduction.



(6) Liquid electronic cigarette cartridges containing nicotine may

contain not more than 20 mg/ml nicotine.



(7) the volume of electronic cigarette refills may not exceed 10

ml.



(8) the volume of the water tank or reservoir for disposable electronic cigarettes

or cartridges must not exceed 2 ml.



§ 4



Additional requirements on reusable electronic cigarettes, which can be

apply for the use of nicotine-containing fumes, and spare

refills



(1) reusable electronic cigarettes, which can be used for

the use of nicotine-containing fumes, and refill them with

the content of nicotine may be placed on the market only if the mechanism for

recurring transactions



and) requires the use of refills, which is securely attached

nozzle long at least 9 mm narrower than the opening electronic tank

cigarettes, for which it is used, and that fits into the hole and has

flow control mechanism, which in the vertical position only for the

atmospheric pressure at a temperature of 20 +-5 ° c does not release more than 20 drops

supplemented fluid per minute, or



(b)) works through the dock system, which releases

liquid into the tank fed by an electronic cigarettes only

the electronic cigarette is associated with a replacement filling.



(2) the directions for use in accordance with § 12 h of paragraph 1. 3 (b). and the Act repeatedly)

disposable electronic cigarettes, which can be used for the use of

fumes containing nicotine, and replacement of them with the content

nicotine must also contain the



and the procedure repeated) guidelines for implementation, including drawings,



(b) in the case of the use of the mechanism) referred to in paragraph 1 (b). and an indication of the width)

the nozzle or the width of the hole the tank referred to in a manner that will allow the

the consumer to verify that the replacement cartridge and electronic cigarette is

compliant, and



(c) in the case of the use of the mechanism) referred to in paragraph 1 (b). b) type

Dock system, which is an electronic cigarette or replacement

cartridge compatible.



(3) the volume of the tank for reusable electronic cigarettes

refilling refill containing nicotine may not exceed 2 ml.



§ 5



The labelling of the electronic cigarette and refill containers to them



(1) information in accordance with § 12 h of paragraph 1. 2 of the Act



and) shall be printed indelibly,



(b)) must be visible and



(c)) must not be placed on the market is obscured or interrupted.



(2) the folders contained in the liquid filling must be on the list in accordance with § 12 h

paragraph. 2 (a). (b)) of the Act listed in descending order by weight.



(3) health warnings on each unit packet and on any

the outer packaging of electronic cigarettes containing nicotine and spare

Nicotine-containing fillings added: "this product contains nicotine, which

It is highly addictive substance. Its use is not recommended for non-smokers. " On

packaging in accordance with the first sentence cannot be brought no additional text that would


any way this health warning, commented on, paraphrased

or referred to it.



(4) a health warning referred to in paragraph 3 shall



and) be parallel to the main text on the stage reserved for this

warning,



(b)) to be printed in black Helvetica bold type, keeping the default

character spacing settings, which is 100% scale and spacing normal,

on a white background; point font size shall be such that the competent

text occupy the greatest part of the surface dedicated to him,



(c)) to be placed at the center of the surface dedicated to them,



(d)) to be on the unit packet and any outside a cuboid shape

packaging, parallel to the lateral edge of the unit packet or outside

packaging,



e) cover 30% of the surface of the unit packet and any

outer packaging that is a health warning printed,



(f)) to be placed on the two largest surfaces of unit packet and

any outer packaging and



(g)) in the ordinary way of opening the unit packet remain nenarušeno.



(5) the designation of the electronic cigarette and refills,

unit packet and on any outside packaging must not contain any

element or feature that



and) promotes electronic cigarette or refill it, or

supports creating a false impression of their consumption in terms of

characteristics of the product, its effects on health, risk and emissions,



(b)) suggests that the electronic cigarette or refill it is

less harmful than other products, or that its goal is to reduce the effects of

some harmful smoke constituents, or that it has vitality, energizing,

healing, rejuvenating or natural effects or characteristics of the product

organic farming, or other health benefits or benefits for

lifestyle,



(c)) recalls the foodstuff or cosmetic product, or



(d)) suggests that the electronic cigarette or refill it has

enhanced biodegradability or other advantages in terms of

of the environment.



(6) the unit packet and any outside packaging of electronic cigarettes and

It refills may not indicate the economic benefits, including the benefits

through the printed vouchers offering discounts, free distribution,

offers of "two for the price of one", or other similar offers.



(7) an element or feature that is prohibited under paragraph 5 or 6,

the text, symbol, name, trademark, figurative or other character.



