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18 March 2021. No. 426.

DRAFT
Order on labelling and health warnings on tobacco substitutes

Order on labelling and packaging of tobacco substitutes
Pursuant to section 19a(2), section 22c and section 45(2) of the Act on tobacco products, etc., see order no 965 of 26 August 2019 as amended by Act no. 2071 of 21 December 2020, the following is laid down:

Pursuant to § 19 a (2) § 22 c of the Act on tobacco products, etc., cf. Order No 965 of 26 August 2019 as amended by § 2 of Act No xx of xx 2020, the following is laid down:

Chapter 1
Part 1

Definitions

§ 1.The following definitions apply for the purposes of this Order:
Section 1. In this order, tobacco surrogate means:
Product containing nicotine that is not a tobacco product, see para 2, or an electronic cigarette, see section 2(1) of the Act on electronic cigarettes etc. and which is not approved by marketing permission in accordance with the Act on medications or EU legislative regulations laying down common procedures for approval of medicinal products for human use and equipment intended to be used in conjunction with this product.

Tobacco surrogate: Product containing nicotine that is not a tobacco product, cf. No 2, or an electronic cigarette, cf. § 2(1) of the Act on electronic cigarettes etc. and which is not approved by marketing permission in accordance with the Act on medications or EU legislative regulations laying down common procedures for approval of medicinal products for human use and equipment intended to be used in conjunction with this product.
Part 2

Chapter 2
Labelling

Labelling and packaging of tobacco substitutes

§ 2.Each single pack and any outer packaging of tobacco substitutes must contain a list of:
Section 2. Each single pack and any outer packaging of tobacco substitutes must contain a list of:

1) all the ingredients included in the product in descending order by weight,

2) an indication of the product's nicotine content and delivery per. dose, batch number and
2) Batch number.

3) a recommendation to keep the product out of the reach of children.

§ 3.The person who markets a tobacco surrogate in this country must ensure that each single pack and any outer packaging does not contain elements or features that
Section 3. The person who markets a tobacco surrogate in this country must ensure that each single pack and any outer packaging does not contain elements or features that

1) promote a tobacco surrogate, encourage use or give a false impression of the characteristics, effects, risks or emissions of the products;
1) encourage use or give a false impression of the characteristics, effects, risks or emissions of the products;

2) give the impression that a particular tobacco surrogate is less harmful than other products;


5) give the impression that a particular tobacco surrogate has an improved biodegradability or other environmental benefits.

Paragraph 2 The elements and features prohibited under § 3(1–5), include, but are not limited to, text, symbols, names, trademarks, figures or other signs.
(2) The elements and features prohibited under section 3 para (1–5), include, but are not limited to, text, symbols, names, trademarks, figures or other signs.

§ 4.The person who markets tobacco surrogates in this country must ensure that each single pack and any outer packaging does not contain or otherwise be associated with coupons offering discounts, free distribution, two-for-one offers or other promotional measures.
Section 4. The person who markets tobacco surrogates in this country must ensure that each single pack and any outer packaging does not contain or otherwise is associated with coupons offering discounts, free distribution, two-for-one offers or other promotional measures.

Chapter 3
Part 3

Health warnings on tobacco surrogates
Health warnings

§ 5.Each single pack and any outer packaging of tobacco surrogates must be provided with the following health warning in Danish:
Section 5. Each single pack and any outer packaging of tobacco surrogates must be provided with the following health warning in Danish: “This product contains nicotine, which is a highly addictive substance.”

‘Nicotine is a highly addictive substance.’

§ 6.The health warning on each single pack and any outer packaging of tobacco substitutes must:
Section 6. The health warning on each single pack and any outer packaging of tobacco substitutes must:

be placed on the three largest surfaces on the single pack and any outer packaging, respectively

cover 30% of the surface of the single pack and any outer packaging

the dimensions of the health warning are calculated in relation to the surface in question when the package is closed.

be printed in bold in Times New Roman font in white on a background that is the colour matte black C0, M0, Y0 and K100
be printed in bold in Helvetica font in white on a white background,

designed with a font of a size so that it covers the largest possible proportion of the area reserved for the health warning when the package is closed

placed in the centre of the area reserved for the warning,

for the top and bottom of the gasket stand one in a straight line centred on the middle of the surface that it covers
be in a straight line and in the same direction of reading as the main text of the surface reserved for the warning;

on box-shaped packages and any outer packaging is placed parallel to the side edge of the single pack or the outer packaging,

cover the entire area of the single pack or the outer packaging reserved for it,
(2) The dimensions of the health warning is calculated in relation to the respective surface when the package is closed.

§ 7.Each health warning on a single pack and any outer packaging must be printed or affixed in such a way that it cannot be removed or erased and is fully visible, including it must not be completely or partially obscured or broken by price tags, packaging material, covers, boxes or boxes or other items when the tobacco surrogate is marketed.
Section 7. Each health warning on a single pack and any outer packaging must be printed or affixed in such a way that it cannot be removed or erased and is fully visible, including it must not be completely or partially obscured or broken by price tags, packaging material, covers, boxes or boxes or other items when the tobacco surrogate is marketed.

§ 8.The health warning must not be commented on, reformulated or covered by references of any kind on the single pack or any outer packaging.
Section 8. The health warning may not be commented on, reformulated or covered by references of any kind on the single pack or any outer packaging.

§ 9.Each health warning must remain intact after opening the single pack.
Section 9. Each health warning must remain intact after opening the single pack.

§ 10.Images of single packs and any outer packaging addressed to consumers must comply with the provisions of this chapter.
(2) For at least one of the other health warnings, the legibility and visibility of the text must remain intact if broken by opening the unit packet.

§ 11.Unless a more severe penalty is due under another law, anyone who breaches the rules in §§ 2–10 will be fined.
Section 10. Images of single packs and any outer packaging addressed to consumers must comply with the provisions of this part.

Paragraph 2 Entities, etc. (legal persons) may be rendered criminally liable in accordance with the provisions in Chapter 5 of the Penal Code [Straffeloven].
Section 11. Unless a more severe penalty is due under another act, anyone who breaches the rules in sections 2-10 will be fined.

Chapter 4
(2) (legal persons) may be rendered criminally liable in accordance with the provisions in part 5 of the Danish Penal Code.

Part 4

Entry into force

§ 12.This Order will enter into force on 1 April 2021.
Section 12. The order enters into force on 1 July 2021.

Ministry of Health, [date]
Ministry of Health, 18 March 2021

Magnus Heunicke

/Maria Ramskov Larsen
Magnus Heunicke / Zelle Huma Sheikh