Draft Technical Regulation on Blignicotine Bags - BH xxxx:2025

Recently, the Ministry of Industry and Commerce of Bahrain has released the draft of the technical regulation for nicotine pouches, BH xxxx:2025 Draft BH Technical Regulation Nicotine pouches. The technical regulation has specific requirements for nicotine pouch products, additives and packaging. The main contents are as follows:
Definition of Nicotine Patch: A product containing nicotine and/or nicotine compounds, flavoring agents and other permitted ingredients, which allows nicotine to be absorbed through oral administration. It does not contain tobacco and is intended for use through the oral mucosa and then discarded after use.

Product Requirements
Without official approval, it is prohibited to import, produce or sell this product.
2. The nicotine used in nicotine pouches must meet the purity standard of pharmaceutical grade, or comply with the European Pharmacopoeia or the United States Pharmacopeia.
3. The nicotine content in each small bag should not exceed 20mg.
4. The pH value of the final product should be no more than 9.1.
5. During the product's service life, the moisture activity in the bag should be ≤ 0.7 at any time. (If it exceeds 0.7, the toxicological risk should be evaluated, with a particular focus on microbial activity.)
6. The quantity of nicotine sachets in each box of packaging should be between 15 and 20.
7. The maximum allowable residual levels of pollutants and toxic substances shall not exceed the stipulations of Standard BH GSO 193. The product shall not contain any pollutants or toxins that may pose a danger to human health.
8. The material of nicotine pouches must be of food grade and meet the requirements of standards BH GSO 2231, BH GSO 839 and BH GSO 2700.
9. The product complies with the requirements of BH GSO ISO 8317, is equipped with a tamper-proof device for children, and is protected and tightly sealed by placing child protection labels and exposing sealing devices.
10. The product must comply with the requirements of this technical regulation throughout the entire shelf-life indicated on the packaging.

Prohibited substances / additives for use in products
It is prohibited to use psychotropic drugs, narcotic drugs, hallucinogens, sedatives, active substances and similar substances, as well as any other substances that may pose a threat to human health.
2. Prohibition of the use of substances belonging to the following categories:
Carcinogenicity (Class 1 or Class 2).
Reproductive cell mutations (B1, A1, 1 or 2 types).
Reproductive toxicity (Class A1 or B1, or affecting or through lactation).
- Cancer (IARC) is classified as "carcinogenic to humans" (Group 1) or "possibly carcinogenic to humans", and the International Agency for Research on Cancer classifies it as "Group 2A" or "possibly carcinogenic to humans" (Group 2B).
It has been identified by the National Toxicology Program (NTP) of the United States as "known" or "reasonably expected" to cause cancer in humans.
3. No additional flavoring agents are allowed to be added:

Additives permitted for use in the product
Permit the use of the additives mentioned in Technical Regulation BH GSO 250
The additives stipulated in Table 3 of Food Standard CXS 192;
The additives specified in the list of food additives of the US FDA;
The additives stipulated in Technical Regulation BH GSO 995.
2. Flavorings may be used in products in accordance with the provisions of Technical Regulation BH-GSO 707, except for the following flavorings: spices, alcohol, candies, chewing gum, vanilla, coffee, cocoa, tea and cola.

Packaging Requirements
The packaging must contain the following information:
Product Name
The number of bags contained in the package;
Production (or packaging) date and expiration date (in months and years) (based on the research on shelf life);
- Nicotine content per bag / mg;
Description of product usage instructions
Country of Origin, Manufacturer's Country or Packaging Country;
Total weight of packaging and net weight per bag (in grams);
- The ingredients are listed in order of weight.
If the standard BH GSO 9(a) stipulated food allergens are used, they must be indicated on the product label.
It is necessary to write the phrase "Sold in the Kingdom of Bahrain" in both Arabic and English.

For sale in the Kingdom of Bahrain 
The following health warnings must be written in Arabic and English (in text) on the packaging, covering at least 30% of the packaging area:

2. The bags and packaging sold directly to consumers must be sealed so that it can be determined whether they have been opened or whether their components have been tampered with.
3. The data must be clear, legible and printed in a fully visible manner. It cannot be erased, removed, partially or completely hidden, or covered in any way; the text must be in a color that is completely different from the background color and cannot be similar to it.
4. The instructions and health warnings on the information card should not be easily removed under normal usage conditions. They should be adhered to the main display surface, the secondary display surface or pasted in a consecutive-page form on the supplementary information card as stipulated in the health warning table.

The packaging must not carry the following information.
The outer packaging, containers, paper, parcels, ropes or any other accessories must not contain any fragrances that would alter the odor or taste of the product, nor should they contain nicotine, tobacco or tobacco extracts.
2. The package or its outer packaging shall not contain printed coupons, discount offers, or any kind of offers that mention free distribution, linked offers, combining a set of offers into one package, or any other similar offers that can provide economic benefits to consumers and encourage them to make purchases.
3. Any information that violates public safety regulations;
4. Describing or displaying on the inner or outer surfaces of the product packaging, on the packaging materials or on the outer glass paper, labels, descriptive data, names, shapes or symbols that may give rise to false, misleading or promotional impressions regarding the product quality; or misleading consumers in a false or deceptive manner; or labels, descriptive data, names, shapes or symbols that may cause false impressions regarding the product quality;
5. The product shall not be characterized in any way as being less harmful than any other type of product, or as indicating a reduced risk of smoking-related diseases, for example, but not limited to: being natural, organic, free of additives, free of (or with very little) flavoring, or any indication regarding the intensity of the product's effect (mild, moderate, intense), or claiming to have an economic advantage over other similar products, or suggesting therapeutic benefits in terms of weight loss, attractiveness or posture.
6. Social or social life or quality, such as femininity, masculinity, grace or improved biological performance, or their improvement of mood or psychological state, or the similarity of the size and appearance of packaging and information cards to food, cosmetics or children's toys.