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Key Facts

Denmark

Map of Denmark

Reception Date

30.09.20

Category

HEALTH, MEDICAL EQUIPMENT

Medical devices

Ministries & Departments

Sundheds- og Ældreministeriet

Responsible Departments

Erhvervsstyrelsen

Products & Services concerned

SOOS - HEALTH, MEDICAL EQUIPMENT

Related EU Law

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Explanation

The Order is based on a bill that implements an agreement on a national action plan against smoking by children and young people agreed on 18 December 2019 between the Government (Social Democrats) and Venstre (Danish Liberal Party), Radikale Venstre (Danish Social Liberal Party), Socialistisk Folkeparti (Socialist People’s Party), Enhedslisten (Red-Green Alliance), Det Konservative Folkeparti (Conservative People’s Party) and Alternativet (the Alternative). The agreement includes a wide range of initiatives intended to stop and prevent smoking and nicotine dependency among children and young people, and the agreement implements a number of the initiatives that patient associations and professionals have urged for several years.

Summary

The Order lays down more detailed requirements for the standardisation of e-cigarettes and refill containers with and without nicotine. The Order regulates:

Notification Timeline

This timeline summarizes key events in the notification process

Law is drafted in Denmark Denmark notifies the draft law 30.09.20 Draft law returns to Denmark Commenting Periode Ends 31.12.20 1 Member States & EC Responses 0 Detailed Opinions 1 Comments 1 External Stakeholders Responses

Notification Comparison

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Document Corner
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Originating Department: Sundheds- og Ældreministeriet
Responsible Department: Erhvervsstyrelsen
Received: 2020-09-30 00:00:00
Country: Denmark
Category: HEALTH, MEDICAL EQUIPMENT

Draft Order on the standardisation of e-cigarettes and refill containers with and without nicotine.

Notification No.: 2020-0604-DK

1. ------IND- 2020 0604 DK-- EN- ------ 20201007 --- --- PROJET
19 April 2021. No. 699.

Standardisation of e-cigarettes and refill containers with and without nicotine
Order on the standardisation of electronic cigarettes and refill containers with and without nicotine

Pursuant to § 9(a)(2) of the Act on electronic cigarettes, etc. cf. Act No 426 of 18 May 2016 on electronic cigarettes, etc. as amended by § 2 of Act No 1558 of 18 December 2018 and § 3 of Act No xx of xx 2020, the following is laid down:
Pursuant to § 9(2) and § 33(2) of the Act on electronic cigarettes, etc. cf. Consolidation Act No 580 of 26 March 2021, the following is laid down:

Chapter 1


§ 1. The following definitions apply for the purposes of this Order:

Brand name: Name of electronic cigarette and refill container with and without nicotine belonging to the same product category.
Trade mark: The trade mark under which the product is marketed on the Danish market, to which the information is reported and notified pursuant to Order No 599 of 03/06/2016.

Variant name: Name used to distinguish different electronic cigarettes and refill containers with and without nicotine belonging to the same brand name.
Product name: The product’s potential ”product name”, if any, under which it is marketed on the Danish market and notified under Order No 599 of 03/06/2016.

Single pack: The smallest individual package of an electronic cigarette or a refill container with and without nicotine that is marketed.

Outer packaging: Any packaging in which electronic cigarettes, refillable containers with and without nicotine or related products are marketed and which enclose one or more single packs.

Outer surfaces: Surfaces that are visible when a single pack is closed and/or outer packaging is unbroken.

Wrapping material: Transparent, colourless material enclosing one or more single packs.
Inner surfaces: Surfaces that are not visible when the individual package is closed.

Uncoated: Not varnished, covered or treated in a way that makes the surface appear other than matte.
Wrapping material: Transparent, colourless material enclosing one or more single packs and outer packaging.

Matt: that a surface appears completely matt, and thus not shiny, glossy, shimmering or the like.

Band: A tear-off band that can be used to open a single pack, outer packaging and wrapping material.