§ 6



How to perform the notification obligation in the marketing of

electronic cigarette and refill containers to them



(1) notification pursuant to § 12 h of paragraph 1. 4 (b). and the Act is done)

through a common electronic gateway for submission of

the information in the format specified in the annex to decision

governing a common format for the reporting of electronic cigarettes and

refill containers and by brand and type of the electronic cigarette or

refills them. These notices contain



and a list of all ingredients contained) in the liquid tank and emissions

emerging use of electronic cigarettes or refill it

by brand name and type, including their amount,



(b)) the toxicological data on ingredients and emissions in accordance with subparagraph (a)), and even

When heated, in particular with regard to their effects on the health of consumers,

If inhaled, and any of their addictive effect,



c) information about the nicotine doses and income when consumed under normal

or foreseeable conditions, as regards the electronic cigarette and

refill them with the content of nicotine,



(d) a description of the components) electronic cigarettes and refills, including

the possible opening and filling mechanism of these products,



e) description of the production process, including information, whether or not the production process

includes series production, and a statement that the manufacturing process ensures the

compliance with the requirements set out in this Decree, in the law, other legal

prescription and directly applicable European Union legislation,



f) a statement that the manufacturer or importer shall bear full responsibility for the

the quality and safety of the product when it is placed on the market and

the use, under normal or foreseeable conditions, and



g) the name and contact details of the producer responsibility legal or natural

persons in the European Union and, where appropriate, the importer into the European Union.



(2) before the first notification in accordance with § 12 h of paragraph 1. 4 (b). and manufacturer) of the Act

or importer shall request the Ministry of health about its identification

number (hereinafter referred to as "the identification number of the petitioner") created

the operator of a joint electronic entrance gate. The manufacturer, or

the importer shall submit information that contains its identification

data, and validation activities in accordance with national legislation,

the Member State in which he is established. The identification number of the petitioner is

It's for all the following announcement made through

common electronic gateway and any other correspondence with the

The Ministry of health.



(3) on the basis of the petitioner shall be assigned identification number of the manufacturer or

the importer of any product which is to be announced, the identification number

electronic cigarettes or e cigarettes refills.

When submitting the notification about products that have the same composition and

the appearance, the manufacturer and the importer will use the same identification number

electronic cigarettes or e cigarettes refills,

unless otherwise specified in this Decree. This procedure applies regardless of the

brand and product subtype and the number of markets in which the products are placed.

If you cannot ensure that products that have the same composition and

look, use the same identification number electronic cigarettes or

electronic cigarette refills must be given different

the identification numbers of the electronic cigarette or refills

electronic cigarettes, which have been allocated to such products.



(4) a notice under section 13 h of paragraph 1. 4 (b). the law shall be submitted)

not later than 6 months before the intended placing on the market.



(5) a notice under section 13 h of paragraph 1. 5 of the Act shall be submitted prior to

the market.



(6) when submitting a notification shall be marked with all the information that the manufacturer

and the importers considered trade secret or otherwise confidential, and

the request of the Ministry of health are these claims properly reasoned.



§ 7




The extent of the data required for registration before the start of placing on the market

electronic cigarettes or refill containers to them in the form of

cross-border distance selling



(1) the notice on the basis of retail registration is done

the seller in accordance with § 13 para. 4 and 5 of the Act, contains



and) the name or names, first and last name, or the name or business name

retailer and the address of the place where they will be electronic

cigarettes or refills them supplied,



(b) the start date of the activity), which is offering electronic cigarettes

or refill containers into them to consumers in the context of cross-border

distance sales through the services of the information society, and



(c)) the address of the website that is used for the purpose of sale on

distance, even with all the information necessary for the identification of this Internet

the page.



(2) the information referred to in paragraph 1 shall be communicated in electronic form via the remote

transmission of the data.



§ 8



The communication of information about the market for electronic cigarettes and spare

fillings



(1) notification pursuant to § 12 h of paragraph 1. 4 (b). (b)) of the Act contains



a) summary information on the sales volume by brand name and type

of the product,



(b) information on the preferences of different) consumer groups, including

young people, non-smokers and the main types of simultaneous users,



(c)) for information about how the sale of products and



d) summaries of any market surveys carried out to determine the information

According to the letter a) to (c)).



(2) the information referred to in paragraph 1 (b). (d)) to electronic cigarettes and

the replacement functions with the content of nicotine in the Czech and

the English language. Information referred to in paragraph 1 (b). (d)) to electronic

cigarettes and nicotine replacement functions without content are presented in

the Czech language.



(3) the information referred to in paragraph 1 shall be submitted for each calendar year,

and until 31 December 1998. may the following calendar year.



§ 9



Labelling of herbal products for smoking



(1) the information referred to in section 12j para. 2 of the Act



and) shall be printed indelibly,



(b)) must be visible and



(c)) must not be placed on the market is obscured or interrupted.



