Compliance Guidelines for Swedish Nicotine Bags (Smokeless Nicotine Products)

Sweden has a long history in the field of snuff products and has an open attitude towards new nicotine products. In Sweden, smokeless nicotine products are regulated by the Smokeless Nicotine Products Act. In 2020, Sweden released the SIS/TS 72:2020 standard for oral products containing nicotine but not tobacco, which will be updated in 2024. The purpose of this standard is to establish standards for manufacturers, importers, distributors, and retailers of oral products containing nicotine but not tobacco, and to provide quality and safety information to consumers, the public, and regulatory agencies. The following is an introduction to the main regulations and requirements for nicotine bags (smoke-free nicotine products) in Sweden:

1. Overview of regulations

Regulatory agency: Swedish Public Health Agency

Related laws and regulations:

Tobacco Free Nicotine Products Act

Tobacco Free Nicotine Products Act

Regulations on Tobacco Free Nicotine Products

2. Product Definition

Nicotine containing and tobacco free oral products refer to pre packaged products that contain nicotine compounds, usually with flavorings and other ingredients, but do not contain tobacco, specifically designed for oral use and absorb nicotine through the oral mucosa.

3. Product requirements

Maximum allowable nicotine content: 20mg/unit

PH value: ≤ 9.1

Water activity: ≤ 0.7 (otherwise toxicological risk assessment)

Food contact material safety

4. Ingredient restrictions

Do not contain vitamins or other additives to avoid misleading consumers into believing that the product has health benefits,

Not containing caffeine, taurine, or other additives or stimulants related to energy and vitality.

Only high-purity ingredients can be used in the production process

Prohibit the use of additives that are carcinogenic, mutagenic, or toxic to reproduction as defined in EC No 1907/2006

5. Main packaging labeling requirements

Nicotine content (mg/unit)

Ingredient List

Health Warning

Batch number and expiration date

 Reminder for use under 18 years old

The labeling requirements of CLP regulations

6. Age restrictions

Smokeless nicotine products are not allowed to be sold or delivered to individuals under the age of 18, and individuals under the age of 18 are also not allowed to bring them into the country.

7. Notification requirements:

Manufacturers and importers: Products must be reported to the Public Health Department, and notifications must be submitted at least 6 months before the product is launched. Significant changes must be resubmitted.

Retailers: Before retail smokeless nicotine products, they must first submit a sales notice and pay the relevant fees.

8. Marketing and Advertising Requirements

Do not excessively promote or induce the use of smokeless nicotine products.

 It is prohibited to mention product flavors unless it is for consumer information needs.

Advertisements must not target or depict individuals under the age of 25.

Health warnings must be displayed in advertisements, and multiple warnings should be used alternately.

9. Legislative Trends

Recently, there has been a proposal to limit the maximum nicotine content to 12mg/g, which still needs further follow-up.

If you have any questions, please contact us. We will continue to follow up on the legislative progress of regulations and provide you with high-quality testing and certification services.

Contact phone number: 0755-28506411

e-mail address: service@element-testing.com

website: http://www.element-testing.com

Shenzhen Element Testing Co., Ltd. (referred to as Element) focuses on providing testing and compliance services for electronic atomizer enterprises.

The Element laboratory is equipped with dozens of advanced detection instruments and equipment, such as imported simulated smoking machines (Vaping Machines), liquid chromatography triple series quadrupole liquid chromatography-mass spectrometry (LC-MS-MS), inductively coupled plasma mass spectrometry (ICP-MS), gas chromatography-mass spectrometry (GC-MS), inductively coupled plasma emission spectrometer (ICP-OES), high-performance liquid chromatography (HPLC-DAD), gas chromatography (GC-FID/ECD/TCD), ion chromatography (IC), X-ray fluorescence spectroscopy (XRF), electronic cigarette life testing machine, pressure relief safety tester, pressure relief safety tester, glow wire tester, needle flame tester, IPX3, IPX4 testing Box, salt spray testing box, constant temperature and humidity box, mechanical testing system, battery pack drop stacking testing machine, electrostatic discharge (ESD) tester, etc.

The staff of Element Laboratory have a bachelor's degree or above and have worked in the field of testing and compliance services for many years. Among them, the engineer of the electronic atomizer project is one of the first senior experts in China engaged in electronic atomizer testing and compliance services.

Element adheres to the research of laws, regulations, and testing standards, continuously delivers the latest legal and regulatory information to customers, completes the method validation of new testing standards in the first time, and applies them to the testing of related products.