France Introduces First Experimental Standard for Nicotine Pouches Through AFNOR XP V37-500
France has taken a major step toward establishing a regulatory framework for nicotine pouches with the release of the experimental standard XP V37-500 by the French Association for Standardization (AFNOR).
The standard defines requirements for nicotine pouch composition, manufacturing processes, packaging, labeling, and safety assessments. Developed with participation from industry experts, manufacturers, research organizations, and evaluation bodies, the standard represents France’s first dedicated technical framework for nicotine pouch products.
British American Tobacco France (BAT France) has expressed support for the initiative, stating that the standard could help improve product quality control, transparency, and consumer protection while addressing the growth of unregulated products in the market.
Key Highlights
- AFNOR released the experimental nicotine pouch standard XP V37-500 in France.
- The standard establishes requirements for ingredients, production, packaging, and consumer information.
- Nicotine content is limited to a maximum of 16.6 mg per pouch.
- Only food-grade or pharmaceutical-grade ingredients are permitted.
- Manufacturers must implement GMP-certified production and full ingredient traceability.
- Products require toxicological risk assessments covering ingredients, packaging materials, and consumer exposure.
- The standard aims to reduce the circulation of illegal and unregulated nicotine pouch products.
AFNOR Develops France’s First Nicotine Pouch Standard
According to BAT France, AFNOR recently introduced XP V37-500, an experimental standard specifically designed for nicotine pouch products.
AFNOR, officially known as the Association française de normalisation, is France’s national standardization organization responsible for developing and coordinating technical standards.
The new standard was created through cooperation between multiple stakeholders, including:
- Industry experts;
- Nicotine product manufacturers;
- Testing and evaluation organizations;
- Scientific research institutions.
The release of XP V37-500 marks the first time France has established a dedicated technical specification for nicotine pouches.
XP V37-500 Sets Requirements for Nicotine Pouch Ingredients
The standard introduces strict requirements regarding product composition.
Under XP V37-500:
- Only food-grade or pharmaceutical-grade ingredients may be used;
- Nicotine must come from natural sources;
- Nicotine must meet defined quality specifications;
- Nicotine concentration must not exceed 16.6 mg per pouch.
These requirements are designed to improve consistency across products and ensure that manufacturers maintain greater control over raw materials.
Manufacturing Must Follow GMP Standards and Full Traceability Rules
The standard requires nicotine pouch manufacturers to adopt strict production controls.
Manufacturers must:
- Follow Good Manufacturing Practices (GMP);
- Maintain complete traceability of raw materials;
- Ensure consistent quality throughout production processes.
By introducing manufacturing requirements similar to those used in pharmaceutical and food industries. AFNOR aims to create a more transparent and controlled production environment.
Mandatory Toxicological Risk Assessment for All Ingredients
A key component of XP V37-500 is the requirement for comprehensive toxicological evaluation.
Each ingredient must undergo a Toxicological Risk Assessment (TRA) that considers:
- Potential impurities;
- Packaging materials;
- Consumer exposure duration;
- Possible health risks associated with product use.
The requirement extends beyond nicotine itself and evaluates the entire product system, including materials that come into direct or indirect contact with consumers.
Nicotine Pouch Packaging and Labeling Requirements Strengthened
The standard also introduces detailed packaging requirements.
According to XP V37-500:
- Packaging materials must comply with European food-contact safety standards;
- Products must use tamper-resistant packaging;
- Labels must provide complete ingredient information.
Consumer information requirements include:
- Nicotine content;
- Ingredient list;
- Allergen or skin sensitizer information;
- Instructions and precautions for use;
- Clear warnings regarding nicotine addiction risks.
These requirements aim to improve transparency and allow adult consumers to make informed decisions.
Standard Draws on UK and Swedish Regulatory Experience
AFNOR stated that XP V37-500 builds on existing regulatory approaches developed in countries such as the United Kingdom and Sweden.
The standard incorporates European experience in areas including:
- Product quality control;
- Ingredient transparency;
- Manufacturing requirements;
- Consumer protection measures.
Supporters argue that establishing clear technical requirements could help create a more structured nicotine pouch market while reducing the availability of illegal products that do not meet safety standards.
BAT France Supports Stronger Nicotine Pouch Regulation
British American Tobacco France welcomed the introduction of XP V37-500, describing the standard as an important step toward improving quality assurance and transparency.
Sébastien Charbonneau, Director of Public Affairs at BAT France, stated that a strict standard could provide reliable quality control for nicotine pouch products sold to adult consumers through professional distribution channels.
He also emphasized that stronger regulation could contribute to combating the growth of illegal markets involving unregulated nicotine products.
France Moves Toward Structured Regulation of Emerging Nicotine Products
The introduction of XP V37-500 reflects a broader European discussion about how emerging nicotine products should be regulated.
As nicotine pouches gain market attention, regulators and industry stakeholders are increasingly focusing on:
- Product safety;
- Ingredient transparency;
- Manufacturing standards;
- Youth protection;
- Illegal market prevention.
For nicotine pouch manufacturers and suppliers, the French standard could become an important reference point for future compliance requirements and market access strategies in France and potentially other European markets.