(2) health warnings on each unit packet and on any

the outer packaging of herbal products for smoking: smoking

This product damages your health. " On the packaging in accordance with the first sentence cannot be

indicate any additional text that would in any way this health

warning commented on, paraphrased or referred to it.



(3) a health warning referred to in paragraph 2 must be printed on the front and

the back of the outer surface of the unit packet and any

outside packaging.



(4) a health warning referred to in paragraph 2 shall



and) be printed in black Helvetica bold type, keeping the default

character spacing settings, which is 100% scale and spacing normal,

on a white background; point font size shall be such that the competent

text occupy the greatest part of the surface dedicated to him,



(b)) to be placed at the center of the surface dedicated to them,



(c)) to be on the unit packet and any outside a cuboid shape

packaging, parallel to the lateral edge of the unit packet or outside

packaging,



d) cover 30% of the surface of the unit packet and any

outside packaging, on which are printed health warnings, and



(e)) in the ordinary way of opening the unit packet remain nenarušeno.



(5) the designation itself herbal product intended for smoking,

unit packet and any outside packaging must not contain any

element or feature that



and) promotes herbal product for smoking or supports its

consumption by creating false impression about its characteristics, the effects of

health, risk and emissions,



(b)) indicates that a herbal product for smoking is less

damaging than other products, or that his goal is to reduce the effects of

some harmful smoke constituents, or that it has vitality, energizing,

healing, rejuvenating or natural effects or characteristics of the product

organic farming or other health benefits or benefits for

lifestyle,



(c)) recalls the foodstuff or cosmetic product, or



(d)), States that the herbal product for smoking does not contain any

additives or flavourings.



(6) an element or feature of which is prohibited pursuant to paragraph 5, may be

text, symbol, name, trademark, figurative or other character.



§ 10



How to perform the notification obligation in the marketing of herbal remedies

products for smoking



(1) a notice under section 12j para. 3 of the Act shall be carried out through

electronic gateway for submission of information in a format

provided for in the annex to the decision relating to the common

the format for the presentation and disclosure of information on tobacco

products and by brand and type of herbal product intended for smoking.

These notices contain



and) the name and contact details of the producer responsibility legal or natural

persons in the European Union, or the importer into the European Union and



(b)) a list of all the ingredients that are used in the production of herbal product

to smoking by brand name and type, including their

quantity.



(2) before the first notification under section 12j para. 3 of the Act, the manufacturer or

the importer will ask the Ministry of health about the identification number

promoters created by the operator, joint electronic input

gateway. The manufacturer or importer shall provide upon request information containing

his identification and validation activities in accordance with national

legislation of the Member State in which he is established. Identification

the number of the petitioner shall be used for all subsequent notifications

carried out through the joint electronic entrance gate and when

any other correspondence with the Ministry of health.



(3) on the basis of the petitioner shall be assigned identification number of the manufacturer or

the importer of any product which is to be announced, the identification number

herbal product intended for smoking. In the submission of

products that have the same composition and appearance, the manufacturer and importer

It's the same identification number of the herbal product intended for

smoking, unless otherwise specified in this Decree. This procedure applies without

regardless of the brand and the product subtype and the number of markets in which the products are

placed. If you cannot ensure that products that have the same composition


and look, use the same identification number of the herbal product

intended for smoking, must be given different identification numbers

herbal product intended for smoking, which was that these products

allocated.



(4) a notice under section 12j para. paragraph 3 and section 12j. 4 of the law shall be submitted

no later than 2 months prior to the intended placing on the market.



(5) when submitting a notification shall be marked with all the information that manufacturers

and importers are considered trade secret or otherwise confidential, and

the request of the Ministry of health are these claims properly reasoned.



§ 11



Transitional provision



Notification obligations pursuant to § 6 and 10 for electronic cigarettes and

refill containers into them and herbal products for smoking

placed on the market before the date of entry into force of this Decree shall be

met by the end of the third calendar month following

After the effective date of this Ordinance.



§ 12



Final provision



This Decree was notified in accordance with the directive of the European Parliament

and of the Council (EU) 1535 of 9 June. September 2015, the procedure for the provision

information in the field of technical regulations and of rules on services,

the information society.



section 13 of the



The effectiveness of the



This Decree shall take effect on the 15th day following its publication.



Minister:



JUDr. Ing. Louis, MBA, in r.



1) directive of the European Parliament and of the Council/40/EU of 3. April

2014 on the approximation of the laws, regulations and administrative provisions of the Member States

concerning the manufacture, presentation and sale of tobacco and

related products and repealing Directive 2001/37/EC.



Commission implementing decision (EU) 2015/2183 of 24 September. November 2015,

establishing a common format for the reporting of electronic cigarettes

and refill containers.



Commission implementing decision (EU) 2016/586 from day 14. April 2016

the technical standards for the feeding mechanism of electronic cigarettes.