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Compliance Guidelines for Swedish Nicotine Bags (Smokeless Nicotine Products)
Author.
LCS
Source:
Post time:
2026-09-28
In Sweden, smokeless nicotine products are regulated by the Smokeless Nicotine Products Act. This legislation regulates the sale and marketing of products such as product announcements, product requirements, and smokeless nicotine products. This article introduces the compliance requirements for smoke-free nicotine products.
What is smoke-free nicotine product?
Smokeless nicotine products refer to products that do not contain tobacco but contain nicotine for consumption, with nicotine bags being the most common.
Notice requirements
Manufacturers and importers must submit a notice of smoke-free nicotine products at least six months prior to the planned launch of the product; Every time there is a significant change to the product, a new notice must be submitted.
Announcement fee
Declaration fee: 4200 SEK per product
Annual compliance fee: 4200 SEK per product per year
Announcement information
1. Manufacturer's name and contact information;
2. List of all ingredients in the product, classified by brand and variety, including quantity;
3. Toxicological data of product ingredients;
4. Information regarding nicotine dosage and nicotine intake under normal or reasonably foreseeable conditions;
5. Declaration that the manufacturing process description and production process comply with the requirements of smokeless nicotine products;
6. Disclaimer that the manufacturer and (where applicable) importer are fully responsible for the quality and safety of the product when provided to consumers under normal or reasonably foreseeable conditions.
Product Requirements
1. Nicotine content: ≤ 20mg/bag;
2. pH value: ≤ 9.1
3. Water activity: ≤ 0.7
4. Prohibited ingredients: vitamins or other additives; Caffeine, taurine, or other additives or stimulants related to energy and vitality, carcinogenic, mutagenic, or toxic to reproduction.
5. Ingredient purity: Only high-purity ingredients can be used. Only when it is technically impossible to avoid traces of these substances during the production process, can they exist within the detection limit.
6. Except for nicotine, only ingredients that do not pose a risk to human health can be used in the production of smokeless nicotine products.
Label requirements
1. All ingredients are arranged in descending order of weight;
2. Nicotine content and distribution information per dose;
3. It is recommended to keep the product out of reach of children.
4. Product batch number and expiration date;
5. Prohibited for those under 18 years old;
6. Health Warning: "Denna produkt inneh å ller nikotin som ä r ett mycket beroendeframkalande ä mne." (This product contains nicotine, a highly addictive substance.)
Health Warning Requirements
1. Repeatedly display on the two largest surfaces of a single packaging and possible outer packaging;
2. Covering 30% of the area on individual packaging and possible outer packaging;
3. Use Helvetica font and present it in bold; Place black text on a white background;
4. Adopt the maximum font size that allows the text to cover the specified annotation area as much as possible;
5. Warning signs should be placed in the center of the reserved area; For rectangular packaging and possible outer packaging, warning signs should be parallel to the side of the individual packaging or outer packaging; Parallel to the main text in that area.
6. It can be indicated by using adhesive labels, but such adhesive labels cannot be removed.
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