Nicotine Concentration: From 35 mg/ml to 20 mg/ml

The Minister of Health has gazetted the Control of Smoking Products for Public Health (Packaging and Labelling) Regulations 2024 [P.U. (A) 261], which came into force on 1 October 2024, setting the limit for nicotine concentration in vape liquids at 35 mg per ml (35 mg/ml). This is the government’s initial step in its efforts to control nicotine concentration. However, it is feared that information on the content and harmful ingredients is not known to all parties, especially the community in Malaysia.

After a 12-month transition period starting 1 October 2025, the nicotine concentration will be further reduced to 20 mg per ml (20 mg/ml). The reduction of up to 42 percent of the total concentration is in line with the nicotine concentration limits applicable in European Union countries, the United Kingdom and Canada as a consumer protection measure.

 

FIR MID NIR spectrum of Nicotine solution which is not pure and it is used in this unregulated industry

Registration and Monitoring of Vape Liquids

In addition, all vape liquids that want to be marketed in Malaysia must be registered with the Ministry of Health as stipulated in the Smoking Products Control for Public Health (Registration of Tobacco Products, Smoking Materials and Tobacco Substitute Products) Regulations 2024 [P.U. (A) 262]. This regulation ensures stricter control and monitoring of products that will be on the Malaysian market.

In addition to Nicotine, the regulation requires manufacturers and importers to state the emission concentration of Acetaldehyde, Acrolein, Formaldehyde, and other aldehydes found in vape smoke. This strict measure shows the government's commitment in listing ingredients related to the use of nicotine and other chemicals in smoking products. If you look closely, it includes chemicals before and after the chemical reaction occurs.

However, this is still incomplete because:

Manufacturers and importers only need to state the concentration of the chemical. There is no limit on the emission concentration of Acetaldehyde, Acrolein, Formaldehyde, and other aldehydes found in vape smoke. In several countries around the world, including France and the Philippines, the (AFNOR)-XP D 90-300-2 standard sets the maximum concentration of Acetaldehyde at 200 mg/ml, Acrolein 22 mg/ml, and Formaldehyde 22 mg/ml in e-liquid.

Type of material for bottling. Plastic bottles cannot be made of polyvinyl chloride (PVC), polystyrene (PS), polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS), styrene-acrylonitrile (SAN), polyoxymethylene (POM).

In addition, the AFNOR standard also sets the purity of the ingredients used in vape liquids. For example, Nicotine or CAS: 54-11-5 used must comply with the requirements of the European (Ph.Eur.) or American (USP) Pharmacopoeia.

The Smoking Products Control for Public Health (Registration of Tobacco Products, Smoking Materials and Tobacco Substitute Products) Regulations 2024 [P.U. (A) 262] also does not specify a list of prohibited substances in vape liquids. The AFNOR standard states that among the prohibited substances are substances classified as carcinogenic, mutagenic or reprotoxic (CMR 1 and 2) and substances classified as specific target organ toxicity for respiratory tracts (STOT category 1).

What about e-liquid without Nicotine? For example, in Sweden, e-liquid that does not contain Nicotine is not included in the legislation on e-cigarettes. However, it is still regulated by several other chemical regulations.

For further information and the latest developments on this issue, consumers are advised to refer to the Federal Government Gazette from time to time.

Dr Mohd Rashidi Abdull Manap AMRSC, FSSM is a faculty member at the Department of Chemistry, Universiti Putra Malaysia (UPM). In addition, he is a Visiting Research Fellow at Lund University, Sweden, currently based at BMC - Biomedicinskt Centrum.

 

Date of Input: 13/03/2025 | Updated: 19/03/2025 | norlida_mn