Since 2009, the Brazilian Tobacco Authority (Anvisa) has been prohibiting the use of e-cigarettes until July 2022, when Anvisa continued to ban the import and sale of e-cigarette devices in Brazil. Recently, the Brazilian Parliament released draft Act No. 5008 of 2023 on its website, which mainly covers the production, import, export, sales, regulation, supervision, and promotion of e-cigarettes, as well as other related measures. If this bill can be passed, it means the regulation and legalization of Brazil's e-cigarette market.

The following is a partial introduction to the draft:

The concept of electronic cigarettes

Electronic cigarettes include nicotine electronic transmission systems (SEAN) and non nicotine electronic systems (SESN), such as atomizers, cigarette bombs, electronic cigarettes, and similar products, tobacco heating electronic systems (SEAT), such as heating tobacco products, heating non combustible products, and tobacco free heating electronic subsystems (SEAST), such as herbal heating products.

Product requirements

1. Only closed SEAN products (including nicotine vapor products) are allowed to be sold, and open SEAN products (open nicotine e-cigarettes that can be refilled with tobacco oil) cannot be sold;

2. The volume of nicotine containing tobacco oil should not exceed 22mL, and the nicotine concentration should not exceed 35mg/mL;

3. Heat tobacco packaging with 20 cigarettes per pack, and the nicotine release from tobacco should not exceed 1mg/cigarette;

4. Additives must be food and drug grade high-purity substances;

5. Prohibit the addition of vitamins, caffeine, taurine, colorants, vitamin E acetate, mineral oil, vegetable oil, animal oil, and other substances;

6. It is prohibited to add additives that increase the risks of electronic cigarettes other than nicotine and its salts;

7. It has functions that prevent children from opening and tampering.

Packaging requirements

The outer packaging of the product must include the following information:

(a) List of ingredients by additive category

(b) Clearly indicate nicotine concentration;

(c) Batch number, production date, and expiration date;

(d) Clear instructions for placing the product out of reach of children or adolescents;

(e) The following health warning message covers 20% of the maximum main display area of the outer packaging (applicable to e-cigarettes containing nicotine/heated non combustible cigarettes)

Este produto cont é m nicotina que é uma subst â ncia que causa depend ê ncia N ã o é recomendado o consulmo por n ã o fumantes This product contains nicotine ingredients that can lead to addiction. It is not recommended for non-smokers to consume

It is prohibited to use words, symbols, patterns, or images on electronic cigarette packaging that induce or imply product advantages and have specific appeal to minors under the age of 18.

The use of sounds, flavors, numbers, expressions, or images that are clearly related to desserts, candies, or children/adolescents is prohibited in the name of electronic cigarettes.

If the taste of e-cigarettes is tobacco, fruit, mint, mint, etc., as long as their names, symbols, or images do not have elements related to desserts, candies, or children/teenagers, they are not considered dessert flavors.

The product must be accompanied by instructions in the local language

Registration requirements

1. Electronic cigarettes sold in Brazil must be registered with the National Health Administration (Anvisa) and submitted with a toxicological evaluation report. Registration requires an annual supervision and hygiene inspection fee of R $100000.00 per year.

2. Safety regulations: Register with the National Institute of Metrology, Quality, and Technology (Inmetro) for charging safety and battery specifications of electronic cigarettes.

3. Communication: If wireless technology is used, registration with the National Telecommunications Administration (Anatel) is required.

4. Registration related to waste disposal

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

Contact number: 0755-28506411

Email 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 tandem four stage liquid mass spectrometry (LC-MSMS), inductively coupled plasma mass spectrometry (ICP-MS), gas chromatography-mass spectrometry (GC-MS), inductively coupled plasma emission spectroscopy (ICP-OES), high-performance liquid chromatography (HPLC-DAD), gas chromatography (GC-FID/ECD/TCD), ion chromatography (IC) X-ray fluorescence spectroscopy analyzer (XRF), electronic cigarette life testing machine, pressure relief safety tester, pressure relief safety tester, glow wire tester, needle flame tester, IPX3, IPX4 test box, salt spray test box, constant temperature and humidity box, mechanical testing system, battery drop stacking testing machine, electrostatic discharge (ESD) tester, etc.

The staff of the Element laboratory all have a bachelor's degree or above and have worked in the field of testing and compliance services for many years. Among them, the engineers of the electronic atomizer project are the first batch of senior experts in China engaged in electronic atomizer testing and compliance services.

Element adheres to the research of laws, regulations and testing standards, continuously transmits the latest legal and regulatory information to customers, completes the method validation of new testing standards as soon as possible, and applies them to the testing of related products.