§ 2. Single packs of electronic cigarettes and refill containers with and without nicotine as well as outer packaging and wrapping material must have a standardised design in accordance with the requirements of this order and other legislation that regulates labelling, etc. of single packs, outer packaging and wrapping material on electronic cigarettes and refill containers with and without nicotine.

Paragraph 2. Single packs, outer packaging and wrapping material may only be given labelling, etc. which follow from this order and other legislation.
Paragraph 2. Single packs, outer packaging and wrapping material may only be given labelling, information etc. which follow from this order and other legislation.

§ 3. The inner and outer surfaces of single packs and outer packaging must be uncoated Pantone 7771 C.
Paragraph 3. Labelling, information, etc. resulting from other legislation must be presented in a way that does not give the single pack or outer packaging a unique expression, awareness-raising effect, or that otherwise is considered to be contrary to the requirement of a standardised design for all products containing electronic cigarettes or refillable containers with and without nicotine.

§ 3. The inner and outer surfaces of single packs and outer packaging must be matt Pantone 448 C, white or silver grey and outer packaging must be matt Pantone 448 C.

Paragraph 2. Bands on single packs or outer packaging of electronic cigarettes and refillable containers with and without nicotine must be square, transparent and without colour.

§ 4. All elements of single packs and outer packaging of electronic cigarettes and refillable containers with and without nicotine must be tasteless, odourless and silent.

Chapter 3

Surfaces etc. on single packs and outer packaging of electronic cigarettes and refill containers with and without nicotine

§ 4. Surfaces must be flat and smooth, and must not contain irregular elements such as marking, embossing, texture, depressions, elevations or anything else in shape or structure.
§ 5. Surfaces must be flat and smooth, and must not contain irregular elements such as marking, embossing, texture, depressions, elevations or anything else in shape or structure.

Paragraph 2. Excluded are certain elements necessary for folding the material, fastening the bottom and opening and closing the single pack.

Paragraph 3. Excluded are certain elements necessary for folding the material, fastening the bottom and opening and closing the outer packaging.

Paragraph 4. Exceptions under paragraph 5(2) and (3) shall apply only as long as the unevenness does not give the package a unique expression, awareness-raising effect, or otherwise may be considered contrary to the requirement of a standardised design, for all single packs and outer packaging containing electronic cigarettes and refillable containers with and without nicotine.

§ 6. Surfaces, etc. of single packs and outer packaging may be applied only to elements laid down by law.

Chapter 4

Wrapping material on single packs and outer packaging on electronic cigarettes and refill containers with and without nicotine

§ 5. Single packs and outer packaging must be covered with wrapping material.
§ 7. Single packs and outer packaging must be covered with wrapping material.

Paragraph 2. Wrapping material must be flat and smooth and must not contain irregular elements such as labelling, embossing, texture, depressions, elevations or anything else in shape or structure.


Paragraph 4. A black band must not cover or hide health warnings, and other labelling, etc. under other legislation.

Paragraph 5. The wrapping material shall be applied only to elements necessary for the production process and shall not alter the standardised expression.

Chapter 5

Labelling etc. on single packs and outer packaging of electronic cigarettes and refill containers with and without nicotine

§ 6. Labelling pursuant to this order may not completely or partially obscure text, warnings or other labelling, etc. that follow from other legislation.
§ 8. Labelling pursuant to this order may not completely or partially obscure text, warnings or other labelling, etc. that follow from other legislation.

§ 7. Single packs and outer packaging must be given markings in two places with the brand name and variant name. The text used
§ 9. Single packs and outer packaging may be given markings in two places with the trade mark and product name. The text used

must consist of lowercase letters a–å, but with the initial letter being uppercase,
must consist of lowercase letters a–å, but such that the initial letter can be uppercase,

must consist of the numbers 0–9,

must have the font Helvetica,

must have the colour uncoated Pantone 451 C,
may consist of the symbols brackets (-), acute accent (´), apostrophe (’) and the and-sign (&)

must have the colour matt Pantone Cool Gray 2 C,

must have a font size of up to 10 points and

must be parallel to the health warning.

Paragraph 2. The brand name can fill one line and up to 14 letters and numbers in total.
Paragraph 2. The trade mark can fill one line.

Paragraph 3. The variant name must fill one line and must be placed directly below the brand name.
Paragraph 3. The product name must fill one line and must be placed directly below the trade mark.

§ 8. Outer packaging and single packs must be given labelling with information on method of use, product ID, number and contents in accordance with the contents of the package.
§ 10. Single packs and outer packaging must be labelled with product ID, information on the number and contents in accordance with the contents of the package and may be labelled with information on the type of product to be used with the product.

Paragraph 2. Outer packaging and single packs for electronic cigarettes and refill containers with and without nicotine containing characteristic aromas may once contain:
Paragraph 2. Outer packaging and single packs for electronic cigarettes and refill containers with and without nicotine containing characteristic aromas may be labelled once with

‘With tobacco flavour’, or


Paragraph 3. The text used according to paragraphs 1 and 2

must consist of lowercase letters a–å, but with the initial letter being uppercase,
must consist of lowercase letters a–å, but such that the initial letter can be uppercase,

must consist of the numbers 0–9,

must have the font Helvetica New Roman,
must have the font Helvetica,

must have the colour uncoated Pantone 451 C,
must have the colour matt Pantone Cool Gray 2 C,

must have a font size of up to 10 points and

must be written in the same direction as the health warning.

§ 9. Single packs and outer packaging containing electronic cigarettes and refill containers with and without nicotine must each be given labelling with a bar code, provided that:
§ 11. Single packs and outer packaging containing electronic cigarettes and refill containers with and without nicotine must each be given labelling with a bar code, provided that

it is used for payment purposes, distribution or stock control,

it is either black on a white background or uncoated Pantone 451 C on a white background,
it is either black on a white background or matt Pantone Cool Gray 2 C on a white background,

it does not constitute an image, pattern or symbol that mimics anything other than a barcode and

it is located on the bottom or side of the package if the package is box-shaped.

§ 12. Single packs and outer packaging for electronic cigarettes and refillable containers with and without nicotine may be affixed to production labelling, including batch number, provided that the labelling

is used to comply with other applicable rules, including rules on tracking and charges,

is either black on white background or matt Pantone Cool Gray 2 C on white background,

does not constitute an image, pattern or symbol that mimics anything other than production labelling,

is on the bottom or side of the package and

must not otherwise be considered as contrary to the requirement for a standardised design for all products containing electronic cigarettes and refillable containers with and without nicotine.

Chapter 6

Penalties

§ 10. Unless a higher penalty is due under another law, the person who violates §§ 2–9 is fined.
§ 13. Unless a higher penalty is due under another law, the person who violates §§ 2–12 is fined.

Paragraph 2. Entities, etc. (legal persons) may be rendered criminally liable in accordance with the provisions in Chapter 5 of the Penal Code [Straffeloven].
Paragraph 2. (legal persons) may be rendered criminally liable in accordance with the provisions in Chapter 5 of the Penal Code [Straffeloven].

Chapter 7

Entry into force

§ 11. This Order will enter into force on 1 October 2021.
§ 14. This Order will enter into force on 1 October 2021.

Ministry of Health, the ….
The Danish Ministry of Health, 19 April 2021

Magnus Heunicke

/Mie Saabye
/ Zelle Huma Sheikh

Download the Draft & Final Versions of the Law

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Commenting Organisations

This section lists all organisations that have submitted comments on this notification. Each entry includes the organisation’s name, the number of contributions made, and a link to view their comments. Explore the list to understand which stakeholders are actively engaging in the consultation process.
Organisation Comments Date Total Contributions
IEVA - Independent European Vape Alliance Download 2020-12-11 8
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